15.11.2023
–
02.05.2024
Tirzepatid
Mounjaro®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
23%
Hint for
minor additional benefit
15.11.2023
–
02.05.2024
Niraparib / Abirateronacetat
Akeega®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma, metastastic, castration resistent, BRCA1/2-Mutation, Chemotherapy not indicated, combination with prednis(ol)one
50%
Hint for
considerable additional benefit
15.11.2023
–
02.05.2024
Midostaurin (3, reassessment >€30m)
Rydapt®
Novartis Pharma AG
Oncological diseases
Systemic Mastocytosis
100%
no additional benefit
( Orphan (turnover limit))
15.11.2023
–
02.05.2024
Midostaurin (2, reassessment >€30m)
Rydapt®
Novartis Pharma AG
Oncological diseases
Acute myeloic Leukemia, FLT3-Mutation
100%
no additional benefit
( Orphan (turnover limit))
15.11.2023
–
02.05.2024
Baricitinib (6)
Olumiant®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Polyarticular juvenile idiopathic Arthritis, RF+ or RF− polyarticular and expanded oligoarticular, ≥ 2 years
100%
no additional benefit
15.11.2023
–
02.05.2024
Baricitinib (5)
Olumiant®
Lilly Deutschland GmbH
Skin diseases
Juvenile Psoriatic Arthritis, ≥ 2 years
100%
no additional benefit
15.11.2023
–
02.05.2024
Baricitinib (4)
Olumiant®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Enthesitis-associated arthritis, ≥ 2 years
100%
no additional benefit
15.11.2023
–
02.05.2024
Baricitinib (3)
Olumiant®
Lilly Deutschland GmbH
Skin diseases
Atopische dermatitis, ≥ 2 until < 17 years
100%
no additional benefit
01.11.2023
–
02.05.2024
Elacestrant
Orserdu®
Stemline Therapeutics B.V.
Oncological diseases
Breast carcinoma, ER+, HER2-, with ESR1 mutation, after min. 1 previous therapy
39%
Indication of
considerable additional benefit
01.11.2023
–
02.05.2024
Somapacitan
Sogroya®
Novo Nordisk Pharma GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 years
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.11.2023
–
02.05.2024
Brolucizumab (3, reassessment)
Beovu®
Novartis Pharma GmbH
Eye diseases
Neovascular age-related macular degeneration
100%
no additional benefit
15.10.2023
–
04.04.2024
Epcoritamab
Tepkinly®
Abbvie Deutschland GmbH & Co. KG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.10.2023
–
21.03.2024
Sirolimus
Hyftor®
Plusultra pharma GmbH
Skin diseases
Facial angiofibroma in tuberous sclerosis, ≥ 6 years.
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.10.2023
–
21.03.2024
Pegunigalsidase alfa
Elfabrio®
Chiesi GmbH
Metabolic diseases
Morbus Fabry
100%
no additional benefit
01.10.2023
–
21.03.2024
Nivolumab (27)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma (stage IIB or IIC), adjuvant therapy, ≥ 12 years, monotherapy).
100%
no additional benefit
15.09.2023
–
07.03.2024
Talquetamab
Talvey®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 prior therapies
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.09.2023
–
07.03.2024
Risdiplam (2)
Evrysdi®
Roche Pharma AG
Nervous system diseases
Spinal muscular atrophy, < 2 months
100%
no additional benefit
15.09.2023
–
07.03.2024
Lonapegsomatropin
Skytrofa®
Ascendis Pharma Endocrinology GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years.
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.09.2023
–
15.02.2024
Teclistamab
Tecvayli®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 prior therapies
100%
no additional benefit
01.09.2023
–
15.02.2024
Vosoritid (2, reassessement >€30m)
Voxzogo®
BioMarin International Limited
Other diseases
Achondroplasia, ≥ 2 years
100%
Indication of
non-quantifiable additional benefit
( Orphan (turnover limit))
01.09.2023
–
15.02.2024
Tisagenlecleucel (7, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukemia, relapsed/refractory, 0 ≤ 25 years).
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.09.2023
–
15.02.2024
Tisagenlecleucel (6, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma, relapsed or refractory, ≥ 2 prior therapies).
100%
Hint for
non-quantifiable additional benefit
( Orphan)
30.08.2023
–
15.02.2024
Nonacog beta pegol (2)
Refixia®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia B, < 12 years
100%
no additional benefit
15.08.2023
–
15.02.2024
Sacituzumab govitecan (2)
Trodelvy®
Gilead Sciences GmbH
Oncological diseases
Breast carcinoma, HR+, HER2-, at least 3 prior therapies.
100%
Indication of
considerable additional benefit
15.08.2023
–
15.02.2024
Migalastat (3, reassessment >€30m)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease, ≥ 12 years
100%
no additional benefit
( Orphan (turnover limit))
15.08.2023
–
15.02.2024
Trifluridin / Tipiracil (4)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal cancer, after 2 prior therapies, combination with bevacizumab)
100%
Hint for
considerable additional benefit
01.08.2023
–
01.02.2024
Bedaquilin (4, reassessment)
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis.
100%
Hint for
considerable additional benefit
( Orphan)
01.08.2023
–
01.02.2024
Nivolumab (26)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung cancer, PD-L1 expression ≥ 1 %, neoadjuvant therapy, combination with platinum-based chemotherapy
100%
Hint for
non-quantifiable additional benefit
01.08.2023
–
01.02.2024
Glofitamab
Columvi®
Roche Pharma AG
Oncological diseases
B-cell lymphoma, diffuse large cell (DLBCL)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.08.2023
–
01.02.2024
Mavacamten
Camzyos®
Bristol-Myers Squibb GmbH & Co. KGaA
Cardiovascular diseases
Symptomatic hypertrophic obstructive cardiomyopathy (NYHA Klasse II–III)
100%
Hint for
considerable additional benefit
01.08.2023
–
01.02.2024
Eftrenonacog alfa (2, reassessment >€30m)
Alprolix®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia B
100%
no additional benefit
( Orphan (turnover limit))
01.08.2023
–
01.02.2024
Empagliflozin (5)
Jardiance®
Boehringer Ingelheim Pharma GmbH
Genitourinary system diseases
Chronic renal insufficiency
100%
no additional benefit
01.08.2023
–
01.02.2024
Dalbavancin (2)
Xydalba®
Advanz Pharma Germany GmbH
Infectious diseases
Acute bacterial skin and soft tissue infections (ABSSSI), ≥ 3 months
100%
additional benefit considered proven
01.08.2023
–
01.02.2024
Cipaglucosidase alfa
Pombiliti®
Amicus Therapeutics GmbH
Metabolic diseases
Pompe's disease, combination with miglustat
100%
Hint for
minor additional benefit
15.07.2023
–
18.01.2024
Lumacaftor / Ivacaftor (5)
Orkambi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis, homozygous F508del mutation in CFTR gene, 1 to < 2 years)
100%
Hint for
non-quantifiable additional benefit
15.07.2023
–
18.01.2024
Ivosidenib (2)
Tibsovo®
Servier Deutschland GmbH
Oncological diseases
Cholangiocarcinoma with IDH1-R132 mutation, after at least 1 prior therapy
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.07.2023
–
18.01.2024
Ivosidenib
Tibsovo®
Servier Deutschland GmbH
Oncological diseases
Acute myeloid leukemia with IDH1-R132 mutation, first-line, combination with azacitidine
100%
Indication of
major additional benefit
( Orphan)
15.07.2023
–
18.01.2024
Mirikizumab
Omvoh®
Lilly Deutschland GmbH
Digestive system diseases
Ulcerative colitis, pre-treated
100%
no additional benefit
15.07.2023
–
18.01.2024
Dimethylfumarat (3)
Tecfidera®
Biogen GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS) (new indication: children and adolescents aged 13 years and older))
100%
no additional benefit
01.07.2023
–
21.12.2023
Nivolumab (25)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adolescents ≥ 12 to 18 years, monotherapy or combination with ipilimumab).
100%
no additional benefit
01.07.2023
–
21.12.2023
Nivolumab (24)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy, adolescents ≥ 12 to 18 years, monotherapy
100%
no additional benefit
01.08.2023
–
21.12.2023
Axicabtagen-Ciloleucel (6)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Follicular lymphoma, after ≥ 3 prior therapies
100%
no additional benefit
( Orphan (turnover limit))
01.07.2023
–
21.12.2023
Axicabtagen-Ciloleucel (4, reassessment >€30m)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies
100%
no additional benefit
( Orphan (turnover limit))
01.07.2023
–
21.12.2023
Axicabtagen-Ciloleucel (5)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory
50%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.07.2023
–
21.12.2023
Riociguat (4)
Adempas®
MSD SHARP & DOHME GMBH
Cardiovascular diseases
Pulmonary arterial hypertension, < 18 years of age
100%
no additional benefit
01.07.2023
–
21.12.2023
Bimekizumab (4)
Bimzelx®
UCB Pharma GmbH
Skin diseases
Psoriatic arthritis, monotherapy or in combination with methotrexate
100%
no additional benefit
01.07.2023
–
21.12.2023
Bimekizumab (3)
Bimzelx®
UCB Pharma GmbH
Musculoskeletal system diseases
Ankylosing spondylitis
100%
no additional benefit
01.07.2023
–
21.12.2023
Bimekizumab (2)
Bimzelx®
UCB Pharma GmbH
Musculoskeletal system diseases
Axial spondyloarthritis, non-radiographic
100%
no additional benefit
01.07.2023
–
21.12.2023
Selumetinib (2, reassessment)
Koselugo®
AstraZeneca GmbH
Oncological diseases
Neurofibromatosis (≥ 3 to < 18 years, type 1)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.06.2023
–
07.12.2023
Sacubitril / Valsartan (2)
Entresto®
Novartis Pharma GmbH
Cardiovascular diseases
Chronic heart failure with left ventricular dysfunction, ≥ 1 year)
100%
no additional benefit
15.06.2023
–
07.12.2023
Secukinumab (9)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Hidradenitis suppurativa (Acne inversa)
100%
no additional benefit
15.06.2023
–
07.12.2023
Ravulizumab (5)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
100%
no additional benefit
01.06.2023
–
16.11.2023
Lisocabtagen maraleucel (2)
Breyanzi®
Bristol-Myers Squibb GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B; after 1 prior therapy, relapse within 12 months or refractory).
50%
Hint for
considerable additional benefit
15.05.2023
–
02.11.2023
Setmelanotid (2)
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, Bardet-Biedl syndrome, ≥ 6 years
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.05.2023
–
02.11.2023
Loncastuximab tesirin
Zynlonta®
Swedish Orphan Biovitrum GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL) and highly malignant B-cell lymphoma (HGBL), ≥ 2 prior therapies)
100%
no additional benefit
15.05.2023
–
02.11.2023
Luspatercept (5, reassessment >€30m)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Β-thalassaemia, transfusion-dependent anaemia
100%
no additional benefit
( Orphan (turnover limit))
15.05.2023
–
02.11.2023
Luspatercept (4, reassessment >€30m)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Myelodysplastic syndrome with transfusion-dependent anaemia, pre-treated
100%
no additional benefit
( Orphan (turnover limit))
15.05.2023
–
02.11.2023
Tixagevimab / Cilgavimab (2)
Evusheld®
AstraZeneca GmbH
Infectious diseases
COVID-19, Preexposition prophylaxis, ≥ 12 years
100%
no additional benefit
01.05.2023
–
19.10.2023
Cemiplimab (5)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1 %, combination with platinum-based chemotherapy
100%
no additional benefit
01.05.2023
–
19.10.2023
Cemiplimab (4)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Cervix carcinoma, pretreated
50%
Indication of
considerable additional benefit
01.05.2023
–
19.10.2023
Etranacogen Dezaparvovec
Hemgenix®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia B
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.05.2023
–
19.10.2023
Upadacitinib (7)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Morbus Crohn, pretreated
100%
no additional benefit
01.05.2023
–
05.10.2023
Lasmiditan
Rayvow®
Lilly Deutschland GmbH
Nervous system diseases
Migraine acute therapy
100%
no additional benefit
15.04.2023
–
05.10.2023
Tabelecleucel
Ebvallo®
Pierre Fabre Pharma GmbH
Oncological diseases
Relapsed or refractory Epstein-Barr virus positive posttransplant lymphoproliferative disease (EBV+ PTLD), pretreated, 2 years and older.
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.04.2023
–
05.10.2023
Deucravacitinib
Sotyktu®
Bristol-Myers Squibb GmbH & Co. KGaA
Skin diseases
Moderate to severe plaque psoriasis
100%
no additional benefit
01.04.2023
–
05.10.2023
Belantamab-Mafodotin (2, reassessment)
Blenrep®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Multiple myeloma, at least 4 prior therapies, monotherapy
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.04.2023
–
05.10.2023
Durvalumab (5)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Biliary tumors, first-line, combination with gemcitabine and cisplatin
100%
Indication of
minor additional benefit
01.04.2023
–
05.10.2023
Durvalumab (4)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with tremelimumab and platinum-based chemotherapy
100%
no additional benefit
01.04.2023
–
05.10.2023
Durvalumab (3)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, combination with tremelimumab
100%
no additional benefit
01.04.2023
–
05.10.2023
Tremelimumab
Tremelimumab AstraZeneca®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with durvalumab and platinum-based chemotherapy
100%
no additional benefit
01.04.2023
–
05.10.2023
Tremelimumab (2, Imjudo®)
Imjudo®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, combination with durvalumab
100%
no additional benefit
01.04.2023
–
05.10.2023
Dupilumab (9)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Prurigo nodularis
100%
Hint for
non-quantifiable additional benefit
01.04.2023
–
21.09.2023
Darolutamid (2)
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma, metastatic, hormone-sensitive, combination with docetaxel and androgen deprivation therapy
100%
Indication of
considerable additional benefit
01.04.2023
–
21.09.2023
Olaparib (11, reassessment)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy
100%
no additional benefit
01.04.2023
–
21.09.2023
Pitolisant (3)
Wakix®
Bioprojet Deutschland GmbH
Nervous system diseases
Narcolepsy, with or without cataplexy (children and adolescents, 6-17 years)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2023
–
21.09.2023
Dulaglutid (3)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2, ≥ 10 years
100%
no additional benefit
01.04.2023
–
21.09.2023
Luspatercept (3)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Β-thalassaemia, non-transfusion-dependent anaemia
100%
Indication of
minor additional benefit
( Orphan (turnover limit))
01.04.2023
–
21.09.2023
Rucaparib (3, reassessment)
Rubraca®
zr pharma& GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
100%
no additional benefit
01.04.2023
–
21.09.2023
Dupilumab (8)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Digestive system diseases
Eosinophilic oesophagitis, ≥ 12 years, min. 40 kg
100%
no additional benefit
01.04.2023
–
21.09.2023
Dupilumab (7)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis, 6 months to 5 years
50%
Hint for
non-quantifiable additional benefit
15.03.2023
–
21.09.2023
Esketamin (3, reassessment)
Spravato®
Janssen-Cilag GmbH
Mental illnesses
Depression, therapy resistent, in combination with SSRI or SNRI
100%
Hint for
considerable additional benefit
01.03.2023
–
17.08.2023
Voclosporin
Lupkynis®
Otsuka Pharma GmbH
Musculoskeletal system diseases
Lupusnephritis
100%
no additional benefit
01.03.2023
–
17.08.2023
Emicizumab (3)
Hemlibra®
Roche Pharma AG
Hematopoietic diseases
Moderate haemophilia A, without factor VIII inhibitors, with severe bleeding phenotype
100%
no additional benefit
01.03.2023
–
17.08.2023
Finerenon (2)
Kerendia®
Bayer Vital GmbH
Genitourinary system diseases
Chronic kidney disease in type 2 diabetes, stages 1 and 2 with albuminuria
100%
Hint for
non-quantifiable additional benefit
01.03.2023
–
17.08.2023
Finerenon
Kerendia®
Bayer Vital GmbH
Genitourinary system diseases
Chronic kidney disease in type 2 diabetes, stages 3 and 4 with albuminuria
100%
no additional benefit
01.03.2023
–
17.08.2023
Dolutegravir / Abacavir / Lamivudin (2)
Triumeq®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 14 kg to < 12 years
100%
no additional benefit
01.03.2023
–
17.08.2023
Dapagliflozin (8)
Forxiga®
AstraZeneca GmbH
Cardiovascular diseases
Chronic heart failure with left ventricular ejection fraction LVEF > 40 %
100%
Hint for
minor additional benefit
15.02.2023
–
17.08.2023
Ciltacabtagene Autoleucel
Carvykti®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 previous therapies
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.02.2023
–
03.08.2023
Fenfluramin (2)
Fintepla®
Zogenix GmbH
Nervous system diseases
Lennox-Gastaut syndrome, add-on therapy, ≥ 2 years
100%
Hint for
considerable additional benefit
( Orphan)
01.02.2023
–
03.08.2023
Sotorasib (2, reassessment)
Lumykras®
Amgen Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 prior therapy
44%
Hint for
non-quantifiable additional benefit
01.02.2023
–
20.07.2023
Trastuzumab-Deruxtecan (4)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Adenocarcinoma (AC) of the stomach or gastro-oesophageal junction, HER2-positive, after trastuzumab-based therapy
100%
no additional benefit
01.02.2023
–
20.07.2023
Trastuzumab-Deruxtecan (3)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2-low, pre-treated
100%
Indication of
considerable additional benefit
01.02.2023
–
20.07.2023
Ibrutinib (8)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, combination with venetoclax
100%
no additional benefit
01.02.2023
–
20.07.2023
Spesolimab
Spevigo®
Boehringer Ingelheim Pharma GmbH & Co. KG
Skin diseases
Generalised pustular psoriasis, acute treatment
100%
no additional benefit
15.01.2023
–
06.07.2023
Lutetium (177Lu) Vipivotidtetraxetan
Pluvicto®
Novartis Radiopharmaceuticals GmbH
Oncological diseases
Prostate carcinoma (PC), combination with androgen deprivation therapy, PSMA-positive, metastatic, castration-resistant, progression after inhibition of the AR pathway and taxane-based chemotherapy
50%
Indication of
considerable additional benefit
15.01.2023
–
06.07.2023
Maralixibat
Livmarli®
Mirum Pharmaceuticals Germany GmbH
Digestive system diseases
Alagille-Syndrome, ≥ 2 months
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.01.2023
–
06.07.2023
Olaparib (10)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Prostate carcinoma (PC), metastatic, castration-resistant, chemotherapy not clinically indicated, combination with abiraterone and/or prednisone
25%
Hint for
considerable additional benefit
02.01.2023
–
15.06.2023
Risankizumab (3)
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Morbus Crohn, pre-treated
40%
Hint for
minor additional benefit
02.01.2023
–
15.06.2023
Bictegravir / Emtricitabin / Tenofoviralafenamid (2)
Biktarvy®
Gilead Sciences GmbH
Infectious diseases
HIV-Infection, 2 until < 18 years
100%
no additional benefit
02.01.2023
–
15.06.2023
Sutimlimab
Enjaymo®
Sanofi-Aventis Deutschland GmbH
Hematopoietic diseases
Cold agglutinin disease (CAD)
100%
Hint for
minor additional benefit
( Orphan)
02.01.2023
–
15.06.2023
Abemaciclib (6, reassessment)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HR+, HER2-, combination with aromatase inhibitor
100%
Hint for
minor additional benefit
15.12.2022
–
15.06.2023
Latanoprost / Netarsudil
Roclanda®
Santen GmbH
Eye diseases
Reduction of increased intraocular pressure in open-angle glaucoma or ocular hypertension
100%
no additional benefit
15.12.2022
–
15.06.2023
Zanubrutinib (4)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line
50%
Hint for
minor additional benefit
15.12.2022
–
15.06.2023
Zanubrutinib (3)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Marginal zone lymphoma (MZL), after at least 1 previous therapy with anti-CD20 antibody
100%
no additional benefit
15.12.2022
–
15.06.2023
Zanubrutinib (2)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), relapsed and/or refractory
23%
Indication of
minor additional benefit
01.12.2022
–
01.06.2023
Olopatadin / Mometason
Ryaltris®
Berlin-Chemie AG
Respiratory system diseases
Allergic rhinitis
100%
no additional benefit
01.12.2022
–
01.06.2023
Maribavir
Livtencity®
Takeda GmbH
Infectious diseases
Cytomegalovirus infection (CMI), refractory to therapy
100%
Hint for
minor additional benefit
( Orphan)
15.11.2022
–
12.05.2023
Tezepelumab
Tezspire®
AstraZeneca GmbH
Respiratory system diseases
Bronchial asthma (AB), ≥ 12 years
100%
no additional benefit
15.11.2022
–
12.05.2023
Tralokinumab (2)
Adtralza®
LEO Pharma GmbH
Skin diseases
Atopic dermatitis (AD), 12 to < 18 years
100%
no additional benefit
15.11.2022
–
12.05.2023
Daridorexant
Quviviq®
Idorsia Pharmaceuticals Germany GmbH
Mental illnesses
Sleep disorders (mental illnesses)
100%
no additional benefit
09.02.2023
–
20.04.2023
Dalbavancin
Xydalba®
Advanz Pharma Germany GmbH
Infectious diseases
Acute bacterial skin and skin structure infections (ABSSSI)
resolution w/o assessement
01.11.2022
–
20.04.2023
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3)
Genvoya®
Gilead Sciences GmbH
Infectious diseases
HIV infection, 2 to < 6 years
100%
no additional benefit
01.11.2022
–
20.04.2023
Olaparib (9, reassessment)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma (OC), fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab
100%
Hint for
considerable additional benefit
01.11.2022
–
20.04.2023
Ravulizumab (4)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
100%
no additional benefit
15.10.2022
–
20.04.2023
Tixagevimab / Cilgavimab
Evusheld®
AstraZeneca GmbH
Infectious diseases
COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre
33%
Hint for
minor additional benefit
15.10.2022
–
06.04.2023
Faricimab (2)
Vabysmo®
Roche Pharma AG
Eye diseases
Neovascular age-related macular degeneration (AMD)
100%
no additional benefit
15.10.2022
–
06.04.2023
Remdesivir (4)
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg)
100%
no additional benefit
15.10.2022
–
06.04.2023
Remdesivir (3)
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years
100%
no additional benefit
15.10.2022
–
06.04.2023
Vutrisiran
Amvuttra®
Alnylam Germany GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis (hTTA) with polyneuropathy (stage 1 or 2)
100%
Indication of
minor additional benefit
( Orphan)
15.10.2022
–
06.04.2023
Relugolix
Orgovyx®
Accord Healthcare GmbH
Oncological diseases
Prostate carcinoma (PC), advanced, hormone-sensitive
100%
no additional benefit
15.10.2022
–
06.04.2023
Lonafarnib
Zokinvy®
EigerBio Europe Ltd
Other diseases
Hutchinson-Gilford progeria syndrome or progeroid laminopathy, 12 months and over
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.10.2022
–
06.04.2023
Faricimab
Vabysmo®
Roche Pharma AG
Eye diseases
Diabetic macular edema (DME)
100%
no additional benefit
01.10.2022
–
06.04.2023
Difelikefalin
Kapruvia®
Fresenius Medical Care Nephrologica Deutschland GmbH
Skin diseases
Pruritus in chronic kidney disease (CKD), haemodialysis patients
100%
no additional benefit
01.09.2022
–
06.04.2023
Lisocabtagen maraleucel
Breyanzi®
Bristol-Myers Squibb GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma and follicular lymphoma (PMBCL) grade 3B, after ≥ 2 prior therapies
100%
no additional benefit
01.10.2022
–
16.03.2023
Selinexor (2)
Nexpovio®
Stemline Therapeutics B.V.
Oncological diseases
Multiple myeloma (MM) at least 1 prior therapy, combination with bortezomib and dexamethasone
100%
no additional benefit
01.10.2022
–
16.03.2023
Selinexor
Nexpovio®
Stemline Therapeutics B.V.
Oncological diseases
Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone
100%
no additional benefit
01.10.2022
–
16.03.2023
Asciminib
Scemblix®
Novartis Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, after ≥ 2 prior therapies
100%
Indication of
minor additional benefit
( Orphan)
01.10.2022
–
16.03.2023
Melphalanflufenamid
Pepaxti®
Oncopeptides AB
Oncological diseases
Multiple myeloma (MM) after at least 3 previous therapies, combination with dexamethasone)
100%
no additional benefit
01.10.2022
–
16.03.2023
Olipudase alfa
Xenpozyme®
Sanofi-Aventis Deutschland
Metabolic diseases
Acid sphingomyelinase deficiency (ASMD) type A/B or type B
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.10.2022
–
16.03.2023
Pertuzumab (4, reassessment)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast carcinoma (BC), early with high risk of recurrence, adjuvant therapy, combination with trastuzumab and chemotherapy
100%
Indication of
minor additional benefit
01.10.2022
–
16.03.2023
Pertuzumab / Trastuzumab (4, reassessment)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy
100%
Indication of
minor additional benefit
01.10.2022
–
16.03.2023
Selpercatinib (5)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older
100%
no additional benefit
01.10.2022
–
16.03.2023
Brexucabtagene-Autoleucel (2)
Tecartus®
Gilead Sciences GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), aged > 26
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.09.2022
–
16.03.2023
Valoctocogene roxaparvovec
Roctavian®
BioMarin International Ltd.
Hematopoietic diseases
Hemophilia A
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.09.2022
–
16.02.2023
Burosumab (6)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
FGF23-related hypophosphatemia in tumour-induced osteomalacia
100%
no additional benefit
( Orphan (turnover limit))
01.09.2022
–
16.02.2023
Efgartigimod alfa
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
100%
Hint for
considerable additional benefit
( Orphan)
01.09.2022
–
16.02.2023
Eptinezumab
Vyepti®
Lundbeck GmbH
Nervous system diseases
Migraine prophylaxis
100%
no additional benefit
01.09.2022
–
16.02.2023
Olaparib (8)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Breast carcinoma (BC), HER2, BRCA1/2 mutation, pre-treated, high risk of recurrence, adjuvant, monotherapy or combination with chemotherapy.
100%
Indication of
minor additional benefit
01.09.2022
–
16.02.2023
Upadacitinib (6)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Ulcerative colitis (UC), pre-treated
100%
no additional benefit
01.09.2022
–
16.02.2023
Upadacitinib (5)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Musculoskeletal system diseases
Axial spondyloarthritis (AS), non-radiographic
100%
no additional benefit
01.09.2022
–
16.02.2023
Birkenrindenextrakt
Filsuvez®
Amryt Pharma GmbH
Other diseases
Wound treatment in epidermolysis bullosa (from 6 months)
100%
Hint for
minor additional benefit
( Orphan)
15.08.2022
–
02.02.2023
Ceftolozan / Tazobactam (7)
Zerbaxa®
MSD Sharp & Dohme GmbH
Infectious diseases
Bacterial infections, multiple indications, < 18 years of age
100%
additional benefit considered proven
15.08.2022
–
02.02.2023
Capmatinib
Tabrecta®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients
100%
no additional benefit
15.08.2022
–
02.02.2023
Eladocagene Exuparvovec
Upstaza®
PTC Therapeutics International Limited
Metabolic diseases
Aromatic L-amino acid decarboxylase (AADC) deficiency, ≥ 18 months
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.08.2022
–
02.02.2023
Trastuzumab-Deruxtecan (2)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2+, after 1 prior therapy
100%
Indication of
non-quantifiable additional benefit
01.08.2022
–
02.02.2023
Trastuzumab-Deruxtecan
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2+, at least 2 previous therapies
100%
Indication of
considerable additional benefit
01.08.2022
–
02.02.2023
Pembrolizumab (30)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Cervical carcinoma, PD-L1 expression ≥ 1 (CPS), combination with or without bevacizumab
40%
Indication of
considerable additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (29)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma (RCC), adjuvant, monotherapy, pre-treated patients
100%
Hint for
minor additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (28)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Colorectal cancer (CRC)) with MSI-H or with dMMR, after fluoropyrimidine-based combination therapy.
100%
no additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (27)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma with MSI-H or with dMMR, pre-treated
100%
no additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (26)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Gastric carcinoma with MSI-H or dMMR, pre-treated
74%
Hint for
non-quantifiable additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (25)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Small bowel carcinoma with MSI-H or dMMR, pre-treated
100%
no additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (24)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Biliary carcinoma with MSI-H or dMMR, pre-treated
100%
no additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (23)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, adjuvant therapy, ≥ 12 years, monotherapy
100%
Indication of
non-quantifiable additional benefit
01.08.2022
–
19.01.2023
Pembrolizumab (22)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, ≥ 12 to < 18 years
100%
no additional benefit
01.08.2022
–
19.01.2023
Glycopyrronium
Axhidrox®
Dr. August Wolff GmbH & Co. KG Arzneimittel
Other diseases
Severe primary axillary hyperhidrosis
100%
no additional benefit
01.08.2022
–
19.01.2023
Inebilizumab
Uplizna®
Horizon Therapeutics GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
100%
no additional benefit
01.08.2022
–
19.01.2023
Eravacyclin
Xerava®
PAION Deutschland GmbH
Infectious diseases
Reserve antibiotics: Complicated intra-abdominal infections (cIAI)
100%
additional benefit considered proven
15.07.2022
–
05.01.2023
Secukinumab (8)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Juvenile psoriatic arthritis (PA), ≥ 6 years
100%
no additional benefit
15.07.2022
–
05.01.2023
Secukinumab (7)
Cosentyx®
Novartis Pharma GmbH
Musculoskeletal system diseases
Enthesitis-related arthritis (ERA)
100%
no additional benefit
15.07.2022
–
05.01.2023
Atezolizumab (10)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 % of TC, EGFR/ALK negative, adjuvant therapy after resection and chemotherapy.
100%
Hint for
non-quantifiable additional benefit
01.07.2022
–
15.12.2022
Mosunetuzumab
Lunsumio®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), after ≥ 2 prior therapies
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.07.2022
–
15.12.2022
Pembrolizumab (21)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast carcinoma (BC), triple-negative (TNBC), high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
50%
Hint for
minor additional benefit
01.07.2022
–
15.12.2022
Selpercatinib (4)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), RET fusion+, first-line
100%
no additional benefit
01.07.2022
–
15.12.2022
Palbociclib (3, reassessment)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast carcinoma (BC), patient population a1
100%
no additional benefit
01.07.2022
–
15.12.2022
Nirmatrelvir / Ritonavir
Paxlovid®
Pfizer Pharma GmbH
Infectious diseases
COVID-19, no need for supplementary oxygen, increased risk of severe progression
100%
Hint for
considerable additional benefit
01.07.2022
–
15.12.2022
Cerliponase alfa (2, reassessment)
Brineura®
BioMarin Deutschland GmbH
Metabolic diseases
Neuronal ceroid lipofuscinosis (NCL) type 2
100%
Hint for
major additional benefit
( Orphan)
01.06.2022
–
01.12.2022
Enfortumab Vedotin
Padcev®
Astellas Pharma Europe B.V
Oncological diseases
Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor
47%
Hint for
considerable additional benefit
01.06.2022
–
01.12.2022
Setmelanotid
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years.
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.06.2022
–
01.12.2022
Cabozantinib (8, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients
100%
no additional benefit
01.06.2022
–
01.12.2022
Polatuzumab Vedotin (2)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.06.2022
–
01.12.2022
Tisagenlecleucel (5)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Follicular lymphoma (FL), pre-treated patients
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.05.2022
–
03.11.2022
Axicabtagen-Ciloleucel (3, reassessment)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
15.05.2022
–
03.11.2022
Voxelotor
Oxbryta®
Global Blood Therapeutics Germany GmbH
Hematopoietic diseases
Haemolytic anaemia in sickle cell disease, monotherapy or combination with hydroxycarbamide, ≥ 12 years.
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.05.2022
–
03.11.2022
Sotrovimab
Xevudy®
GlaxoSmithKline GmbH & Co. KG
Infectious diseases
COVID-19, ≥ 12 years
33%
Hint for
considerable additional benefit
01.05.2022
–
03.11.2022
Imipenem / Cilastatin / Relebactam (2)
Recarbrio®
MSD Sharp & Dohme GmbH
Infectious diseases
Bacterial infections, multiple indications
100%
additional benefit considered proven
01.05.2022
–
03.11.2022
Ceftolozan / Tazobactam (6)
Zerbaxa®
MSD Sharp & Dohme GmbH
Infectious diseases
Bacterial infections, multiple indications
100%
additional benefit considered proven
01.05.2022
–
03.11.2022
Ceftazidim / Avibactam (2)
Zavicefta®
Pfizer Pharma GmbH
Infectious diseases
Bacterial infections, multiple indications
100%
additional benefit considered proven
01.05.2022
–
20.10.2022
Tebentafusp
Kimmtrak®
Immunocore Ireland Ltd.
Oncological diseases
Uveal melanoma, HLA-A*02:01-positive
100%
Hint for
considerable additional benefit
( Orphan)
01.05.2022
–
20.10.2022
Brolucizumab (2)
Beovu®
Novartis Pharma GmbH
Eye diseases
Diabetic macular edema
100%
no additional benefit
01.05.2022
–
20.10.2022
Abemaciclib (5)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy
40%
Hint for
minor additional benefit
01.05.2022
–
20.10.2022
Doravirin / Lamivudin / Tenofovirdisoproxil (2)
Delstrigo®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection, 12 to < 18 years
100%
no additional benefit
01.05.2022
–
20.10.2022
Doravirin (2)
Pifeltro®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection, 12 to < 18 years
100%
no additional benefit
01.05.2022
–
20.10.2022
Nivolumab (23)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma (UC) PD-L1 expression ≥ 1 %, adjuvant therapy
65%
Hint for
non-quantifiable additional benefit
01.05.2022
–
20.10.2022
Nivolumab (22)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
100%
Indication of
considerable additional benefit
01.05.2022
–
20.10.2022
Nivolumab (21)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma (SCC) of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with ipilimumab
100%
Hint for
considerable additional benefit
15.04.2022
–
06.10.2022
Casirivimab / Imdevimab (2)
Ronapreve®
Roche Pharma AG
Infectious diseases
Post-exposure prophylaxis of COVID-19 infection, ≥ 12 years
33%
Hint for
minor additional benefit
15.04.2022
–
06.10.2022
Casirivimab / Imdevimab
Ronapreve®
Roche Pharma AG
Infectious diseases
COVID-19-Infection, ≥ 12 years
33%
Hint for
considerable additional benefit
15.04.2022
–
06.10.2022
Dupilumab (6)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Asthma bronchiale, ≥ 6 until ≤ 11 years
100%
no additional benefit
15.04.2022
–
06.10.2022
Glucarpidase
Voraxaze®
SERB GmbH
Other diseases
Reduction of toxic MTX plasma concentrations; children ≥ 28 days and adults.
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2022
–
06.10.2022
Anifrolumab
Saphnelo®
AstraZeneca GmbH
Musculoskeletal system diseases
Systemic lupus erythematosus (SLE)
100%
no additional benefit
01.04.2022
–
15.09.2022
Avapritinib (2)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Systemic mastocytosis, after at least 1 prior therapy
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2022
–
15.09.2022
Somatrogon
Ngenla®
Pfizer Pharma GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2022
–
15.09.2022
Dolutegravir (4, reassessment)
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, age 6 to < 18 years
resolution w/o assessement
01.04.2022
–
15.09.2022
Voretigen Neparvovec (2, reassessment)
Luxturna®
Novartis Pharma GmbH
Eye diseases
Hereditary retinal dystrophy
100%
Hint for
considerable additional benefit
( Orphan)
01.04.2022
–
15.09.2022
Pegcetacoplan
Aspaveli®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2022
–
15.09.2022
Idebenon (2, reassessment)
Raxone®
Chiesi GmbH
Eye diseases
Leber's hereditary optic neuropathy (LHOP)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2022
–
15.09.2022
Empagliflozin (4)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Cardiovascular diseases
Chronic heart failure (CHF) with preserved ejection fraction
100%
Hint for
minor additional benefit
01.04.2022
–
15.09.2022
Daratumumab (9, reassessment)
Darzalex®
Janssen-Cilag
Oncological diseases
Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
100%
Proof of
considerable additional benefit
( Orphan (turnover limit))
01.03.2022
–
01.09.2022
Brivaracetam (3)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Focal seizures in epilepsy, additional therapy, 2 to < 4 years
100%
no additional benefit
01.03.2022
–
01.09.2022
Lorlatinib (2)
Lorviqua®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), ALK+, first-line
100%
no additional benefit
01.03.2022
–
01.09.2022
Tepotinib
Tepmetko®
Merck Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients
100%
no additional benefit
01.03.2022
–
01.09.2022
Vedolizumab (2)
Entyvio®
Takeda GmbH
Digestive system diseases
Antibiotic-refractory pouchitis, pre-treated patients
100%
no additional benefit
15.02.2022
–
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (10)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
100%
no additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (9)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
100%
no additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (8)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor)
100%
no additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (7)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor, 6 to ≤ 11 years (homozygous for F508del mutation)
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (6)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
100%
Indication of
considerable additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor (26)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor
100%
no additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor (25)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor
100%
no additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor (24)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor).
100%
no additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor (23)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (homozygous for F508del mutation)
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Ivacaftor (22)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
100%
Indication of
considerable additional benefit
( Orphan (turnover limit))
15.02.2022
–
04.08.2022
Avacopan
Tavneos®
Vifor Pharma Deutschland GmbH
Musculoskeletal system diseases
Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide
100%
Hint for
minor additional benefit
( Orphan)
15.02.2022
–
04.08.2022
Sotorasib
Lumykras®
Amgen Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies
100%
no additional benefit
repealed subpopulations
15.02.2022
–
04.08.2022
Sofosbuvir / Velpatasvir (3)
Epclusa®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, ≥ 3 to < 6 years of age
100%
no additional benefit
01.02.2022
–
21.07.2022
Calcifediol
Rayaldee®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Secondary hyperparathyroidism in chronic renal failure
100%
no additional benefit
01.02.2022
–
21.07.2022
Isofluran
Sedaconda®
Sedana Medical AB
Other diseases
Sedation of mechanically ventilated patients during intensive care therapy (ICT)
100%
no additional benefit
01.02.2022
–
21.07.2022
Burosumab (5, reassessment >€50m)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia, ≥ 18 years of age
100%
no additional benefit
( Orphan (turnover limit))
01.02.2022
–
21.07.2022
Burosumab (4, reassessment >€50m)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia, ≥ 1 to < 18 years of age
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.02.2022
–
21.07.2022
Duvelisib (2)
Copiktra®
Secura Bio Limited
Oncological diseases
Follicular lymphoma (FL), after ≥ 2 prior therapies
100%
no additional benefit
01.02.2022
–
21.07.2022
Duvelisib
Copiktra®
Secura Bio Limited
Oncological diseases
Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies
100%
no additional benefit
15.01.2022
–
07.07.2022
Abrocitinib
Cibinqo®
Pfizer Pharma GmbH
Skin diseases
Atopic Dermatitis (AD)
100%
Hint for
considerable additional benefit
15.01.2022
–
07.07.2022
Amivantamab
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy
100%
no additional benefit
15.01.2022
–
07.07.2022
Remdesivir (2)
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, no need for supplementary oxygen, increased risk of severe progression
100%
Hint for
minor additional benefit
15.12.2021
–
07.07.2022
Lenvatinib (7, Kisplyx®)
Kisplyx®
Eisai GmbH
Oncological diseases
Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab
100%
no additional benefit
15.12.2021
–
07.07.2022
Lenvatinib (6)
Lenvima®
Eisai GmbH
Oncological diseases
Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab
100%
Indication of
considerable additional benefit
15.12.2021
–
07.07.2022
Pembrolizumab (20)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib
100%
Indication of
considerable additional benefit
15.12.2021
–
07.07.2022
Pembrolizumab (19)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib
100%
no additional benefit
15.12.2021
–
16.06.2022
Zanubrutinib
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy
100%
no additional benefit
01.01.2022
–
16.06.2022
Idecabtagen vicleucel
Abecma®
Bristol-Myers Squibb GmbH & Co KGaA
Oncological diseases
Multiple myeloma (MM), at least 3 previous therapies
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.01.2022
–
16.06.2022
Evolocumab (3)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age
100%
no additional benefit
01.01.2022
–
16.06.2022
Ripretinib
Qinlock®
Deciphera Pharmaceuticals (Netherlands) B.V.
Oncological diseases
Gastrointestinal stromal tumours (GIST), ≥ 3 prior therapies
100%
Hint for
major additional benefit
( Orphan)
15.12.2021
–
16.06.2022
Pralsetinib
Gavreto®
Roche Registration GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), RET fusion+
100%
no additional benefit
15.12.2021
–
16.06.2022
Tofacitinib (7)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Ankylosing spondylitis (AS)
100%
no additional benefit
15.12.2021
–
16.06.2022
Ozanimod (2)
Zeposia®
Bristol-Myers Squibb GmbH & Co. KGaA
Digestive system diseases
Ulcerative colitis (UC), pre-treated patients
100%
no additional benefit
15.12.2021
–
16.06.2022
Dapagliflozin (7)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus Type 2, ≥ 10 years
100%
no additional benefit
01.12.2021
–
19.05.2022
Ponesimod (2)
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relaps multiple sclerosis (MS)
50%
Indication of
minor additional benefit
01.12.2021
–
19.05.2022
Abemaciclib (4, reassessment)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with fulvestrant
42%
Indication of
minor additional benefit
01.12.2021
–
19.05.2022
Filgotinib (2)
Jyseleca®
Galapagos Biopharma Germany GmbH
Digestive system diseases
Ulcerative colitis (UC), pretreated patients
100%
no additional benefit
01.12.2021
–
19.05.2022
Mepolizumab (5)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Musculoskeletal system diseases
Eosinophilic granulomatosis with polyangiitis
100%
no additional benefit
01.12.2021
–
19.05.2022
Mepolizumab (4)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic rhinosinusitis with nasal polyps
100%
no additional benefit
01.12.2021
–
19.05.2022
Mepolizumab (3)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Hematopoietic diseases
Hypereosinophilic syndrome
100%
Hint for
considerable additional benefit
01.12.2021
–
19.05.2022
Ertugliflozin
Steglatro®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus (DM) type 2
100%
no additional benefit
01.12.2021
–
19.05.2022
Nivolumab (20)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Adenocarcinoma (AC) of the stomach, gastroesophageal junction or esophagus, CPS ≥ 5, HER2-negative, first-line, combination with fluoropyrimidine- and platinum-based combination chemotherapy
100%
Hint for
considerable additional benefit
01.12.2021
–
19.05.2022
Risankizumab (2)
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Psoriatic arthritis (PA), monotherapy or combination with methotrexate
100%
no additional benefit
01.12.2021
–
19.05.2022
Sacituzumab Govitecan
Trodelvy®
Gilead Sciences GmbH
Oncological diseases
Breast cancer (BC) triple-negative, after 2 previous therapies
100%
Indication of
major additional benefit
01.12.2021
–
19.05.2022
Lusutrombopag
Mulpleo®
Shionogi GmbH
Hematopoietic diseases
Thrombocytopenia in chronic liver disease
100%
no additional benefit
15.11.2021
–
05.05.2022
Cefiderocol (2)
Fetcroja®
Shionogi GmbH
Infectious diseases
Infections caused by aerobic gram-negative pathogens
100%
additional benefit considered proven
15.11.2021
–
05.05.2022
Delamanid (2)
Deltyba®
Otsuka Novel Products
Infectious diseases
Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.11.2021
–
05.05.2022
Elbasvir / Grazoprevir (2)
Zepatier®
MSD Sharp & Dohme B.V.
Infectious diseases
Chronic hepatitis C (HCV), 12 to < 18 years
100%
no additional benefit
15.11.2021
–
05.05.2022
Pembrolizumab (18)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ 10 (CPS), first-line, combination with platinum- and fluoropyrimidine-based chemotherapy.
34%
Indication of
considerable additional benefit
15.11.2021
–
05.05.2022
Pembrolizumab (17)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast cancer (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy
50%
Hint for
considerable additional benefit
01.09.2021
–
05.05.2022
Icosapent-Ethyl
Vazkepa®
Amarin Pharmaceuticals Ireland Limited
Metabolic diseases
Dyslipidemia, pre-treated patients
100%
no additional benefit
01.11.2021
–
21.04.2022
Ixazomib (2, reassessment)
Ninlaro®
Takeda GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.11.2021
–
21.04.2022
Pitolisant (2, Ozawade®)
Ozawade®
Bioprojet Deutschland GmbH
Nervous system diseases
Daytime sleepiness in obstructive sleep apnea, after previous therapy
100%
no additional benefit
15.10.2021
–
07.04.2022
Sofosbuvir / Velpatasvir / Voxilaprevir (2)
Vosevi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C (HCV), 12 to < 18 years
100%
no additional benefit
15.10.2021
–
07.04.2022
Albutrepenonacog alfa (2, reassessment >€50m)
Idelvion®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia B, congenital factor IX deficiency
100%
no additional benefit
( Orphan (turnover limit))
15.10.2021
–
07.04.2022
Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse)
Palforzia®
Aimmune Therapeutics Germany GmbH
Other diseases
Peanut allergy, ≥ 4 years
100%
no additional benefit
01.10.2021
–
18.03.2022
Solriamfetol (2)
Sunosi®
Jazz Pharmaceuticals Ireland
Nervous system diseases
Daytime sleepiness in obstructive sleep apnoea, after previous therapy
100%
no additional benefit
01.10.2021
–
18.03.2022
Vandetanib (4, reassessment)
Caprelsa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC)
100%
no additional benefit
01.10.2021
–
18.03.2022
Vosoritid
Voxzogo®
BioMarin International Limited
Other diseases
Achondroplasia, ≥ 2 years
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.10.2021
–
18.03.2022
Daratumumab (8, reassessment)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
100%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.10.2021
–
18.03.2022
Lumacaftor / Ivacaftor (4, reassessment)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, ≥ 2 to ≤ 5 years
100%
Hint for
non-quantifiable additional benefit
01.10.2021
–
18.03.2022
Ravulizumab (3)
Ultomiris®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Paroxysmal hemoglobinuria, pediatric patients
100%
no additional benefit
15.09.2021
–
03.03.2022
Tofacitinib (6)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Polyarticular juvenile idiopathic arthritis, RF+ or RF polyarthritis and dilated oligoarthritis, and juvenile psoriatic arthritis, ≥ 2 years
100%
no additional benefit
15.09.2021
–
03.03.2022
Roxadustat
Evrenzo®
Astellas Pharma GmbH
Hematopoietic diseases
Symptomatic anemia in chronic kidney disease (CKD)
100%
no additional benefit
15.09.2021
–
03.03.2022
Bimekizumab
Bimzelx®
UCB Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
100%
Indication of
minor additional benefit
15.09.2021
–
03.03.2022
Vericiguat
Verquvo®
Bayer Vital GmbH
Cardiovascular diseases
Chronic heart failure (CHF)
100%
Hint for
minor additional benefit
15.09.2021
–
03.03.2022
Odevixibat
Bylvay®
Albireo Pharma AB
Digestive system diseases
Cholestasis, ≥ 6 months
100%
Hint for
minor additional benefit
( Orphan)
15.09.2021
–
03.03.2022
Tafasitamab
Minjuvi®
Incyte Biosciences Germany
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.09.2021
–
17.02.2022
Misoprostol
Angusta®
Norgine GmbH
Other diseases
Labor induction
100%
no additional benefit
01.09.2021
–
17.02.2022
Nivolumab (19)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Carcinoma of the esophagus and gastro-esophageal junction, pre-treated patients, adjuvant therapy
100%
Indication of
non-quantifiable additional benefit
01.09.2021
–
17.02.2022
Migalastat (2)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease, 12 to < 16 years
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.09.2021
–
17.02.2022
Tofacitinib (5, reassessment)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA), pretreated patients, monotherapy or combination with methotrexate
100%
no additional benefit
01.09.2021
–
17.02.2022
Tirbanibulin
Klisyri®
Almirall Hermal GmbH
Skin diseases
Actinic keratosis (AK), Olsen grade I
100%
no additional benefit
01.09.2021
–
17.02.2022
Relugolix / Estradiol / Norethisteronacetat
Ryeqo®
Gedeon Richter Pharma GmbH
Genitourinary system diseases
Uterine myoma
50%
Hint for
considerable additional benefit
01.09.2021
–
17.02.2022
Dapagliflozin (6)
Forxiga®
AstraZeneca GmbH
Genitourinary system diseases
Chronic kidney disease (CKD)
50%
Hint for
considerable additional benefit
01.09.2021
–
17.02.2022
Upadacitinib (4)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Atopic dermatitis (AD), ≥ 12 years
33%
Indication of
considerable additional benefit
15.08.2021
–
03.02.2022
Selumetinib
Koselugo®
AstraZeneca GmbH
Oncological diseases
Neurofibromatosis (type 1), ≥ 3 to < 18 years
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.08.2021
–
03.02.2022
Daratumumab (7)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason
38%
Hint for
minor additional benefit
( Orphan (turnover limit))
23.11.2020
–
20.01.2022
Imipenem / Cilastatin / Relebactam
Recarbrio®
MSD Sharp & Dohme GmbH
Infectious diseases
Pneumonia, Bacteriemia
resolution w/o assessement
20.08.2020
–
20.01.2022
Ceftolozan / Tazobactam (5)
Zerbaxa®
MSD Sharp & Dohme GmbH
Infectious diseases
Complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP)
resolution w/o assessement
01.08.2021
–
20.01.2022
Teriflunomid (2)
Aubagio®
Sanofi-Aventis Deutschland GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS), 10 to 17 years
100%
no additional benefit
01.08.2021
–
20.01.2022
Blinatumomab (6)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years
100%
Indication of
major additional benefit
( Orphan)
01.08.2021
–
20.01.2022
Nivolumab (18)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Colorectal carcinoma (CRC) with mismatch repair deficiency or high microsatellite instability, pre-treated patients, combination with ipilimumab
100%
no additional benefit
01.08.2021
–
20.01.2022
Cemiplimab (3)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Basal cell carcinoma (BCC), locally advanced or metastasised
97%
Hint for
minor additional benefit
01.08.2021
–
20.01.2022
Cemiplimab (2)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
100%
no additional benefit
01.08.2021
–
20.01.2022
Daratumumab (6)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
50%
Hint for
minor additional benefit
( Orphan (turnover limit))
31.07.2020
–
20.01.2022
Ceftazidim / Avibactam
Zavicefta®
Pfizer Pharma GmbH
Infectious diseases
Complicated intra-abdominal infections, complicated urinary tract infections, nosocomial pneumonias, infections caused by aerobic gram-negative pathogens
resolution w/o assessement
15.07.2021
–
06.01.2022
Satralizumab
Enspryng®
Roche Pharma AG
Nervous system diseases
Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years
100%
Hint for
minor additional benefit
( Orphan)
15.07.2021
–
06.01.2022
Empagliflozin (3)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Cardiovascular diseases
Chronic heart failure (CHF)
100%
Hint for
minor additional benefit
15.07.2021
–
06.01.2022
Tralokinumab
Adtralza®
LEO Pharma A/S
Skin diseases
Atopic dermatitis (AD)
100%
no additional benefit
15.07.2021
–
06.01.2022
Angiotensin-II-Acetat
Giapreza®
La Jolla Pharmaceutical II B.V.
Cardiovascular diseases
Hypotension
100%
no additional benefit
01.07.2021
–
16.12.2021
Brentuximab Vedotin (6, reassessment)
Adcetris®
Takeda GmbH
Oncological diseases
Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone
100%
Hint for
minor additional benefit
( Orphan)
01.07.2021
–
16.12.2021
Cabozantinib (7, reassessment)
Cometriq®
Ipsen Pharma GmbH
Oncological diseases
Thyroid carcinoma (MTC)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.07.2021
–
16.12.2021
Glecaprevir / Pibrentasvir (3)
Maviret®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C, 3 to < 12 years
100%
no additional benefit
01.07.2021
–
16.12.2021
Nivolumab (17)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Malignant pleural mesothelioma, first-line, combination with ipilimumab
50%
Indication of
considerable additional benefit
01.07.2021
–
16.12.2021
Osimertinib (4)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy
50%
Indication of
non-quantifiable additional benefit
01.07.2021
–
16.12.2021
Elotuzumab (3, reassessment)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
100%
Hint for
considerable additional benefit
15.06.2021
–
02.12.2021
Dostarlimab
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Endometrial carcinoma (EC), after platinum-based therapy
100%
no additional benefit
15.06.2021
–
02.12.2021
Tagraxofusp
Elzonris®
Stemline Therapeutics B.V.
Oncological diseases
Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.06.2021
–
02.12.2021
Venetoclax (5)
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Acute myeloid leukaemia (AML), combination therapy, first-line
100%
Hint for
considerable additional benefit
15.06.2021
–
02.12.2021
Berotralstat
Orladeyo®
BioCryst Pharma Deutschland GmbH
Other diseases
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
100%
no additional benefit
15.06.2021
–
02.12.2021
Ponesimod
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relapsing multiple sclerosis (MS)
100%
no additional benefit
01.06.2021
–
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (5)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation).
100%
no additional benefit
( Orphan (turnover limit))
01.06.2021
–
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (4)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
100%
no additional benefit
( Orphan (turnover limit))
01.06.2021
–
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (3)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)).
100%
no additional benefit
( Orphan (turnover limit))
01.06.2021
–
19.11.2021
Ivacaftor (21)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation)
100%
no additional benefit
( Orphan (turnover limit))
01.06.2021
–
19.11.2021
Ivacaftor (20)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
100%
no additional benefit
( Orphan (turnover limit))
01.06.2021
–
19.11.2021
Ivacaftor (19)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and gating mutation (incl. R117H))
100%
no additional benefit
( Orphan (turnover limit))
01.06.2021
–
19.11.2021
Bosutinib (4, reassessment)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, first-line
100%
no additional benefit
01.06.2021
–
19.11.2021
Enzalutamid (5)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy
100%
no additional benefit
01.06.2021
–
19.11.2021
Cenobamat
Ontozry®
Angelini Pharma Deutschland GmbH
Nervous system diseases
Epilepsy, focal seizures, after at least 2 previous therapies
100%
no additional benefit
01.06.2021
–
19.11.2021
Atezolizumab (9)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), PD-L1 expression ≥50 % on TC or ≥10 % on IC, EGFR/ALK negative, first-line
100%
no additional benefit
15.05.2021
–
04.11.2021
Isatuximab (2)
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma (MM), after at least 2 previous therapies, combination with pomalidomide and dexamethasone
100%
Hint for
minor additional benefit
15.05.2021
–
04.11.2021
Isatuximab
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma (MM), after at least 1 prior therapy, combination with carfilzomib and dexamethasone
100%
no additional benefit
15.05.2021
–
04.11.2021
Lanadelumab (2, reassessment >€50m)
Takhzyro®
Takeda GmbH
Other diseases
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
100%
no additional benefit
( Orphan (turnover limit))
15.05.2021
–
04.11.2021
Onasemnogen-Abeparvovec
Zolgensma®
Novartis Gene Therapies EU Limited
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
100%
no additional benefit
( Orphan (turnover limit))
15.05.2021
–
04.11.2021
Obinutuzumab (6, reassessment >€50m)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), first-line
100%
no additional benefit
( Orphan (turnover limit))
15.05.2021
–
04.11.2021
Obinutuzumab (5, reassessment >€50m)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Chronic lymphocytic leukemia (CLL)
100%
no additional benefit
( Orphan (turnover limit))
15.05.2021
–
04.11.2021
Obinutuzumab (4, reassessment >€50m)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL)
100%
no additional benefit
( Orphan (turnover limit))
15.05.2021
–
04.11.2021
Cannabidiol (5)
Epidyolex®
GW Pharmaceuticals plc
Other diseases
Seizures in Tuberous Sclerosis, ≥ 2 years
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.05.2021
–
04.11.2021
Atidarsagen autotemcel OTL-200
Libmeldy®
Orchard Therapeutics GmbH
Metabolic diseases
Metachromatic leukodystrophy with biallelic mutation in the ARSA gene
50%
Hint for
major additional benefit
( Orphan)
01.05.2021
–
21.10.2021
Cabotegravir
Vocabria®
ViiV Healthcare GmbH
Infectious diseases
HIV-1 infection, pre-treated, combination with rilpivirin
100%
no additional benefit
01.05.2021
–
21.10.2021
Erenumab (2, reassessment)
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
100%
Hint for
considerable additional benefit
01.05.2021
–
21.10.2021
Risdiplam
Evrysdi®
Roche Pharma AG
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
42%
Hint for
non-quantifiable additional benefit
( Orphan)
01.05.2021
–
21.10.2021
Cabozantinib (6, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with nivolumab
100%
no additional benefit
01.05.2021
–
21.10.2021
Nivolumab (16)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with cabozantinib
100%
no additional benefit
01.05.2021
–
21.10.2021
Rilpivirin (3, Rekambys®)
Rekambys®
ViiV Healthcare GmbH
Infectious diseases
HIV-1 infection, pre-treated, combination with cabotegravir
100%
no additional benefit
16.07.2020
–
21.10.2021
Cefiderocol
Fetcroja®
Shionogi GmbH
Infectious diseases
Infections caused by aerobic gram-negative pathogens
resolution w/o assessement
15.04.2021
–
07.10.2021
Pemigatinib
Pemazyre®
Incyte Biosciences Germany GmbH
Oncological diseases
Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.04.2021
–
16.09.2021
Nivolumab (15, reassessment)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy
100%
Hint for
considerable additional benefit
01.04.2021
–
16.09.2021
Natrium-Zirkonium-Cyclosilikat
Lokelma®
AstraZeneca GmbH
Metabolic diseases
Hyperkalemia
100%
no additional benefit
01.04.2021
–
16.09.2021
Remdesivir
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, ≥ 12 years, additional oxygen supply
34%
Hint for
minor additional benefit
01.04.2021
–
16.09.2021
Avatrombopag (2)
Doptelet®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Thrombocytopenia in chronic liver disease
100%
no additional benefit
01.04.2021
–
16.09.2021
Avatrombopag
Doptelet®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Immune thrombocytopenia (ITP)
100%
no additional benefit
01.04.2021
–
16.09.2021
Fostemsavir
Rukobia®
ViiV Healthcare GmbH
Infectious diseases
Multidrug-resistant HIV infection
100%
no additional benefit
01.04.2021
–
16.09.2021
Pembrolizumab (16)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years
46%
Hint for
considerable additional benefit
01.04.2021
–
16.09.2021
Pembrolizumab (15, reassessment)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC), CPS ≥ 10, first-line
100%
no additional benefit
01.04.2021
–
16.09.2021
Pembrolizumab (14)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Colorectal carcinoma (CRC) with MSI-H or dMMR, first-line
87%
Hint for
minor additional benefit
01.04.2021
–
16.09.2021
Bedaquilin (3)
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis, 5 to 11 years
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.03.2021
–
02.09.2021
Imlifidase
Idefirix®
Hansa Biopharma AB
Other diseases
Desensitisation in kidney transplantation
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.03.2021
–
02.09.2021
Fedratinib
Inrebic®
Celgene GmbH
Oncological diseases
Myelofibrosis (MF)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.03.2021
–
02.09.2021
Tucatinib
Tukysa®
Seagen Germany GmbH
Oncological diseases
Breast cancer (BC) HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine
100%
Hint for
considerable additional benefit
15.03.2021
–
02.09.2021
Selpercatinib (3)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy
100%
no additional benefit
15.03.2021
–
02.09.2021
Selpercatinib (2)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Medullary thyroid carcinoma (MTC), RET-mutated, after cabozantinib and/or vandetanib prior therapy, ≥ 12 years
100%
no additional benefit
15.03.2021
–
02.09.2021
Selpercatinib
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), RET fusion+, after platinum-based chemotherapy and/or immunotherapy
100%
no additional benefit
01.03.2021
–
19.08.2021
Avelumab (4)
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Urothelial carcinoma (UC), first-line
100%
Hint for
considerable additional benefit
01.03.2021
–
19.08.2021
Esketamin (2)
Spravato®
Janssen-Cilag GmbH
Mental illnesses
Depression, therapy resistant, combination with SSRI or SNRI
100%
no additional benefit
repealed
01.03.2021
–
19.08.2021
Esketamin
Spravato®
Janssen-Cilag GmbH
Mental illnesses
Depression, acute treatment, combination therapy
100%
Hint for
minor additional benefit
15.02.2021
–
05.08.2021
Beclometason / Formoterol / Glycopyrronium
Trimbow®
Chiesi GmbH
Respiratory system diseases
Asthma
100%
no additional benefit
15.02.2021
–
05.08.2021
Baloxavir marboxil (2)
Xofluza®
Roche Pharma AG
Infectious diseases
Influenza prophylaxis, ≥ 12 years
58%
Indication of
considerable additional benefit
15.02.2021
–
05.08.2021
Baloxavir marboxil
Xofluza®
Roche Pharma AG
Infectious diseases
Influenza, ≥ 12 years
100%
no additional benefit
15.02.2021
–
05.08.2021
Autologe Anti-CD19-transduzierte CD3-positive Zellen
Tecartus®
Gilead Sciences GmbH
Oncological diseases
Mantle cell lymphoma (MCL), pretreated
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.12.2020
–
05.08.2021
Acalabrutinib (3)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment
40%
Hint for
considerable additional benefit
01.02.2021
–
15.07.2021
Blinatumomab (5)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.02.2021
–
15.07.2021
Pertuzumab / Trastuzumab (3)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, metastatic or locally recurrent
100%
no additional benefit
01.02.2021
–
15.07.2021
Pertuzumab / Trastuzumab (2)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant
100%
no additional benefit
01.02.2021
–
15.07.2021
Pertuzumab / Trastuzumab
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) early stage, HER2+, adjuvant treatment
100%
Hint for
minor additional benefit
repealed
01.02.2021
–
15.07.2021
Levofloxacin / Dexamethason
Ducressa®
Santen GmbH
Eye diseases
Infections and inflammations associated with cataract surgery
100%
no additional benefit
01.02.2021
–
15.07.2021
Dolutegravir (3)
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV-Infection, children ≥ 4 weeks to < 6 years
100%
no additional benefit
01.02.2021
–
15.07.2021
Niraparib (4, reassessment)
Zejula®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
100%
no additional benefit
( Orphan (turnover limit))
01.02.2021
–
15.07.2021
Fenfluramin
Fintepla®
Zogenix GmbH
Nervous system diseases
Dravet syndrome, ≥ 2 years
100%
Hint for
considerable additional benefit
( Orphan)
01.02.2021
–
15.07.2021
Inclisiran
Leqvio®
Novartis Pharma GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
100%
no additional benefit
01.02.2021
–
15.07.2021
Upadacitinib (3)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Psoriasis arthritis (PA)
69%
Hint for
considerable additional benefit
01.02.2021
–
15.07.2021
Upadacitinib (2)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Musculoskeletal system diseases
Ankylosing spondylitis
100%
no additional benefit
15.01.2021
–
15.07.2021
Carfilzomib (4)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone
100%
no additional benefit
( Orphan (turnover limit))
01.01.2021
–
01.07.2021
Nivolumab (14)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma of esophagus, pretreated patients
36%
Hint for
minor additional benefit
01.01.2021
–
01.07.2021
Afamelanotid (2, reassessment)
Scenesse®
Clinuvel (UK) Limited
Metabolic diseases
Erythropoietic protoporphyria
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.01.2021
–
01.07.2021
Dupilumab (5)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis (AD), 6 to 11 years
100%
Hint for
non-quantifiable additional benefit
01.01.2021
–
01.07.2021
Lenvatinib (5, reassessment, Kisplyx®)
Kisplyx®
Eisai GmbH
Oncological diseases
Renal cell carcinoma (RCC)
100%
no additional benefit
01.01.2021
–
01.07.2021
Lumasiran
Oxlumo®
Alnylam Germany GmbH
Metabolic diseases
Hyperoxaluria
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.12.2020
–
03.06.2021
Ipilimumab (6)
Yervoy®
Bristol-Myers Squibb Pharma EEIG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy
73%
Indication of
minor additional benefit
15.12.2020
–
03.06.2021
Nivolumab (13)
Opdivo®
Bristol-Myers Squibb Pharma EEIG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), combination with ipilimumab and platinum-based chemotherapy, first-line
73%
Indication of
minor additional benefit
15.12.2020
–
03.06.2021
Perampanel (5)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years
100%
no additional benefit
15.12.2020
–
03.06.2021
Perampanel (4)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years
100%
no additional benefit
15.12.2020
–
03.06.2021
Sucroferric Oxyhydroxide (2)
Velphoro®
Fresenius Medical Care Deutschland GmbH
Genitourinary system diseases
Serum phosphate level control in chronic kidney disease, ≥ 2 to 18 years
100%
no additional benefit
01.12.2020
–
03.06.2021
Olaparib (7)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy
100%
no additional benefit
01.12.2020
–
03.06.2021
Olaparib (6)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment
100%
Hint for
considerable additional benefit
01.12.2020
–
03.06.2021
Olaparib (5)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab
100%
no additional benefit
repealed
01.12.2020
–
03.06.2021
Sebelipase alfa (2, reassessment)
Kanuma®
Alexion Pharma Germany GmbH
Metabolic diseases
Lysosomal acid lipase deficiency
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.12.2020
–
03.06.2021
Acalabrutinib (2)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line
25%
Hint for
minor additional benefit
01.12.2020
–
03.06.2021
Acalabrutinib
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL); monotherapy, first-line
25%
Hint for
minor additional benefit
01.12.2020
–
20.05.2021
Tezacaftor / Ivacaftor (5)
Symkevi®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation)
100%
no additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Guselkumab (2)
Tremfya®
Janssen-Cilag GmbH
Skin diseases
Psoriatic arthritis (PA)
100%
no additional benefit
01.12.2020
–
20.05.2021
Nusinersen (2, reassessment >€50m)
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
19%
Indication of
major additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Tezacaftor / Ivacaftor (4)
Symkevi®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del)
100%
no additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Tafamidis (4, reassessment >€50m)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid cardiomyopathy
100%
Indication of
considerable additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Tafamidis (3, reassessment >€50m)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid Neuropathy
100%
no additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Niraparib (3)
Zejula®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy
100%
no additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Ivacaftor (18)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation)
100%
no additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Ivacaftor (17)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation)
100%
no additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Ivacaftor (16)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Ivacaftor (15)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.12.2020
–
20.05.2021
Dapagliflozin (5)
Forxiga®
AstraZeneca GmbH
Cardiovascular diseases
Chronic heart failure (CHF)
100%
Hint for
considerable additional benefit
01.12.2020
–
20.05.2021
Crizanlizumab
Adakveo®
Novartis Pharma GmbH
Hematopoietic diseases
Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years
100%
Hint for
minor additional benefit
repealed
( Orphan)
01.12.2020
–
20.05.2021
Amikacin (liposomal)
Arikayce® liposomal
Insmed Germany GmbH
Infectious diseases
Mycobacterium Avium Complex (MAC) infection
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.12.2020
–
20.05.2021
Atezolizumab (8)
Tecentriq®
Roche Pharma AG
Oncological diseases
Hepatocellular carcinoma (HCC), combination with bevacizumab
76%
Indication of
considerable additional benefit
15.02.2021
–
06.05.2021
Eszopiclon
Lunivia®
Hennig Arzneimittel GmbH & Co. KG
Nervous system diseases
Sleep disorders
100%
no additional benefit
15.11.2020
–
06.05.2021
Baricitinib (2)
Olumiant®
Lilly Deutschland GmbH
Skin diseases
Atopic dermatitis (AD)
100%
no additional benefit
01.11.2020
–
15.04.2021
Avapritinib
Ayvakyt®
Blueprint Medicines (Germany)
Oncological diseases
Gastrointestinal stromal tumor (GIST)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.11.2020
–
15.04.2021
Burosumab (3)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 18 years
100%
Hint for
minor additional benefit
repealed
( Orphan)
01.11.2020
–
15.04.2021
Bempedoinsäure / Ezetimib
Nustendi®
Daiichi Sankyo Deutschland GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
100%
no additional benefit
01.11.2020
–
15.04.2021
Bempedoinsäure
Nilemdo®
Daiichi Sankyo Deutschland GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
100%
no additional benefit
01.11.2020
–
15.04.2021
Semaglutid (2, reassessment)
Ozempic®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.10.2020
–
15.04.2021
Cannabidiol (4, reassessment)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
100%
Hint for
considerable additional benefit
( Orphan)
15.10.2020
–
15.04.2021
Cannabidiol (3, reassessment)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
100%
Hint for
considerable additional benefit
( Orphan)
15.10.2020
–
15.04.2021
Filgotinib
Jyseleca®
Gilead Sciences GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
33%
Hint for
minor additional benefit
01.10.2020
–
01.04.2021
Ibrutinib (7)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab
59%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.10.2020
–
01.04.2021
Durvalumab (2)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Small cell lung cancer (SCLC), first-line, combination with etoposide and either carboplatin or cisplatin
100%
Hint for
minor additional benefit
01.10.2020
–
01.04.2021
Sofosbuvir / Velpatasvir (2)
Epclusa®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, ≥ 6 to < 18 years
100%
no additional benefit
15.09.2020
–
04.03.2021
Belantamab-Mafodotin
Blenrep®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Multiple myeloma (MM), at least 4 prior therapies, monotherapy
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.09.2020
–
18.02.2021
Alpelisib
Piqray®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) with PIK3CA mutation, pre-treated patients, combination with fulvestrant
41%
no additional benefit
01.09.2020
–
18.02.2021
Bulevirtid
Hepcludex®
MYR GmbH
Infectious diseases
Chronic hepatitis Delta
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.09.2020
–
18.02.2021
Ivacaftor / Tezacaftor / Elexacaftor
Kaftrio®
Vertex Pharmaceuticals Ltd
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation)
100%
Indication of
major additional benefit
( Orphan (turnover limit))
01.09.2020
–
18.02.2021
Ivacaftor / Tezacaftor / Elexacaftor (2)
Kaftrio®
Vertex Pharmaceuticals Ltd
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation)
100%
Hint for
major additional benefit
( Orphan (turnover limit))
01.09.2020
–
18.02.2021
Ivacaftor (14)
Kalydeco®
Vertex Pharmaceuticals Ltd
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and MF mutation)
100%
Hint for
major additional benefit
( Orphan (turnover limit))
01.09.2020
–
18.02.2021
Ivacaftor (13)
Kalydeco®
Vertex Pharmaceuticals Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation)
100%
Indication of
major additional benefit
( Orphan (turnover limit))
01.09.2020
–
18.02.2021
Entrectinib (2)
Rozlytrek®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line
100%
no additional benefit
01.09.2020
–
18.02.2021
Entrectinib
Rozlytrek®
Roche Pharma AG
Oncological diseases
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
100%
no additional benefit
01.09.2020
–
18.02.2021
Ibalizumab
Trogarzo®
Theratechnologies Europe limited
Infectious diseases
Multidrug-resistant HIV infection
100%
no additional benefit
01.09.2020
–
18.02.2021
Secukinumab (6)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Plaque psoriasis (PP), ≥ 6 to < 18 years
100%
Hint for
minor additional benefit
01.09.2020
–
18.02.2021
Secukinumab (5)
Cosentyx®
Novartis Pharma GmbH
Musculoskeletal system diseases
Axial spondyloarthritis
100%
no additional benefit
01.09.2020
–
18.02.2021
Secukinumab (4, reassessment)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Psoriatic arthritis (PA)
35%
Indication of
minor additional benefit
15.08.2020
–
18.02.2021
Glasdegib
Daurismo®
Pfizer Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML), combination with cytarabine (LDAC)
100%
Hint for
considerable additional benefit
( Orphan)
15.08.2020
–
04.02.2021
Nintedanib (5, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Interstitial pulmonary disease with systemic sclerosis
100%
no additional benefit
15.08.2020
–
04.02.2021
Trifaroten
Selgamis®
Galderma Laboratorium GmbH
Skin diseases
Acne vulgaris, ≥ 12 years
100%
no additional benefit
15.08.2020
–
04.02.2021
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat
Enerzair® Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Bronchial asthma
100%
no additional benefit
15.08.2020
–
04.02.2021
Nintedanib (4, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Progressive fibrosing interstitial lung diseases
100%
Indication of
minor additional benefit
01.08.2020
–
21.01.2021
Ravulizumab (2)
Ultomiris®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Atypical hemolytic uremic syndrome (aHUS)
100%
no additional benefit
01.08.2020
–
21.01.2021
Sofosbuvir (3)
Sovaldi®
Gilead Sciences Ireland UC
Infectious diseases
Chronic hepatitis C, 3 to < 12 years
100%
Hint for
non-quantifiable additional benefit
01.08.2020
–
21.01.2021
Luspatercept (2)
Reblozyl®
Celgene GmbH
Hematopoietic diseases
Beta thalassemia
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.08.2020
–
21.01.2021
Luspatercept
Reblozyl®
Celgene GmbH
Hematopoietic diseases
Myelodysplastic syndrome (MDS)
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.08.2020
–
21.01.2021
Ledipasvir / Sofosbuvir (3)
Harvoni®
Gilead Sciences Ireland UC
Infectious diseases
Chronic hepatitis C, 3 to < 12 years
50%
Hint for
non-quantifiable additional benefit
01.08.2020
–
21.01.2021
Ixekizumab (4)
Taltz®
Lilly Deutschland GmbH
Skin diseases
Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg
100%
no additional benefit
01.08.2020
–
21.01.2021
Ixekizumab (3)
Taltz®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Axial spondyloarthritis
100%
no additional benefit
15.07.2020
–
07.01.2021
Osilodrostat
Isturisa®
Recordati Rare Diseases Germany GmbH
Metabolic diseases
Endogenous Cushing syndrome
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.07.2020
–
07.01.2021
Ozanimod
Zeposia®
Celgene GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
90%
Indication of
minor additional benefit
15.07.2020
–
07.01.2021
Caplacizumab (2)
Cablivi®
Sanofi-Aventis Deutschland GmbH
Hematopoietic diseases
Thrombotic thrombocytopenic purpura (aTTP)Thrombotic thrombocytopenic purpura (TTP), 12 to < 18 years
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.07.2020
–
17.12.2020
Encorafenib (2)
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Metastatic colorectal carcinoma (CRC)
100%
Hint for
considerable additional benefit
01.07.2020
–
17.12.2020
Fostamatinib
Tavlesse®
Grifols Deutschland GmbH
Hematopoietic diseases
Chronic immune thrombocytopenia
100%
no additional benefit
01.07.2020
–
17.12.2020
Ivacaftor (12)
Kalydeco®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), patients ≥ 6 months to < 18 years
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.07.2020
–
17.12.2020
Tezacaftor / Ivacaftor (3, reassessment >€50m)
Symkevi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del)
100%
no additional benefit
( Orphan (turnover limit))
01.07.2020
–
17.12.2020
Tezacaftor / Ivacaftor (2, reassessment >€50m)
Symkevi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del)
100%
no additional benefit
( Orphan (turnover limit))
15.06.2020
–
03.12.2020
Brentuximab Vedotin (5)
Adcetris®
Takeda GmbH
Oncological diseases
Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone
100%
Hint for
minor additional benefit
repealed
( Orphan)
15.06.2020
–
03.12.2020
Mogamulizumab
Poteligeo®
Kyowa Kirin GmbH
Oncological diseases
Mycosis Fungoides; Sézary Syndrome
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.06.2020
–
20.11.2020
Talazoparib
Talzenna®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC) BRCA1/2 mutation, HER2-
100%
Hint for
considerable additional benefit
01.06.2020
–
20.11.2020
Ponatinib (3, reassessment)
Iclusig®
Incyte Biosciences Germany GmbH
Oncological diseases
Chronic myeloid leukaemia (CML)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.06.2020
–
20.11.2020
Ponatinib (2, reassessment)
Iclusig®
Incyte Biosciences Germany GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.05.2020
–
05.11.2020
Naldemedin
Rizmoic®
Hexal AG
Digestive system diseases
Opioid-induced constipation
100%
no additional benefit
15.05.2020
–
05.11.2020
Apremilast (2)
Otezla®
Amgen GmbH
Other diseases
Behçet's disease
100%
no additional benefit
15.05.2020
–
05.11.2020
Enzalutamid (4, reassessment)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
100%
Indication of
minor additional benefit
15.05.2020
–
05.11.2020
Solriamfetol
Sunosi®
Jazz Pharmaceuticals
Nervous system diseases
Narcolepsy
100%
no additional benefit
01.05.2020
–
15.10.2020
Brigatinib (2)
Alunbrig®
Takeda GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients
50%
Hint for
considerable additional benefit
01.05.2020
–
15.10.2020
Darolutamid
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
100%
Indication of
considerable additional benefit
15.04.2020
–
15.10.2020
Venetoclax (4)
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab
100%
no additional benefit
15.04.2020
–
15.10.2020
Insulin glargin / Lixisenatid (2)
Suliqua®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors
100%
no additional benefit
15.04.2020
–
15.10.2020
Givosiran
Givlaari®
Alnylam Germany GmbH
Metabolic diseases
Acute hepatic porphyria, ≥ 12 years
100%
Indication of
considerable additional benefit
( Orphan)
01.04.2020
–
01.10.2020
Avelumab (3, reassessment)
Bavencio®
Merck Serono GmbH
Oncological diseases
Metastatic Merkel-cell carcinoma (MCC)
100%
no additional benefit
01.04.2020
–
01.10.2020
Trifluridin / Tipiracil (3, reassessment)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC), pre-treated patients
100%
Hint for
minor additional benefit
01.04.2020
–
01.10.2020
Apalutamid (3, reassessment)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
100%
Indication of
minor additional benefit
01.04.2020
–
01.10.2020
Cobicistat (2)
Tybost®
Gilead Sciences GmbH
Infectious diseases
HIV infection, combination with atazanavir or darunavir, 12 to < 18 years
100%
no additional benefit
15.03.2020
–
17.09.2020
Tisagenlecleucel (3, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
15.03.2020
–
17.09.2020
Tisagenlecleucel (4, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
01.07.2020
–
03.09.2020
Indacaterol / Mometason
Atectura® Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Bronchial asthma
100%
no additional benefit
15.03.2020
–
03.09.2020
Brolucizumab
Beovu®
Novartis Pharma GmbH
Eye diseases
Neovascular age-related macular degeneration
100%
no additional benefit
repealed
15.03.2020
–
03.09.2020
Fidaxomicin (2)
Dificlir®
Astellas Pharma GmbH
Infectious diseases
Clostridioides difficile infection, children and adolescents
54%
Hint for
considerable additional benefit
15.03.2020
–
03.09.2020
Romosozumab
Evenity®
UCB Pharma GmbH
Musculoskeletal system diseases
Osteoporosis (postmenopausal)
100%
Indication of
minor additional benefit
15.03.2020
–
03.09.2020
Riociguat (2, reassessment >€50m)
Adempas®
MSD Sharp & Dohme GmbH
Cardiovascular diseases
Chronic thromboembolic pulmonary hypertension
100%
no additional benefit
( Orphan (turnover limit))
15.03.2020
–
03.09.2020
Riociguat (3, reassessment >€50m)
Adempas®
MSD Sharp & Dohme GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
100%
no additional benefit
( Orphan (turnover limit))
15.03.2020
–
03.09.2020
Abemaciclib (3, reassessment)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Mammary carcinoma, HR+, HER2-, combination with fulvestrant
39%
Hint for
minor additional benefit
repealed subpopulations
01.03.2020
–
20.08.2020
Tafamidis (2)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid cardiomyopathy
100%
Hint for
considerable additional benefit
repealed
( Orphan)
01.03.2020
–
20.08.2020
Apalutamid (2)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), hormone-sensitive, combination with androgen deprivation therapy
100%
no additional benefit
01.03.2020
–
20.08.2020
Ribociclib (3, reassessment)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, combination with fulvestrant
58%
Indication of
minor additional benefit
01.03.2020
–
20.08.2020
Ribociclib (4, reassessment)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, combination with aromatase inhibitor
100%
Hint for
minor additional benefit
15.02.2020
–
20.08.2020
Polatuzumab Vedotin
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.02.2020
–
20.08.2020
Siponimod
Mayzent®
Novartis Pharma GmbH
Nervous system diseases
Secondary progressive multiple sclerosis (MS)
100%
no additional benefit
15.02.2020
–
20.08.2020
Bedaquilin (2)
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.02.2020
–
20.08.2020
Daratumumab (5)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
100%
Hint for
minor additional benefit
repealed
( Orphan (turnover limit))
15.02.2020
–
20.08.2020
Daratumumab (4)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
15.02.2020
–
20.08.2020
Ramucirumab (6)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
100%
no additional benefit
01.02.2020
–
16.07.2020
Dulaglutid (2, reassessment)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
31%
Hint for
minor additional benefit
01.02.2020
–
16.07.2020
Upadacitinib
Rinvoq®
AbbVie Deutschland GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
34%
Hint for
considerable additional benefit
15.01.2020
–
02.07.2020
Trastuzumab Emtansin (2)
Kadcyla®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) early stage, HER2+, adjuvant treatment
100%
Indication of
minor additional benefit
15.12.2019
–
04.06.2020
Ivacaftor (11)
Kalydeco®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), ≥ 6 to < 12 months
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.12.2019
–
14.05.2020
Neratinib
Nerlynx®
Pierre Fabre Pharma
Oncological diseases
Breast cancer (BC) HR+, HER2+, adjuvant therapy
100%
Hint for
minor additional benefit
01.12.2019
–
14.05.2020
Gilteritinib
XOSPATA®
Astellas Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML), FLT3 mutation
100%
Hint for
considerable additional benefit
( Orphan)
01.12.2019
–
14.05.2020
Avelumab (2)
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with axitinib
23%
Hint for
considerable additional benefit
01.12.2019
–
14.05.2020
Dupilumab (4)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Chronic rhinosinusitis with nasal polyps
100%
Indication of
considerable additional benefit
01.12.2019
–
14.05.2020
Pembrolizumab (13)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy
100%
Indication of
minor additional benefit
01.12.2019
–
14.05.2020
Pembrolizumab (12)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy
100%
Hint for
considerable additional benefit
01.12.2019
–
14.05.2020
Pembrolizumab (11)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with axitinib
23%
Indication of
considerable additional benefit
15.11.2019
–
14.05.2020
Belimumab (2)
Benlysta®
GlaxoSmithKline GmbH & Co. KG
Musculoskeletal system diseases
Systemic lupus erythematosus
100%
Hint for
non-quantifiable additional benefit
15.11.2019
–
14.05.2020
Betibeglogene autotemcel
Zynteglo®
bluebird bio (Germany) GmbH
Hematopoietic diseases
Beta thalassemia
100%
Hint for
non-quantifiable additional benefit
( Orphan)
15.10.2019
–
02.04.2020
Cannabidiol (2)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
15.10.2019
–
02.04.2020
Niraparib (2, reassessment >€50m)
Zejula®
TESARO Bio Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
100%
no additional benefit
repealed
( Orphan (turnover limit))
15.10.2019
–
02.04.2020
Cannabidiol
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
15.10.2019
–
02.04.2020
Larotrectinib
Vitrakvi®
Bayer Vital GmbH
Oncological diseases
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
100%
no additional benefit
01.10.2019
–
02.04.2020
Atezolizumab (4)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with bevacizumab, paclitaxel and carboplatin; maintenance therapy
100%
no additional benefit
15.10.2019
–
02.04.2020
Trifluridin / Tipiracil (2)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Metastatic gastric cancer, pre-treated patients
100%
Indication of
minor additional benefit
15.10.2019
–
02.04.2020
Asfotase alfa (2, reassessment >€50m)
Strensiq®
Alexion Pharma Germany GmbH
Metabolic diseases
Hypophosphatasia (HPP)
0.8%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.10.2019
–
02.04.2020
Atezolizumab (6)
Tecentriq®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), triple-negative, PD-L1 expression ≥1%
100%
Hint for
non-quantifiable additional benefit
01.10.2019
–
02.04.2020
Atezolizumab (5)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with nab-paclitaxel and carboplatin; maintenance therapy
100%
no additional benefit
15.10.2019
–
02.04.2020
Atezolizumab (7)
Tecentriq®
Roche Pharma AG
Oncological diseases
Small cell lung cancer (SCLC), first-line, combination with carboplatin and etoposide; maintenance therapy
100%
Hint for
minor additional benefit
01.10.2019
–
02.04.2020
Elotuzumab (2)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
100%
Hint for
considerable additional benefit
repealed
01.10.2019
–
02.04.2020
Burosumab (2, reassessment)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
100%
Hint for
non-quantifiable additional benefit
repealed
( Orphan)
15.09.2019
–
05.03.2020
Ropeginterferon alfa-2b
Besremi®
AOP Orphan Pharmaceuticals AG
Oncological diseases
Polycythemia vera
100%
no additional benefit
01.09.2019
–
20.02.2020
Ivacaftor (10)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), 12 ro < 24 months
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ivacaftor (9, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation
100%
Hint for
minor additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ivacaftor (8, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 2 to 5 years
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ivacaftor (7, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), various gating mutations, ≥ 6 years
100%
Hint for
non-quantifiable additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ivacaftor (6, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor
100%
no additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ivacaftor (5, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor
100%
no additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ivacaftor (4, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
86%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ramucirumab (5)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
100%
Proof of
minor additional benefit
01.09.2019
–
20.02.2020
Dupilumab (2)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Bronchial asthma, ≥ 12 years
100%
no additional benefit
01.09.2019
–
20.02.2020
Dupilumab (3)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis (AD), 12 to < 18 years
100%
Hint for
non-quantifiable additional benefit
01.09.2019
–
20.02.2020
Andexanet alfa
Ondexxya®
Portola Deutschland GmbH
Hematopoietic diseases
Antidote for reversal of anticoagulation (factor Xa)
100%
no additional benefit
01.09.2019
–
20.02.2020
Ibrutinib (5)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab
26%
Hint for
minor additional benefit
( Orphan (turnover limit))
01.09.2019
–
20.02.2020
Ibrutinib (6)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Waldenström's disease, combination with rituximab
100%
no additional benefit
( Orphan (turnover limit))
15.08.2019
–
20.02.2020
Volanesorsen
Waylivra®
Akcea Therapeutics Germany GmbH
Metabolic diseases
Chylomicronaemia syndrome
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.08.2019
–
06.02.2020
Turoctocog alfa pegol
Esperoct®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia A
100%
no additional benefit
01.08.2019
–
06.02.2020
Dolutegravir / Lamivudin
Dovato®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 12 years
100%
no additional benefit
01.08.2019
–
06.02.2020
Ravulizumab
Ultomiris®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Paroxysmal hemoglobinuria
100%
no additional benefit
01.08.2019
–
06.02.2020
Cemiplimab
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Squamous cell carcinoma (SCC)
100%
no additional benefit
15.07.2019
–
16.01.2020
Olaparib (3)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Breast cancer (BC) BRCA1/2 mutations, HER2-
100%
Hint for
minor additional benefit
15.07.2019
–
16.01.2020
Olaparib (4)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy
100%
no additional benefit
repealed
01.07.2019
–
19.12.2019
Vigabatrin
Kigabeq®
Desitin GmbH
Nervous system diseases
Epilepsy, West syndrome, < 7 years
100%
no additional benefit
01.07.2019
–
19.12.2019
Vigabatrin (2)
Kigabeq®
Desitin GmbH
Nervous system diseases
Epilepsy, focal seizures, < 7 years
100%
no additional benefit
01.07.2019
–
19.12.2019
Pegvaliase
Palynziq®
BioMarin International Limited
Metabolic diseases
Phenylketonuria
100%
Hint for
non-quantifiable additional benefit
( Orphan)
01.07.2019
–
19.12.2019
Dapagliflozin / Metformin (3, reassessment)
Xigduo®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
50%
Hint for
minor additional benefit
01.07.2019
–
19.12.2019
Dapagliflozin (4, reassessment)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
41%
Hint for
minor additional benefit
15.06.2019
–
05.12.2019
Pomalidomid (3)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone
100%
no additional benefit
( Orphan (turnover limit))
01.06.2019
–
22.11.2019
Empagliflozin / Linagliptin
Glyxambi®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.06.2019
–
22.11.2019
Risankizumab
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Plaque psoriasis (PP)
82%
Proof of
considerable additional benefit
01.06.2019
–
22.11.2019
Lorlatinib
Lorviqua®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
100%
no additional benefit
15.05.2019
–
07.11.2019
Fremanezumab
Ajovy®
Teva GmbH
Nervous system diseases
Migraine prophylaxis
1.0%
Hint for
considerable additional benefit
01.05.2019
–
17.10.2019
Dacomitinib
Vizimpro®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
100%
no additional benefit
01.05.2019
–
17.10.2019
Lisdexamfetamindimesilat (2, Elvanse Adult®)
Elvanse Adult®
Shire Deutschland GmbH
Mental illnesses
Attention deficit hyperactivity disorder (ADHD), ≥ 18 years
100%
no additional benefit
01.05.2019
–
17.10.2019
Dapagliflozin (3)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 1
100%
Hint for
minor additional benefit
repealed
15.04.2019
–
17.10.2019
Radium-223-dichlorid (2, reassessment)
Xofigo®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC)
100%
no additional benefit
15.04.2019
–
17.10.2019
Voretigen Neparvovec
Luxturna®
Novartis Pharma GmbH
Eye diseases
Hereditary retinal dystrophy
100%
Hint for
considerable additional benefit
repealed
( Orphan)
15.04.2019
–
17.10.2019
Glecaprevir / Pibrentasvir (2)
Maviret®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C, 12 to < 18 years
100%
no additional benefit
15.04.2019
–
17.10.2019
Nintedanib (3, reassessment >€50m, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Idiopathic pulmonary fibrosis
100%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.04.2019
–
19.09.2019
Pembrolizumab (10)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel
71%
Hint for
considerable additional benefit
01.04.2019
–
19.09.2019
Pembrolizumab (9)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy
100%
Hint for
non-quantifiable additional benefit
01.04.2019
–
19.09.2019
Pembrolizumab (8)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, adjuvant therapy
100%
Indication of
non-quantifiable additional benefit
01.04.2019
–
19.09.2019
Galcanezumab
Emgality®
Lilly Deutschland GmbH
Nervous system diseases
Migraine prophylaxis
1.0%
Hint for
considerable additional benefit
15.03.2019
–
05.09.2019
Brentuximab Vedotin (4)
Adcetris®
Takeda Pharma GmbH
Oncological diseases
Hodgkin lymphoma (HL), CD30+, first-line
100%
non-quantifiable additional benefit
( Orphan)
15.03.2019
–
05.09.2019
Emicizumab (2)
Hemlibra®
Roche Pharma AG
Hematopoietic diseases
Hemophilia A, without factor VIII inhibitors
100%
no additional benefit
01.03.2019
–
19.08.2019
Regadenoson (2)
Rapiscan®
GE Healthcare Buchler GmbH & Co. KG
Other diseases
Stenosis, Fractional Flow Reserve Measurement (FFR)
100%
no additional benefit
repealed
01.03.2019
–
15.08.2019
Rucaparib
Rubraca®
Clovis Oncology Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, after at least 2 previous therapies
100%
no additional benefit
repealed
01.03.2019
–
15.08.2019
Rucaparib (2)
Rubraca®
Clovis Oncology Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
100%
no additional benefit
repealed
15.02.2019
–
15.08.2019
Blinatumomab (3)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients
100%
non-quantifiable additional benefit
( Orphan)
15.02.2019
–
15.08.2019
Lumacaftor / Ivacaftor (3)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, 2 to 5 years
100%
Hint for
non-quantifiable additional benefit
repealed
15.02.2019
–
15.08.2019
Blinatumomab (4)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years
100%
non-quantifiable additional benefit
( Orphan)
15.02.2019
–
15.08.2019
Lenvatinib (4, reassessment)
Lenvima®
Eisai GmbH
Oncological diseases
Thyroid carcinoma (DTC)
100%
no additional benefit
15.02.2019
–
15.08.2019
Ipilimumab (5)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with nivolumab
100%
Indication of
considerable additional benefit
15.02.2019
–
15.08.2019
Nivolumab (12)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with ipilimumab
100%
Indication of
considerable additional benefit
01.02.2019
–
01.08.2019
Mexiletin
Namuscla®
Lupin Europe GmbH
Nervous system diseases
Myotonia
100%
non-quantifiable additional benefit
( Orphan)
01.02.2019
–
01.08.2019
Apalutamid
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
100%
Hint for
minor additional benefit
repealed
01.02.2019
–
01.08.2019
Lanadelumab
Takhzyro®
Shire Deutschland GmbH, Teil der Takeda Group
Other diseases
Hereditary angioedema (HAE)
100%
considerable additional benefit
repealed
( Orphan)
15.01.2019
–
04.07.2019
Doravirin
Pifeltro®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection
100%
no additional benefit
15.01.2019
–
04.07.2019
Doravirin / Lamivudin / Tenofovirdisoproxil
Delstrigo®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection
100%
no additional benefit
15.01.2019
–
04.07.2019
Glycerolphenylbutyrat (2)
Ravicti®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Urea cycle disorders (UCD), 0 to < 2 months
100%
non-quantifiable additional benefit
( Orphan)
15.01.2019
–
04.07.2019
Brigatinib
Alunbrig®
Takeda Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
100%
no additional benefit
15.01.2019
–
04.07.2019
Bedaquilin
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis
100%
considerable additional benefit
repealed
( Orphan)
15.01.2019
–
04.07.2019
Melatonin
Slenyto®
InfectoPharm Arzneimittel und Consilium GmbH
Nervous system diseases
Sleep disorders
100%
Hint for
minor additional benefit
15.01.2019
–
04.07.2019
Ribociclib (2)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor
100%
no additional benefit
repealed subpopulations
01.01.2019
–
20.06.2019
Damoctocog alfa pegol
Jivi®
Bayer Vital GmbH
Hematopoietic diseases
Hemophilia A, ≥ 12 years
100%
no additional benefit
01.01.2019
–
20.06.2019
Pembrolizumab (7, reassessment)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC), CPS ≥ 10, first-line
100%
no additional benefit
repealed
01.01.2019
–
20.06.2019
Fingolimod (5)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Multiple sclerosis (MS), ≥ 10 to < 18 years
57%
Hint for
non-quantifiable additional benefit
01.01.2019
–
20.06.2019
Atezolizumab (3, reassessment)
Tecentriq®
Roche Pharma AG
Oncological diseases
Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line
100%
no additional benefit
15.12.2018
–
06.06.2019
Cabozantinib (5, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
100%
Hint for
minor additional benefit
01.12.2018
–
16.05.2019
Tezacaftor / Ivacaftor
Symkevi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, ≥ 12 years
91%
considerable additional benefit
repealed
( Orphan)
01.12.2018
–
16.05.2019
Enzalutamid (3)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
100%
no additional benefit
repealed
01.12.2018
–
16.05.2019
Venetoclax (2)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), combination with rituximab
37%
Indication of
minor additional benefit
01.12.2018
–
16.05.2019
Venetoclax (3, reassessment)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), monotherapy
100%
no additional benefit
01.12.2018
–
16.05.2019
Insulin degludec (4, reassessment)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.11.2018
–
02.05.2019
Fluticasonfuroat / Umeclidinium / Vilanterol (2)
Trelegy Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD), inadequate control with LAMA and LABA
100%
no additional benefit
15.11.2018
–
02.05.2019
Tildrakizumab
Ilumetri®
Almirall Hermal GmbH
Skin diseases
Plaque psoriasis (PP)
100%
no additional benefit
01.11.2018
–
02.05.2019
Alirocumab (2, reassessment)
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolemia or mixed dyslipidaemia
100%
no additional benefit
01.11.2018
–
02.05.2019
Axicabtagen-Ciloleucel (2)
Yescarta®
Kite, Gilead company
Oncological diseases
Primary mediastinal large B-cell lymphoma (PMBCL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.11.2018
–
02.05.2019
Axicabtagen-Ciloleucel
Yescarta®
Kite, Gilead company
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.11.2018
–
02.05.2019
Abemaciclib (2)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with fulvestrant
100%
no additional benefit
repealed subpopulations
01.11.2018
–
02.05.2019
Abemaciclib
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with aromatase inhibitor
100%
no additional benefit
repealed subpopulations
01.11.2018
–
02.05.2019
Semaglutid
Ozempic®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
37%
Hint for
minor additional benefit
repealed
01.11.2018
–
02.05.2019
Erenumab
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
1.0%
Hint for
considerable additional benefit
repealed subpopulations
15.10.2018
–
04.04.2019
Pembrolizumab (6)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Squamous cell carcinoma head and neck
100%
no additional benefit
15.10.2018
–
04.04.2019
Ocriplasmin (2, reassessment)
Jetrea®
Oxurion NV
Eye diseases
Vitreomacular traction (VMT)
94%
Hint for
minor additional benefit
15.10.2018
–
04.04.2019
Durvalumab
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), maintenance therapy
100%
Hint for
considerable additional benefit
01.10.2018
–
22.03.2019
Trametinib (3)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Melanoma, in combination with dabrafenib, BRAF V600 mutation, adjuvant therapy
100%
Indication of
considerable additional benefit
01.10.2018
–
22.03.2019
Dabrafenib (4)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with trametinib, adjuvant therapy
100%
Indication of
considerable additional benefit
01.10.2018
–
22.03.2019
Patisiran
Onpattro®
Alnylam Germany GmbH
Metabolic diseases
Amyloidosis
100%
considerable additional benefit
( Orphan)
01.10.2018
–
22.03.2019
Inotersen
Tegsedi®
Akcea Therapeutics Germany GmbH
Metabolic diseases
Amyloidosis
100%
non-quantifiable additional benefit
( Orphan)
01.10.2018
–
22.03.2019
Metreleptin
Myalepta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Lipodystrophy
100%
non-quantifiable additional benefit
( Orphan)
01.10.2018
–
22.03.2019
Binimetinib
Mektovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with encorafenib
100%
no additional benefit
01.10.2018
–
22.03.2019
Encorafenib
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with binimetinib
100%
no additional benefit
01.10.2018
–
22.03.2019
Palbociclib (2, reassessment)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC), patient population b1 and b2
100%
no additional benefit
01.10.2018
–
22.03.2019
Lenvatinib (3)
Lenvima®
Eisai GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
100%
no additional benefit
01.10.2018
–
22.03.2019
Daunorubicin / Cytarabin (liposomale Formulierung)
Vyxeos® liposomal
Jazz Pharmaceuticals
Oncological diseases
Therapy-related acute myeloid leukaemia (AML); acute myeloid leukaemia (AML) with multilinear dysplasia
100%
considerable additional benefit
( Orphan)
01.10.2018
–
22.03.2019
Mepolizumab (2)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma, ≥ 6 to < 18 years
100%
no additional benefit
01.10.2018
–
22.03.2019
Sitagliptin (3, reassessment)
Januvia®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with metformin
100%
Hint for
minor additional benefit
01.10.2018
–
22.03.2019
Tenofoviralafenamid (2, reassessment)
Vemlidy®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis B, ≥ 12 years
100%
no additional benefit
01.10.2018
–
22.03.2019
Caplacizumab
Cablivi®
Sanofi-Aventis Deutschland GmbH
Hematopoietic diseases
Thrombotic thrombocytopenic purpura (TTP)
100%
non-quantifiable additional benefit
( Orphan)
01.10.2018
–
22.03.2019
Vestronidase alfa
Mepsevii®
Ultragenyx Germany GmbH
Metabolic diseases
Mucopolysaccharidosis (MPS VII; Sly syndrome)
100%
non-quantifiable additional benefit
( Orphan)
01.10.2018
–
22.03.2019
Daratumumab (3)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone
100%
Hint for
considerable additional benefit
( Orphan (turnover limit))
15.09.2018
–
07.03.2019
Tisagenlecleucel
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.09.2018
–
07.03.2019
Tisagenlecleucel (2)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.09.2018
–
21.02.2019
Tofacitinib (4)
Xeljanz®
Pfizer Pharma GmbH
Skin diseases
Psoriatic arthritis (PA)
69%
Hint for
minor additional benefit
01.09.2018
–
21.02.2019
Tofacitinib (3)
Xeljanz®
Pfizer Pharma GmbH
Digestive system diseases
Ulcerative colitis
100%
no additional benefit
01.09.2018
–
21.02.2019
Nivolumab (11)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy
100%
Hint for
non-quantifiable additional benefit
repealed
01.09.2018
–
21.02.2019
Gemtuzumab Ozogamicin
Mylotarg®
Pfizer Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
100%
non-quantifiable additional benefit
( Orphan)
01.09.2018
–
21.02.2019
Bosutinib (3, reassessment)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+
100%
no additional benefit
01.09.2018
–
21.02.2019
Ingenolmebutat (2, reassessment)
Picato®
LEO Pharma GmbH
Skin diseases
Actinic keratosis (AK)
50%
Hint for
non-quantifiable additional benefit
repealed
01.08.2018
–
17.01.2019
Brivaracetam (2)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, add-on therapy, 4 to < 16 years
100%
no additional benefit
15.07.2018
–
17.01.2019
Osimertinib (3)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
84%
Hint for
considerable additional benefit
01.07.2018
–
20.12.2018
Ipilimumab (4)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, combination with nivolumab
85%
no additional benefit
15.06.2018
–
20.12.2018
Nivolumab (10, reassessment)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
100%
Indication of
less benefit
01.07.2018
–
20.12.2018
Pertuzumab (3)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), early with high risk of recurrence, adjuvant, combination with trastuzumab and chemotherapy
100%
Indication of
minor additional benefit
repealed
01.07.2018
–
20.12.2018
Bictegravir / Emtricitabin / Tenofoviralafenamid
Biktarvy®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
01.07.2018
–
20.12.2018
Velmanase alfa
Lamzede®
Chiesi GmbH
Metabolic diseases
Alpha mannosidosis
100%
non-quantifiable additional benefit
( Orphan)
15.06.2018
–
06.12.2018
Olaparib (2, reassessment)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy
100%
Hint for
minor additional benefit
15.06.2018
–
06.12.2018
Cabozantinib (4, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carciRenal cell carcinoma (RCC), first-linenoma (RCC)
100%
no additional benefit
15.06.2018
–
06.12.2018
Dolutegravir / Rilpivirin
Juluca®
ViiV Healthcare GmbH
Infectious diseases
HIV infection
100%
no additional benefit
01.06.2018
–
22.11.2018
Bosutinib (2)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, first-line
100%
no additional benefit
repealed
01.06.2018
–
22.11.2018
Darvadstrocel
Alofisel®
Takeda Pharma Vertrieb GmbH & Co. KG
Digestive system diseases
Anal fistulas in Crohn's disease
100%
non-quantifiable additional benefit
( Orphan)
01.05.2018
–
01.11.2018
Extrakt aus Cannabis Sativa (2, reassessment)
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
100%
Indication of
minor additional benefit
01.05.2018
–
01.11.2018
Tofacitinib (2, reassessment)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
100%
no additional benefit
repealed
15.05.2018
–
01.11.2018
Rurioctocog alfa pegol
Adynovi®
Shire Deutschland GmbH
Hematopoietic diseases
Hemophilia A, ≥ 12 years
100%
no additional benefit
15.05.2018
–
01.11.2018
Hydrocortison
Alkindi®
Diurnal Ltd.
Metabolic diseases
Adrenal insufficiency, < 18 years
100%
no additional benefit
15.05.2018
–
01.11.2018
Ertugliflozin / Sitagliptin
Steglujan®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.04.2018
–
04.10.2018
Cariprazin
Reagila®
Recordati Pharma GmbH
Mental illnesses
Schizophrenia
21%
Indication of
minor additional benefit
15.04.2018
–
04.10.2018
Burosumab
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.04.2018
–
20.09.2018
Bezlotoxumab
Zinplava®
MSD Sharp & Dohme GmbH
Infectious diseases
Prevention of recurrent Clostridium difficile infection
100%
Indication of
minor additional benefit
01.04.2018
–
20.09.2018
Emicizumab
Hemlibra®
Roche Pharma AG
Hematopoietic diseases
Hemophilia A
50%
Hint for
non-quantifiable additional benefit
01.04.2018
–
20.09.2018
Patiromer
Veltassa®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Hyperkalemia
100%
no additional benefit
01.04.2018
–
20.09.2018
Glycopyrroniumbromid
Sialanar®
Proveca Limited
Other diseases
Sialorrhea
100%
Hint for
non-quantifiable additional benefit
15.03.2018
–
06.09.2018
Evolocumab (2, reassessment)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
100%
no additional benefit
01.03.2018
–
16.08.2018
Fluticasonfuroat / Umeclidinium / Vilanterol
Trelegy Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
100%
no additional benefit
01.03.2018
–
16.08.2018
Glycerolphenylbutyrat
Ravicti®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Urea cycle disorders (UCD), ≥ 2 months
100%
non-quantifiable additional benefit
( Orphan)
01.03.2018
–
16.08.2018
Ixekizumab (2)
Taltz®
Lilly Deutschland GmbH
Skin diseases
Psoriatic arthritis (PA)
35%
Hint for
minor additional benefit
01.03.2018
–
16.08.2018
Insulin glargin / Lixisenatid
Suliqua®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.02.2018
–
02.08.2018
Sonidegib
Odomzo®
Sun Pharmaceuticals Germany GmbH
Oncological diseases
Basal cell carcinoma (BCC)
100%
no additional benefit
15.02.2018
–
02.08.2018
Benralizumab
Fasenra®
AstraZeneca GmbH
Respiratory system diseases
Bronchial asthma
50%
Hint for
minor additional benefit
15.02.2018
–
02.08.2018
Letermovir
Prevymis®
MSD Sharp & Dohme GmbH
Infectious diseases
Cytomegalovirus infection
100%
non-quantifiable additional benefit
( Orphan)
15.02.2018
–
02.08.2018
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment)
Relvar® Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma
resolution w/o assessement
15.02.2018
–
02.08.2018
Ipilimumab (3)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, ≥ 12 to < 18 years
100%
no additional benefit
01.02.2018
–
02.08.2018
Ocrelizumab
Ocrevus®
Roche Pharma AG
Nervous system diseases
Multiple sclerosis (MS)
81%
Proof of
minor additional benefit
01.02.2018
–
02.08.2018
Lumacaftor / Ivacaftor (2)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in CFTR gene, ≥ 6 years
100%
Hint for
non-quantifiable additional benefit
15.01.2018
–
05.07.2018
Brentuximab Vedotin (3)
Adcetris®
Takeda Pharma GmbH
Oncological diseases
Cutaneous T-cell lymphoma, CD30+
100%
minor additional benefit
( Orphan)
15.01.2018
–
05.07.2018
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2)
Genvoya®
Gilead Sciences GmbH
Infectious diseases
HIV infection, 6 to < 12 years
100%
no additional benefit
15.01.2018
–
05.07.2018
Allogene, genetisch modifizierte T-Zellen
Zalmoxis®
Dompé farmaceutici S.p.A
Oncological diseases
Haematological malignancies, concomitant therapy in haploidentical haematopoietic stem cell transplantation
100%
non-quantifiable additional benefit
( Orphan)
01.01.2018
–
21.06.2018
Alectinib (2)
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
100%
Hint for
non-quantifiable additional benefit
01.01.2018
–
21.06.2018
Dapagliflozin / Metformin (2, reassessment)
Xigduo®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed
01.01.2018
–
21.06.2018
Dapagliflozin (2, reassessment)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed
15.12.2017
–
07.06.2018
Abirateronacetat (3)
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), high-risk, combination with androgen deprivation therapy
100%
Indication of
considerable additional benefit
15.12.2017
–
07.06.2018
Niraparib
Zejula®
TESARO Bio Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.12.2017
–
17.05.2018
Cladribin
Mavenclad®
Merck Serono GmbH
Nervous system diseases
Highly active relapsing multiple sclerosis (MS)
100%
no additional benefit
01.12.2017
–
17.05.2018
Dupilumab
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis (AD)
100%
Indication of
considerable additional benefit
01.12.2017
–
17.05.2018
Guselkumab
Tremfya®
Janssen-Cilag GmbH
Skin diseases
Plaque psoriasis (PP)
45%
Proof of
considerable additional benefit
01.12.2017
–
17.05.2018
Perampanel (3)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years
100%
no additional benefit
15.11.2017
–
03.05.2018
Cenegermin
Oxervate®
Dompé farmaceutici S.p.A
Eye diseases
Keratitis
100%
non-quantifiable additional benefit
( Orphan)
15.11.2017
–
03.05.2018
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2)
Stribild®
Gilead Sciences GmbH
Infectious diseases
HIV infection, 12 to < 18 years
100%
no additional benefit
01.11.2017
–
19.04.2018
Tivozanib
Fotivda®
EUSA Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC)
100%
no additional benefit
01.11.2017
–
19.04.2018
Nonacog beta pegol
Refixia®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia B, ≥ 12 years
100%
no additional benefit
15.10.2017
–
05.04.2018
Cabozantinib (3, reassessment, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after VEGF pre-therapy
100%
Indication of
minor additional benefit
15.10.2017
–
05.04.2018
Telotristatethyl
Xermelo®
Ipsen Pharma GmbH
Oncological diseases
Carcinoid tumor, neuroendocrine tumors, combination with SAA therapy
100%
non-quantifiable additional benefit
( Orphan)
15.10.2017
–
05.04.2018
Midostaurin
Rydapt®
Novartis Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML); Systemic mastocytosis (ASM)
80%
considerable additional benefit
repealed
( Orphan)
15.10.2017
–
05.04.2018
Obinutuzumab (3)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), first-line
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.10.2017
–
05.04.2018
Sofosbuvir (2)
Sovaldi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, 12 to < 18 years
100%
Hint for
non-quantifiable additional benefit
15.09.2017
–
16.03.2018
Ribociclib
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, postmenopausal women, combination with aromatase inhibitor
100%
no additional benefit
repealed
15.09.2017
–
16.03.2018
Pembrolizumab (5)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC)
61%
Indication of
considerable additional benefit
repealed subpopulations
15.09.2017
–
16.03.2018
Elosulfase alfa (2, reassessment)
Vimizim®
BioMarin Deutschland GmbH
Metabolic diseases
Mucopolysaccharidosis (type IVA)
100%
minor additional benefit
( Orphan)
01.10.2017
–
16.03.2018
Atezolizumab
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
40%
Indication of
considerable additional benefit
01.10.2017
–
16.03.2018
Atezolizumab (2)
Tecentriq®
Roche Pharma AG
Oncological diseases
Urothelial carcinoma (UC), first-line
61%
Hint for
minor additional benefit
repealed subpopulations
01.10.2017
–
16.03.2018
Avelumab
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Merkel-cell carcinoma (MCC)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.10.2017
–
16.03.2018
Dimethylfumarat (2, Skilarence®)
Skilarence®
Almirall Hermal GmbH
Skin diseases
Plaque psoriasis (PP)
100%
no additional benefit
01.10.2017
–
16.03.2018
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid
Symtuza®
Janssen-Cilag GmbH
Infectious diseases
HIV infection
100%
no additional benefit
01.09.2017
–
01.03.2018
Brodalumab
Kyntheum®
LEO Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
45%
Indication of
non-quantifiable additional benefit
15.08.2017
–
15.02.2018
Carfilzomib (3, reassessment >€50m)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone
100%
Hint for
considerable additional benefit
( Orphan (turnover limit))
15.08.2017
–
15.02.2018
Sarilumab
Kevzara®
Sanofi-Aventis Deutschland GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
34%
Hint for
considerable additional benefit
15.08.2017
–
15.02.2018
Sofosbuvir / Velpatasvir / Voxilaprevir
Vosevi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
100%
no additional benefit
15.08.2017
–
15.02.2018
Daratumumab (2, reassessment >€50m)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), monotherapy; multiple myeloma, at least 1 prior therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
72%
Indication of
considerable additional benefit
repealed subpopulations
( Orphan (turnover limit))
15.08.2017
–
15.02.2018
Ledipasvir / Sofosbuvir (2)
Harvoni®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, 12 to < 18 years
50%
Hint for
non-quantifiable additional benefit
01.08.2017
–
01.02.2018
Saxagliptin / Metformin (4)
Komboglyze®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy other than insulin and sulphonylurea
100%
no additional benefit
01.08.2017
–
01.02.2018
Glecaprevir / Pibrentasvir
Maviret®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C
100%
no additional benefit
01.08.2017
–
01.02.2018
Ceritinib (3)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
100%
no additional benefit
15.07.2017
–
18.01.2018
Inotuzumab Ozogamicin
Besponsa®
Pfizer Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
100%
minor additional benefit
( Orphan)
01.07.2017
–
21.12.2017
Nivolumab (9)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma (UC)
100%
no additional benefit
01.07.2017
–
21.12.2017
Nusinersen
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
10%
major additional benefit
repealed
( Orphan)
01.07.2017
–
21.12.2017
Cerliponase alfa
Brineura®
BioMarin Deutschland GmbH
Metabolic diseases
Neuronal ceroid lipofuscinosis type 2
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.06.2017
–
07.12.2017
Blinatumomab (2, reassessment)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
100%
considerable additional benefit
( Orphan)
15.06.2017
–
07.12.2017
Nivolumab (8, reassessment)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
100%
no additional benefit
repealed
01.06.2017
–
17.11.2017
Etelcalcetid
Parsabiv®
Amgen GmbH
Metabolic diseases
Secondary hyperparathyroidism (HPT)
100%
no additional benefit
01.06.2017
–
17.11.2017
Nivolumab (7)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma head and neck
77%
Hint for
considerable additional benefit
01.06.2017
–
17.11.2017
Rolapitant
Varuby®
TESARO Bio Germany GmbH
Other diseases
Nausea and vomiting due to chemotherapy
100%
no additional benefit
01.06.2017
–
17.11.2017
Pembrolizumab (4)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Hodgkin lymphoma (HL)
100%
no additional benefit
01.05.2017
–
19.10.2017
Dabrafenib (3)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation, combination with trametinib
100%
no additional benefit
01.05.2017
–
19.10.2017
Trametinib (2)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation
100%
no additional benefit
01.05.2017
–
19.10.2017
Tofacitinib
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
100%
no additional benefit
repealed
01.05.2017
–
19.10.2017
Alectinib
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
81%
Hint for
minor additional benefit
01.05.2017
–
19.10.2017
Osimertinib (2, reassessment)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation
100%
Hint for
considerable additional benefit
01.04.2017
–
21.09.2017
Axitinib (2, reassessment)
Inlyta®
Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after failure of sunitinib or a cytokine theryapy
0.3%
Hint for
minor additional benefit
01.04.2017
–
21.09.2017
Tenofoviralafenamid
Vemlidy®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis B, ≥ 12 years
100%
no additional benefit
repealed
01.04.2017
–
21.09.2017
Dolutegravir (2)
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, 6 to < 12 years
100%
no additional benefit
01.04.2017
–
21.09.2017
Baricitinib
Olumiant®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
100%
no additional benefit
01.03.2017
–
17.08.2017
Secukinumab (3, reassessment)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
100%
Indication of
considerable additional benefit
01.03.2017
–
17.08.2017
Ixekizumab
Taltz®
Lilly Deutschland GmbH
Skin diseases
Plaque psoriasis (PP)
55%
Indication of
considerable additional benefit
15.02.2017
–
03.08.2017
Pembrolizumab (3)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
100%
Indication of
considerable additional benefit
01.02.2017
–
20.07.2017
Lonoctocog alfa
Afstyla®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia A
100%
no additional benefit
15.01.2017
–
06.07.2017
Obeticholsäure
Ocaliva®
Intercept Pharma Deutschland GmbH
Digestive system diseases
Biliary cirrhosis
100%
non-quantifiable additional benefit
( Orphan)
15.01.2017
–
06.07.2017
Reslizumab
Cinqaero®
Teva GmbH
Respiratory system diseases
Bronchial asthma
50%
Hint for
minor additional benefit
15.01.2017
–
06.07.2017
Vandetanib (3)
Caprelsa®
Genzyme GmbH
Oncological diseases
Thyroid carcinoma, ≥ 5 years
100%
Hint for
non-quantifiable additional benefit
15.01.2017
–
06.07.2017
Ixazomib
Ninlaro®
Takeda Pharma GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.12.2016
–
15.06.2017
Elbasvir / Grazoprevir
Zepatier®
MSD Sharp & Dohme GmbH
Infectious diseases
Chronic hepatitis C
100%
no additional benefit
01.01.2017
–
15.06.2017
Nivolumab (6)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Hodgkin lymphoma (HL)
100%
no additional benefit
01.01.2017
–
15.06.2017
Venetoclax
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Chronic lymphocytic leukaemia (CLL), monotherapy
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.12.2016
–
18.05.2017
Palbociclib
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC)
100%
no additional benefit
repealed subpopulations
01.12.2016
–
18.05.2017
Olaratumab
Lartruvo®
Lilly Deutschland GmbH
Oncological diseases
Soft tissue sarcoma
100%
considerable additional benefit
repealed
( Orphan)
01.11.2016
–
20.04.2017
Cabozantinib (2, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC)
100%
Hint for
non-quantifiable additional benefit
repealed
15.10.2016
–
06.04.2017
Macitentan (2, reassessment >€50m)
Opsumit®
Actelion Pharmaceuticals Deutschland GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
100%
no additional benefit
( Orphan (turnover limit))
01.10.2016
–
16.03.2017
Opicapon
Ongentys®
Bial-Portela & Ca, S.A.
Nervous system diseases
Morbus Parkinson
100%
no additional benefit
01.10.2016
–
16.03.2017
Ceritinib (2, reassessment)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
81%
Hint for
considerable additional benefit
01.10.2016
–
16.03.2017
Crizotinib (4)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ROS1+
100%
no additional benefit
01.10.2016
–
16.03.2017
Lenvatinib (2, Kisplyx®)
Kisplyx®
Eisai GmbH
Oncological diseases
Renal cell carcinoma (RCC)
100%
Hint for
minor additional benefit
repealed
01.10.2016
–
16.03.2017
Idelalisib (3)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), combination with ofatumumab; Chronic lymphocytic leukaemia (CLL), first-line, 17p deletion/TP53 mutation, combination with rituximab
0.4%
Hint for
non-quantifiable additional benefit
01.10.2016
–
16.03.2017
Ibrutinib (4)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), at least 1 prior therapy, combination with bendamustine and rituximab
50%
Hint for
considerable additional benefit
( Orphan (turnover limit))
15.08.2016
–
02.02.2017
Pembrolizumab (2)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
40%
Indication of
considerable additional benefit
15.08.2016
–
02.02.2017
Trifluridin / Tipiracil
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC), pre-treated patients
100%
Hint for
minor additional benefit
repealed
01.08.2016
–
19.01.2017
Teduglutid (2)
Revestive®
Shire Deutschland GmbH
Digestive system diseases
Short bowel syndrome, 1 to < 18 years
100%
non-quantifiable additional benefit
( Orphan)
01.08.2016
–
19.01.2017
Tasimelteon
Hetlioz®
Vanda Pharmceutical Inc
Nervous system diseases
Sleep disorders (sleep-wake rhythm), blind adults
100%
non-quantifiable additional benefit
( Orphan)
01.08.2016
–
19.01.2017
Pitolisant
Wakix®
Bioprojet Pharma SARL
Nervous system diseases
Narcolepsy
100%
non-quantifiable additional benefit
( Orphan)
01.08.2016
–
19.01.2017
Brentuximab Vedotin (2)
Adcetris®
Takeda Pharma GmbH
Oncological diseases
Hodgkin lymphoma (HL), CD30+, increased risk of recurrence or progression after transplantation
100%
non-quantifiable additional benefit
( Orphan)
01.08.2016
–
19.01.2017
Carfilzomib (2)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), combination with dexamethasone
100%
minor additional benefit
repealed
( Orphan)
15.07.2016
–
05.01.2017
Emtricitabin / Rilpivirin / Tenofoviralafenamid
Odefsey®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
15.07.2016
–
05.01.2017
Sofosbuvir / Velpatasvir
Epclusa®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
28%
Hint for
considerable additional benefit
01.07.2016
–
15.12.2016
Ibrutinib (3)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukemia (CLL), first-line
100%
no additional benefit
( Orphan (turnover limit))
01.07.2016
–
15.12.2016
Sitagliptin / Metformin (2, reassessment)
Janumet®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with sulphonylurea or insulin
100%
no additional benefit
01.07.2016
–
15.12.2016
Sitagliptin (2, reassessment)
Januvia®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with metformin, sulphonylurea or PPARɣ.
35%
Hint for
minor additional benefit
repealed subpopulations
01.07.2016
–
15.12.2016
Saxagliptin / Metformin (3, reassessment)
Komboglyze®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with insulin
100%
no additional benefit
01.07.2016
–
15.12.2016
Saxagliptin (2, reassessment)
Onglyza®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy
100%
no additional benefit
01.07.2016
–
15.12.2016
Crizotinib (3, reassessment)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
71%
Hint for
considerable additional benefit
01.07.2016
–
15.12.2016
Obinutuzumab (2)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.06.2016
–
15.12.2016
Nivolumab (5)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, combination with ipilimumab
100%
no additional benefit
repealed subpopulations
15.06.2016
–
15.12.2016
Selexipag
Uptravi®
Actelion Pharmaceuticals Deutschland GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
100%
no additional benefit
15.06.2016
–
15.12.2016
Eftrenonacog alfa
Alprolix®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia B
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.06.2016
–
15.12.2016
Talimogen laherparepvec
Imlygic®
Amgen GmbH
Oncological diseases
Melanoma, stage IIIB, IIIC, IVMI1a
100%
no additional benefit
01.06.2016
–
01.12.2016
Eribulin (3)
Halaven®
Eisai GmbH
Oncological diseases
Liposarcoma
50%
Hint for
considerable additional benefit
01.06.2016
–
01.12.2016
Albutrepenonacog alfa
Idelvion®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia B
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.06.2016
–
01.12.2016
Migalastat
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease
100%
non-quantifiable additional benefit
( Orphan)
01.06.2016
–
01.12.2016
Elotuzumab
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
100%
Hint for
minor additional benefit
01.06.2016
–
01.12.2016
Ataluren (2, reassessment)
Translarna®
PTC Therapeutics International Limited
Musculoskeletal system diseases
Duchenne muscular dystrophy (DMD), ≥ 5 years
100%
minor additional benefit
( Orphan)
01.06.2016
–
01.12.2016
Daratumumab
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), monotherapy, pre-treated patients
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.05.2016
–
03.11.2016
Emtricitabin / Tenofoviralafenamid
Descovy®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
01.05.2016
–
20.10.2016
Ospemifen
Senshio®
Shionogi GmbH
Genitourinary system diseases
Vulvovaginal atrophy
100%
no additional benefit
01.05.2016
–
20.10.2016
Ramucirumab (4, reassessment)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel
50%
Hint for
minor additional benefit
01.05.2016
–
20.10.2016
Afatinib (3)
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology
100%
no additional benefit
01.05.2016
–
20.10.2016
Nivolumab (4)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC)
92%
Indication of
considerable additional benefit
01.05.2016
–
20.10.2016
Nivolumab (3)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, after previous chemotherapy
40%
Indication of
considerable additional benefit
15.03.2016
–
15.09.2016
Osimertinib
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation
100%
no additional benefit
repealed subpopulations
01.04.2016
–
15.09.2016
Necitumumab
Portrazza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
100%
no additional benefit
01.04.2016
–
15.09.2016
Ticagrelor (2)
Brilique®
AstraZeneca GmbH
Cardiovascular diseases
Prevention of atherothrombotic events in patients with myocardial infarction and high risk for an atherothrombotic event
100%
Hint for
minor additional benefit
01.04.2016
–
15.09.2016
Idelalisib (2, reassessment)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukemia (CLL)
24%
Hint for
non-quantifiable additional benefit
repealed
01.03.2016
–
01.09.2016
Empagliflozin / Metformin
Synjardy®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.03.2016
–
01.09.2016
Empagliflozin (2, reassessment)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
42%
Hint for
considerable additional benefit
01.03.2016
–
01.09.2016
Ramucirumab (3)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC)
100%
no additional benefit
01.03.2016
–
01.09.2016
Ramucirumab (2)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
100%
no additional benefit
15.02.2016
–
04.08.2016
Afamelanotid
Scenesse®
Clinuvel Ltd.
Metabolic diseases
Erythropoietic protoporphyria
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.02.2016
–
04.08.2016
Brivaracetam
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 16 years
100%
no additional benefit
15.02.2016
–
04.08.2016
Vismodegib (2, reassessment)
Erivedge®
Roche Pharma AG
Oncological diseases
Basal cell carcinoma (BCC)
95%
Hint for
minor additional benefit
01.02.2016
–
21.07.2016
Umeclidinium
Incruse®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
100%
no additional benefit
01.02.2016
–
21.07.2016
Ibrutinib (2, reassessment >€50m)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), Waldenström's disease
12%
Indication of
considerable additional benefit
( Orphan (turnover limit))
01.02.2016
–
21.07.2016
Mepolizumab
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma
50%
Hint for
minor additional benefit
01.01.2016
–
16.06.2016
Rilpivirin (2)
Edurant®
Janssen-Cilag GmbH
Infectious diseases
HIV infection, 12 to < 18 years
100%
no additional benefit
01.01.2016
–
16.06.2016
Sacubitril / Valsartan
Entresto®
Novartis Pharma GmbH
Cardiovascular diseases
Symptomatic chronic heart failure
68%
Hint for
considerable additional benefit
01.01.2016
–
16.06.2016
Efmoroctocog alfa
Elocta®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia A
100%
no additional benefit
01.01.2016
–
16.06.2016
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid
Genvoya®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
01.01.2016
–
16.06.2016
Crizotinib (2)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
100%
Hint for
considerable additional benefit
15.12.2015
–
02.06.2016
Secukinumab (2)
Cosentyx®
Novartis Pharma GmbH
Musculoskeletal system diseases
Psoriatic arthritis (PA), Radiographic axial spondyloarthritis (AS)Psoriatic arthritis (PA), Bekhterev's disease
100%
no additional benefit
repealed subpopulations
15.12.2015
–
02.06.2016
Blinatumomab
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.12.2015
–
02.06.2016
Carfilzomib
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.12.2015
–
02.06.2016
Cobimetinib
Cotellic®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation, combination with vemurafenib
100%
Indication of
considerable additional benefit
15.12.2015
–
02.06.2016
Ivacaftor (3)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), R117H mutation, 2 to 5 years, > 18 years
75%
minor additional benefit
repealed
( Orphan)
15.12.2015
–
02.06.2016
Lumacaftor / Ivacaftor
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), > 12 years, homozygous F508del mutation
100%
Indication of
considerable additional benefit
01.12.2015
–
19.05.2016
Aflibercept (6)
Eylea®
Bayer Vital GmbH
Eye diseases
Myopic choroidal neovascularisation
100%
no additional benefit
01.12.2015
–
19.05.2016
Fingolimod (4)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Highly active relapsing-remitting multiple sclerosis (MS), after inadequate pre-treatment
100%
no additional benefit
15.11.2015
–
04.05.2016
Alirocumab
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolemia or mixed dyslipidaemia
100%
no additional benefit
repealed subpopulations
15.11.2015
–
04.05.2016
Isavuconazol
Cresemba®
Basilea Pharmaceutica International Ltd.
Infectious diseases
Aspergillosis, mucormycosis
100%
non-quantifiable additional benefit
( Orphan)
15.10.2015
–
07.04.2016
Aclidiniumbromid (2, reassessment)
Eklira® Genuair®
AstraZeneca GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
5%
Indication of
considerable additional benefit
01.10.2015
–
17.03.2016
Trametinib
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation
50%
Indication of
considerable additional benefit
01.10.2015
–
17.03.2016
Sebelipase alfa
Kanuma®
Synageva BioPharma Limited
Metabolic diseases
Lysosomal acid lipase deficiency
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.10.2015
–
17.03.2016
Regorafenib (3, reassessment)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Colorectal carcinoma (CRC)
100%
no additional benefit
01.10.2015
–
17.03.2016
Pomalidomid (2, reassessment >€50m)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone
50%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.10.2015
–
17.03.2016
Panobinostat
Farydak®
Novartis Pharma GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with pomalidomide and dexamethasone
100%
non-quantifiable additional benefit
( Orphan)
01.10.2015
–
17.03.2016
Idebenon
Raxone®
Santhera Pharmaceuticals
Eye diseases
Leber hereditary optic neuropathy
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.10.2015
–
17.03.2016
Dabrafenib (2)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with trametinib
100%
Indication of
considerable additional benefit
01.10.2015
–
17.03.2016
Asfotase alfa
Strensiq®
Alexion Europe SAS
Metabolic diseases
Hypophosphatasia (HPP)
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.09.2015
–
09.03.2016
Evolocumab
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
100%
no additional benefit
repealed subpopulations
01.09.2015
–
18.02.2016
Pertuzumab (2)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), inflammatory or early with high risk of recurrence, neoadjuvant, combination with trastuzumab and chemotherapy
100%
no additional benefit
15.08.2015
–
04.02.2016
Insulin degludec / Liraglutid (2)
Xultophy®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with oral antidiabetics
100%
no additional benefit
15.08.2015
–
04.02.2016
Tiotropium / Olodaterol
Spiolto® Respimat®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
92%
Indication of
minor additional benefit
15.08.2015
–
04.02.2016
Pembrolizumab
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma
71%
Indication of
considerable additional benefit
15.08.2015
–
04.02.2016
Netupitant / Palonosetron
Akynzeo®
RIEMSER Pharma GmbH
Other diseases
Nausea and vomiting due to chemotherapy
100%
no additional benefit
15.08.2015
–
04.02.2016
Nivolumab (2)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology, after previous chemotherapy
87%
Indication of
considerable additional benefit
15.08.2015
–
04.02.2016
Gaxilose
LacTest™
VENTER PHARMA S.L.
Metabolic diseases
Diagnosis of hypolactasia
100%
no additional benefit
01.08.2015
–
21.01.2016
Edoxaban
Lixiana®
Daiichi Sankyo Deutschland GmbH
Cardiovascular diseases
Prophylaxis of thromboembolic events
81%
Indication of
minor additional benefit
15.07.2015
–
07.01.2016
Nivolumab
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma
15%
Indication of
considerable additional benefit
15.07.2015
–
07.01.2016
Belatacept (2, reassessment)
Nulojix®
Bristol-Myers Squibb GmbH & Co. KGaA
Genitourinary system diseases
Prophylaxis of graft rejection (GvHD) after kidney transplantation
100%
Indication of
considerable additional benefit
01.07.2015
–
17.12.2015
Lenvatinib
Lenvima®
Eisai GmbH
Oncological diseases
Thyroid carcinoma (DTC)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.07.2015
–
17.12.2015
Ceritinib
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
100%
no additional benefit
repealed
15.06.2015
–
27.11.2015
Lomitapid (2, reassessment)
Lojuxta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Hypercholesterolemia
100%
no additional benefit
01.06.2015
–
27.11.2015
Secukinumab
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
8%
Indication of
considerable additional benefit
repealed subpopulations
01.06.2015
–
27.11.2015
Olaparib
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.06.2015
–
27.11.2015
Ivermectin
Soolantra®
Galderma Laboratorium GmbH
Skin diseases
Inflammatory lesions of rosacea
100%
no additional benefit
15.05.2015
–
05.11.2015
Afatinib (2, reassessment)
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients
42%
Indication of
major additional benefit
15.05.2015
–
05.11.2015
Safinamid
Xadago®
Zambon S.p.A.
Nervous system diseases
Morbus Parkinson
100%
no additional benefit
01.05.2015
–
15.10.2015
Vortioxetin
Brintellix®
Lundbeck GmbH
Mental illnesses
Major depression
100%
no additional benefit
01.05.2015
–
15.10.2015
Insulin degludec / Liraglutid
Xultophy®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.04.2015
–
15.10.2015
Ruxolitinib (3)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Polycythaemia vera
100%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.04.2015
–
01.10.2015
Fingolimod (3, reassessment)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
21%
Indication of
considerable additional benefit
repealed subpopulations
01.04.2015
–
01.10.2015
Eliglustat
Cerdelga®
Genzyme GmbH
Metabolic diseases
Sphingolipidoses (Gaucher disease type 1)
100%
non-quantifiable additional benefit
( Orphan)
15.03.2015
–
03.09.2015
Aflibercept (5)
Eylea®
Bayer Vital GmbH
Eye diseases
Macular edema following retinal branch vein occlusion
100%
no additional benefit
15.03.2015
–
03.09.2015
Nintedanib (2, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Idiopathic pulmonary fibrosis
100%
minor additional benefit
repealed
( Orphan)
01.03.2015
–
20.08.2015
Insulin degludec (3)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1 and type 2, ≥ 1 to < 18 years
100%
no additional benefit
15.02.2015
–
05.08.2015
Apremilast
Otezla®
Celgene GmbH
Skin diseases
Plaque psoriasis (PP); Psoriatic arthritis (PA)
100%
no additional benefit
01.02.2015
–
16.07.2015
Ombitasvir / Paritaprevir / Ritonavir
Viekirax®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C
9%
Indication of
considerable additional benefit
01.02.2015
–
16.07.2015
Ramucirumab
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel
100%
minor additional benefit
repealed
( Orphan)
01.02.2015
–
16.07.2015
Dasabuvir
Exviera®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C
24%
Indication of
considerable additional benefit
01.02.2015
–
16.07.2015
Dulaglutid
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
30%
Hint for
minor additional benefit
repealed
01.02.2015
–
16.07.2015
Aclidiniumbromid / Formoterol
Duaklir® Genuair®
AstraZeneca GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
5%
Indication of
considerable additional benefit
01.01.2015
–
18.06.2015
Pasireotid (2)
Signifor®
Novartis Pharma GmbH
Metabolic diseases
Acromegaly
100%
minor additional benefit
( Orphan)
01.01.2015
–
18.06.2015
Nintedanib
Vargatef®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
100%
Indication of
minor additional benefit
01.01.2015
–
18.06.2015
Enzalutamid (2)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy
100%
Indication of
considerable additional benefit
01.01.2015
–
18.06.2015
Tafluprost / Timolol
Taptiqom®
Santen GmbH
Eye diseases
Reduction of intraocular pressure in patients with glaucoma/hypertension
100%
no additional benefit
01.12.2014
–
21.05.2015
Ataluren
Translarna®
PTC Therapeutics International Limited
Musculoskeletal system diseases
Duchenne muscular dystrophy (DMD), ≥ 5 years
100%
minor additional benefit
repealed
( Orphan)
01.12.2014
–
21.05.2015
Vildagliptin (2, reassessment)
Galvus®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.12.2014
–
21.05.2015
Ledipasvir / Sofosbuvir
Harvoni®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
79%
Hint for
considerable additional benefit
01.11.2014
–
21.05.2015
Alipogentiparvovec
Glybera®
Chiesi GmbH
Metabolic diseases
Familial lipoprotein lipase deficiency
100%
non-quantifiable additional benefit
( Orphan)
15.11.2014
–
07.05.2015
Simoctocog alfa
Nuwiq®
Octapharma GmbH
Hematopoietic diseases
Hemophilia A
100%
no additional benefit
01.11.2014
–
16.04.2015
Lurasidon
Latuda®
Takeda Pharma GmbH
Mental illnesses
Schizophrenia
100%
no additional benefit
01.11.2014
–
16.04.2015
Ibrutinib
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.10.2014
–
19.03.2015
Albiglutid
Eperzan®
GlaxoSmithKline GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
35%
Indication of
minor additional benefit
01.10.2014
–
19.03.2015
Dolutegravir / Abacavir / Lamivudin
Triumeq®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 12 years
9%
Indication of
considerable additional benefit
01.10.2014
–
19.03.2015
Sucroferric Oxyhydroxide
Velphoro®
Fresenius Medical Care Deutschland GmbH
Genitourinary system diseases
Serum phosphate level control in chronic kidney disease
100%
no additional benefit
01.10.2014
–
19.03.2015
Sipuleucel-T
Provenge®
Dendreon UK Limited
Oncological diseases
Prostate carcinoma (PC)
100%
Hint for
non-quantifiable additional benefit
01.10.2014
–
19.03.2015
Idelalisib
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), Follicular lymphoma (FL)
20%
Hint for
non-quantifiable additional benefit
repealed subpopulations
15.09.2014
–
05.03.2015
Aflibercept (4)
Eylea®
Bayer Vital GmbH
Eye diseases
Diabetic macular edema
100%
no additional benefit
01.09.2014
–
19.02.2015
Teduglutid
Revestive®
NPS Pharma Germany GmbH
Digestive system diseases
Short bowel syndrome
100%
minor additional benefit
( Orphan)
01.09.2014
–
19.02.2015
Daclatasvir
Daklinza®
Bristol-Myers Squibb GmbH & Co. KGaA
Infectious diseases
Chronic hepatitis C
1.4%
Hint for
considerable additional benefit
01.09.2014
–
19.02.2015
Regorafenib (2)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Gastrointestinal stromal tumor (GIST)
100%
no additional benefit
01.09.2014
–
19.02.2015
Propranolol
Hemangiol®
Pierre Fabre Dermatologie
Other diseases
Infantile hemangioma
33%
Indication of
major additional benefit
01.09.2014
–
19.02.2015
Nalmefen
Selincro®
Lundbeck GmbH
Mental illnesses
Reduction of alcohol consumption in alcohol dependence
100%
no additional benefit
01.09.2014
–
19.02.2015
Ivacaftor (2)
Kalydeco®
Vertex Pharmaceuticals Limited
Metabolic diseases
Cystic fibrosis (CF), various mutations, ≥ 6 years
100%
minor additional benefit
repealed
( Orphan)
01.09.2014
–
19.02.2015
Apixaban (3)
Eliquis®
Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Cardiovascular diseases
Treatment and prophylaxis of venous thrombosis and pulmonary embolism
47%
Indication of
minor additional benefit
15.08.2014
–
05.02.2015
Obinutuzumab
Gazyvaro®
Roche Pharma AG
Oncological diseases
Chronic lymphocytic leukemia (CLL)
100%
non-quantifiable additional benefit
repealed
( Orphan)
15.08.2014
–
05.02.2015
Empagliflozin
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed
15.08.2014
–
05.02.2015
Canagliflozin / Metformin
Vokanamet®
Janssen-Cilag GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.08.2014
–
22.01.2015
Cabozantinib
Cometriq®
Swedish Orphan Biovitrum GmbH
Oncological diseases
Thyroid carcinoma (MTC)
100%
minor additional benefit
repealed
( Orphan)
01.08.2014
–
22.01.2015
Eribulin (2, reassessment)
Halaven®
Eisai GmbH
Oncological diseases
Breast cancer (BC), after at least 2 chemotherapies; mammary carcinoma, after at least 1 chemotherapy
75%
Hint for
considerable additional benefit
15.07.2014
–
08.01.2015
Umeclidinium / Vilanterol
Anoro®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
100%
no additional benefit
15.07.2014
–
08.01.2015
Vedolizumab
Entyvio®
Takeda Pharma Vertrieb GmbH & Co. KG
Digestive system diseases
Ulcerative colitis, Crohn's disease
100%
no additional benefit
01.07.2014
–
18.12.2014
Fingolimod (2)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Multiple sclerosis (MS), pre-treated
100%
no additional benefit
repealed
15.06.2014
–
04.12.2014
Siltuximab
Sylvant®
Janssen-Cilag GmbH
Oncological diseases
Multicentric Castleman Disease (MCD)
100%
non-quantifiable additional benefit
( Orphan)
15.06.2014
–
04.12.2014
Insulin degludec (2)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with GLP-1 agonists
100%
no additional benefit
repealed
01.06.2014
–
20.11.2014
Simeprevir
Olysio®
Janssen-Cilag GmbH
Infectious diseases
Chronic hepatitis C
91%
Indication of
considerable additional benefit
01.06.2014
–
20.11.2014
Elosulfase alfa
Vimizim®
BioMarin Deutschland GmbH
Metabolic diseases
Mucopolysaccharidosis (type IVA)
100%
minor additional benefit
repealed
( Orphan)
01.06.2014
–
20.11.2014
Mirabegron
Betmiga®
Astellas Pharma GmbH
Genitourinary system diseases
Imperative desire to urinate
100%
no additional benefit
01.06.2014
–
20.11.2014
Lebende Larven von Lucilia sericata
BioBag®
BioMonde GmbH
Other diseases
Chronic or hard to heal wounds
100%
no additional benefit
15.05.2014
–
06.11.2014
Perampanel (2, reassessment)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
100%
no additional benefit
15.05.2014
–
06.11.2014
Cholsäure
Orphacol®
Laboratoires CTRS
Metabolic diseases
Bile acid synthesis disorder
100%
non-quantifiable additional benefit
( Orphan)
15.05.2014
–
06.11.2014
Ruxolitinib (2, reassessment >€50m)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Myelofibrosis (MF)
100%
Hint for
considerable additional benefit
( Orphan (turnover limit))
01.05.2014
–
16.10.2014
Dimethylfumarat
Tecfidera®
Biogen GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
100%
no additional benefit
01.05.2014
–
16.10.2014
Insulin degludec
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1 and type 2
100%
no additional benefit
repealed subpopulations
01.05.2014
–
16.10.2014
Riociguat
Adempas®
Bayer Vital GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTPH)
100%
minor additional benefit
repealed
( Orphan)
01.04.2014
–
18.09.2014
Cobicistat
Tybost®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
15.03.2014
–
04.09.2014
Canagliflozin
Invokana®
Janssen-Cilag GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.02.2014
–
07.08.2014
Dapagliflozin / Metformin
Xigduo®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed
15.02.2014
–
07.08.2014
Dolutegravir
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 12 years
11%
Proof of
considerable additional benefit
15.05.2014
–
17.07.2014
Olodaterol
Striverdi®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
100%
no additional benefit
01.02.2014
–
17.07.2014
Sofosbuvir
Sovaldi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
4%
Indication of
considerable additional benefit
01.02.2014
–
17.07.2014
Macitentan
Opsumit®
Actelion Pharmaceuticals Deutschland GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
100%
minor additional benefit
repealed
( Orphan)
15.01.2014
–
03.07.2014
Retigabin (3, reassessment)
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
100%
no additional benefit
15.01.2014
–
03.07.2014
Turoctocog alfa
NovoEight®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia A
100%
no additional benefit
01.01.2014
–
19.06.2014
Trastuzumab Emtansin
Kadcyla®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, pre-treated patients
72%
Indication of
considerable additional benefit
01.01.2014
–
19.06.2014
Radium-223-dichlorid
Xofigo®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC)
78%
Indication of
considerable additional benefit
repealed
01.01.2014
–
19.06.2014
Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2)
Eviplera®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
15.12.2013
–
05.06.2014
Lomitapid
Lojuxta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Hypercholesterolemia
100%
no additional benefit
repealed
15.12.2013
–
05.06.2014
Ipilimumab (2)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, first-line
100%
no additional benefit
15.11.2013
–
08.05.2014
Afatinib
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients
44%
Indication of
considerable additional benefit
repealed
15.11.2013
–
08.05.2014
Indacaterol / Glycopyrronium
Ultibro Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
5%
Indication of
minor additional benefit
01.10.2013
–
03.04.2014
Dabrafenib
Tafinlar®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Melanoma, BRAF V600 mutation
100%
no additional benefit
01.10.2013
–
20.03.2014
Teriflunomid
Aubagio®
sanofi-aventis groupe / Genzyme GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
100%
no additional benefit
01.10.2013
–
20.03.2014
Regorafenib
Stivarga®
Bayer Vital GmbH
Oncological diseases
Colorectal carcinoma (CRC)
100%
Hint for
minor additional benefit
repealed
01.10.2013
–
20.03.2014
Aflibercept (3)
Eylea®
Bayer Vital GmbH
Eye diseases
Macular edema following retinal vein occlusion
100%
no additional benefit
01.01.2014
–
20.03.2014
Fluticasonfuroat / Vilanterol-Trifenatat
Relvar® Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma, COPD
100%
no additional benefit
15.09.2013
–
06.03.2014
Vemurafenib (2, reassessment)
Zelboraf®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation
100%
Indication of
considerable additional benefit
01.09.2013
–
20.02.2014
Pomalidomid
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone
100%
considerable additional benefit
repealed
( Orphan)
01.09.2013
–
20.02.2014
Enzalutamid
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy
100%
Indication of
considerable additional benefit
15.08.2013
–
06.02.2014
Vismodegib
Erivedge®
Roche Pharma AG
Oncological diseases
Basal cell carcinoma (BCC)
95%
Hint for
minor additional benefit
repealed
01.08.2013
–
23.01.2014
Ponatinib
Iclusig®
ARIAD Pharmaceuticals (Germany) GmbH
Oncological diseases
Chronic myeloid leukaemia (CML); acute lymphoblastic leukaemia (ALL), Ph+ or T315I mutation
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.07.2013
–
19.12.2013
Nepafenac
Nevanac®
Alcon Pharma GmbH
Eye diseases
Postoperative pain after eye surgery
100%
no additional benefit
15.06.2013
–
05.12.2013
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil
Stribild®
Gilead Sciences GmbH
Infectious diseases
HIV infection
100%
no additional benefit
01.06.2013
–
14.11.2013
Lisdexamfetamindimesilat
Elvanse®
Shire Deutschland GmbH
Mental illnesses
Attention deficit hyperactivity disorder (ADHD), ≥ 6 to < 18
100%
no additional benefit
01.05.2013
–
17.10.2013
Ocriplasmin
Jetrea®
ThromboGenics NV / Alcon Pharma GmbH
Eye diseases
Vitreomacular traction (VMT)
95%
Hint for
considerable additional benefit
repealed
01.05.2013
–
17.10.2013
Linaclotid
Constella®
Almirall Hermal GmbH
Digestive system diseases
Irritable bowel syndrome (IBS)
100%
no additional benefit
01.05.2013
–
17.10.2013
Bosutinib
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML)
100%
non-quantifiable additional benefit
repealed
( Orphan)
01.04.2013
–
01.10.2013
Vildagliptin
Galvus®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed subpopulations
01.04.2013
–
01.10.2013
Vildagliptin / Metformin
Eucreas®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.04.2013
–
01.10.2013
Sitagliptin / Metformin
Janumet®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
78%
Hint for
minor additional benefit
repealed
01.04.2013
–
01.10.2013
Sitagliptin
Januvia®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
64%
Hint for
minor additional benefit
repealed
01.04.2013
–
01.10.2013
Saxagliptin / Metformin (2)
Komboglyze®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with sulphonylurea
100%
no additional benefit
01.04.2013
–
01.10.2013
Saxagliptin
Onglyza®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy
49%
Hint for
minor additional benefit
repealed
01.04.2013
–
01.10.2013
Pertuzumab
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, combination with trastuzumab and docetaxel
33%
Hint for
considerable additional benefit
01.04.2013
–
01.10.2013
Colestilan
BindRen®
Mitsubishi Pharma Deutschland GmbH
Other diseases
Hyperphosphatemia
100%
no additional benefit
15.03.2013
–
05.09.2013
Vandetanib (2, reassessment)
Caprelsa®
AstraZeneca GmbH
Oncological diseases
Thyroid carcinoma (MTC)
100%
Hint for
minor additional benefit
repealed
15.03.2013
–
05.09.2013
Lixisenatid
Lyxumia®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.03.2013
–
15.08.2013
Aflibercept (2, Zaltrap®)
Zaltrap®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC)
100%
Indication of
minor additional benefit
15.01.2013
–
04.07.2013
Ingenolmebutat
Picato®
LEO Pharma GmbH
Skin diseases
Actinic keratosis (AK)
100%
no additional benefit
repealed
15.01.2013
–
04.07.2013
Fidaxomicin
Dificlir®
Astellas Pharma GmbH
Infectious diseases
Clostridium difficile infections
41%
Proof of
considerable additional benefit
15.01.2013
–
04.07.2013
Abirateronacetat (2)
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy
100%
Indication of
considerable additional benefit
01.01.2013
–
20.06.2013
Apixaban (2)
Eliquis®
Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Cardiovascular diseases
Prophylaxis of strokes and systemic embolisms
100%
Indication of
minor additional benefit
15.12.2012
–
06.06.2013
Dapagliflozin
Forxiga®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed
15.12.2012
–
06.06.2013
Aflibercept
Eylea®
Bayer Vital GmbH
Eye diseases
Neovascular age-related macular degeneration
100%
no additional benefit
01.12.2012
–
16.05.2013
Pixantron
Pixuvri®
CTI Life Sciences Ltd.
Oncological diseases
B-Cell Non-Hodgkin Lymphoma (NHL)
100%
no additional benefit
01.12.2012
–
16.05.2013
Linagliptin (3)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
01.12.2012
–
16.05.2013
Brentuximab Vedotin
Adcetris®
Takeda Pharma Vertrieb GmbH & Co. KG
Oncological diseases
Hodgkin lymphoma (HL), CD30+; Systemic anaplastic large cell lymphoma
100%
non-quantifiable additional benefit
( Orphan)
15.11.2012
–
02.05.2013
Saxagliptin / Metformin
Komboglyze®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
85%
Hint for
minor additional benefit
repealed
01.11.2012
–
02.05.2013
Decitabin
Dacogen®
Janssen-Cilag GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
100%
minor additional benefit
( Orphan)
15.11.2012
–
02.05.2013
Crizotinib
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
71%
Hint for
considerable additional benefit
repealed
01.10.2012
–
21.03.2013
Axitinib
Inlyta®
Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after failure of sunitinib or a cytokine theryapy
0.7%
Indication of
minor additional benefit
repealed
01.10.2012
–
21.03.2013
Aclidiniumbromid
Eklira® Genuair®
Almirall Hermal GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
100%
no additional benefit
repealed
15.09.2012
–
07.03.2013
Ruxolitinib
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Myelofibrosis (MF)
100%
minor additional benefit
repealed
( Orphan)
15.09.2012
–
07.03.2013
Perampanel
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
100%
no additional benefit
repealed
01.09.2012
–
21.02.2013
Linagliptin (2, reassessment)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
15.08.2012
–
07.02.2013
Ivacaftor
Kalydeco®
Vertex Pharmaceuticals GmbH
Metabolic diseases
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
84%
considerable additional benefit
repealed
( Orphan)
01.07.2012
–
20.12.2012
Tegafur / Gimeracil / Oteracil
Teysuno®
Nordic Pharma GmbH
Oncological diseases
Gastric carcinoma
100%
no additional benefit
15.06.2012
–
06.12.2012
Pasireotid
Signifor®
Novartis Pharma GmbH
Metabolic diseases
Pituitary dysfunction
100%
minor additional benefit
( Orphan)
15.03.2012
–
06.09.2012
Vemurafenib
Zelboraf®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation
100%
Indication of
considerable additional benefit
repealed
15.03.2012
–
06.09.2012
Vandetanib
Caprelsa®
AstraZeneca GmbH
Oncological diseases
Thyroid carcinoma (MTC)
100%
no additional benefit
repealed
01.08.2011
–
02.08.2012
Ipilimumab
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, second-line
100%
Indication of
considerable additional benefit
27.07.2011
–
02.08.2012
Belimumab
Benlysta®
GlaxoSmithKline GmbH & Co. KG
Musculoskeletal system diseases
Systemic lupus erythematosus
100%
Indication of
considerable additional benefit
29.07.2011
–
02.08.2012
Fampridin
Fampyra®
Biogen GmbH
Nervous system diseases
Multiple sclerosis (MS)
100%
no additional benefit
15.07.2011
–
05.07.2012
Belatacept
Nulojix®
Bristol-Myers Squibb GmbH & Co. KGaA
Genitourinary system diseases
Prophylaxis of graft rejection (GvHD) after kidney transplantation
100%
Indication of
minor additional benefit
repealed
15.01.2012
–
05.07.2012
Emtricitabin / Rilpivirin / Tenofovirdisoproxil
Eviplera®
Gilead Sciences GmbH
Infectious diseases
HIV infection, pre-treated patients
100%
Proof of
minor additional benefit
15.01.2012
–
05.07.2012
Rilpivirin
Edurant®
Janssen-Cilag GmbH
Infectious diseases
HIV infection
100%
Proof of
minor additional benefit
01.07.2011
–
21.06.2012
Extrakt aus Cannabis Sativa
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
100%
Hint for
minor additional benefit
repealed
15.12.2011
–
07.06.2012
Tafamidis
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid Neuropathy
100%
minor additional benefit
repealed
( Orphan)
15.06.2011
–
07.06.2012
Apixaban
Eliquis®
Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Cardiovascular diseases
Prophylaxis of venous thromboembolism
58%
Indication of
minor additional benefit
15.05.2011
–
03.05.2012
Aliskiren / Amlodipin
Rasilamlo®
Novartis Pharma GmbH
Cardiovascular diseases
Essential hypertension, add-on therapy
100%
no additional benefit
15.05.2011
–
03.05.2012
Retigabin
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
100%
no additional benefit
repealed
01.05.2011
–
19.04.2012
Eribulin
Halaven®
Eisai GmbH
Oncological diseases
Breast cancer (BC) after at least 2 chemotherapies
80%
Hint for
minor additional benefit
repealed
01.05.2011
–
19.04.2012
Collagenase aus Clostridium histolyticum
Xiapex®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Dupuytren's contracture
100%
no additional benefit
15.10.2011
–
29.03.2012
Telaprevir
Incivo®
Janssen-Cilag GmbH
Infectious diseases
Chronic hepatitis C
100%
Indication of
non-quantifiable additional benefit
15.04.2011
–
29.03.2012
Regadenoson
Rapiscan®
Rapidscan Pharma Solutions EU Ltd.
Other diseases
Myocardial perfusion imaging
100%
no additional benefit
15.04.2011
–
29.03.2012
Fingolimod
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
18%
Hint for
minor additional benefit
repealed
15.04.2011
–
29.03.2012
Cabazitaxel
Jevtana®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Prostate carcinoma (PC), docetaxel pre-treatment, combination with prednisone or prednisolone
85%
Indication of
minor additional benefit
01.10.2011
–
29.03.2012
Linagliptin
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
100%
no additional benefit
repealed
01.10.2011
–
29.03.2012
Abirateronacetat
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy, combination with prednisone or prednisolone
85%
Indication of
considerable additional benefit
15.01.2012
–
15.03.2012
Azilsartan Medoxomil
Edarbi®
Takeda Pharma GmbH
Cardiovascular diseases
Arterial hypertension
100%
no additional benefit
15.09.2011
–
15.03.2012
Pirfenidon
Esbriet®
InterMune Deutschland GmbH
Respiratory system diseases
Idiopathic pulmonary fibrosis
100%
non-quantifiable additional benefit
( Orphan)
01.09.2011
–
01.03.2012
Boceprevir
Victrelis®
MSD Sharp & Dohme GmbH
Infectious diseases
Chronic hepatitis C
100%
Indication of
non-quantifiable additional benefit
01.08.2011
–
19.01.2012
Bromfenac
Yellox®
Bausch & Lomb / Dr. Mann Pharma
Eye diseases
Postoperative inflammation of the eye
100%
no additional benefit
01.01.2011
–
15.12.2011
Ticagrelor
Brilique®
AstraZeneca GmbH
Cardiovascular diseases
Prevention of atherothrombotic events in acute coronary syndrome
82%
Proof of
considerable additional benefit
01.06.2011
–
18.08.2011
Pitavastatin
Livazo®
Merckle Recordati GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
100%
no additional benefit