|
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
|
|
Idecabtagen vicleucel
|
Abecma®
|
Bristol-Myers Squibb GmbH & Co KGaA
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), at least 3 previous therapies
|
100%
Hint for
non-quantifiable additional benefit
|
|
Evolocumab (3)
|
Repatha®
|
Amgen GmbH
|
Metabolic diseases
|
Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age
|
100%
no additional benefit
|
|
Ripretinib
|
Qinlock®
|
Deciphera Pharmaceuticals (Netherlands) B.V.
|
Oncological diseases
ORPHAN
|
Gastrointestinal stromal tumours (GIST), ≥ 3 prior therapies
|
100%
Hint for
major additional benefit
|
|
Pralsetinib
|
Gavreto®
|
Roche Registration GmbH
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), RET fusion+
|
100%
no additional benefit
|
|
Tofacitinib (7)
|
Xeljanz®
|
Pfizer Pharma GmbH
|
Musculoskeletal system diseases
|
Ankylosing spondylitis (AS)
|
100%
no additional benefit
|
|
Ozanimod (2)
|
Zeposia®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Digestive system diseases
|
Ulcerative colitis (UC), pre-treated patients
|
100%
no additional benefit
|
|
Dapagliflozin (7)
|
Forxiga®
|
AstraZeneca GmbH
|
Metabolic diseases
|
Diabetes mellitus Type 2, ≥ 10 years
|
100%
no additional benefit
|
|
Ponesimod (2)
|
Ponvory®
|
Janssen-Cilag GmbH
|
Nervous system diseases
|
Relaps multiple sclerosis (MS)
|
50%
Indication of
minor additional benefit
|
|
Abemaciclib (4, reassessment)
|
Verzenios®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Mammary carcinoma (BC), HR+, HER2-, combination with fulvestrant
|
42%
Indication of
minor additional benefit
|
|
Filgotinib (2)
|
Jyseleca®
|
Galapagos Biopharma Germany GmbH
|
Digestive system diseases
|
Ulcerative colitis (UC), pretreated patients
|
100%
no additional benefit
|
|
Mepolizumab (5)
|
Nucala®
|
GlaxoSmithKline GmbH & Co. KG
|
Musculoskeletal system diseases
|
Eosinophilic granulomatosis with polyangiitis
|
100%
no additional benefit
|
|
Mepolizumab (4)
|
Nucala®
|
GlaxoSmithKline GmbH & Co. KG
|
Respiratory system diseases
|
Chronic rhinosinusitis with nasal polyps
|
100%
no additional benefit
|
|
Mepolizumab (3)
|
Nucala®
|
GlaxoSmithKline GmbH & Co. KG
|
Hematopoietic diseases
|
Hypereosinophilic syndrome
|
100%
Hint for
considerable additional benefit
|
|
Ertugliflozin
|
Steglatro®
|
MSD Sharp & Dohme GmbH
|
Metabolic diseases
|
Diabetes mellitus (DM) type 2
|
100%
no additional benefit
|
|
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
|
|
Lusutrombopag
|
Mulpleo®
|
Shionogi GmbH
|
Hematopoietic diseases
|
Thrombocytopenia in chronic liver disease
|
100%
no additional benefit
|
|
Sacituzumab Govitecan
|
Trodelvy®
|
Gilead Sciences GmbH
|
Oncological diseases
|
Mammary carcinoma (BC), triple-negative, after 2 previous therapies
|
100%
Indication of
major additional benefit
|
|
Risankizumab (2)
|
Skyrizi®
|
AbbVie Deutschland GmbH & Co. KG
|
Skin diseases
|
Psoriatic arthritis (PA), monotherapy or combination with methotrexate
|
100%
no additional benefit
|
|
Cefiderocol (2)
|
Fetcroja®
|
Shionogi GmbH
|
Infectious diseases
|
Infections caused by aerobic gram-negative pathogens
|
100%
additional benefit considered proven
|
|
Delamanid (2)
|
Deltyba®
|
Otsuka Novel Products
|
Infectious diseases
ORPHAN
|
Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg
|
100%
Hint for
non-quantifiable additional benefit
|
|
Elbasvir / Grazoprevir (2)
|
Zepatier®
|
MSD Sharp & Dohme B.V.
|
Infectious diseases
|
Chronic hepatitis C (HCV), 12 to < 18 years
|
100%
no additional benefit
|
|
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
|
|
Pembrolizumab (17)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Mammary carcinoma (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy
|
50%
Hint for
considerable additional benefit
|
|
Icosapent-Ethyl
|
Vazkepa®
|
Amarin Pharmaceuticals Ireland Limited
|
Metabolic diseases
|
Dyslipidemia, pre-treated patients
|
100%
no additional benefit
|
|
Ixazomib (2, reassessment)
|
Ninlaro®
|
Takeda GmbH
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
|
100%
Hint for
non-quantifiable additional benefit
|
|
Pitolisant (2, Ozawade®)
|
Ozawade®
|
Bioprojet Deutschland GmbH
|
Nervous system diseases
|
Daytime sleepiness in obstructive sleep apnea, after previous therapy
|
100%
no additional benefit
|
|
Sofosbuvir / Velpatasvir / Voxilaprevir (2)
|
Vosevi®
|
Gilead Sciences GmbH
|
Infectious diseases
|
Chronic hepatitis C (HCV), 12 to < 18 years
|
100%
no additional benefit
|
|
Albutrepenonacog alfa (2, reassessment >€50m)
|
Idelvion®
|
CSL Behring GmbH
|
Hematopoietic diseases
ORPHAN
|
Hemophilia B, congenital factor IX deficiency
|
100%
no additional benefit
|
|
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
|
|
Vandetanib (4, reassessment)
|
Caprelsa®
|
Sanofi-Aventis Deutschland GmbH
|
Oncological diseases
|
Thyroid carcinoma (MTC)
|
100%
no additional benefit
|
|
Vosoritid
|
Voxzogo®
|
BioMarin International Limited
|
Other diseases
ORPHAN
|
Achondroplasia, ≥ 2 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Daratumumab (8, reassessment)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
|
100%
Hint for
considerable additional benefit
|
|
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
|
|
Ravulizumab (3)
|
Ultomiris®
|
Alexion Pharma Germany GmbH
|
Hematopoietic diseases
|
Paroxysmal hemoglobinuria, pediatric patients
|
100%
no additional benefit
|
|
Solriamfetol (2)
|
Sunosi®
|
Jazz Pharmaceuticals Ireland
|
Nervous system diseases
|
Daytime sleepiness in obstructive sleep apnoea, after previous therapy
|
100%
no additional benefit
|
|
Vericiguat
|
Verquvo®
|
Bayer Vital GmbH
|
Cardiovascular diseases
|
Chronic heart failure (CHF)
|
100%
Hint for
minor additional benefit
|
|
Bimekizumab
|
Bimzelx®
|
UCB Pharma GmbH
|
Skin diseases
|
Plaque psoriasis (PP)
|
100%
Indication of
minor additional benefit
|
|
Roxadustat
|
Evrenzo®
|
Astellas Pharma GmbH
|
Hematopoietic diseases
|
Symptomatic anemia in chronic kidney disease (CKD)
|
100%
no additional benefit
|
|
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
|
|
Tafasitamab
|
Minjuvi®
|
Incyte Biosciences Germany
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide
|
100%
Hint for
non-quantifiable additional benefit
|
|
Odevixibat
|
Bylvay®
|
Albireo Pharma AB
|
Digestive system diseases
ORPHAN
|
Cholestasis, ≥ 6 months
|
100%
Hint for
minor additional benefit
|
|
Misoprostol
|
Angusta®
|
Norgine GmbH
|
Other diseases
|
Labor induction
|
100%
no additional benefit
|
|
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
|
|
Migalastat (2)
|
Galafold®
|
Amicus Therapeutics GmbH
|
Metabolic diseases
ORPHAN
|
Fabry disease, 12 to < 16 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Tofacitinib (5, reassessment)
|
Xeljanz®
|
Pfizer Pharma GmbH
|
Musculoskeletal system diseases
|
Rheumatoid arthritis (RA), pretreated patients, monotherapy or combination with methotrexate
|
100%
no additional benefit
|
|
Tirbanibulin
|
Klisyri®
|
Almirall Hermal GmbH
|
Skin diseases
|
Actinic keratosis (AK), Olsen grade I
|
100%
no additional benefit
|
|
Relugolix / Estradiol / Norethisteronacetat
|
Ryeqo®
|
Gedeon Richter Pharma GmbH
|
Genitourinary system diseases
|
Uterine myoma
|
50%
Hint for
considerable additional benefit
|
|
Dapagliflozin (6)
|
Forxiga®
|
AstraZeneca GmbH
|
Genitourinary system diseases
|
Chronic kidney disease (CKD)
|
50%
Hint for
considerable additional benefit
|
|
Upadacitinib (4)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. KG
|
Skin diseases
|
Atopic dermatitis (AD), ≥ 12 years
|
33%
Indication of
considerable additional benefit
|
|
Selumetinib
|
Koselugo®
|
AstraZeneca GmbH
|
Oncological diseases
ORPHAN
|
Neurofibromatosis (type 1), ≥ 3 to < 18 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Daratumumab (7)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason
|
38%
Hint for
minor additional benefit
|
|
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)
|
Exempted from benefit assessment (reserve antbiotic)
|
|
Teriflunomid (2)
|
Aubagio®
|
Sanofi-Aventis Deutschland GmbH
|
Nervous system diseases
|
Relapsing-remitting multiple sclerosis (MS), 10 to 17 years
|
100%
no additional benefit
|
|
Blinatumomab (6)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years
|
100%
Indication of
major additional benefit
|
|
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
|
|
Cemiplimab (3)
|
Libtayo®
|
Sanofi-Aventis Deutschland GmbH
|
Oncological diseases
|
Basal cell carcinoma (BCC), locally advanced or metastasised
|
97%
Hint for
minor additional benefit
|
|
Cemiplimab (2)
|
Libtayo®
|
Sanofi-Aventis Deutschland GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), first-line
|
100%
no additional benefit
|
|
Daratumumab (6)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
|
50%
Hint for
minor additional benefit
|
|
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
|
Exempted from benefit assessment (reserve antbiotic)
|
|
Imipenem / Cilastatin / Relebactam
|
Recarbrio®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
Pneumonia, Bacteriemia
|
Exempted from benefit assessment (reserve antbiotic)
|
|
Satralizumab
|
Enspryng®
|
Roche Pharma AG
|
Nervous system diseases
ORPHAN
|
Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years
|
100%
Hint for
minor additional benefit
|
|
Empagliflozin (3)
|
Jardiance®
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Cardiovascular diseases
|
Chronic heart failure (CHF)
|
100%
Hint for
minor additional benefit
|
|
Tralokinumab
|
Adtralza®
|
LEO Pharma A/S
|
Skin diseases
|
Atopic dermatitis (AD)
|
100%
no additional benefit
|
|
Angiotensin-II-Acetat
|
Giapreza®
|
La Jolla Pharmaceutical II B.V.
|
Cardiovascular diseases
|
Hypotension
|
100%
no additional benefit
|
|
Brentuximab Vedotin (6, reassessment)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
ORPHAN
|
Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone
|
100%
Hint for
minor additional benefit
|
|
Cabozantinib (7, reassessment)
|
Cometriq®
|
Ipsen Pharma GmbH
|
Oncological diseases
ORPHAN
|
Thyroid carcinoma (MTC)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Glecaprevir / Pibrentasvir (3)
|
Maviret®
|
AbbVie Deutschland GmbH & Co. KG
|
Infectious diseases
|
Chronic hepatitis C, 3 to < 12 years
|
100%
no additional benefit
|
|
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
|
|
Osimertinib (4)
|
Tagrisso®
|
AstraZeneca GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy
|
50%
Indication of
non-quantifiable additional benefit
|
|
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
|
|
Dostarlimab
|
Jemperli®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
|
Endometrial carcinoma (EC), after platinum-based therapy
|
100%
no additional benefit
|
|
Tagraxofusp
|
Elzonris®
|
Stemline Therapeutics B.V.
|
Oncological diseases
ORPHAN
|
Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line
|
100%
Hint for
non-quantifiable additional benefit
|
|
Venetoclax (5)
|
Venclyxto®
|
AbbVie Deutschland GmbH & Co. KG
|
Oncological diseases
|
Acute myeloid leukaemia (AML), combination therapy, first-line
|
100%
Hint for
considerable additional benefit
|
|
Berotralstat
|
Orladeyo®
|
BioCryst Pharma Deutschland GmbH
|
Other diseases
|
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
|
100%
no additional benefit
|
|
Ponesimod
|
Ponvory®
|
Janssen-Cilag GmbH
|
Nervous system diseases
|
Relapsing multiple sclerosis (MS)
|
100%
no additional benefit
|
|
Ivacaftor / Tezacaftor / Elexacaftor (5)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation).
|
100%
no additional benefit
|
|
Ivacaftor / Tezacaftor / Elexacaftor (4)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
|
100%
no additional benefit
|
|
Ivacaftor / Tezacaftor / Elexacaftor (3)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)).
|
100%
no additional benefit
|
|
Ivacaftor (21)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
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
|
|
Ivacaftor (20)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
|
100%
no additional benefit
|
|
Bosutinib (4, reassessment)
|
Bosulif®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Chronic myeloid leukaemia (CML), Ph+, first-line
|
100%
no additional benefit
|
|
Enzalutamid (5)
|
Xtandi®
|
Astellas Pharma GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy
|
100%
no additional benefit
|
|
Cenobamat
|
Ontozry®
|
Angelini Pharma Deutschland GmbH
|
Nervous system diseases
|
Epilepsy, focal seizures, after at least 2 previous therapies
|
100%
no additional benefit
|
|
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
|
|
Ivacaftor (19)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
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
|
|
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
|
|
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
|
|
Lanadelumab (2, reassessment >€50m)
|
Takhzyro®
|
Takeda GmbH
|
Other diseases
ORPHAN
|
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
|
100%
no additional benefit
|
|
Onasemnogen-Abeparvovec
|
Zolgensma®
|
Novartis Gene Therapies EU Limited
|
Nervous system diseases
ORPHAN
|
5q-associated spinal muscular atrophy (SMA)
|
100%
no additional benefit
|
|
Obinutuzumab (6, reassessment >€50m)
|
Gazyvaro®
|
Roche Pharma AG
|
Oncological diseases
ORPHAN
|
Follicular lymphoma (FL), first-line
|
100%
no additional benefit
|
|
Obinutuzumab (5, reassessment >€50m)
|
Gazyvaro®
|
Roche Pharma AG
|
Oncological diseases
ORPHAN
|
Chronic lymphocytic leukemia (CLL)
|
100%
no additional benefit
|
|
Obinutuzumab (4, reassessment >€50m)
|
Gazyvaro®
|
Roche Pharma AG
|
Oncological diseases
ORPHAN
|
Follicular lymphoma (FL)
|
100%
no additional benefit
|
|
Cannabidiol (5)
|
Epidyolex®
|
GW Pharmaceuticals plc
|
Other diseases
ORPHAN
|
Seizures in Tuberous Sclerosis, ≥ 2 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Atidarsagen autotemcel OTL-200
|
Libmeldy®
|
Orchard Therapeutics GmbH
|
Metabolic diseases
ORPHAN
|
Metachromatic leukodystrophy with biallelic mutation in the ARSA gene
|
50%
Hint for
major additional benefit
|
|
Cabotegravir
|
Vocabria®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
HIV-1 infection, pre-treated, combination with rilpivirin
|
100%
no additional benefit
|
|
Erenumab (2, reassessment)
|
Aimovig®
|
Novartis Pharma GmbH
|
Nervous system diseases
|
Migraine prophylaxis
|
100%
Hint for
considerable additional benefit
|
|
Risdiplam
|
Evrysdi®
|
Roche Pharma AG
|
Nervous system diseases
ORPHAN
|
5q-associated spinal muscular atrophy (SMA)
|
42%
Hint for
non-quantifiable additional benefit
|
|
Cabozantinib (6, Cabometyx®)
|
Cabometyx®
|
Ipsen Pharma GmbH
|
Oncological diseases
|
Renal cell carcinoma (RCC), first-line, combination with nivolumab
|
100%
no additional benefit
|
|
Nivolumab (16)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Renal cell carcinoma (RCC), first-line, combination with cabozantinib
|
100%
no additional benefit
|
|
Rilpivirin (3, Rekambys®)
|
Rekambys®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
HIV-1 infection, pre-treated, combination with cabotegravir
|
100%
no additional benefit
|
|
Cefiderocol
|
Fetcroja®
|
Shionogi GmbH
|
Infectious diseases
|
Infections caused by aerobic gram-negative pathogens
|
Exempted from benefit assessment (reserve antbiotic)
|
|
Pemigatinib
|
Pemazyre®
|
Incyte Biosciences Germany GmbH
|
Oncological diseases
ORPHAN
|
Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy
|
100%
Hint for
non-quantifiable additional benefit
|
|
Nivolumab (15, reassessment)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Melanoma, adjuvant therapy
|
100%
Hint for
considerable additional benefit
|
|
Natrium-Zirkonium-Cyclosilikat
|
Lokelma®
|
AstraZeneca GmbH
|
Metabolic diseases
|
Hyperkalemia
|
100%
no additional benefit
|
|
Remdesivir
|
Veklury®
|
Gilead Sciences GmbH
|
Infectious diseases
|
COVID-19, ≥ 12 years, additional oxygen supply
|
34%
Hint for
minor additional benefit
|
|
Avatrombopag (2)
|
Doptelet®
|
Swedish Orphan Biovitrum GmbH
|
Hematopoietic diseases
|
Thrombocytopenia in chronic liver disease
|
100%
no additional benefit
|
|
Avatrombopag
|
Doptelet®
|
Swedish Orphan Biovitrum GmbH
|
Hematopoietic diseases
|
Immune thrombocytopenia (ITP)
|
100%
no additional benefit
|
|
Fostemsavir
|
Rukobia®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
Multidrug-resistant HIV infection
|
100%
no additional benefit
|
|
Pembrolizumab (16)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years
|
46%
Hint for
considerable additional benefit
|
|
Pembrolizumab (15, reassessment)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Urothelial carcinoma (UC), CPS ≥ 10, first-line
|
100%
no additional benefit
|
|
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
|
|
Bedaquilin (3)
|
Sirturo®
|
Janssen-Cilag GmbH
|
Infectious diseases
ORPHAN
|
Multidrug-resistant pulmonary tuberculosis, 5 to 11 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Imlifidase
|
Idefirix®
|
Hansa Biopharma AB
|
Other diseases
ORPHAN
|
Desensitisation in kidney transplantation
|
100%
Hint for
non-quantifiable additional benefit
|
|
Fedratinib
|
Inrebic®
|
Celgene GmbH
|
Oncological diseases
ORPHAN
|
Myelofibrosis (MF)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Tucatinib
|
Tukysa®
|
Seagen Germany GmbH
|
Oncological diseases
|
Mammary carcinoma, HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine
|
100%
Hint for
considerable additional benefit
|
|
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
|
|
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
|
|
Selpercatinib (3)
|
Retsevmo®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy
|
100%
no additional benefit
|
|
Avelumab (4)
|
Bavencio®
|
Merck Serono GmbH / Pfizer Pharma GmbH
|
Oncological diseases
|
Urothelial carcinoma (UC), first-line
|
100%
Hint for
considerable additional benefit
|
|
Esketamin (2)
|
Spravato®
|
Janssen-Cilag GmbH
|
Mental illnesses
|
Depression, therapy resistant, combination with SSRI or SNRI
|
100%
no additional benefit
|
|
Esketamin
|
Spravato®
|
Janssen-Cilag GmbH
|
Mental illnesses
|
Depression, acute treatment, combination therapy
|
100%
Hint for
minor additional benefit
|
|
Beclometason / Formoterol / Glycopyrronium
|
Trimbow®
|
Chiesi GmbH
|
Respiratory system diseases
|
Asthma
|
100%
no additional benefit
|
|
Baloxavir marboxil (2)
|
Xofluza®
|
Roche Pharma AG
|
Infectious diseases
|
Influenza prophylaxis, ≥ 12 years
|
58%
Indication of
considerable additional benefit
|
|
Baloxavir marboxil
|
Xofluza®
|
Roche Pharma AG
|
Infectious diseases
|
Influenza, ≥ 12 years
|
100%
no additional benefit
|
|
Autologe Anti-CD19-transduzierte CD3-positive Zellen
|
Tecartus®
|
Gilead Sciences GmbH
|
Oncological diseases
ORPHAN
|
Mantle cell lymphoma (MCL), pretreated
|
100%
Hint for
non-quantifiable additional benefit
|
|
Acalabrutinib (3)
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
|
Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment
|
40%
Hint for
considerable additional benefit
|
|
Blinatumomab (5)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+
|
100%
Hint for
non-quantifiable additional benefit
|
|
Pertuzumab / Trastuzumab (3)
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Mammary carcinoma, HER2+, metastatic or locally recurrent
|
100%
no additional benefit
|
|
Pertuzumab / Trastuzumab (2)
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Mammary carcinoma, HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant
|
100%
no additional benefit
|
|
Pertuzumab / Trastuzumab
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Mammary carcinoma, early stage, HER2+, adjuvant treatment
|
100%
Hint for
minor additional benefit
|
|
Levofloxacin / Dexamethason
|
Ducressa®
|
Santen GmbH
|
Eye diseases
|
Infections and inflammations associated with cataract surgery
|
100%
no additional benefit
|
|
Dolutegravir (3)
|
Tivicay®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
HIV-Infection, children ≥ 4 weeks to < 6 years
|
100%
no additional benefit
|
|
Niraparib (4, reassessment)
|
Zejula®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
ORPHAN
|
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
|
100%
no additional benefit
|
|
Fenfluramin
|
Fintepla®
|
Zogenix GmbH
|
Nervous system diseases
ORPHAN
|
Dravet syndrome, ≥ 2 years
|
100%
Hint for
considerable additional benefit
|
|
Inclisiran
|
Leqvio®
|
Novartis Pharma GmbH
|
Metabolic diseases
|
Primary hypercholesterolaemia or mixed dyslipidaemia
|
100%
no additional benefit
|
|
Upadacitinib (3)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. KG
|
Skin diseases
|
Psoriasis arthritis (PA)
|
69%
Hint for
considerable additional benefit
|
|
Upadacitinib (2)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. KG
|
Musculoskeletal system diseases
|
Ankylosing spondylitis
|
100%
no additional benefit
|
|
Carfilzomib (4)
|
Kyprolis®
|
Amgen GmbH
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone
|
100%
no additional benefit
|
|
Nivolumab (14)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Squamous cell carcinoma of esophagus, pretreated patients
|
36%
Hint for
minor additional benefit
|
|
Afamelanotid (2, reassessment)
|
Scenesse®
|
Clinuvel (UK) Limited
|
Metabolic diseases
ORPHAN
|
Erythropoietic protoporphyria
|
100%
Hint for
non-quantifiable additional benefit
|
|
Dupilumab (5)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Skin diseases
|
Atopic dermatitis (AD), 6 to 11 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Lenvatinib (5, reassessment, Kisplyx®)
|
Kisplyx®
|
Eisai GmbH
|
Oncological diseases
|
Renal cell carcinoma (RCC)
|
100%
no additional benefit
|
|
Lumasiran
|
Oxlumo®
|
Alnylam Germany GmbH
|
Metabolic diseases
ORPHAN
|
Hyperoxaluria
|
100%
Hint for
non-quantifiable additional benefit
|
|
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
|
|
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
|
|
Perampanel (5)
|
Fycompa®
|
Eisai GmbH
|
Nervous system diseases
|
Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years
|
100%
no additional benefit
|
|
Perampanel (4)
|
Fycompa®
|
Eisai GmbH
|
Nervous system diseases
|
Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years
|
100%
no additional benefit
|
|
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
|
|
Olaparib (7)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy
|
100%
no additional benefit
|
|
Olaparib (6)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment
|
100%
Hint for
considerable additional benefit
|
|
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
|
|
Sebelipase alfa (2, reassessment)
|
Kanuma®
|
Alexion Pharma Germany GmbH
|
Metabolic diseases
ORPHAN
|
Lysosomal acid lipase deficiency
|
100%
Hint for
non-quantifiable additional benefit
|
|
Acalabrutinib (2)
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
|
Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line
|
25%
Hint for
minor additional benefit
|
|
Acalabrutinib
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
|
Chronic lymphocytic leukaemia (CLL); monotherapy, first-line
|
25%
Hint for
minor additional benefit
|
|
Tezacaftor / Ivacaftor (5)
|
Symkevi®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation)
|
100%
no additional benefit
|
|
Guselkumab (2)
|
Tremfya®
|
Janssen-Cilag GmbH
|
Skin diseases
|
Psoriatic arthritis (PA)
|
100%
no additional benefit
|
|
Nusinersen (2, reassessment >€50m)
|
Spinraza®
|
Biogen GmbH
|
Nervous system diseases
ORPHAN
|
Spinal muscular atrophy (SMA)
|
19%
Indication of
major additional benefit
|
|
Tezacaftor / Ivacaftor (4)
|
Symkevi®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del)
|
100%
no additional benefit
|
|
Tafamidis (4, reassessment >€50m)
|
Vyndaqel®
|
Pfizer Pharma GmbH
|
Metabolic diseases
ORPHAN
|
Amyloid cardiomyopathy
|
100%
Indication of
considerable additional benefit
|
|
Tafamidis (3, reassessment >€50m)
|
Vyndaqel®
|
Pfizer Pharma GmbH
|
Metabolic diseases
ORPHAN
|
Amyloid Neuropathy
|
100%
no additional benefit
|
|
Niraparib (3)
|
Zejula®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
ORPHAN
|
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy
|
100%
no additional benefit
|
|
Ivacaftor (18)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation)
|
100%
no additional benefit
|
|
Ivacaftor (17)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation)
|
100%
no additional benefit
|
|
Ivacaftor (16)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ivacaftor (15)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
|
100%
Hint for
non-quantifiable additional benefit
|
|
Dapagliflozin (5)
|
Forxiga®
|
AstraZeneca GmbH
|
Cardiovascular diseases
|
Chronic heart failure (CHF)
|
100%
Hint for
considerable additional benefit
|
|
Amikacin (liposomal)
|
Arikayce® liposomal
|
Insmed Germany GmbH
|
Infectious diseases
ORPHAN
|
Mycobacterium Avium Complex (MAC) infection
|
100%
Hint for
non-quantifiable additional benefit
|
|
Atezolizumab (8)
|
Tecentriq®
|
Roche Pharma AG
|
Oncological diseases
|
Hepatocellular carcinoma (HCC), combination with bevacizumab
|
76%
Indication of
considerable additional benefit
|
|
Crizanlizumab
|
Adakveo®
|
Novartis Pharma GmbH
|
Hematopoietic diseases
ORPHAN
|
Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years
|
100%
Hint for
minor additional benefit
|
|
Eszopiclon
|
Lunivia®
|
Hennig Arzneimittel GmbH & Co. KG
|
Nervous system diseases
|
Sleep disorders
|
100%
no additional benefit
|
|
Baricitinib (2)
|
Olumiant®
|
Lilly Deutschland GmbH
|
Skin diseases
|
Atopic dermatitis (AD)
|
100%
no additional benefit
|
|
Avapritinib
|
Ayvakyt®
|
Blueprint Medicines (Germany)
|
Oncological diseases
ORPHAN
|
Gastrointestinal stromal tumor (GIST)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Burosumab (3)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
ORPHAN
|
X-linked hypophosphatemia (XLH), ≥ 18 years
|
100%
Hint for
minor additional benefit
|
|
Bempedoinsäure / Ezetimib
|
Nustendi®
|
Daiichi Sankyo Deutschland GmbH
|
Metabolic diseases
|
Primary hypercholesterolaemia or mixed dyslipidaemia
|
100%
no additional benefit
|
|
Bempedoinsäure
|
Nilemdo®
|
Daiichi Sankyo Deutschland GmbH
|
Metabolic diseases
|
Primary hypercholesterolaemia or mixed dyslipidaemia
|
100%
no additional benefit
|
|
Semaglutid (2, reassessment)
|
Ozempic®
|
Novo Nordisk Pharma GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2
|
100%
no additional benefit
|
|
Cannabidiol (4, reassessment)
|
Epidyolex®
|
GW Pharmaceuticals plc
|
Nervous system diseases
ORPHAN
|
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
|
100%
Hint for
considerable additional benefit
|
|
Cannabidiol (3, reassessment)
|
Epidyolex®
|
GW Pharmaceuticals plc
|
Nervous system diseases
ORPHAN
|
Dravet syndrome, ≥ 2 years, combination with clobazam
|
100%
Hint for
considerable additional benefit
|
|
Filgotinib
|
Jyseleca®
|
Gilead Sciences GmbH
|
Musculoskeletal system diseases
|
Rheumatoid arthritis (RA)
|
33%
Hint for
minor additional benefit
|
|
Ibrutinib (7)
|
Imbruvica®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab
|
59%
Hint for
considerable additional benefit
|
|
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
|
|
Sofosbuvir / Velpatasvir (2)
|
Epclusa®
|
Gilead Sciences GmbH
|
Infectious diseases
|
Chronic hepatitis C, ≥ 6 to < 18 years
|
100%
no additional benefit
|
|
Belantamab-Mafodotin
|
Blenrep®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), at least 4 prior therapies, monotherapy
|
100%
Hint for
non-quantifiable additional benefit
|
|
Alpelisib
|
Piqray®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Mammary carcinoma with PIK3CA mutation, pre-treated patients, combination with fulvestrant
|
41%
no additional benefit
|
|
Bulevirtid
|
Hepcludex®
|
MYR GmbH
|
Infectious diseases
ORPHAN
|
Chronic hepatitis Delta
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ivacaftor / Tezacaftor / Elexacaftor
|
Kaftrio®
|
Vertex Pharmaceuticals Ltd
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation)
|
100%
Indication of
major additional benefit
|
|
Ivacaftor / Tezacaftor / Elexacaftor (2)
|
Kaftrio®
|
Vertex Pharmaceuticals Ltd
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation)
|
100%
Hint for
major additional benefit
|
|
Ivacaftor (14)
|
Kalydeco®
|
Vertex Pharmaceuticals Ltd
|
Metabolic diseases
ORPHAN
|
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
|
|
Ivacaftor (13)
|
Kalydeco®
|
Vertex Pharmaceuticals Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation)
|
100%
Indication of
major additional benefit
|
|
Entrectinib (2)
|
Rozlytrek®
|
Roche Pharma AG
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line
|
100%
no additional benefit
|
|
Entrectinib
|
Rozlytrek®
|
Roche Pharma AG
|
Oncological diseases
|
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
|
100%
no additional benefit
|
|
Ibalizumab
|
Trogarzo®
|
Theratechnologies Europe limited
|
Infectious diseases
|
Multidrug-resistant HIV infection
|
100%
no additional benefit
|
|
Secukinumab (6)
|
Cosentyx®
|
Novartis Pharma GmbH
|
Skin diseases
|
Plaque psoriasis (PP), ≥ 6 to < 18 years
|
100%
Hint for
minor additional benefit
|
|
Secukinumab (5)
|
Cosentyx®
|
Novartis Pharma GmbH
|
Musculoskeletal system diseases
|
Axial spondyloarthritis
|
100%
no additional benefit
|
|
Secukinumab (4, reassessment)
|
Cosentyx®
|
Novartis Pharma GmbH
|
Skin diseases
|
Psoriatic arthritis (PA)
|
35%
Indication of
minor additional benefit
|
|
Glasdegib
|
Daurismo®
|
Pfizer Pharma GmbH
|
Oncological diseases
ORPHAN
|
Acute myeloid leukaemia (AML), combination with cytarabine (LDAC)
|
100%
Hint for
considerable additional benefit
|
|
Nintedanib (5, Ofev®)
|
Ofev®
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Respiratory system diseases
|
Interstitial pulmonary disease with systemic sclerosis
|
100%
no additional benefit
|
|
Trifaroten
|
Selgamis®
|
Galderma Laboratorium GmbH
|
Skin diseases
|
Acne vulgaris, ≥ 12 years
|
100%
no additional benefit
|
|
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat
|
Enerzair® Breezhaler®
|
Novartis Pharma GmbH
|
Respiratory system diseases
|
Bronchial asthma
|
100%
no additional benefit
|
|
Nintedanib (4, Ofev®)
|
Ofev®
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Respiratory system diseases
|
Progressive fibrosing interstitial lung diseases
|
100%
Indication of
minor additional benefit
|
|
Ravulizumab (2)
|
Ultomiris®
|
Alexion Pharma Germany GmbH
|
Hematopoietic diseases
|
Atypical hemolytic uremic syndrome (aHUS)
|
100%
no additional benefit
|
|
Sofosbuvir (3)
|
Sovaldi®
|
Gilead Sciences Ireland UC
|
Infectious diseases
|
Chronic hepatitis C, 3 to < 12 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Luspatercept (2)
|
Reblozyl®
|
Celgene GmbH
|
Hematopoietic diseases
ORPHAN
|
Beta thalassemia
|
100%
Hint for
non-quantifiable additional benefit
|
|
Luspatercept
|
Reblozyl®
|
Celgene GmbH
|
Hematopoietic diseases
ORPHAN
|
Myelodysplastic syndrome (MDS)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ledipasvir / Sofosbuvir (3)
|
Harvoni®
|
Gilead Sciences Ireland UC
|
Infectious diseases
|
Chronic hepatitis C, 3 to < 12 years
|
50%
Hint for
non-quantifiable additional benefit
|
|
Ixekizumab (4)
|
Taltz®
|
Lilly Deutschland GmbH
|
Skin diseases
|
Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg
|
100%
no additional benefit
|
|
Ixekizumab (3)
|
Taltz®
|
Lilly Deutschland GmbH
|
Musculoskeletal system diseases
|
Axial spondyloarthritis
|
100%
no additional benefit
|
|
Osilodrostat
|
Isturisa®
|
Recordati Rare Diseases Germany GmbH
|
Metabolic diseases
ORPHAN
|
Endogenous Cushing syndrome
|
100%
Hint for
non-quantifiable additional benefit
|
|
Caplacizumab (2)
|
Cablivi®
|
Sanofi-Aventis Deutschland GmbH
|
Hematopoietic diseases
ORPHAN
|
Thrombotic thrombocytopenic purpura (aTTP)Thrombotic thrombocytopenic purpura (TTP), 12 to < 18 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ozanimod
|
Zeposia®
|
Celgene GmbH
|
Nervous system diseases
|
Relapsing-remitting multiple sclerosis (MS)
|
90%
Indication of
minor additional benefit
|
|
Brentuximab Vedotin (5)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
ORPHAN
|
Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone
|
100%
Hint for
minor additional benefit
repealed
|
|
Encorafenib (2)
|
Braftovi®
|
Pierre Fabre Pharma GmbH
|
Oncological diseases
|
Metastatic colorectal carcinoma (CRC)
|
100%
Hint for
considerable additional benefit
|
|
Fostamatinib
|
Tavlesse®
|
Grifols Deutschland GmbH
|
Hematopoietic diseases
|
Chronic immune thrombocytopenia
|
100%
no additional benefit
|
|
Ivacaftor (12)
|
Kalydeco®
|
Vertex Pharmaceuticals
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), patients ≥ 6 months to < 18 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Tezacaftor / Ivacaftor (3, reassessment >€50m)
|
Symkevi®
|
Vertex Pharmaceuticals
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del)
|
100%
no additional benefit
|
|
Tezacaftor / Ivacaftor (2, reassessment >€50m)
|
Symkevi®
|
Vertex Pharmaceuticals
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del)
|
100%
no additional benefit
|
|
Mogamulizumab
|
Poteligeo®
|
Kyowa Kirin GmbH
|
Oncological diseases
ORPHAN
|
Mycosis Fungoides; Sézary Syndrome
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ponatinib (2, reassessment)
|
Iclusig®
|
Incyte Biosciences Germany GmbH
|
Oncological diseases
ORPHAN
|
Acute myeloid leukaemia (AML)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ponatinib (3, reassessment)
|
Iclusig®
|
Incyte Biosciences Germany GmbH
|
Oncological diseases
ORPHAN
|
Chronic myeloid leukaemia (CML)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Talazoparib
|
Talzenna®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Mammary carcinoma, BRCA1/2 mutation, HER2-
|
100%
Hint for
considerable additional benefit
|
|
Naldemedin
|
Rizmoic®
|
Hexal AG
|
Digestive system diseases
|
Opioid-induced constipation
|
100%
no additional benefit
|
|
Apremilast (2)
|
Otezla®
|
Amgen GmbH
|
Other diseases
|
Behçet's disease
|
100%
no additional benefit
|
|
Enzalutamid (4, reassessment)
|
Xtandi®
|
Astellas Pharma GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), non-metastatic, high-risk
|
100%
Indication of
minor additional benefit
|
|
Solriamfetol
|
Sunosi®
|
Jazz Pharmaceuticals
|
Nervous system diseases
|
Narcolepsy
|
100%
no additional benefit
|
|
Brigatinib (2)
|
Alunbrig®
|
Takeda GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients
|
50%
Hint for
considerable additional benefit
|
|
Darolutamid
|
Nubeqa®
|
Bayer Vital GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), non-metastatic, high-risk
|
100%
Indication of
considerable additional benefit
|
|
Venetoclax (4)
|
Venclyxto®
|
AbbVie Deutschland GmbH & Co. KG
|
Oncological diseases
|
Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab
|
100%
no additional benefit
|
|
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
|
|
Givosiran
|
Givlaari®
|
Alnylam Germany GmbH
|
Metabolic diseases
ORPHAN
|
Acute hepatic porphyria, ≥ 12 years
|
100%
Indication of
considerable additional benefit
|
|
Avelumab (3, reassessment)
|
Bavencio®
|
Merck Serono GmbH
|
Oncological diseases
|
Metastatic Merkel-cell carcinoma (MCC)
|
100%
no additional benefit
|
|
Trifluridin / Tipiracil (3, reassessment)
|
Lonsurf®
|
Servier Deutschland GmbH
|
Oncological diseases
|
Colorectal carcinoma (CRC), pre-treated patients
|
100%
Hint for
minor additional benefit
|
|
Apalutamid (3, reassessment)
|
Erleada®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), non-metastatic, high-risk
|
100%
Indication of
minor additional benefit
|
|
Cobicistat (2)
|
Tybost®
|
Gilead Sciences GmbH
|
Infectious diseases
|
HIV infection, combination with atazanavir or darunavir, 12 to < 18 years
|
100%
no additional benefit
|
|
Tisagenlecleucel (3, reassessment)
|
Kymriah®
|
Novartis Pharma GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia (ALL)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Tisagenlecleucel (4, reassessment)
|
Kymriah®
|
Novartis Pharma GmbH
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL)
|
100%
Hint for
non-quantifiable additional benefit
|
|
Indacaterol / Mometason
|
Atectura® Breezhaler®
|
Novartis Pharma GmbH
|
Respiratory system diseases
|
Bronchial asthma
|
100%
no additional benefit
|
|
Brolucizumab
|
Beovu®
|
Novartis Pharma GmbH
|
Eye diseases
|
Neovascular age-related macular degeneration
|
100%
no additional benefit
|
|
Fidaxomicin (2)
|
Dificlir®
|
Astellas Pharma GmbH
|
Infectious diseases
|
Clostridioides difficile infection, children and adolescents
|
54%
Hint for
considerable additional benefit
|
|
Romosozumab
|
Evenity®
|
UCB Pharma GmbH
|
Musculoskeletal system diseases
|
Osteoporosis (postmenopausal)
|
100%
Indication of
minor additional benefit
|
|
Riociguat (2, reassessment >€50m)
|
Adempas®
|
MSD Sharp & Dohme GmbH
|
Cardiovascular diseases
ORPHAN
|
Chronic thromboembolic pulmonary hypertension
|
100%
no additional benefit
|
|
Riociguat (3, reassessment >€50m)
|
Adempas®
|
MSD Sharp & Dohme GmbH
|
Cardiovascular diseases
ORPHAN
|
Pulmonary arterial hypertension (PAH)
|
100%
no additional benefit
|
|
Abemaciclib (3, reassessment)
|
Verzenios®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2-, combination with fulvestrant
|
39%
Hint for
minor additional benefit
repealed subpopulations
|
|
Tafamidis (2)
|
Vyndaqel®
|
Pfizer Pharma GmbH
|
Metabolic diseases
ORPHAN
|
Amyloid cardiomyopathy
|
100%
Hint for
considerable additional benefit
repealed
|
|
Apalutamid (2)
|
Erleada®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), hormone-sensitive, combination with androgen deprivation therapy
|
100%
no additional benefit
|
|
Ribociclib (3, reassessment)
|
Kisqali®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2-, combination with fulvestrant
|
58%
Indication of
minor additional benefit
|
|
Ribociclib (4, reassessment)
|
Kisqali®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2-, combination with aromatase inhibitor
|
100%
Hint for
minor additional benefit
|
|
Polatuzumab Vedotin
|
Polivy®
|
Roche Pharma AG
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab
|
100%
Hint for
non-quantifiable additional benefit
|
|
Siponimod
|
Mayzent®
|
Novartis Pharma GmbH
|
Nervous system diseases
|
Secondary progressive multiple sclerosis (MS)
|
100%
no additional benefit
|
|
Bedaquilin (2)
|
Sirturo®
|
Janssen-Cilag GmbH
|
Infectious diseases
ORPHAN
|
Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Daratumumab (5)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
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
|
|
Daratumumab (4)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
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
|
|
Ramucirumab (6)
|
Cyramza®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
|
100%
no additional benefit
|
|
Dulaglutid (2, reassessment)
|
Trulicity®
|
Lilly Deutschland GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2
|
31%
Hint for
minor additional benefit
|
|
Upadacitinib
|
Rinvoq®
|
AbbVie Deutschland GmbH
|
Musculoskeletal system diseases
|
Rheumatoid arthritis (RA)
|
34%
Hint for
considerable additional benefit
|
|
Trastuzumab Emtansin (2)
|
Kadcyla®
|
Roche Pharma AG
|
Oncological diseases
|
Mammary carcinoma, early stage, HER2+, adjuvant treatment
|
100%
Indication of
minor additional benefit
|
|
Ivacaftor (11)
|
Kalydeco®
|
Vertex Pharmaceuticals
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), ≥ 6 to < 12 months
|
100%
Hint for
non-quantifiable additional benefit
|
|
Neratinib
|
Nerlynx®
|
Pierre Fabre Pharma
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2+, adjuvant therapy
|
100%
Hint for
minor additional benefit
|
|
Gilteritinib
|
XOSPATA®
|
Astellas Pharma GmbH
|
Oncological diseases
ORPHAN
|
Acute myeloid leukaemia (AML), FLT3 mutation
|
100%
Hint for
considerable additional benefit
|
|
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
|
|
Dupilumab (4)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Respiratory system diseases
|
Chronic rhinosinusitis with nasal polyps
|
100%
Indication of
considerable additional benefit
|
|
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
|
|
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
|
|
Pembrolizumab (11)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Renal cell carcinoma (RCC), first-line, combination with axitinib
|
23%
Indication of
considerable additional benefit
|
|
Belimumab (2)
|
Benlysta®
|
GlaxoSmithKline GmbH & Co. KG
|
Musculoskeletal system diseases
|
Systemic lupus erythematosus
|
100%
Hint for
non-quantifiable additional benefit
|
|
Betibeglogene autotemcel
|
Zynteglo®
|
bluebird bio (Germany) GmbH
|
Hematopoietic diseases
ORPHAN
|
Beta thalassemia
|
100%
Hint for
non-quantifiable additional benefit
|
|
Cannabidiol (2)
|
Epidyolex®
|
GW Pharmaceuticals plc
|
Nervous system diseases
ORPHAN
|
Dravet syndrome, ≥ 2 years, combination with clobazam
|
100%
Hint for
non-quantifiable additional benefit
repealed
|
|
Niraparib (2, reassessment >€50m)
|
Zejula®
|
TESARO Bio Germany GmbH
|
Oncological diseases
ORPHAN
|
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
|
100%
no additional benefit
repealed
|
|
Cannabidiol
|
Epidyolex®
|
GW Pharmaceuticals plc
|
Nervous system diseases
ORPHAN
|
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
|
100%
Hint for
non-quantifiable additional benefit
repealed
|
|
Larotrectinib
|
Vitrakvi®
|
Bayer Vital GmbH
|
Oncological diseases
|
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
|
100%
no additional benefit
|
|
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
|
|
Asfotase alfa (2, reassessment >€50m)
|
Strensiq®
|
Alexion Pharma Germany GmbH
|
Metabolic diseases
ORPHAN
|
Hypophosphatasia (HPP)
|
0.8%
Hint for
non-quantifiable additional benefit
|
|
Atezolizumab (6)
|
Tecentriq®
|
Roche Pharma AG
|
Oncological diseases
|
Mammary carcinoma, triple-negative, PD-L1 expression ≥1%
|
100%
Hint for
non-quantifiable additional benefit
|
|
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
|
|
Trifluridin / Tipiracil (2)
|
Lonsurf®
|
Servier Deutschland GmbH
|
Oncological diseases
|
Metastatic gastric cancer, pre-treated patients
|
100%
Indication of
minor additional benefit
|
|
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
|
|
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
|
|
Burosumab (2, reassessment)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
ORPHAN
|
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ropeginterferon alfa-2b
|
Besremi®
|
AOP Orphan Pharmaceuticals AG
|
Oncological diseases
|
Polycythemia vera
|
100%
no additional benefit
|
|
Ivacaftor (10)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), 12 ro < 24 months
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ivacaftor (9, reassessment >€50m)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation
|
100%
Hint for
minor additional benefit
|
|
Ivacaftor (8, reassessment >€50m)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), patients from 2 to 5 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ivacaftor (7, reassessment >€50m)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), various gating mutations, ≥ 6 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Ivacaftor (6, reassessment >€50m)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor
|
100%
no additional benefit
|
|
Ivacaftor (5, reassessment >€50m)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor
|
100%
no additional benefit
|
|
Ivacaftor (4, reassessment >€50m)
|
Kalydeco®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
|
86%
Hint for
considerable additional benefit
|
|
Ramucirumab (5)
|
Cyramza®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Hepatocellular carcinoma (HCC)
|
100%
Proof of
minor additional benefit
|
|
Dupilumab (2)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Respiratory system diseases
|
Bronchial asthma, ≥ 12 years
|
100%
no additional benefit
|
|
Dupilumab (3)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Skin diseases
|
Atopic dermatitis (AD), 12 to < 18 years
|
100%
Hint for
non-quantifiable additional benefit
|
|
Andexanet alfa
|
Ondexxya®
|
Portola Deutschland GmbH
|
Hematopoietic diseases
|
Antidote for reversal of anticoagulation (factor Xa)
|
100%
no additional benefit
|
|
Ibrutinib (5)
|
Imbruvica®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab
|
26%
Hint for
minor additional benefit
|
|
Ibrutinib (6)
|
Imbruvica®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Waldenström's disease, combination with rituximab
|
100%
no additional benefit
|
|
Volanesorsen
|
Waylivra®
|
Akcea Therapeutics Germany GmbH
|
Metabolic diseases
ORPHAN
|
Chylomicronaemia syndrome
|
100%
Hint for
non-quantifiable additional benefit
|
|
Turoctocog alfa pegol
|
Esperoct®
|
Novo Nordisk Pharma GmbH
|
Hematopoietic diseases
|
Hemophilia A
|
100%
no additional benefit
|
|
Dolutegravir / Lamivudin
|
Dovato®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
HIV infection, ≥ 12 years
|
100%
no additional benefit
|
|
Ravulizumab
|
Ultomiris®
|
Alexion Pharma Germany GmbH
|
Hematopoietic diseases
|
Paroxysmal hemoglobinuria
|
100%
no additional benefit
|
|
Cemiplimab
|
Libtayo®
|
Sanofi-Aventis Deutschland GmbH
|
Oncological diseases
|
Squamous cell carcinoma (SCC)
|
100%
no additional benefit
|
|
Olaparib (3)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Mammary carcinoma, BRCA1/2 mutations, HER2-
|
100%
Hint for
minor additional benefit
|
|
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
|
|
Vigabatrin
|
Kigabeq®
|
Desitin GmbH
|
Nervous system diseases
|
Epilepsy, West syndrome, < 7 years
|
100%
no additional benefit
|
|
Vigabatrin (2)
|
Kigabeq®
|
Desitin GmbH
|
Nervous system diseases
|
Epilepsy, focal seizures, < 7 years
|
100%
no additional benefit
|
|
Pegvaliase
|
Palynziq®
|
BioMarin International Limited
|
Metabolic diseases
ORPHAN
|
Phenylketonuria
|
100%
Hint for
non-quantifiable additional benefit
|
|
Dapagliflozin / Metformin (3, reassessment)
|
Xigduo®
|
AstraZeneca GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2
|
50%
Hint for
minor additional benefit
|
|
Dapagliflozin (4, reassessment)
|
Forxiga®
|
AstraZeneca GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2
|
41%
Hint for
minor additional benefit
|
|
Pomalidomid (3)
|
Imnovid®
|
Celgene GmbH
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone
|
100%
no additional benefit
|
|
Empagliflozin / Linagliptin
|
Glyxambi®
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Metabolic diseases
|
Diabetes mellitus type 2
|
100%
no additional benefit
|
|
Risankizumab
|
Skyrizi®
|
AbbVie Deutschland GmbH & Co. KG
|
Skin diseases
|
Plaque psoriasis (PP)
|
82%
Proof of
considerable additional benefit
|
|
Lorlatinib
|
Lorviqua®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
|
100%
no additional benefit
|
|
Fremanezumab
|
Ajovy®
|
Teva GmbH
|
Nervous system diseases
|
Migraine prophylaxis
|
1.0%
Hint for
considerable additional benefit
|
|
Dacomitinib
|
Vizimpro®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
|
100%
no additional benefit
|
|
Lisdexamfetamindimesilat (2, Elvanse Adult®)
|
Elvanse Adult®
|
Shire Deutschland GmbH
|
Mental illnesses
|
Attention deficit hyperactivity disorder (ADHD), ≥ 18 years
|
100%
no additional benefit
|
|
Dapagliflozin (3)
|
Forxiga®
|
AstraZeneca GmbH
|
Metabolic diseases
|
Diabetes mellitus type 1
|
100%
Hint for
minor additional benefit
repealed
|
|
Radium-223-dichlorid (2, reassessment)
|
Xofigo®
|
Bayer Vital GmbH
|
Oncological diseases
|
Prostate carcinoma (PC)
|
100%
no additional benefit
|
|
Voretigen Neparvovec
|
Luxturna®
|
Novartis Pharma GmbH
|
Eye diseases
ORPHAN
|
Hereditary retinal dystrophy
|
100%
Hint for
considerable additional benefit
|
|
Glecaprevir / Pibrentasvir (2)
|
Maviret®
|
AbbVie Deutschland GmbH & Co. KG
|
Infectious diseases
|
Chronic hepatitis C, 12 to < 18 years
|
100%
no additional benefit
|
|
Nintedanib (3, reassessment >€50m, Ofev®)
|
Ofev®
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Respiratory system diseases
ORPHAN
|
Idiopathic pulmonary fibrosis
|
100%
Hint for
considerable additional benefit
|
|
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
|
|
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
|
|
Pembrolizumab (8)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Melanoma, adjuvant therapy
|
100%
Indication of
non-quantifiable additional benefit
|
|
Galcanezumab
|
Emgality®
|
Lilly Deutschland GmbH
|
Nervous system diseases
|
Migraine prophylaxis
|
1.0%
Hint for
considerable additional benefit
|
|
Brentuximab Vedotin (4)
|
Adcetris®
|
Takeda Pharma GmbH
|
Oncological diseases
ORPHAN
|
Hodgkin lymphoma (HL), CD30+, first-line
|
100%
non-quantifiable additional benefit
|
|
Emicizumab (2)
|
Hemlibra®
|
Roche Pharma AG
|
Hematopoietic diseases
|
Hemophilia A, without factor VIII inhibitors
|
100%
no additional benefit
|
|
Regadenoson (2)
|
Rapiscan®
|
GE Healthcare Buchler GmbH & Co. KG
|
Other diseases
|
Stenosis, Fractional Flow Reserve Measurement (FFR)
|
100%
no additional benefit
|
|
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
|
|
Rucaparib (2)
|
Rubraca®
|
Clovis Oncology Germany GmbH
|
Oncological diseases
|
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
|
100%
no additional benefit
|
|
Blinatumomab (3)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients
|
100%
non-quantifiable additional benefit
|
|
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
|
|
Blinatumomab (4)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years
|
100%
non-quantifiable additional benefit
|
|
Lenvatinib (4, reassessment)
|
Lenvima®
|
Eisai GmbH
|
Oncological diseases
|
Thyroid carcinoma (DTC)
|
100%
no additional benefit
|
|
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
|
|
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
|
|
Mexiletin
|
Namuscla®
|
Lupin Europe GmbH
|
Nervous system diseases
ORPHAN
|
Myotonia
|
100%
non-quantifiable additional benefit
|
|
Apalutamid
|
Erleada®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), non-metastatic, high-risk
|
100%
Hint for
minor additional benefit
repealed
|
|
Lanadelumab
|
Takhzyro®
|
Shire Deutschland GmbH, Teil der Takeda Group
|
Other diseases
ORPHAN
|
Hereditary angioedema (HAE)
|
100%
considerable additional benefit
repealed
|
|
Doravirin
|
Pifeltro®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
HIV infection
|
100%
no additional benefit
|
|
Doravirin / Lamivudin / Tenofovirdisoproxil
|
Delstrigo®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
HIV infection
|
100%
no additional benefit
|
|
Glycerolphenylbutyrat (2)
|
Ravicti®
|
Swedish Orphan Biovitrum GmbH
|
Metabolic diseases
ORPHAN
|
Urea cycle disorders (UCD), 0 to < 2 months
|
100%
non-quantifiable additional benefit
|
|
Brigatinib
|
Alunbrig®
|
Takeda Pharma GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
|
100%
no additional benefit
|
|
Bedaquilin
|
Sirturo®
|
Janssen-Cilag GmbH
|
Infectious diseases
ORPHAN
|
Multidrug-resistant pulmonary tuberculosis
|
100%
considerable additional benefit
|
|
Melatonin
|
Slenyto®
|
InfectoPharm Arzneimittel und Consilium GmbH
|
Nervous system diseases
|
Sleep disorders
|
100%
Hint for
minor additional benefit
|
|
Ribociclib (2)
|
Kisqali®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor
|
100%
no additional benefit
repealed subpopulations
|
|
Damoctocog alfa pegol
|
Jivi®
|
Bayer Vital GmbH
|
Hematopoietic diseases
|
Hemophilia A, ≥ 12 years
|
100%
no additional benefit
|
|
Pembrolizumab (7, reassessment)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Urothelial carcinoma (UC), CPS ≥ 10, first-line
|
100%
no additional benefit
repealed
|
|
Fingolimod (5)
|
Gilenya®
|
Novartis Pharma GmbH
|
Nervous system diseases
|
Multiple sclerosis (MS), ≥ 10 to < 18 years
|
57%
Hint for
non-quantifiable additional benefit
|
|
Atezolizumab (3, reassessment)
|
Tecentriq®
|
Roche Pharma AG
|
Oncological diseases
|
Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line
|
100%
no additional benefit
|
|
Cabozantinib (5, Cabometyx®)
|
Cabometyx®
|
Ipsen Pharma GmbH
|
Oncological diseases
|
Hepatocellular carcinoma (HCC)
|
100%
Hint for
minor additional benefit
|
|
Tezacaftor / Ivacaftor
|
Symkevi®
|
Vertex Pharmaceuticals (Europe) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), F508del mutation, ≥ 12 years
|
91%
considerable additional benefit
repealed
|
|
Enzalutamid (3)
|
Xtandi®
|
Astellas Pharma GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), non-metastatic, high-risk
|
100%
no additional benefit
repealed
|
|
Venetoclax (2)
|
Venclyxto®
|
AbbVie Deutschland GmbH
|
Oncological diseases
|
Chronic lymphocytic leukaemia (CLL), combination with rituximab
|
37%
Indication of
minor additional benefit
|
|
Venetoclax (3, reassessment)
|
Venclyxto®
|
AbbVie Deutschland GmbH
|
Oncological diseases
|
Chronic lymphocytic leukaemia (CLL), monotherapy
|
100%
no additional benefit
|
|
Insulin degludec (4, reassessment)
|
Tresiba®
|
Novo Nordisk Pharma GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2
|
100%
no additional benefit
|
|
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
|
|
Tildrakizumab
|
Ilumetri®
|
Almirall Hermal GmbH
|
Skin diseases
|
Plaque psoriasis (PP)
|
100%
no additional benefit
|
|
Alirocumab (2, reassessment)
|
Praluent®
|
Sanofi-Aventis Deutschland GmbH
|
Metabolic diseases
|
Hypercholesterolemia or mixed dyslipidaemia
|
100%
no additional benefit
|
|
Axicabtagen-Ciloleucel (2)
|
Yescarta®
|
Kite, Gilead company
|
Oncological diseases
ORPHAN
|
Primary mediastinal large B-cell lymphoma (PMBCL)
|
100%
non-quantifiable additional benefit
|
|
Axicabtagen-Ciloleucel
|
Yescarta®
|
Kite, Gilead company
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL)
|
100%
non-quantifiable additional benefit
|
|
Abemaciclib (2)
|
Verzenios®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2-, combination with fulvestrant
|
100%
no additional benefit
repealed subpopulations
|
|
Abemaciclib
|
Verzenios®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Mammary carcinoma, HR+, HER2-, combination with aromatase inhibitor
|
100%
no additional benefit
|
|
Semaglutid
|
Ozempic®
|
Novo Nordisk Pharma GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2
|
37%
Hint for
minor additional benefit
repealed
|
|
Erenumab
|
Aimovig®
|
Novartis Pharma GmbH
|
Nervous system diseases
|
Migraine prophylaxis
|
1.0%
Hint for
considerable additional benefit
repealed subpopulations
|
|
Pembrolizumab (6)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Squamous cell carcinoma head and neck
|
100%
no additional benefit
|
|
Ocriplasmin (2, reassessment)
|
Jetrea®
|
Oxurion NV
|
Eye diseases
|
Vitreomacular traction (VMT)
|
94%
Hint for
minor additional benefit
|
|
Durvalumab
|
Imfinzi®
|
AstraZeneca GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), maintenance therapy
|
100%
Hint for
considerable additional benefit
|
|
Trametinib (3)
|
Mekinist®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Melanoma, in combination with dabrafenib, BRAF V600 mutation, adjuvant therapy
|
100%
Indication of
considerable additional benefit
|
|
Dabrafenib (4)
|
Tafinlar®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Melanoma, BRAF V600 mutation, combination with trametinib, adjuvant therapy
|
100%
Indication of
considerable additional benefit
|
|
Patisiran
|
Onpattro®
|
Alnylam Germany GmbH
|
Metabolic diseases
ORPHAN
|
Amyloidosis
|
100%
considerable additional benefit
|
|
Inotersen
|
Tegsedi®
|
Akcea Therapeutics Germany GmbH
|
Metabolic diseases
ORPHAN
|
Amyloidosis
|
100%
non-quantifiable additional benefit
|
|
Metreleptin
|
Myalepta®
|
Aegerion Pharmaceuticals GmbH
|
Metabolic diseases
ORPHAN
|
Lipodystrophy
|
100%
non-quantifiable additional benefit
|
|
Binimetinib
|
Mektovi®
|
Pierre Fabre Pharma GmbH
|
Oncological diseases
|
Melanoma, BRAF V600 mutation, combination with encorafenib
|
100%
no additional benefit
|
|
Encorafenib
|
Braftovi®
|
Pierre Fabre Pharma GmbH
|
Oncological diseases
|
Melanoma, BRAF V600 mutation, combination with binimetinib
|
100%
no additional benefit
|
|
Palbociclib (2, reassessment)
|
Ibrance®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Mammary carcinoma
|
100%
no additional benefit
|
|
Lenvatinib (3)
|
Lenvima®
|
Eisai GmbH
|
Oncological diseases
|
Hepatocellular carcinoma (HCC)
|
100%
no additional benefit
|
|
Daunorubicin / Cytarabin (liposomale Formulierung)
|
Vyxeos® liposomal
|
Jazz Pharmaceuticals
|
Oncological diseases
ORPHAN
|
Therapy-related acute myeloid leukaemia (AML); acute myeloid leukaemia (AML) with multilinear dysplasia
|
100%
considerable additional benefit
|
|
Mepolizumab (2)
|
Nucala®
|
GlaxoSmithKline GmbH & Co. KG
|
Respiratory system diseases
|
Bronchial asthma, ≥ 6 to < 18 years
|
100%
no additional benefit
|
|
Sitagliptin (3, reassessment)
|
Januvia®
|
MSD Sharp & Dohme GmbH
|
Metabolic diseases
|
Diabetes mellitus type 2, combination with metformin
|
100%
Hint for
minor additional benefit
|
|
Tenofoviralafenamid (2, reassessment)
|
Vemlidy®
|
Gilead Sciences GmbH
|
Infectious diseases
|
Chronic hepatitis B, ≥ 12 years
|
100%
no additional benefit
|
|
Caplacizumab
|
Cablivi®
|
Sanofi-Aventis Deutschland GmbH
|
Hematopoietic diseases
ORPHAN
|
Thrombotic thrombocytopenic purpura (TTP)
|
100%
non-quantifiable additional benefit
|
|
Vestronidase alfa
|
Mepsevii®
|
Ultragenyx Germany GmbH
|
Metabolic diseases
ORPHAN
|
Mucopolysaccharidosis (MPS VII; Sly syndrome)
|
100%
non-quantifiable additional benefit
|
|
Daratumumab (3)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone
|
100%
Hint for
considerable additional benefit
|
|
Tisagenlecleucel
|
Kymriah®
|
Novartis Pharma GmbH
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL)
|
100%
non-quantifiable additional benefit
repealed
|
|
Tisagenlecleucel (2)
|
Kymriah®
|
Novartis Pharma GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia (ALL)
|
100%
non-quantifiable additional benefit
repealed
|
|
Tofacitinib (4)
|
Xeljanz®
|
Pfizer Pharma GmbH
|
Musculoskeletal system diseases
|
Psoriatic arthritis (PA)
|
69%
Hint for
minor additional benefit
|
|
Tofacitinib (3)
|
Xeljanz®
|
Pfizer Pharma GmbH
|
Digestive system diseases
|
Ulcerative colitis
|
100%
no additional benefit
|
|
Nivolumab (11)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Melanoma, adjuvant therapy
|
100%
Hint for
non-quantifiable additional benefit
repealed
|
|
Gemtuzumab Ozogamicin
|
Mylotarg®
|
Pfizer Pharma GmbH
|
Oncological diseases
ORPHAN
|
Acute myeloid leukaemia (AML)
|
100%
non-quantifiable additional benefit
|
|
Bosutinib (3, reassessment)
|
Bosulif®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Chronic myeloid leukaemia (CML), Ph+
|
100%
no additional benefit
|
|
Ingenolmebutat (2, reassessment)
|
Picato®
|
LEO Pharma GmbH
|
Skin diseases
|
Actinic keratosis (AK)
|
50%
Hint for
non-quantifiable additional benefit
repealed
|
|
Brivaracetam (2)
|
Briviact®
|
UCB Pharma GmbH
|
Nervous system diseases
|
Epilepsy, focal seizures, add-on therapy, 4 to < 16 years
|
100%
no additional benefit
|
|
Osimertinib (3)
|
Tagrisso®
|
AstraZeneca GmbH
|
Oncological diseases
|
Non-small cell lung carcinoma (NSCLC), first-line
|
84%
Hint for
considerable additional benefit
|
|
Ipilimumab (4)
|
Yervoy®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Melanoma, combination with nivolumab
|
85%
no additional benefit
|
|
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
|
|
Pertuzumab (3)
|
Perjeta®
|
Roche Pharma AG
|
Oncological diseases
|
Mammary carcinoma, early with high risk of recurrence, adjuvant, combination with trastuzumab and chemotherapy
|
100%
Indication of
minor additional benefit
|
|
Bictegravir / Emtricitabin / Tenofoviralafenamid
|
Biktarvy®
|
Gilead Sciences GmbH
|
Infectious diseases
|
HIV infection
|
100%
no additional benefit
|
|
Velmanase alfa
|
Lamzede®
|
Chiesi GmbH
|
Metabolic diseases
ORPHAN
|
Alpha mannosidosis
|
100%
non-quantifiable additional benefit
|
|
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
|
|
Cabozantinib (4, Cabometyx®)
|
Cabometyx®
|
Ipsen Pharma GmbH
|
Oncological diseases
|
Renal cell carciRenal cell carcinoma (RCC), first-linenoma (RCC)
|
100%
no additional benefit
|
|