Currently active benefit assessment procedures persuant to art. 35a SGB V

Nivolumab (14) Opdivo® Bristol-​Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Squamous cell carcinoma of esophagus, pretreated patients
Afamelanotid (2, reassessment) Scenesse® Clinuvel (UK) Limited Metabolic diseases
METABOL ORPHAN
erythropoetic Protoporphyria
Dupilumab (5) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases
OTHER
Atopic Dermatitis, 6 - 11 years
Lenvatinib (5, Kisplyx®, reassessment) Kisplyx® Eisai GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC)
Lumasiran Oxlumo® Alnylam Germany GmbH Metabolic diseases
METABOL ORPHAN
hyperoxaluria
Ipilimumab (6) Yervoy® Bristol-Myers Squibb Pharma EEIG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC), first line, combination with Nivolumab and platin-based chemotherapy
Nivolumab (13) Opdivo® Bristol-Myers Squibb Pharma EEIG Oncological diseases
ONCO
Non-small-cell lung carcinoma (NSCLC), combination with ipilimumab and platin-based chemotherapy, first line
Perampanel (5) Fycompa® Eisai GmbH Nervous system diseases
CNS
Epilepsia, primary focal seizure, ≥ 4 years
Perampanel (4) Fycompa® Eisai GmbH Nervous system diseases
CNS
Epilepsia, primary general seizure, ≥ 7 years
Sucroferric Oxyhydroxide (2) Velphoro® Fresenius Medical Care Deutschland GmbH Other diseases
OTHER
Serumphosphate control in renal insuffiency, ≥ 2 until 18 years
Olaparib (7) Lynparza® AstraZeneca GmbH Oncological diseases
ONCO
Adenocarzinoma of Pankreas, BRCA1/2-Mutation, Maintenance therapy
Olaparib (6) Lynparza® AstraZeneca GmbH Oncological diseases
ONCO
Prostata carcinoma, BRCA1/2-Mutation, Progredience afte hormonal therapy
Olaparib (5) Lynparza® AstraZeneca GmbH Oncological diseases
ONCO
Ovarial carzinoma, tube carcinoma or primary Peritoneal carcinoma, FIGO-Stadium III/ IV, HRD-positive, Maintenance, combination with Bevacizumab
Guselkumab (2) Tremfya® Janssen-Cilag GmbH Musculoskeletal system diseases
OTHER
Psoriasis-Arthritis (PA)
Nusinersen (2, reassessment >€50m) Spinraza® Biogen GmbH Nervous system diseases
CNS ORPHAN
Spinal Muscelatrophia (SMA)
Sebelipase alfa (2, reassessment) Kanuma® Alexion Pharma Germany GmbH Metabolic diseases
OTHER ORPHAN
Defieniency of lysosomal acid lipase (LAL)
Tezacaftor / Ivacaftor (5) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases
OTHER ORPHAN
cystic fibrosis (CF) combination therapy with Ivacaftor in patients aged 6 to < 12 years (heterozygous with regard to F508del and CF mutation)
Tezacaftor / Ivacaftor (4) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases
OTHER ORPHAN
cystic fibrosis (CF) combination therapy with Ivacaftor in patients aged 6 to < 12 years (homozygous with regard to F508del mutation)
Tafamidis (4, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Other diseases
OTHER ORPHAN
Amyloidosis in cardiomyopathy
Tafamidis (3, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Other diseases
OTHER ORPHAN
Amyloidosis
Niraparib (3) Zejula® GlaxoSmithKline GmbH & Co. KG Oncological diseases
ONCO
ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy)
Ivacaftor (18) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases
OTHER ORPHAN
cystic fibrosis (CF) combination therapy with Tezacaftor/Ivacaftor in patients aged 6 to < 12 years (heterozygous with regard to F508del and RF mutation)
Ivacaftor (17) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases
OTHER ORPHAN
cystic fibrosis (CF) combination therapy with Tezacaftor/Ivacaftor in patients aged 6 to < 12 years (homozygous F508del mutation)
Ivacaftor (16) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases
OTHER ORPHAN
cystic fibrosis (CF) patients from 4 to < 6 months, R117H mutation
Ivacaftor (15) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases
OTHER ORPHAN
cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
Dapagliflozin (5) Forxiga® AstraZeneca GmbH Cardiovascular diseases
CV
chronic heart failure (CHF)
Acalabrutinib (3) Calquence® AstraZeneca GmbH Oncological diseases
ONCO
Chronic lymphocytic leukemia (CLL)
Acalabrutinib (2) Calquence® AstraZeneca GmbH Oncological diseases
ONCO
chronic lymphatic Leukemia; combination with Obinutuzumab, first-line
Acalabrutinib Calquence® AstraZeneca GmbH Oncological diseases
ONCO
chronic lymphatic Leukemia (CLL); Monotherapy, first-line
Amikacin Arikayce® Mykobakterium-avium-Komplex (MAC) Lungeninfektionen Infectious diseases
INFECT ORPHAN
Mycobacterial-avium-complex (MAC) Lung infection)
Atezolizumab (8) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
hepatocellular carzinoma (HCC), combination with Bevacizumab
Crizanlizumab Adakveo® Novartis Pharma GmbH Hematopoietic diseases
CV ORPHAN
Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years
Avapritinib Ayvakyt® Blueprint Medicines (Germany) Oncological diseases
ONCO ORPHAN
Gastrointestinal stromal tumor
Burosumab (3) Crysvita® Kyowa Kirin GmbH Metabolic diseases
OTHER ORPHAN
X-chromosomal Hypophosphatemia, ≥ 18 years
Bempedoinsäure / Ezetimib Nustendi® Daiichi Sankyo Deutschland GmbH Metabolic diseases
CV
Hypercholesterolemia, Dyslipidemia
Bempedoinsäure Nilemdo® Daiichi Sankyo Deutschland GmbH Metabolic diseases
CV
Hypercholesterolemia, Dyslipidemia
Semaglutid (2, reassessment) Ozempic® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus Typw 2 (metabolism)
Cannabidiol (4, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases
ORPHAN
Lennox-Gastaut-Syndrome, ≥ 2 years, combination with Clobazam
Cannabidiol (3, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases
CNS ORPHAN
Dravet-Syndrome, ≥ 2 years, combination with Clobazam
Filgotinib Jyseleca® Gilead Sciences GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (muscle-skeleton-system)
Alpelisib Piqray® Novartis Pharma GmbH Oncological diseases
ONCO
breast cancer
Bulevirtid Hepcludex® MYR GmbH Infectious diseases
INFECT ORPHAN
Chronic Hepatitis-D-Virus (HDV)-Infection, HDV-RNA-positive
Ivacaftor / Tezacaftor / Elexacaftor Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor in patients > 12 years (homoocygotic bzgl. F508del und MF-Mutation))
Ivacaftor / Tezacaftor / Elexacaftor (2) Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor in patients > 12 years (heterocygotic bzgl. F508del und MF-Mutation))
Ivacaftor (14) Kalydeco® Vertex Pharmaceuticals Ltd Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor/Tezacaftor/Elexacaftor in patients >12 yearse (heterocygotic or F508del- and MF-Mutation)
Ivacaftor (13) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor/Tezacaftor/Elexacaftor in patients > 12 years (homocygotic or F508del-Mutation
Entrectinib (2) Rozlytrek® Roche Pharma AG Oncological diseases
ONCO
NSCLC, ROS1-positive, advanced, first line
Entrectinib Rozlytrek® Roche Pharma AG Oncological diseases
ONCO
Solide Tumors, Neurotrophic Tyrosin-Receptor-Kinase (NTRK)-Genfusion, tissue-independent
Ibalizumab Trogarzo® Theratechnologies Europe limited Infectious diseases
INFECT
HIV-Infection
Secukinumab (6) Cosentyx® Novartis Pharma GmbH Skin diseases
OTHER
Plaque-Psoriasis, > 6 years
Secukinumab (5) Cosentyx® Novartis Pharma GmbH Skin diseases
OTHER
axiale Spondyloarthritis
Secukinumab (4) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases
OTHER
Psoriasis-Arthritis (PA)
Nintedanib (5, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
OTHER ORPHAN
interstitial pulmonary disease with systemic sclerosis
Trifaroten Selgamis® Galderma Laboratorium GmbH Skin diseases
OTHER
Acne vulgaris
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat Enerzair® Breezhaler® Novartis Pharma GmbH Respiratory system diseases
OTHER
Asthma bronchiale
Nintedanib (4, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
OTHER ORPHAN
chronic fibrotic interstitial progressive pulmonary disease
Glasdegib Daurismo® PFIZER PHARMA GmbH Oncological diseases
ONCO ORPHAN
acute myeloic leucemia (AML)
Ravulizumab (2) Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases
OTHER
Atypical hemolytic-uremic syndrome (aHUS)
Sofosbuvir (3) Sovaldi® Gilead Sciences Ireland UC Infectious diseases
INFECT
Chronic hepatitis C infection
Luspatercept (2) Reblozyl® Celgene GmbH Hematopoietic diseases
OTHER ORPHAN
β-thalassemia
Luspatercept Reblozyl® Celgene GmbH Hematopoietic diseases
OTHER ORPHAN
Anemia due to myelodysplastic syndromes (MDS)
Ledipasvir / Sofosbuvir (3) Harvoni® Gilead Sciences Ireland UC Infectious diseases
INFECT
Chronic hepatitis C infection, <12 years
Ixekizumab (4) Taltz® Lilly Deutschland GmbH Skin diseases
OTHER
Plaque psoriasis, children ≥6–<18 years
Ixekizumab (3) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases
OTHER
Axial spondyloarthritis
Ibrutinib (7) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
CLL, first line, combination with Rituximab
Durvalumab (2) Imfinzi® AstraZeneca GmbH Oncological diseases
ONCO
NSCLC, first line, combination with Etoposid and either Carboplatin nor Cisplatin
Sofosbuvir / Velpatasvir (2) Epclusa® Gilead Sciences GmbH Infectious diseases
INFECT
chronic hepatitis C, ≥ 6 and < 18 years
Belantamab-Mafodotin Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases
ONCO ORPHAN
Multiples Myeloma, at least 4 prior reatments, monotherapy
Baricitinib (2) Olumiant® Lilly Deutschland GmbH Skin diseases
OTHER
atopic dermatitis (AD)