All G-BA resolutions regarding early benefit assessments (§35a SGB V)

Indacaterol / Mometason Atectura® Breezhaler® Novartis Pharma GmbH Respiratory system diseases
OTHER
Asthma 100% no additional benefit
Brigatinib (2) Alunbrig® Takeda GmbH Oncological diseases
ONCO
non-small cell lung carcinoma (ALK+ NSCLC) 50% Hint for considerable additional benefit
Darolutamid Nubeqa® Bayer Vital GmbH Oncological diseases
ONCO
Prostate carcinoma 100% Indication of considerable additional benefit
Venetoclax (4) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases
ONCO
Chronic lymphocytic leukemia (CLL) 100% no additional benefit
Insulin glargin / Lixisenatid (2) Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Givosiran Givlaari® Alnylam Germany GmbH Metabolic diseases
METABOL ORPHAN
Acute hepatic porphyria 100% Indication of considerable additional benefit
Avelumab (3, reassessment) Bavencio® Merck Serono GmbH Oncological diseases
ONCO
Merkel cell carcinoma 100% no additional benefit
Trifluridin / Tipiracil (3, reassessment) Lonsurf® Servier Deutschland GmbH Oncological diseases
ONCO
Colorectal carcinoma, pretreated patients 100% Hint for minor additional benefit
Apalutamid (3, reassessment) Erleada® Janssen-Cilag GmbH Oncological diseases
ONCO
Prostate carcinoma (mHSPC) 100% Indication of minor additional benefit
Cobicistat (2) Tybost® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Brolucizumab Beovu® Novartis Pharma GmbH Eye diseases
OTHER
Macular degeneration 100% no additional benefit
Fidaxomicin (2) Dificlir® Astellas Pharma GmbH Infectious diseases
INFECT
Clostriudium difficile associated diarrhea (CDAD) 54% Hint for considerable additional benefit
Romosozumab Evenity® UCB Pharma GmbH Musculoskeletal system diseases
OTHER
Osteoporosis, postmenopausal women 100% Indication of minor additional benefit
Tisagenlecleucel (3, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Pediatric Acute lymphoblastic leukemia (pedALL) 100% Hint for non-quantifiable additional benefit
Tisagenlecleucel (4, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Diffuse large B-cell lymphoma (DLBCL) 100% Hint for non-quantifiable additional benefit
Riociguat (2, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases
CV ORPHAN
Chronic thromboembolic pulmonary Hypertension (CTEPH) 100% no additional benefit
Riociguat (3, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases
CV ORPHAN
Pulmonary Arterial Hypertension (PAH) 100% no additional benefit
Abemaciclib (3, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases
ONCO
Breast cancer 39% Hint for minor additional benefit
Tafamidis (2) Vyndaqel® Pfizer Pharma GmbH Other diseases
METABOL ORPHAN
Amyloidosis 100% Hint for considerable additional benefit
Apalutamid (2) Erleada® Janssen-Cilag GmbH Oncological diseases
ONCO
Prostate carcinoma, hormon-sensitive, combination with androgene withdrawal 100% no additional benefit
Ribociclib (3, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases
ONCO
Breast cancer 58% Indication of minor additional benefit
Ribociclib (4, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases
ONCO
Breast cancer 100% Hint for minor additional benefit
Polatuzumab Vedotin Polivy® Roche Pharma AG Oncological diseases
ONCO ORPHAN
Diffuse large B-cell lymphoma (DLBCL) 100% Hint for non-quantifiable additional benefit
Siponimod Mayzent® Novartis Pharma GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Bedaquilin (2) Sirturo® Janssen-Cilag GmbH Infectious diseases
INFECT ORPHAN
Tuberculosis 100% Hint for non-quantifiable additional benefit
Daratumumab (5) Darzalex® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Multiple Myeloma (MM) 100% Hint for minor additional benefit
Daratumumab (4) Darzalex® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% Hint for non-quantifiable additional benefit
Ramucirumab (6) Cyramza® Lilly Deutschland GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Dulaglutid (2, reassessment) Trulicity® Lilly Deutschland GmbH Metabolic diseases
CV
Diabetes mellitus type 2 31% Hint for minor additional benefit
Upadacitinib Rinvoq® AbbVie Deutschland GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (RA) 34% Hint for considerable additional benefit
Trastuzumab Emtansin (2) Kadcyla® Roche Pharma AG Oncological diseases
ONCO
Breast cancer 100% Indication of minor additional benefit
Ivacaftor (11) Kalydeco® Vertex Pharmaceuticals Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% Hint for non-quantifiable additional benefit
Neratinib Nerlynx® Pierre Fabre Pharma Oncological diseases
ONCO
Breast cancer 100% Hint for minor additional benefit
Gilteritinib XOSPATA® Astellas Pharma GmbH Oncological diseases
ONCO ORPHAN
Acute myeloid leukemia (AML) 100% Hint for considerable additional benefit
Avelumab (2) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma 23% Hint for considerable additional benefit
Dupilumab (4) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases
OTHER
Chronic rhinosinusitis with nasal polyps 100% Indication of considerable additional benefit
Pembrolizumab (13) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Squamous cell carcinoma (SCC), Head and neck cancer 100% Indication of minor additional benefit
Pembrolizumab (12) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Squamous cell carcinoma (SCC), Head and neck cancer 100% Hint for considerable additional benefit
Pembrolizumab (11) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 23% Indication of considerable additional benefit
Belimumab (2) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases
OTHER
Systemic Lupus Erythematodes (SLE) 100% Hint for non-quantifiable additional benefit
Betibeglogene autotemcel Zynteglo® bluebird bio (Germany) GmbH Hematopoietic diseases
CV ORPHAN
β-thalassemia 100% Hint for non-quantifiable additional benefit
Cannabidiol (2) Epidyolex® GW Pharmaceuticals plc Nervous system diseases
CNS ORPHAN
Dravet syndrome 100% Hint for non-quantifiable additional benefit
Niraparib (2, reassessment >€50m) Zejula® TESARO Bio Germany GmbH Oncological diseases
ONCO ORPHAN
Ovarian carcinoma / fallopian tube carcinoma / peritoneal carcinoma 100% no additional benefit
Cannabidiol Epidyolex® GW Pharmaceuticals plc Nervous system diseases
CNS ORPHAN
Lennox-Gastaut syndrome 100% Hint for non-quantifiable additional benefit
Larotrectinib Vitrakvi® Bayer Vital GmbH Oncological diseases
ONCO
Solid tumors, NTRK gene fusion 100% no additional benefit
Atezolizumab (4) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Asfotase alfa (2, reassessment >€50m) Strensiq® Alexion Pharma Germany GmbH Metabolic diseases
METABOL ORPHAN
Hypophosphatasia (HPP) 0.8% Hint for non-quantifiable additional benefit
Atezolizumab (6) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Breast cancer 100% Hint for non-quantifiable additional benefit
Atezolizumab (5) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Trifluridin / Tipiracil (2) Lonsurf® Servier Deutschland GmbH Oncological diseases
ONCO
Stomach cancer 100% Indication of minor additional benefit
Atezolizumab (7) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Small cell lung carcinoma (ES-SCLC) 100% Hint for minor additional benefit
Elotuzumab (2) Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Multiple myeloma (MM) 100% Hint for considerable additional benefit
Burosumab (2, reassessment) Crysvita® Kyowa Kirin GmbH Metabolic diseases
METABOL ORPHAN
Hypophosphatemia 100% Hint for non-quantifiable additional benefit
Ivacaftor (10) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% Hint for non-quantifiable additional benefit
Ivacaftor (9, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% Hint for minor additional benefit
Ivacaftor (8, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% Hint for non-quantifiable additional benefit
Ivacaftor (7, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% Hint for non-quantifiable additional benefit
Ivacaftor (6, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% no additional benefit
Ivacaftor (5, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% no additional benefit
Ivacaftor (4, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 86% Hint for considerable additional benefit
Ramucirumab (5) Cyramza® Lilly Deutschland GmbH Oncological diseases
ONCO
Hepatocellular carcinoma (HC) 100% Proof of minor additional benefit
Dupilumab (2) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases
OTHER
Asthma 100% no additional benefit
Dupilumab (3) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases
OTHER
Atopic dermatitis 100% Hint for non-quantifiable additional benefit
Andexanet alfa Ondexxya® Portola Deutschland GmbH Hematopoietic diseases
OTHER
Anticoagulation antidote (factor Xa) 100% no additional benefit
Ibrutinib (5) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Chronic lymphocytic leukemia (CLL) 26% Hint for minor additional benefit
Ibrutinib (6) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Waldenstroem's macroglobulinemia 100% no additional benefit
Ropeginterferon alfa-2b Besremi® AOP Orphan Pharmaceuticals AG Oncological diseases
ONCO
Polycythemia vera 100% no additional benefit
Volanesorsen Waylivra® Akcea Therapeutics Germany GmbH Metabolic diseases
METABOL ORPHAN
Familial chylomicronemia syndrome (FCS) 100% Hint for non-quantifiable additional benefit
Turoctocog alfa pegol Esperoct® Novo Nordisk Pharma GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Dolutegravir / Lamivudin Dovato® ViiV Healthcare GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Ravulizumab Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases
OTHER
Paroxysmal hemoglobinuria 100% no additional benefit
Cemiplimab Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases
ONCO
Squamous cell carcinoma (SCC) 100% no additional benefit
Olaparib (3) Lynparza® AstraZeneca GmbH Oncological diseases
ONCO
Breast cancer 100% Hint for minor additional benefit
Vigabatrin Kigabeq® Desitin GmbH Nervous system diseases
CNS
West syndrome 100% no additional benefit
Vigabatrin (2) Kigabeq® Desitin GmbH Nervous system diseases
CNS
Epilepsy, focal seizures, < 7 years 100% no additional benefit
Pegvaliase Palynziq® BioMarin International Limited Metabolic diseases
METABOL ORPHAN
Phenylketonuria (PKU) 100% Hint for non-quantifiable additional benefit
Dapagliflozin / Metformin (3, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 50% Hint for minor additional benefit
Dapagliflozin (4, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 41% Hint for minor additional benefit
Olaparib (4) Lynparza® AstraZeneca GmbH Oncological diseases
ONCO
Ovarian carcinoma / peritoneal carcinoma 100% no additional benefit
Empagliflozin / Linagliptin Glyxambi® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Risankizumab Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases
OTHER
Plaque psoriasis 82% Proof of considerable additional benefit
Lorlatinib Lorviqua® Pfizer Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Pomalidomid (3) Imnovid® Celgene GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% no additional benefit
Dacomitinib Vizimpro® Pfizer Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Lisdexamfetamindimesilat (2, Elvanse Adult®) Elvanse Adult® Shire Deutschland GmbH Mental illnesses
CNS
Attention deficit hyperactivity disorder (ADHD) 100% no additional benefit
Dapagliflozin (3) Forxiga® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 1 100% Hint for minor additional benefit
Fremanezumab Ajovy® Teva GmbH Nervous system diseases
CNS
Migraine 1.0% Hint for considerable additional benefit
Radium-223-dichlorid (2, reassessment) Xofigo® Bayer Vital GmbH Oncological diseases
ONCO
Prostate carcinoma (CRPC) 100% no additional benefit
Voretigen Neparvovec Luxturna® Novartis Pharma GmbH Eye diseases
OTHER ORPHAN
Retinal dystrophy 100% Hint for considerable additional benefit
Pembrolizumab (10) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 71% Hint for considerable additional benefit
Pembrolizumab (9) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% Hint for non-quantifiable additional benefit
Glecaprevir / Pibrentasvir (2) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases
INFECT
Chronic hepatitis C infection 100% no additional benefit
Nintedanib (3, reassessment >€50m, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
METABOL ORPHAN
Idiopathic pulmonary fibrosis 100% Hint for considerable additional benefit
Regadenoson (2) Rapiscan® GE Healthcare Buchler GmbH & Co. KG Other diseases
OTHER
Stenosis, Fractional Flow Reserve Measurement (FFR) 100% no additional benefit
Rucaparib Rubraca® Clovis Oncology Germany GmbH Oncological diseases
ONCO
Ovarian carcinoma 100% no additional benefit
Brentuximab Vedotin (4) Adcetris® Takeda Pharma GmbH Oncological diseases
ONCO ORPHAN
Hodgkin lymphoma (CD30+) 100% Indication of non-quantifiable additional benefit
Rucaparib (2) Rubraca® Clovis Oncology Germany GmbH Oncological diseases
ONCO
Ovarian carcinoma 100% no additional benefit
Emicizumab (2) Hemlibra® Roche Pharma AG Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Pembrolizumab (8) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Melanoma, adjuvant therapy 100% Indication of non-quantifiable additional benefit
Blinatumomab (3) Blincyto® Amgen GmbH Oncological diseases
ONCO ORPHAN
Acute lymphoblastic leukemia (ALL) 100% Indication of non-quantifiable additional benefit
Lumacaftor / Ivacaftor (3) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL
Cystic fibrosis (CF) 100% Hint for non-quantifiable additional benefit
Blinatumomab (4) Blincyto® Amgen GmbH Oncological diseases
ONCO ORPHAN
Acute lymphoblastic leukemia (ALL) 100% non-quantifiable additional benefit
Lenvatinib (4, reassessment) Lenvima® Eisai GmbH Oncological diseases
ONCO
Thyroid cancer (DTC) 100% no additional benefit
Ipilimumab (5) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% Indication of considerable additional benefit
Nivolumab (12) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% Indication of considerable additional benefit
Mexiletin Namuscla® Lupin Europe GmbH Nervous system diseases
CNS ORPHAN
Myotonia 100% Indication of non-quantifiable additional benefit
Apalutamid Erleada® Janssen-Cilag GmbH Oncological diseases
ONCO
Prostate carcinoma (HSPC) 100% Hint for minor additional benefit
Lanadelumab Takhzyro® Shire Deutschland GmbH, Teil der Takeda Group Other diseases
OTHER ORPHAN
Hereditary angioedema (HAE) 100% Indication of considerable additional benefit
Doravirin Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Doravirin / Lamivudin / Tenofovirdisoproxil Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Glycerolphenylbutyrat (2) Ravicti® Swedish Orphan Biovitrum GmbH Metabolic diseases
METABOL ORPHAN
Urea cycle disorders (UCD) 100% Hint for non-quantifiable additional benefit
Brigatinib Alunbrig® Takeda Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Bedaquilin Sirturo® Janssen-Cilag GmbH Infectious diseases
INFECT ORPHAN
Tuberculosis 100% Indication of considerable additional benefit
Melatonin Slenyto® InfectoPharm Arzneimittel und Consilium GmbH Nervous system diseases
CNS
Sleep disorders 100% Hint for minor additional benefit
Ribociclib (2) Kisqali® Novartis Pharma GmbH Oncological diseases
ONCO
Breast cancer 100% no additional benefit
Damoctocog alfa pegol Jivi® Bayer Vital GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Pembrolizumab (7, reassessment) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Urothelial carcinoma (UC) 100% no additional benefit
Fingolimod (5) Gilenya® Novartis Pharma GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 57% Hint for non-quantifiable additional benefit
Atezolizumab (3, reassessment) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Urothelial carcinoma (UC) 100% no additional benefit
Cabozantinib (5, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases
ONCO
Hepatic cellular carcinoma (HCC) 100% Hint for minor additional benefit
Tezacaftor / Ivacaftor Symkevi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 91% Indication of considerable additional benefit
Enzalutamid (3) Xtandi® Astellas Pharma GmbH Oncological diseases
ONCO
Prostate carcinoma (CRPC) 100% no additional benefit
Venetoclax (2) Venclyxto® AbbVie Deutschland GmbH Oncological diseases
ONCO
Chronic lymphocytic leucemia (CLL) 37% Indication of minor additional benefit
Venetoclax (3, reassessment) Venclyxto® AbbVie Deutschland GmbH Oncological diseases
ONCO
Chronic lymphocytic leucemia (CLL) 100% no additional benefit
Insulin degludec (4, reassessment) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Fluticasonfuroat / Umeclidinium / Vilanterol (2) Trelegy Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Tildrakizumab Ilumetri® Almirall Hermal GmbH Skin diseases
OTHER
Plaque psoriasis 100% no additional benefit
Alirocumab (2, reassessment) Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases
CV
Hypercholesterolemia, Dyslipidemia 100% no additional benefit
Axicabtagen-Ciloleucel (2) Yescarta® Kite, Gilead company Oncological diseases
ONCO ORPHAN
Diffuse large B-cell lymphoma (DLBCL) 100% Indication of non-quantifiable additional benefit
Axicabtagen-Ciloleucel Yescarta® Kite, Gilead company Oncological diseases
ONCO ORPHAN
Primary medial major cell B-lymphoma (PMBCL) 100% Indication of non-quantifiable additional benefit
Abemaciclib (2) Verzenios® Lilly Deutschland GmbH Oncological diseases
ONCO
Breast cancer (HER2-) in combination with Fulvestrant 100% no additional benefit
Abemaciclib Verzenios® Lilly Deutschland GmbH Oncological diseases
ONCO
Breast cancer (HER2-) 100% no additional benefit
Semaglutid Ozempic® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 37% Hint for minor additional benefit
Erenumab Aimovig® Novartis Pharma GmbH Nervous system diseases
CNS
Migraine 0.6% Hint for considerable additional benefit
Pembrolizumab (6) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Head and neck cancer 100% no additional benefit
Ocriplasmin (2) Jetrea® Oxurion NV Eye diseases
OTHER
Vitreomacular traction (VMT) 94% Hint for minor additional benefit
Durvalumab Imfinzi® AstraZeneca GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% Hint for considerable additional benefit
Trametinib (3) Mekinist® Novartis Pharma GmbH Oncological diseases
ONCO
Melanoma, adjuvant therapy 100% Indication of considerable additional benefit
Dabrafenib (4) Tafinlar® Novartis Pharma GmbH Oncological diseases
ONCO
Melanoma, adjuvant therapy 100% Indication of considerable additional benefit
Patisiran Onpattro® Alnylam Germany GmbH Metabolic diseases
METABOL ORPHAN
Amyloidosis 100% considerable additional benefit
Inotersen Tegsedi® Akcea Therapeutics Germany GmbH Metabolic diseases
METABOL ORPHAN
Amyloidosis 100% non-quantifiable additional benefit
Metreleptin Myalepta® Aegerion Pharmaceuticals GmbH Metabolic diseases
METABOL ORPHAN
Lipodystrophy 100% Indication of non-quantifiable additional benefit
Binimetinib Mektovi® Pierre Fabre Pharma GmbH Oncological diseases
ONCO
Melanoma 100% no additional benefit
Encorafenib Braftovi® Pierre Fabre Pharma GmbH Oncological diseases
ONCO
Melanoma 100% no additional benefit
Palbociclib (2, reassessment) Ibrance® Pfizer Pharma GmbH Oncological diseases
ONCO
Breast cancer 100% no additional benefit
Lenvatinib (3) Lenvima® Eisai GmbH Oncological diseases
ONCO
Hepatocellular carcinoma (HC) 100% no additional benefit
Daunorubicin / Cytarabin Vyxeos® Jazz Pharmaceuticals Oncological diseases
ONCO ORPHAN
Acute myeloid leukemia (AML) 100% Indication of considerable additional benefit
Mepolizumab (2) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Eosinophilic Asthma 100% no additional benefit
Sitagliptin (3, reassessment) Januvia® MSD Sharp & Dohme GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% Hint for minor additional benefit
Tenofoviralafenamid (2, reassessment) Vemlidy® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis B infection 100% no additional benefit
Caplacizumab Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases
CV ORPHAN
Acquired thrombotic thrombocytopenic purpura (aTTP) 100% non-quantifiable additional benefit
Vestronidase alfa Mepsevii® Ultragenyx Germany GmbH Metabolic diseases
METABOL ORPHAN
Mucopolysaccharidosis 100% non-quantifiable additional benefit
Daratumumab (3) Darzalex® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% Hint for considerable additional benefit
Tisagenlecleucel Kymriah® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Diffuse large B-cell lymphoma (DLBCL) 100% non-quantifiable additional benefit
Tisagenlecleucel (2) Kymriah® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Acute lymphoblastic leukemia (ALL) 100% Hint for non-quantifiable additional benefit
Tofacitinib (4) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases
OTHER
Psoriatic arthritis 69% Hint for minor additional benefit
Tofacitinib (3) Xeljanz® Pfizer Pharma GmbH Digestive system diseases
OTHER
Ulcerative colitis 100% no additional benefit
Nivolumab (11) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma, adjuvant therapy 100% Hint for non-quantifiable additional benefit
Gemtuzumab Ozogamicin Mylotarg® Pfizer Pharma GmbH Oncological diseases
ONCO ORPHAN
Acute myeloid leukemia (AML) 100% non-quantifiable additional benefit
Bosutinib (3, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases
ONCO
Chronic myeloid leukemia (CML) 100% no additional benefit
Ingenolmebutat (2, reassessment) Picato® LEO Pharma GmbH Skin diseases
OTHER
Actinic keratosis 50% Hint for non-quantifiable additional benefit
Brivaracetam (2) Briviact® UCB Pharma GmbH Nervous system diseases
CNS
Epilepsy, add-on treatment 100% no additional benefit
Osimertinib (3) Tagrisso® AstraZeneca GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 84% Hint for considerable additional benefit
Ipilimumab (4) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 85% no additional benefit
Nivolumab (10, reassessment) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 100% Indication of less benefit
Pertuzumab (3) Perjeta® Roche Pharma AG Oncological diseases
ONCO
Breast cancer 100% Indication of minor additional benefit
Bictegravir / Emtricitabin / Tenofoviralafenamid Biktarvy® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Velmanase alfa Lamzede® Chiesi GmbH Metabolic diseases
METABOL ORPHAN
α mannosidosis 100% Hint for non-quantifiable additional benefit
Olaparib (2, reassessment) Lynparza® AstraZeneca GmbH Oncological diseases
ONCO
Ovarian carcinoma 100% Hint for minor additional benefit
Cabozantinib (4, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% no additional benefit
Dolutegravir / Rilpivirin Juluca® ViiV Healthcare GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Bosutinib (2) Bosulif® Pfizer Pharma GmbH Oncological diseases
ONCO
Chronic myeloid leukemia (CML) 100% no additional benefit
Darvadstrocel Alofisel® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases
OTHER ORPHAN
Morbus Crohn associated perianal fistulas 100% non-quantifiable additional benefit
Carfilzomib (3, reassessment >€50m) Kyprolis® Amgen GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% Hint for considerable additional benefit
Extrakt aus Cannabis Sativa (2, reassessment) Sativex® Almirall Hermal GmbH Nervous system diseases
CNS
Multiple sclerosis (MS), spasticity 100% Indication of minor additional benefit
Tofacitinib (2, reassessment) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (RA) 100% no additional benefit
Rurioctocog alfa pegol Adynovi® Shire Deutschland GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Hydrocortison Alkindi® Diurnal Ltd. Metabolic diseases
CV
Adrenal insufficiency (Addison's disease) 100% no additional benefit
Ertugliflozin / Sitagliptin Steglujan® MSD Sharp & Dohme GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Cariprazin Reagila® Recordati Pharma GmbH Mental illnesses
CNS
Schizophrenia 21% Indication of minor additional benefit
Burosumab Crysvita® Kyowa Kirin GmbH Metabolic diseases
METABOL ORPHAN
Hypophosphatemic rickets (XLH) 100% Indication of non-quantifiable additional benefit
Bezlotoxumab Zinplava® MSD Sharp & Dohme GmbH Infectious diseases
INFECT
Clostridium difficile associated diarrhea (CDAD) 100% Indication of minor additional benefit
Emicizumab Hemlibra® Roche Pharma AG Hematopoietic diseases
CV
Hemophilia A 50% Hint for non-quantifiable additional benefit
Patiromer Veltassa® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases
METABOL
Hyperkalemia 100% no additional benefit
Glycopyrroniumbromid Sialanar® Proveca Limited Other diseases
OTHER
Sialorrhea 100% Hint for non-quantifiable additional benefit
Evolocumab (2, reassessment) Repatha® Amgen GmbH Metabolic diseases
CV
Hypercholesterolemia 100% no additional benefit
Fluticasonfuroat / Umeclidinium / Vilanterol Trelegy Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Glycerolphenylbutyrat Ravicti® Swedish Orphan Biovitrum GmbH Metabolic diseases
METABOL ORPHAN
Urea cycle disorders (UCD) 100% Indication of non-quantifiable additional benefit
Ixekizumab (2) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases
OTHER
Psoriatic arthritis 35% Hint for minor additional benefit
Insulin glargin / Lixisenatid Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Sonidegib Odomzo® Sun Pharmaceuticals Germany GmbH Oncological diseases
ONCO
Basal cell carcinoma (1aBCC) 100% no additional benefit
Benralizumab Fasenra® AstraZeneca GmbH Respiratory system diseases
OTHER
Eosinophilic asthma 50% Hint for minor additional benefit
Letermovir Prevymis® MSD Sharp & Dohme GmbH Infectious diseases
INFECT ORPHAN
Cytomegalovirus (CMV) prevention 100% non-quantifiable additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment) Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Asthma 100% no additional benefit
Ipilimumab (3) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 100% no additional benefit
Ocrelizumab Ocrevus® Roche Pharma AG Nervous system diseases
CNS
Multiple sclerosis (MS) 81% Proof of minor additional benefit
Lumacaftor / Ivacaftor (2) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL
Cystic fibrosis (CF) 100% Hint for non-quantifiable additional benefit
Brentuximab Vedotin (3) Adcetris® Takeda Pharma GmbH Oncological diseases
ONCO ORPHAN
Non-Hodgkin lymphoma (CD30+) 100% minor additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2) Genvoya® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Allogene, genetisch modifizierte T-Zellen Zalmoxis® Dompé farmaceutici S.p.A Oncological diseases
OTHER ORPHAN
Hematopoietic stem cell transplantation, add-on therapy 100% Indication of non-quantifiable additional benefit
Alectinib (2) Alecensa® Roche Pharma AG Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 100% Hint for non-quantifiable additional benefit
Dapagliflozin / Metformin (2, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Dapagliflozin (2, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Abirateronacetat (3) Zytiga® Janssen-Cilag GmbH Oncological diseases
ONCO
Prostate carcinoma (HSPC) 100% Indication of considerable additional benefit
Niraparib Zejula® TESARO Bio Germany GmbH Oncological diseases
ONCO ORPHAN
Ovarian carcinoma 100% non-quantifiable additional benefit
Cladribin Mavenclad® Merck Serono GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Dupilumab Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases
OTHER
Atopic dermatitis 100% Indication of considerable additional benefit
Guselkumab Tremfya® Janssen-Cilag GmbH Skin diseases
OTHER
Plaque psoriasis 45% Proof of considerable additional benefit
Perampanel (3) Fycompa® Eisai GmbH Nervous system diseases
CNS
Epilepsy 100% no additional benefit
Cenegermin Oxervate® Dompé farmaceutici S.p.A Eye diseases
OTHER ORPHAN
Neurotrophic keratitis 100% non-quantifiable additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2) Stribild® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Tivozanib Fotivda® EUSA Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% no additional benefit
Nonacog beta pegol Refixia® Novo Nordisk Pharma GmbH Hematopoietic diseases
CV
Hemophilia B 100% no additional benefit
Cabozantinib (3, reassessment, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% Indication of minor additional benefit
Telotristatethyl Xermelo® Ipsen Pharma GmbH Oncological diseases
OTHER ORPHAN
Carcinoid diarrhea 100% non-quantifiable additional benefit
Midostaurin Rydapt® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Acute myeloid leukemia (AML), Mastocytosis (ASM) 100% non-quantifiable additional benefit
Obinutuzumab (3) Gazyvaro® Roche Pharma AG Oncological diseases
ONCO ORPHAN
Follicular lymphoma (FL) 100% non-quantifiable additional benefit
Sofosbuvir (2) Sovaldi® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 100% Hint for non-quantifiable additional benefit
Ribociclib Kisqali® Novartis Pharma GmbH Oncological diseases
ONCO
Breast cancer (HR+ / HER2-) 100% no additional benefit
Pembrolizumab (5) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Urothelial carcinoma (UC) 61% Indication of considerable additional benefit
Elosulfase alfa (2, reassessment) Vimizim® BioMarin Deutschland GmbH Metabolic diseases
METABOL ORPHAN
Mucopolysaccharidosis 100% minor additional benefit
Atezolizumab Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 40% Indication of considerable additional benefit
Atezolizumab (2) Tecentriq® Roche Pharma AG Oncological diseases
ONCO
Urothelial carcinoma (UC) 61% Hint for minor additional benefit
Avelumab Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases
ONCO ORPHAN
Merkel cell carcinoma (MCC) 100% non-quantifiable additional benefit
Dimethylfumarat (2, Skilarence®) Skilarence® Almirall Hermal GmbH Skin diseases
OTHER
Plaque psoriasis 100% no additional benefit
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid Symtuza® Janssen-Cilag GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Brodalumab Kyntheum® LEO Pharma GmbH Skin diseases
OTHER
Plaque psoriasis 45% Indication of non-quantifiable additional benefit
Sarilumab Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (RA) 34% Hint for considerable additional benefit
Sofosbuvir / Velpatasvir / Voxilaprevir Vosevi® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 100% no additional benefit
Daratumumab (2, reassessment >€50m) Darzalex® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 72% Indication of considerable additional benefit
Ledipasvir / Sofosbuvir (2) Harvoni® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 50% Hint for non-quantifiable additional benefit
Saxagliptin / Metformin (4) Komboglyze® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Glecaprevir / Pibrentasvir Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases
INFECT
Chronic hepatitis C infection 100% no additional benefit
Ceritinib (3) Zykadia® Novartis Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 100% no additional benefit
Inotuzumab Ozogamicin Besponsa® Pfizer Pharma GmbH Oncological diseases
ONCO ORPHAN
Acute lymphoblastic leukemia (ALL) 100% minor additional benefit
Nivolumab (9) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Urothelial carcinoma (UC) 100% no additional benefit
Nusinersen Spinraza® Biogen GmbH Nervous system diseases
METABOL ORPHAN
Spinal muscular atrophy (SMA) 10% major additional benefit
Cerliponase alfa Brineura® BioMarin Deutschland GmbH Metabolic diseases
METABOL ORPHAN
Neuronal ceroid lipofuscinosis (CNL2) 100% non-quantifiable additional benefit
Blinatumomab (2, reassessment) Blincyto® Amgen GmbH Oncological diseases
ONCO ORPHAN
Acute lymphoblastic leukemia (ALL) 100% considerable additional benefit
Nivolumab (8, reassessment) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 100% no additional benefit
Etelcalcetid Parsabiv® Amgen GmbH Metabolic diseases
METABOL
Secondary hyperparathyroidism (sHPT) 100% no additional benefit
Nivolumab (7) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Squamous cell carcinoma (SCC), Head and neck cancer 77% Hint for considerable additional benefit
Rolapitant Varuby® TESARO Bio Germany GmbH Other diseases
OTHER
Nausea & vomiting due to chemotherapy 100% no additional benefit
Pembrolizumab (4) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Hodgkin-Lymphoma (HL) 100% no additional benefit
Dabrafenib (3) Tafinlar® Novartis Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (BRAF-V600+ NSCLC) 100% no additional benefit
Trametinib (2) Mekinist® Novartis Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (BRAF-V600+ NSCLC) 100% no additional benefit
Tofacitinib Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (RA) 100% no additional benefit
Alectinib Alecensa® Roche Pharma AG Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 81% Hint for minor additional benefit
Osimertinib (2, reassessment) Tagrisso® AstraZeneca GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (T790M+ NSCLC) 100% Hint for considerable additional benefit
Axitinib (2, reassessment) Inlyta® Pfizer Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 0.3% Hint for minor additional benefit
Tenofoviralafenamid Vemlidy® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis B infection 100% no additional benefit
Dolutegravir (2) Tivicay® ViiV Healthcare GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Baricitinib Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (RA) 100% no additional benefit
Secukinumab (3, reassessment) Cosentyx® Novartis Pharma GmbH Skin diseases
OTHER
Plaque psoriasis 100% Indication of considerable additional benefit
Ixekizumab Taltz® Lilly Deutschland GmbH Skin diseases
OTHER
Plaque psoriasis 55% Indication of considerable additional benefit
Pembrolizumab (3) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% Indication of considerable additional benefit
Lonoctocog alfa Afstyla® CSL Behring GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Obeticholsäure Ocaliva® Intercept Pharma Deutschland GmbH Digestive system diseases
METABOL ORPHAN
Hepatic cirrhosis 100% non-quantifiable additional benefit
Reslizumab Cinqaero® Teva GmbH Respiratory system diseases
OTHER
Asthma 50% Hint for minor additional benefit
Vandetanib (3) Caprelsa® Genzyme GmbH Oncological diseases
ONCO
Medullary thyroid cancer (MTC) 100% Hint for non-quantifiable additional benefit
Ixazomib Ninlaro® Takeda Pharma GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% non-quantifiable additional benefit
Elbasvir / Grazoprevir Zepatier® MSD Sharp & Dohme GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 100% no additional benefit
Nivolumab (6) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Hodgkin-Lymphoma (HL) 100% no additional benefit
Venetoclax Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases
ONCO ORPHAN
Chronic lymphocytic leukemia (CLL) 100% non-quantifiable additional benefit
Palbociclib Ibrance® Pfizer Pharma GmbH Oncological diseases
ONCO
Breast cancer 100% no additional benefit
Olaratumab Lartruvo® Lilly Deutschland GmbH Oncological diseases
ONCO ORPHAN
Soft tissue sarcoma 100% considerable additional benefit
Cabozantinib (2, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% Hint for non-quantifiable additional benefit
Macitentan (2, reassessment >€50m) Opsumit® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases
CV ORPHAN
Pulmonary hypertension (PHT) 100% no additional benefit
Opicapon Ongentys® Bial-Portela & Ca, S.A. Nervous system diseases
CNS
Morbus Parkinson 100% no additional benefit
Ceritinib (2, reassessment) Zykadia® Novartis Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 81% Hint for considerable additional benefit
Crizotinib (4) Xalkori® Pfizer Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Lenvatinib (2, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 100% Hint for minor additional benefit
Idelalisib (3) Zydelig® Gilead Sciences GmbH Oncological diseases
ONCO
Chronic lymphocytic leukemia (CLL) 0.4% Hint for non-quantifiable additional benefit
Ibrutinib (4) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Chronic lymphocytic leukemia (CLL) 50% Hint for considerable additional benefit
Pembrolizumab (2) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 40% Indication of considerable additional benefit
Trifluridin / Tipiracil Lonsurf® Servier Deutschland GmbH Oncological diseases
ONCO
Metastatic colorectal carcinoma (mCRC) 100% Hint for minor additional benefit
Teduglutid (2) Revestive® Shire Deutschland GmbH Digestive system diseases
METABOL ORPHAN
Short bowel syndrome 100% non-quantifiable additional benefit
Tasimelteon Hetlioz® Vanda Pharmceutical Inc Nervous system diseases
CNS ORPHAN
Non-24-hour sleep–wake disorder 100% non-quantifiable additional benefit
Pitolisant Wakix® Bioprojet Pharma SARL Nervous system diseases
CNS ORPHAN
Narcolepsy 100% non-quantifiable additional benefit
Brentuximab Vedotin (2) Adcetris® Takeda Pharma GmbH Oncological diseases
ONCO ORPHAN
Hodgkin lymphoma (CD30+) 100% non-quantifiable additional benefit
Carfilzomib (2) Kyprolis® Amgen GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% minor additional benefit
Emtricitabin / Rilpivirin / Tenofoviralafenamid Odefsey® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Sofosbuvir / Velpatasvir Epclusa® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 28% Hint for considerable additional benefit
Ibrutinib (3) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Chronic lymphocytic leukemia (CLL) 100% no additional benefit
Sitagliptin / Metformin (2, reassessment) Janumet® MSD Sharp & Dohme GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Sitagliptin (2, reassessment) Januvia® MSD Sharp & Dohme GmbH Metabolic diseases
CV
Diabetes mellitus type 2 35% Hint for minor additional benefit
Saxagliptin / Metformin (3, reassessment) Komboglyze® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Saxagliptin (2, reassessment) Onglyza® AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Crizotinib (3, reassessment) Xalkori® Pfizer Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 71% Hint for considerable additional benefit
Obinutuzumab (2) Gazyvaro® Roche Pharma AG Oncological diseases
ONCO ORPHAN
Follicular lymphoma (FL) 100% non-quantifiable additional benefit
Nivolumab (5) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 100% no additional benefit
Selexipag Uptravi® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases
CV
Pulmonary hypertension (PHT) 100% no additional benefit
Eftrenonacog alfa Alprolix® Swedish Orphan Biovitrum GmbH Hematopoietic diseases
CV ORPHAN
Hemophilia B 100% non-quantifiable additional benefit
Talimogen laherparepvec Imlygic® Amgen GmbH Oncological diseases
ONCO
Melanoma 100% no additional benefit
Eribulin (3) Halaven® Eisai GmbH Oncological diseases
ONCO
Liposarcoma 50% Hint for considerable additional benefit
Albutrepenonacog alfa Idelvion® CSL Behring GmbH Hematopoietic diseases
CV ORPHAN
Hemophilia B 100% non-quantifiable additional benefit
Migalastat Galafold® Amicus Therapeutics GmbH Metabolic diseases
OTHER ORPHAN
Morbus Fabry (alpha-galactosidase insuffiency) 100% non-quantifiable additional benefit
Elotuzumab Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Multiple myeloma (MM) 100% Hint for minor additional benefit
Ataluren (2, reassessment) Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases
OTHER ORPHAN
Duchenne muscle dystrophia 100% minor additional benefit
Daratumumab Darzalex® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% non-quantifiable additional benefit
Emtricitabin / Tenofoviralafenamid Descovy® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Ospemifen Senshio® Shionogi GmbH Genitourinary system diseases
OTHER
Postmenopausal vulvovaginal atrophia (VVA) 100% no additional benefit
Ramucirumab (4, reassessment) Cyramza® Lilly Deutschland GmbH Oncological diseases
ONCO
Advanced gastric cancer (adenocarcinoma) 50% Hint for minor additional benefit
Afatinib (3) Giotrif® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Nivolumab (4) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Renal cell carcinoma (RCC) 92% Indication of considerable additional benefit
Nivolumab (3) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 40% Indication of considerable additional benefit
Osimertinib Tagrisso® AstraZeneca GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (T790M+ NSCLC) 100% no additional benefit
Necitumumab Portrazza® Lilly Deutschland GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Ticagrelor (2) Brilique® AstraZeneca GmbH Cardiovascular diseases
CV
Prevention of atherothrombotic events 100% Hint for minor additional benefit
Idelalisib (2, reassessment) Zydelig® Gilead Sciences GmbH Oncological diseases
ONCO
Chronic lymphocytic leukemia (CLL) 24% Hint for non-quantifiable additional benefit
Empagliflozin / Metformin Synjardy® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Empagliflozin (2, reassessment) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases
CV
Diabetes mellitus type 2 42% Hint for considerable additional benefit
Ramucirumab (3) Cyramza® Lilly Deutschland GmbH Oncological diseases
ONCO
Metastatic colorectal carcinoma (mCRC) 100% no additional benefit
Ramucirumab (2) Cyramza® Lilly Deutschland GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Afamelanotid Scenesse® Clinuvel Ltd. Metabolic diseases
METABOL ORPHAN
Erythropoietic protoporphyria (EPP) 100% non-quantifiable additional benefit
Brivaracetam Briviact® UCB Pharma GmbH Nervous system diseases
CNS
Epilepsy, add-on treatment 100% no additional benefit
Vismodegib (2, reassessment) Erivedge® Roche Pharma AG Oncological diseases
ONCO
Basal cell carcinoma (smBCC, laBCC) 95% Hint for minor additional benefit
Umeclidinium Incruse® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Ibrutinib (2, reassessment >€50m) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Mantle cell lymphoma (MCL), Chronic lymphatic leukemia (CLL) 4% Indication of considerable additional benefit
Mepolizumab Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Eosinophilic asthma, severe refractory 50% Hint for minor additional benefit
Rilpivirin (2) Edurant® Janssen-Cilag GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Sacubitril / Valsartan Entresto® Novartis Pharma GmbH Cardiovascular diseases
CV
Heart failure 68% Hint for considerable additional benefit
Efmoroctocog alfa Elocta® Swedish Orphan Biovitrum GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid Genvoya® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Crizotinib (2) Xalkori® Pfizer Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 100% Hint for considerable additional benefit
Secukinumab (2) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases
OTHER
Psoriatic arthritis, Morbus Bechterew 100% no additional benefit
Blinatumomab Blincyto® Amgen GmbH Oncological diseases
ONCO ORPHAN
Acute lymphoblastic leukemia (ALL) 100% non-quantifiable additional benefit
Carfilzomib Kyprolis® Amgen GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% non-quantifiable additional benefit
Cobimetinib Cotellic® Roche Pharma AG Oncological diseases
ONCO
Melanoma (BRAF-V600+) 100% Indication of considerable additional benefit
Ivacaftor (3) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 75% Indication of minor additional benefit
Lumacaftor / Ivacaftor Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases
METABOL
Cystic fibrosis (CF) 100% Indication of considerable additional benefit
Aflibercept (6) Eylea® Bayer Vital GmbH Eye diseases
OTHER
Myopic choroidal neovascularisation 100% no additional benefit
Fingolimod (4) Gilenya® Novartis Pharma GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Alirocumab Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases
CV
Hypercholesterolemia 100% no additional benefit
Isavuconazol Cresemba® Basilea Pharmaceutica International Ltd. Infectious diseases
INFECT ORPHAN
Invasive aspergillosis and mucormycosis 100% non-quantifiable additional benefit
Aclidiniumbromid (2, reassessment) Eklira® Genuair® AstraZeneca GmbH Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 5% Indication of considerable additional benefit
Trametinib Mekinist® Novartis Pharma GmbH Oncological diseases
ONCO
Melanoma 50% Indication of considerable additional benefit
Sebelipase alfa Kanuma® Synageva BioPharma Limited Metabolic diseases
METABOL ORPHAN
Lysosomal lipase acid deficiency (LAL) 100% non-quantifiable additional benefit
Regorafenib (3, reassessment) Stivarga® Bayer Vital GmbH Oncological diseases
ONCO
Metastatic colorectal carcinoma (mCRC) 100% no additional benefit
Pomalidomid (2, reassessment >€50m) Imnovid® Celgene GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 50% Hint for considerable additional benefit
Panobinostat Farydak® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% non-quantifiable additional benefit
Idebenon Raxone® Santhera Pharmaceuticals Eye diseases
OTHER ORPHAN
Leber hereditial optic neuropathy (LHON) 100% non-quantifiable additional benefit
Dabrafenib (2) Tafinlar® Novartis Pharma GmbH Oncological diseases
ONCO
Melanoma (BRAF-V600+) 100% Indication of considerable additional benefit
Asfotase alfa Strensiq® Alexion Europe SAS Metabolic diseases
METABOL ORPHAN
Hypophosphatasia (HPP) 50% Indication of non-quantifiable additional benefit
Evolocumab Repatha® Amgen GmbH Metabolic diseases
CV
Hypercholesterolemia 100% no additional benefit
Pertuzumab (2) Perjeta® Roche Pharma AG Oncological diseases
ONCO
Breast cancer 100% no additional benefit
Insulin degludec / Liraglutid (2) Xultophy® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Tiotropium / Olodaterol Spiolto® Respimat® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 92% Indication of minor additional benefit
Pembrolizumab Keytruda® MSD Sharp & Dohme GmbH Oncological diseases
ONCO
Melanoma 71% Indication of considerable additional benefit
Netupitant / Palonosetron Akynzeo® RIEMSER Pharma GmbH Other diseases
OTHER
Nausea & vomiting due to chemotherapy 100% no additional benefit
Nivolumab (2) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 87% Indication of considerable additional benefit
Gaxilose LacTest™ VENTER PHARMA S.L. Metabolic diseases
OTHER
Diagnosis of hypolactasia 100% no additional benefit
Edoxaban Lixiana® Daiichi Sankyo Deutschland GmbH Cardiovascular diseases
CV
Venous thromboembolism / stroke prevention 81% Indication of minor additional benefit
Nivolumab Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 15% Indication of considerable additional benefit
Belatacept (2, reassessment) Nulojix® Bristol-Myers Squibb GmbH & Co. KGaA Genitourinary system diseases
OTHER
GvHD after kidney transplantation 100% Indication of considerable additional benefit
Lenvatinib Lenvima® Eisai GmbH Oncological diseases
ONCO ORPHAN
Differentiated thyroid cancer (DTC) 100% non-quantifiable additional benefit
Ceritinib Zykadia® Novartis Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 100% no additional benefit
Lomitapid (2, reassessment) Lojuxta® Aegerion Pharmaceuticals GmbH Metabolic diseases
CV
Hypercholesterolemia 100% no additional benefit
Secukinumab Cosentyx® Novartis Pharma GmbH Skin diseases
OTHER
Plaque psoriasis 8% Indication of considerable additional benefit
Olaparib Lynparza® AstraZeneca GmbH Oncological diseases
ONCO ORPHAN
Ovarian carcinoma 100% non-quantifiable additional benefit
Ivermectin Soolantra® Galderma Laboratorium GmbH Skin diseases
OTHER
Roseacea 100% no additional benefit
Afatinib (2, reassessment) Giotrif® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 42% Indication of major additional benefit
Safinamid Xadago® Zambon S.p.A. Nervous system diseases
CNS
Morbus Parkinson 100% no additional benefit
Vortioxetin Brintellix® Lundbeck GmbH Mental illnesses
CNS
Major depression 100% no additional benefit
Insulin degludec / Liraglutid Xultophy® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Ruxolitinib (3) Jakavi® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Polycythaemia vera 100% Hint for considerable additional benefit
Fingolimod (3, reassessment) Gilenya® Novartis Pharma GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 21% Indication of considerable additional benefit
Eliglustat Cerdelga® Genzyme GmbH Metabolic diseases
METABOL ORPHAN
Morbus Gaucher type 1 100% non-quantifiable additional benefit
Aflibercept (5) Eylea® Bayer Vital GmbH Eye diseases
OTHER
Diabetic macular edema 100% no additional benefit
Nintedanib (2, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
METABOL ORPHAN
Idiopathic pulmonary fibrosis 100% Indication of minor additional benefit
Insulin degludec (3) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus 100% no additional benefit
Apremilast Otezla® Celgene GmbH Musculoskeletal system diseases
OTHER
Plaque psoriasis / psoriatic arthritis 100% no additional benefit
Ombitasvir / Paritaprevir / Ritonavir Viekirax® AbbVie Deutschland GmbH & Co. KG Infectious diseases
INFECT
Chronic hepatitis C infection 9% Indication of considerable additional benefit
Ramucirumab Cyramza® Lilly Deutschland GmbH Oncological diseases
ONCO ORPHAN
Advanced gastric cancer (adenocarcinoma) 100% Indication of minor additional benefit
Dasabuvir Exviera® AbbVie Deutschland GmbH & Co. KG Infectious diseases
INFECT
Chronic hepatitis C infection 24% Indication of considerable additional benefit
Dulaglutid Trulicity® Lilly Deutschland GmbH Metabolic diseases
CV
Diabetes mellitus type 2 30% Hint for minor additional benefit
Aclidiniumbromid / Formoterol Duaklir® Genuair® / Brimica® Genuair® AstraZeneca GmbH Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 5% Indication of considerable additional benefit
Pasireotid (2) Signifor® Novartis Pharma GmbH Metabolic diseases
METABOL ORPHAN
Acromegalia 100% minor additional benefit
Nintedanib Vargatef® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 100% Indication of minor additional benefit
Enzalutamid (2) Xtandi® Astellas Pharma GmbH Oncological diseases
ONCO
Prostate carcinoma (CRPC) 100% Indication of considerable additional benefit
Tafluprost / Timolol Taptiqom® Santen GmbH Eye diseases
OTHER
Reduction of intraocular pressure in pat. with glaucoma/hypertension 100% no additional benefit
Ataluren Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases
METABOL ORPHAN
Duchenne muscle dystrophia 100% minor additional benefit
Vildagliptin (2, reassessment) Galvus® Novartis Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Ledipasvir / Sofosbuvir Harvoni® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 79% Hint for considerable additional benefit
Alipogentiparvovec Glybera® Chiesi GmbH Metabolic diseases
METABOL ORPHAN
Lipoprotein deficiency 100% non-quantifiable additional benefit
Simoctocog alfa Nuwiq® Octapharma GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Lurasidon Latuda® Takeda Pharma GmbH Mental illnesses
CNS
Schizophrenia 100% no additional benefit
Ibrutinib Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Mantle cell lymphoma (MCL), Chronic lymphatic leukemia (CLL) 4% Indication of non-quantifiable additional benefit
Albiglutid Eperzan® GlaxoSmithKline GmbH & Co. KG Metabolic diseases
CV
Diabetes mellitus type 2 35% Indication of minor additional benefit
Dolutegravir / Abacavir / Lamivudin Triumeq® ViiV Healthcare GmbH Infectious diseases
INFECT
HIV infection 9% Indication of considerable additional benefit
Sucroferric Oxyhydroxide Velphoro® Fresenius Medical Care Deutschland GmbH Other diseases
OTHER
Control of phosphate plasma level 100% no additional benefit
Sipuleucel-T Provenge® Dendreon UK Limited Oncological diseases
ONCO
Prostate carcinoma (CRPC) 100% Hint for non-quantifiable additional benefit
Idelalisib Zydelig® Gilead Sciences GmbH Oncological diseases
ONCO
Chronic lymphocytic leukemia (CLL), follicular lymphoma (FL) 20% Hint for non-quantifiable additional benefit
Aflibercept (4) Eylea® Bayer Vital GmbH Eye diseases
OTHER
Diabetic macular edema 100% no additional benefit
Teduglutid Revestive® NPS Pharma Germany GmbH Digestive system diseases
METABOL ORPHAN
Malabsorption syndrome 100% minor additional benefit
Daclatasvir Daklinza® Bristol-Myers Squibb GmbH & Co. KGaA Infectious diseases
INFECT
Chronic hepatitis C infection 1.4% Hint for considerable additional benefit
Regorafenib (2) Stivarga® Bayer Vital GmbH Oncological diseases
ONCO
Gastrointestinal stoma tumor (GIST) 100% no additional benefit
Propranolol Hemangiol® Pierre Fabre Dermatologie Other diseases
OTHER
Infantile hemangioma 33% Indication of major additional benefit
Nalmefen Selincro® Lundbeck GmbH Mental illnesses
CNS
Alcohol abuse 100% no additional benefit
Ivacaftor (2) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 100% Indication of minor additional benefit
Apixaban (3) Eliquis® Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH Cardiovascular diseases
CV
Venous thromboembolism 47% Indication of minor additional benefit
Obinutuzumab Gazyvaro® Roche Pharma AG Oncological diseases
ONCO ORPHAN
Chronic lymphocytic leukemia (CLL) 100% Indication of non-quantifiable additional benefit
Empagliflozin Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Canagliflozin / Metformin Vokanamet® Janssen-Cilag GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Cabozantinib Cometriq® Swedish Orphan Biovitrum GmbH Oncological diseases
ONCO ORPHAN
Medullary thyroid cancer (MTC) 100% minor additional benefit
Eribulin (2, reassessment) Halaven® Eisai GmbH Oncological diseases
ONCO
Breast cancer 75% Hint for considerable additional benefit
Umeclidinium / Vilanterol Anoro® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Vedolizumab Entyvio® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases
OTHER
Colitis ulcerosa, Morbus Crohn 100% no additional benefit
Fingolimod (2) Gilenya® Novartis Pharma GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Siltuximab Sylvant® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Multicentric Castleman Disease (MCD) 100% non-quantifiable additional benefit
Insulin degludec (2) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus 100% no additional benefit
Olodaterol Striverdi® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Simeprevir Olysio® Janssen-Cilag GmbH Infectious diseases
INFECT
Chronic hepatitis C infection, add-on treatment 91% Indication of considerable additional benefit
Elosulfase alfa Vimizim® BioMarin Deutschland GmbH Metabolic diseases
METABOL ORPHAN
Mucopolysaccharidosis / Morquio A syndrome 100% minor additional benefit
Mirabegron Betmiga® Astellas Pharma GmbH Genitourinary system diseases
OTHER
Imperative desire to urinate 100% no additional benefit
Lebende Larven von Lucilia sericata BioBag® BioMonde GmbH Other diseases
OTHER
Debridement of chronic severe-healing wounds 100% no additional benefit
Perampanel (2, reassessment) Fycompa® Eisai GmbH Nervous system diseases
CNS
Epilepsy 100% no additional benefit
Cholsäure Orphacol® Laboratoires CTRS Metabolic diseases
METABOL ORPHAN
Heritage dysbalance of primary bilic acid synthesis 100% non-quantifiable additional benefit
Ruxolitinib (2, reassessment >€50m) Jakavi® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Chronic myeloproliferative disease (CML) 100% Hint for considerable additional benefit
Dimethylfumarat Tecfidera® Biogen GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Insulin degludec Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases
CV
Diabetes mellitus 100% no additional benefit
Riociguat Adempas® Bayer Vital GmbH Cardiovascular diseases
CV ORPHAN
Pulmonary hypertension (PHT) 100% minor additional benefit
Canagliflozin Invokana® Janssen-Cilag GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Cobicistat Tybost® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection, add-on treatment 100% no additional benefit
Dapagliflozin / Metformin Xigduo® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Sofosbuvir Sovaldi® Gilead Sciences GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 4% Indication of considerable additional benefit
Dolutegravir Tivicay® ViiV Healthcare GmbH Infectious diseases
INFECT
HIV infection 11% Proof of considerable additional benefit
Macitentan Opsumit® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases
CV ORPHAN
Pulmonary hypertension (PHT) 100% minor additional benefit
Retigabin (3, reassessment) Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases
CNS
Epilepsy, add-on treatment 100% no additional benefit
Turoctocog alfa NovoEight® Novo Nordisk Pharma GmbH Hematopoietic diseases
CV
Hemophilia A 100% no additional benefit
Trastuzumab Emtansin Kadcyla® Roche Pharma AG Oncological diseases
ONCO
Breast cancer (HER2+) 72% Indication of considerable additional benefit
Radium-223-dichlorid Xofigo® Bayer Vital GmbH Oncological diseases
ONCO
Prostate carcinoma (mCRPC) 78% Indication of considerable additional benefit
Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2) Eviplera® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Lomitapid Lojuxta® Aegerion Pharmaceuticals GmbH Metabolic diseases
CV
Hypercholesterolemia 100% no additional benefit
Ipilimumab (2) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 100% no additional benefit
Dabrafenib Tafinlar® GlaxoSmithKline GmbH & Co. KG Oncological diseases
ONCO
Melanoma (BRAF-V600+) 100% no additional benefit
Teriflunomid Aubagio® sanofi-aventis groupe / Genzyme GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Regorafenib Stivarga® Bayer Vital GmbH Oncological diseases
ONCO
Metastatic colorectal carcinoma (mCRC) 100% Hint for minor additional benefit
Aflibercept (3) Eylea® Bayer Vital GmbH Eye diseases
OTHER
Macular edema 100% no additional benefit
Vemurafenib (2, reassessment) Zelboraf® Roche Pharma AG Oncological diseases
ONCO
Melanoma (BRAF-V600+) 100% Indication of considerable additional benefit
Pomalidomid Imnovid® Celgene GmbH Oncological diseases
ONCO ORPHAN
Multiple myeloma (MM) 100% considerable additional benefit
Enzalutamid Xtandi® Astellas Pharma GmbH Oncological diseases
ONCO
Prostate carcinoma (CRPC) 100% Indication of considerable additional benefit
Vismodegib Erivedge® Roche Pharma AG Oncological diseases
ONCO
Basal cell carcinoma (smBCC, laBCC) 95% Hint for minor additional benefit
Ponatinib Iclusig® ARIAD Pharmaceuticals (Germany) GmbH Oncological diseases
ONCO ORPHAN
Chronic myeloic leukemia (CML), Acute lymphoblastic leukemia (Ph+ ALL) 100% Indication of non-quantifiable additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil Stribild® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% no additional benefit
Nepafenac Nevanac® Alcon Pharma GmbH Eye diseases
OTHER
Postoperative pain after eye surgery 100% no additional benefit
Lisdexamfetamindimesilat Elvanse® Shire Deutschland GmbH Mental illnesses
CNS
Attention deficit hyperactivity disorder (ADHD) 100% no additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases
OTHER
Asthma, COPD 100% no additional benefit
Ocriplasmin Jetrea® ThromboGenics NV / Alcon Pharma GmbH Eye diseases
OTHER
Vitreomacular traction (VMT) 95% Hint for considerable additional benefit
Linaclotid Constella® Almirall Hermal GmbH Digestive system diseases
OTHER
Irritable bowel syndrome (IBS) 100% no additional benefit
Bosutinib Bosulif® Pfizer Pharma GmbH Oncological diseases
ONCO ORPHAN
Chronic myeloid leukemia (CML) 100% Indication of non-quantifiable additional benefit
Vildagliptin Galvus® Novartis Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Vildagliptin / Metformin Eucreas® Novartis Pharma GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Sitagliptin / Metformin Janumet® MSD Sharp & Dohme GmbH Metabolic diseases
CV
Diabetes mellitus type 2 78% Hint for minor additional benefit
Sitagliptin Januvia® MSD Sharp & Dohme GmbH Metabolic diseases
CV
Diabetes mellitus type 2 64% Hint for minor additional benefit
Saxagliptin / Metformin (2) Komboglyze® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Saxagliptin Onglyza® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 49% Hint for minor additional benefit
Pertuzumab Perjeta® Roche Pharma AG Oncological diseases
ONCO
Breast cancer (HER2+) 33% Hint for considerable additional benefit
Vandetanib (2, reassessment) Caprelsa® AstraZeneca GmbH Oncological diseases
ONCO
Medullary thyroid cancer (MTC) 100% Hint for minor additional benefit
Lixisenatid Lyxumia® Sanofi-Aventis Deutschland GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Aflibercept (2, Zaltrap®) Zaltrap® Sanofi-Aventis Deutschland GmbH Oncological diseases
ONCO
Metastatic colorectal carcinoma (mCRC) 100% Indication of minor additional benefit
Ingenolmebutat Picato® LEO Pharma GmbH Skin diseases
OTHER
Actinic keratosis 100% no additional benefit
Fidaxomicin Dificlir® Astellas Pharma GmbH Infectious diseases
INFECT
Clostriudium difficile associated diarrhea (CDAD) 41% Proof of considerable additional benefit
Dapagliflozin Forxiga® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Aflibercept Eylea® Bayer Vital GmbH Eye diseases
OTHER
Age-related macular degeneration (AMD) 100% no additional benefit
Pixantron Pixuvri® CTI Life Sciences Ltd. Oncological diseases
ONCO
Non-Hodgkin lymphoma (NHL) 100% no additional benefit
Linagliptin (3) Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Brentuximab Vedotin Adcetris® Takeda Pharma Vertrieb GmbH & Co. KG Oncological diseases
ONCO ORPHAN
Hodgkin lymphoma (CD30+), Anaplastic large-cell lymphoma 100% non-quantifiable additional benefit
Saxagliptin / Metformin Komboglyze® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases
CV
Diabetes mellitus type 2 85% Hint for minor additional benefit
Decitabin Dacogen® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
Acute myeloid leukemia (AML) 100% minor additional benefit
Colestilan BindRen® Mitsubishi Pharma Deutschland GmbH Other diseases
OTHER
Hyperphosphatemia 100% no additional benefit
Crizotinib Xalkori® Pfizer Pharma GmbH Oncological diseases
ONCO
Non-small cell lung carcinoma (ALK+ NSCLC) 71% Hint for considerable additional benefit
Ruxolitinib Jakavi® Novartis Pharma GmbH Oncological diseases
ONCO ORPHAN
Chronic myeloproliferative diseases (CML) 100% Indication of minor additional benefit
Axitinib Inlyta® Pfizer Pharma GmbH Oncological diseases
ONCO
Renal cell carcinoma (RCC) 0.7% Indication of minor additional benefit
Aclidiniumbromid Eklira® Genuair® Almirall Hermal GmbH Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Perampanel Fycompa® Eisai GmbH Nervous system diseases
CNS
Epilepsy 100% no additional benefit
Linagliptin (2, reassessment) Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Ivacaftor Kalydeco® Vertex Pharmaceuticals GmbH Metabolic diseases
METABOL ORPHAN
Cystic fibrosis (CF) 84% considerable additional benefit
Tegafur / Gimeracil / Oteracil Teysuno® Nordic Pharma GmbH Oncological diseases
ONCO
Advanced gastric cancer (adenocarcinoma) 100% no additional benefit
Pasireotid Signifor® Novartis Pharma GmbH Metabolic diseases
METABOL ORPHAN
Dysfunction of pituitary gland 100% minor additional benefit
Vemurafenib Zelboraf® Roche Pharma AG Oncological diseases
ONCO
Melanoma (BRAF-V600+) 100% Indication of considerable additional benefit
Vandetanib Caprelsa® AstraZeneca GmbH Oncological diseases
ONCO
Medullary thyroid cancer (MTC) 100% no additional benefit
Ipilimumab Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases
ONCO
Melanoma 100% Indication of considerable additional benefit
Belimumab Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases
OTHER
Systemic Lupus Erythematodes (SLE) 100% Indication of considerable additional benefit
Belatacept Nulojix® Bristol-Myers Squibb GmbH & Co. KGaA Genitourinary system diseases
OTHER
GvHD after kidney transplantation 100% Indication of minor additional benefit
Abirateronacetat (2) Zytiga® Janssen-Cilag GmbH Oncological diseases
ONCO
Prostate carcinoma 100% Indication of considerable additional benefit
Extrakt aus Cannabis Sativa Sativex® Almirall Hermal GmbH Nervous system diseases
CNS
Multiple sclerosis (MS), spasticity 100% Hint for minor additional benefit
Fampridin Fampyra® Biogen GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 100% no additional benefit
Emtricitabin / Rilpivirin / Tenofovirdisoproxil Eviplera® Gilead Sciences GmbH Infectious diseases
INFECT
HIV infection 100% Proof of minor additional benefit
Rilpivirin Edurant® Janssen-Cilag GmbH Infectious diseases
INFECT
HIV infection 100% Proof of minor additional benefit
Tafamidis Vyndaqel® Pfizer Pharma GmbH Metabolic diseases
METABOL ORPHAN
Amyloidosis 100% minor additional benefit
Aliskiren / Amlodipin Rasilamlo® Novartis Pharma GmbH Cardiovascular diseases
CV
Hypertension 100% no additional benefit
Retigabin Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases
CNS
Epilepsy, add-on treatment 100% no additional benefit
Telaprevir Incivo® Janssen-Cilag GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 100% Indication of non-quantifiable additional benefit
Eribulin Halaven® Eisai GmbH Oncological diseases
ONCO
Breast cancer 80% Hint for minor additional benefit
Mikrobielle Collagenase aus Clostridium histolyticum Xiapex® Pfizer Pharma GmbH Musculoskeletal system diseases
OTHER
Dupuytren's contracture 100% no additional benefit
Apixaban Eliquis® Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH Cardiovascular diseases
CV
Thromboembolism prevention 58% Indication of minor additional benefit
Regadenoson Rapiscan® Rapidscan Pharma Solutions EU Ltd. Other diseases
OTHER
Stress inductor for myocard perfusion 100% no additional benefit
Fingolimod Gilenya® Novartis Pharma GmbH Nervous system diseases
CNS
Multiple sclerosis (MS) 20% Hint for minor additional benefit
Apixaban (2) Eliquis® Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH Cardiovascular diseases
CV
Atrial fibrillation (AF) stroke prevention 100% Indication of minor additional benefit
Afatinib Giotrif® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases
ONCO
Non-small cell lung carcinoma (NSCLC) 44% Indication of considerable additional benefit
Indacaterol / Glycopyrronium Ultibro Breezhaler® Novartis Pharma GmbH Respiratory system diseases
OTHER
Chronic obstructive pulmonary disease (COPD) 5% Indication of minor additional benefit
Galcanezumab Emgality® Lilly Deutschland GmbH Nervous system diseases
CNS
Migraine 1.0% Hint for considerable additional benefit
Cabazitaxel Jevtana® Sanofi-Aventis Deutschland GmbH Oncological diseases
ONCO
Prostate carcinoma 85% Indication of minor additional benefit
Azilsartan Medoxomil Edarbi® Takeda Pharma GmbH Cardiovascular diseases
CV
Hypertension 100% no additional benefit
Ticagrelor Brilique® AstraZeneca GmbH Cardiovascular diseases
CV
NSTEMI/STEMI/stroke prevention 73% Proof of considerable additional benefit
Bromfenac Yellox® Bausch & Lomb / Dr. Mann Pharma Eye diseases
OTHER
Ophthalmitis after cataract extraction 100% no additional benefit
Linagliptin Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases
CV
Diabetes mellitus type 2 100% no additional benefit
Boceprevir Victrelis® MSD Sharp & Dohme GmbH Infectious diseases
INFECT
Chronic hepatitis C infection 100% non-quantifiable additional benefit
Pirfenidon Esbriet® InterMune Deutschland GmbH Respiratory system diseases
METABOL ORPHAN
Idiopathic pulmonary fibrosis 100% non-quantifiable additional benefit
Abirateronacetat Zytiga® Janssen-Cilag GmbH Oncological diseases
ONCO
Prostate carcinoma 85% Indication of considerable additional benefit
Pitavastatin Livazo® Merckle Recordati GmbH Metabolic diseases
CV
Hypercholesterolemia 100% no additional benefit