|
|
Brentuximab Vedotin (13, reassessment >€30m)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
|
Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone
(Orphan (turnover limit))
|
|
|
Dabrafenib (5, Finlee®)
|
Finlee®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Malignant glioma, BRAF V600E mutation, ≥ 1 year, low-grade (LGG) first-line/higher-grade (HGG) after at least 1 prior therapy; combination with trametinib
(Orphan)
|
|
|
Trametinib (4, Spexotras®)
|
Spexotras®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Malignant glioma, BRAF V600E mutation, ≥ 1 year, low-grade (LGG) first-line/higher-grade (HGG) after at least 1 prior therapy; combination with dabrafenib
(Orphan)
|
|
|
Luspatercept (6)
|
Reblozyl®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Hematopoietic diseases
|
Myelodysplastic syndromes with transfusion-dependent anemia, not pretreated, and without ring sideroblasts, pretreated
(Orphan)
|
|
|
Pembrolizumab (35)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with platinum-based chemotherapy
|
|
|
Brentuximab Vedotin (11, reassessment >€30m)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
|
Hodgkin's lymphoma, CD30+, pre-treated
(Orphan (turnover limit))
|
|
|
Brentuximab Vedotin (12, reassessment >€30m)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
|
Systemic anaplastic large cell lymphoma (sALCL) , relapsed, refractory
(Orphan (turnover limit))
|
|
|
Brentuximab Vedotin (10, reassessment >€30m)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
|
Hodgkin's lymphoma, CD30+, increased risk of recurrence or progression after transplantation
(Orphan (turnover limit))
|
|
|
Brentuximab Vedotin (9, reassessment >€30m)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
|
Cutaneous T-cell lymphoma, CD30+, pre-treated
(Orphan (turnover limit))
|
|
|
Brentuximab Vedotin (8, reassessment >€30m)
|
Adcetris®
|
Takeda GmbH
|
Oncological diseases
|
Hodgkin's lymphoma, CD30+, first-line, stage III + IV, in combination with doxorubicin, vinblastine and dacarbazine
(Orphan (turnover limit))
|
|
|
Abaloparatid
|
Eladynos®
|
Theramex Germany GmbH
|
Musculoskeletal system diseases
|
Osteoporosis, postmenopausal women
|
|
|
Abrocitinib (2)
|
Cibinqo®
|
Pfizer Pharma GmbH
|
Skin diseases
|
Atopic dermatitis, ≥ 12 to < 18 years
|
|
|
Pembrolizumab (34)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Non-small cell lung cancer, adjuvant therapy with high risk of recurrence after resection, after prior chemotherapy
|
|
|
Etrasimod
|
Velsipity®
|
Pfizer Pharma GmbH
|
Digestive system diseases
|
Ulcerative colitis, ≥ 16 years
|
|
|
Efgartigimod alfa (2, reassessment >€30m)
|
Vyvgart®
|
Argenx Germany GmbH
|
Nervous system diseases
|
Myasthenia gravis, AChR antibodies+
(Orphan (turnover limit))
|
|
|
Gadopiclenol
|
Elucirem®
|
Guerbet GmbH
|
Other diseases
|
Contrast-enhanced magnetic resonance imaging, ≥ 2 years
|
|
|
Idecabtagen vicleucel (3)
|
Abecma®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Multiple myeloma, at least 2 prior therapies
(Orphan (turnover limit))
|
|
|
Omaveloxolon
|
Skyclarys®
|
Biogen GmbH
|
Nervous system diseases
|
Friedreich's ataxia, ≥ 16 years
(Orphan)
|
|
|
Zilucoplan
|
Zilbrysq®
|
UCB Pharma GmbH
|
Nervous system diseases
|
Myasthenia gravis, AChR antibody+
|
|
|
Rozanolixizumab
|
Rystiggo®
|
UCB Pharma GmbH
|
Nervous system diseases
|
Myasthenia gravis, AChR antibodies+, MuSK antibodies+
(Orphan)
|
|
|
Enalapril
|
Aqumeldi®
|
Proveca Pharma Limited
|
Cardiovascular diseases
|
Heart failure, < 18 years
|
|
|
Decitabin / Cedazuridin
|
Inaqovi®
|
Otsuka Pharma GmbH
|
Oncological diseases
|
Acute myeloid leukaemia, first line
|
|
|
Daridorexant (2)
|
Quviviq®
|
Idorsia Pharmaceuticals Germany GmbH
|
Mental illnesses
|
Sleep disorders
|
|
|
Nirsevimab
|
Beyfortus®
|
Sanofi-Aventis Deutschland GmbH
|
Infectious diseases
|
Secondary prophylaxis of RSV infections, children during their 1st RSV season
|
|
|
Momelotinib
|
Omjjara®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
|
Myelofibrosis
(Orphan)
|
|
|
Talazoparib (2)
|
Talzenna®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Prostate carcinoma, metastasised, castration-resistant, in combination with enzalutamide)
|
|
|
Rezafungin
|
Rezzayo®
|
Mundipharma
|
Infectious diseases
|
Invasive candida infections
(Orphan)
|
|
|
Patiromer (2)
|
Veltassa®
|
Fresenius Medical Care Nephrologica Deutschland GmbH
|
Metabolic diseases
|
Hyperkalaemia, ≥ 12 to < 18 years
|
|
|
Fezolinetant
|
Veoza®
|
Astellas Pharma GmbH
|
Other diseases
|
Severe vasomotor symptoms (VMS) associated with the menopause
|
|
|
Ublituximab
|
Briumvi®
|
Neuraxpharm Arzneimittel GmbH
|
Nervous system diseases
|
Relapsing-remitting multiple sclerosis
|
|
|
Quizartinib
|
Vanflyta®
|
Daiichi Sankyo Deutschland GmbH
|
Oncological diseases
|
Acute myeloid leukaemia (AML)
|
|
|
Pegzilarginase
|
Loargys®
|
Immedica Pharma Germany GmbH
|
Metabolic diseases
|
Hyperargininemia (ARG1-D), ≥ 2 years
(Orphan)
|
|
|
Elranatamab
|
Elrexfio®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Multiple myeloma, relapsed and refractory, after at least 3 previous therapies
|
|
|
Vamorolon
|
Agamree®
|
Santhera Pharmaceuticals GmbH
|
Musculoskeletal system diseases
|
Duchenne muscular dystrophy, ≥ 4 years
(Orphan)
|
|
|
Evinacumab (2)
|
Evkeeza®
|
Ultragenyx Germany GmbH
|
Metabolic diseases
|
Homozygous familial hypercholesterolemia, ≥ 12 years of age
|
|
|
Evinacumab
|
Evkeeza®
|
Ultragenyx Germany GmbH
|
Metabolic diseases
|
Homozygous familial hypercholesterolemia, ≥ 5 to < 12 years of age
|
|
|
Pembrolizumab (33)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Biliary tumours, first-line, combination with gemcitabine and cisplatin
|
|
|
Pembrolizumab (32)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2+, first-line, combination with trastuzumab, fluoropyrimidine- and platinum-based chemotherapy
|
|
|
Pembrolizumab (31)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2, first-line, combination with fluoropyrimidine- and platinum-based chemotherapy
|
|
|
Palopegteriparatid
|
Yorvipath®
|
Ascendis Pharma Endocrinology GmbH
|
Metabolic diseases
|
Chronic hypoparathyroidism, parathyroid hormone (PTH) substitution therapy
(Orphan)
|
|
|
Dostarlimab (2)
|
Jemperli®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
|
Primary advanced or recurrent endometrial carcinoma with dMMR/ MSI-H, combination with carboplatin and paclitaxel
|
|
|
Empagliflozin (6)
|
Jardiance®
|
Boehringer Ingelheim Pharma GmbH
|
Metabolic diseases
|
Diabetes Mellitus Type 2, ≥ 10 years
|
|
|
Avapritinib (3)
|
Ayvakyt®
|
Blueprint Medicines GmbH
|
Oncological diseases
|
Indolent systemic mastocytosis (ISM)
(Orphan)
|
|
|
Polatuzumab (3, reassessment >€30m)
|
Polivy®
|
Roche Pharma AG
|
Oncological diseases
|
Diffuse large B-cell lymphoma, combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
(Orphan (turnover limit))
|
|
|
Polatuzumab (4, reassessment >€30m)
|
Polivy®
|
Roche Pharma AG
|
Oncological diseases
|
Diffuse large B-cell lymphoma, combination with bendamustine and rituximab
(Orphan (turnover limit))
|
|
|
Zanubrutinib (5)
|
Brukinsa®
|
BeiGene Germany GmbH
|
Oncological diseases
|
Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab
|
|
|
Rucaparib (4)
|
Rubraca®
|
pharmaand Deutschland GmbH
|
Oncological diseases
|
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy after first-line therapy
|
|
|
Durvalumab (6)
|
Imfinzi®
|
AstraZeneca GmbH
|
Oncological diseases
|
Hepatocellular carcinoma, first-line, monotherapy
|
|
|
Alirocumab (3)
|
Praluent®
|
Sanofi-Aventis Deutschland GmbH
|
Metabolic diseases
|
Hypercholesterolaemia, ≥ 8 years to 17 years
|
|
|
Lebrikizumab
|
Ebglyss®
|
Almirall Hermal GmbH
|
Skin diseases
|
Atopic dermatitis, ≥ 12 years
|
|
|
Letermovir (3, reassessment >€30m)
|
Prevymis®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
CMV reactivation/disease, prophylaxis after stem cell transplantation
(Orphan (turnover limit))
|
|
|
Letermovir (2)
|
Prevymis®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
CMV disease, prophylaxis after kidney transplantation
(Orphan (turnover limit))
|
|
|
Lanadelumab (3)
|
Takhzyro®
|
Takeda GmbH
|
Other diseases
|
Hereditary angioedema, prophylaxis, 2 to < 12 years
(Orphan (turnover limit))
|
|
|
Ivacaftor / Tezacaftor / Elexacaftor (15, reassessment >€30m)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
|
Cystic fibrosis, combination treatment with ivacaftor, from 2 to ≤ 5 years of age (heterozygous for F508del and MF mutation)
(Orphan (turnover limit))
|
|
|
Ivacaftor / Tezacaftor / Elexacaftor (14, reassessment >€30m)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
|
Cystic fibrosis, combination treatment with ivacaftor, 2 to ≤ 5 years (homozygous for F508del mutation)
(Orphan (turnover limit))
|
|
|
Ivacaftor / Tezacaftor / Elexacaftor (13, reassessment >€30m)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
|
Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
(Orphan (turnover limit))
|
|
|
Ivacaftor / Tezacaftor / Elexacaftor (12)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
|
Cystic fibrosis, F508del mutation, heterozygous and RF mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
|
|
|
Ivacaftor / Tezacaftor / Elexacaftor (11, reassessment >€30m)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
|
Cystic fibrosis, F508del mutation, heterozygous and other or unknown mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
(Orphan (turnover limit))
|
|
|
Cannabidiol (8, reassessment >€30m)
|
Epidyolex®
|
Jazz Pharmaceuticals Germany GmbH
|
Nervous system diseases
|
Dravet syndrome, ≥ 2 years, combination with clobazam
(Orphan (turnover limit))
|
|
|
Cannabidiol (7, reassessment >€30m)
|
Epidyolex®
|
Jazz Pharmaceuticals Germany GmbH
|
Nervous system diseases
|
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
(Orphan (turnover limit))
|
|
|
Cannabidiol (6, reassessment >€30m)
|
Epidyolex®
|
Jazz Pharmaceuticals Germany GmbH
|
Other diseases
|
Seizures associated with tuberous sclerosis, ≥ 2 years
(Orphan (turnover limit))
|
|
|
Tebentafusp (2, reassessment >€30m)
|
Kimmtrak®
|
Immunocore Ireland Ltd.
|
Oncological diseases
|
Uveal melanoma, HLA-A*02:01-positive
(Orphan (turnover limit))
|
|
|
Patisiran (2, reassessment >€30m)
|
Onpattro®
|
Alnylam Germany GmbH
|
Metabolic diseases
|
Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)
(Orphan (turnover limit))
|
|
|
Daratumumab (10, reassessment)
|
Darzalex®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, melphalan and prednisone
(Orphan)
|
|
|
Relugolix / Estradiol / Norethisteronacetat (2)
|
Ryeqo®
|
Gedeon Richter Pharma GmbH
|
Genitourinary system diseases
|
Endometriosis, after medical or surgical treatment
|
|
|
Vosoritid (3)
|
Voxzogo®
|
BioMarin International Limited
|
Other diseases
|
Achondroplasia, ≥ 4 months to < 2 years
(Orphan)
|
|
|
Trastuzumab-Deruxtecan (5)
|
Enhertu®
|
Daiichi Sankyo Deutschland GmbH
|
Oncological diseases
|
Non-small cell lung cancer, HER2(ERBB2) mutation, pre-treated
|
