|
Mosunetuzumab
|
Lunsumio®
|
Roche Pharma AG
|
Oncological diseases
ORPHAN
|
Follicular lymphoma (FL), after ≥ 2 prior therapies
|
|
Pembrolizumab (21)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Breast carcinoma (BC), triple-negative (TNBC), high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
|
|
Selpercatinib (4)
|
Retsevmo®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), RET fusion+, first-line
|
|
Palbociclib (3, reassessment)
|
Ibrance®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Breast carcinoma (BC) , patient population a1
|
|
Nirmatrelvir / Ritonavir
|
Paxlovid®
|
Pfizer Pharma GmbH
|
Infectious diseases
|
COVID-19, no need for supplementary oxygen, increased risk of severe progression
|
|
Cerliponase alfa (2, reassessment)
|
Brineura®
|
BioMarin Deutschland GmbH
|
Metabolic diseases
ORPHAN
|
Neuronal ceroid lipofuscinosis (NCL) type 2
|
|
Enfortumab Vedotin
|
Padcev®
|
Astellas Pharma Europe B.V
|
Oncological diseases
|
Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor
|
|
Setmelanotide
|
Imcivree®
|
Rhythm Pharmaceuticals Inc.
|
Metabolic diseases
ORPHAN
|
Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years.
|
|
Cabozantinib (8)
|
Cabometyx®
|
Ipsen Pharma GmbH
|
Oncological diseases
|
Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients
|
|
Polatuzumab Vedotin (2)
|
Polivy®
|
Roche Pharma AG
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
|
|
Tisagenlecleucel (5)
|
Kymriah®
|
Novartis Pharma GmbH
|
Oncological diseases
ORPHAN
|
Follicular lymphoma (FL), pre-treated patients
|
|
Axicabtagen-Ciloleucel (3, reassessment)
|
Yescarta®
|
Gilead Sciences GmbH
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies
|
|
Voxelotor
|
Oxbryta®
|
Global Blood Therapeutics Germany GmbH
|
Hematopoietic diseases
ORPHAN
|
Haemolytic anaemia in sickle cell disease, monotherapy or combination with hydroxycarbamide, ≥ 12 years.
|
|
Sotrovimab
|
Xevudy®
|
GlaxoSmithKline GmbH & Co. KG
|
Infectious diseases
|
COVID-19, ≥ 12 years
|
|
Tebentafusp
|
Kimmtrak®
|
Immunocore Ireland Ltd.
|
Oncological diseases
ORPHAN
|
Uveales Melanom, HLA-A*02:01-positive
|
|
Brolucizumab (2)
|
Beovu®
|
Novartis Pharma GmbH
|
Eye diseases
|
Diabetic macular edema
|
|
Abemaciclib (5)
|
Verzenios®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Breast carcinoma(BC), HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy
|
|
Imipenem / Cilastatin / Relebactam
|
Recarbrio®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
Bacterial infections, multiple indications
|
|
Ceftolozan / Tazobactam (6)
|
Zerbaxa®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
Bacterial infections, multiple indications
|
|
Ceftazidim / Avibactam
|
Zavicefta®
|
Pfizer Pharma GmbH
|
Infectious diseases
|
Bacterial infections, multiple indications
|
|
Doravirin / Lamivudin / Tenofovirdisoproxil (2)
|
Delstrigo®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
HIV infection, 12 to < 18 years
|
|
Doravirin (2)
|
Pifeltro®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
HIV infection, 12 to < 18 years
|
|
Nivolumab (23)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Urothelial carcinoma (UC) PD-L1 expression ≥ 1 %, adjuvant therapy
|
|
Nivolumab (22)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
|
|
Nivolumab (21)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with ipilimumab
|
|
Casirivimab / Imdevimab
|
Ronapreve®
|
Roche Pharma AG
|
Infectious diseases
|
COVID-19-Infection, ≥ 12 years
|
|
Dupilumab (6)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Respiratory system diseases
|
Asthma bronchiale, ≥ 6 until ≤ 11 years
|
|
Glucarpidase
|
Voraxaze®
|
SERB GmbH
|
Other diseases
ORPHAN
|
Reduction of toxic MTX plasma concentrations; children ≥ 28 days and adults.
|
|
Casirivimab / Imdevimab (2)
|
Ronapreve®
|
Roche Pharma AG
|
Infectious diseases
|
Post-exposure prophylaxis of COVID-19 infection, ≥ 12 years
|
|
Avapritinib (2)
|
Ayvakyt®
|
Blueprint Medicines (Germany) GmbH
|
Oncological diseases
ORPHAN
|
Leukaemia, myeloid, acute (AML); mastocytosis; after at least 1 previous therapy
|
|
Anifrolumab
|
Saphnelo®
|
AstraZeneca GmbH
|
Musculoskeletal system diseases
|
Systemic lupus erythematosus (SLE)
|
|
Somatrogon
|
Ngenla®
|
Pfizer Pharma GmbH
|
Metabolic diseases
ORPHAN
|
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age
|
|
Dolutegravir (4, reassessment)
|
Tivicay®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
HIV infection, age 6 to < 18 years
|
|
Voretigen Neparvovec (2, reassessment)
|
Luxturna®
|
Novartis Pharma GmbH
|
Eye diseases
ORPHAN
|
Hereditary retinal dystrophy
|
|
Pegcetacoplan
|
Aspaveli®
|
Swedish Orphan Biovitrum GmbH
|
Hematopoietic diseases
ORPHAN
|
Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients
|
|
Idebenon (2, reassessment)
|
Raxone®
|
Chiesi GmbH
|
Eye diseases
ORPHAN
|
Leber's hereditary optic neuropathy (LHOP)
|
|
Empagliflozin (4)
|
Jardiance®
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Cardiovascular diseases
|
Chronic heart failure (CHF) with preserved ejection fraction
|
|
Daratumumab (9, reassessment)
|
Darzalex®
|
Janssen-Cilag
|
Oncological diseases
ORPHAN
|
Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
|
|
Brivaracetam (3)
|
Briviact®
|
UCB Pharma GmbH
|
Nervous system diseases
|
Focal seizures in epilepsy, additional therapy, 2 to < 4 years
|
|
Lorlatinib (2)
|
Lorviqua®
|
Pfizer Pharma GmbH
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), ALK+, first-line
|
|
Tepotinib
|
Tepmetko®
|
Merck Europe B.V.
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients
|
|
Vedolizumab (2)
|
Entyvio®
|
Takeda GmbH
|
Digestive system diseases
|
Antibiotic-refractory pouchitis, pre-treated patients
|
|
Ivacaftor / Tezacaftor / Elexacaftor (10)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
|
|
Ivacaftor / Tezacaftor / Elexacaftor (9)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
|
|
Ivacaftor / Tezacaftor / Elexacaftor (8)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
ORPHAN
|
Treatment of patients with CF from 6 to 11 years of age who are are heterozygous for the F508del mutation in the CFTR gene and have an RF mutation on the second allele (patients with F508del/RF mutation). (patients with F508del/RF mutation).
|
|
Ivacaftor / Tezacaftor / Elexacaftor (7)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
|
|
Ivacaftor / Tezacaftor / Elexacaftor (6)
|
Kaftrio®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
|
|
Ivacaftor (26)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutations)
|
|
Ivacaftor (25)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (hmoozygous for F508del mutations)
|
|
Ivacaftor (24)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del mutation)
|
|
Ivacaftor (23)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor/tezacaftor/elexacaftor
|
|
Ivacaftor (22)
|
Kalydeco®
|
Vertex Pharmaceuticals (Germany) GmbH
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor/tezacaftor/elexacaftor
|
|
Avacopan
|
Tavneos®
|
Vifor Pharma Deutschland GmbH
|
Hematopoietic diseases
ORPHAN
|
Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide
|
|
Sotorasib
|
Lumykras®
|
Amgen Europe B.V.
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies
|
|
Sofosbuvir / Velpatasvir (3)
|
Epclusa®
|
Gilead Sciences GmbH
|
Infectious diseases
|
Chronic hepatitis C, ≥ 3 to < 6 years of age
|
|
Calcifediol
|
Rayaldee®
|
Fresenius Medical Care Nephrologica Deutschland GmbH
|
Metabolic diseases
|
Secondary hyperparathyroidism in chronic renal failure
|
|
Isofluran
|
Sedaconda®
|
Sedana Medical AB
|
Other diseases
|
Sedation of mechanically ventilated patients during intensive care therapy (ICT)
|
|
Burosumab (5, reassessment >€50m)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
ORPHAN
|
X-linked hypophosphatemia, ≥ 18 years of age
|
|
Burosumab (4, reassessment >€50m)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
ORPHAN
|
X-linked hypophosphatemia, ≥ 1 to < 18 years of age
|
|
Duvelisib (2)
|
Copiktra®
|
Secura Bio Limited
|
Oncological diseases
|
Follicular lymphoma (FL), after ≥ 2 prior therapies
|
|
Duvelisib
|
Copiktra®
|
Secura Bio Limited
|
Oncological diseases
|
Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies
|
|
Abrocitinib
|
Cibinqo®
|
Pfizer Pharma GmbH
|
Skin diseases
|
Atopic Dermatitis (AD)
|
|
Amivantamab
|
Rybrevant®
|
Janssen-Cilag GmbH
|
Oncological diseases
|
Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy
|
|
Remdesivir (2)
|
Veklury®
|
Gilead Sciences GmbH
|
Infectious diseases
|
COVID-19, no need for supplementary oxygen, increased risk of severe progression
|
|
Lenvatinib (7)
|
Kisplyx®
|
Eisai GmbH
|
Oncological diseases
|
Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab
|
|
Lenvatinib (6)
|
Lenvima®
|
Eisai GmbH
|
Oncological diseases
|
Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab
|
|
Pembrolizumab (20)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib
|
|
Pembrolizumab (19)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib
|