|
|
Olopatadin/Mometason
|
Ryaltris®
|
Berlin-Chemie AG
|
Respiratory system diseases
|
Allergic rhinitis (diseases of the respiratory system)
|
|
|
Maribavir
|
Livtencity®
|
Takeda GmbH
|
Infectious diseases
ORPHAN
|
Cytomegalovirus infection (CMI), refractory to therapy
|
|
|
Tezepelumab
|
Tezspire®
|
AstraZeneca GmbH
|
Respiratory system diseases
|
Bronchial asthma (AB), ≥ 12 years
|
|
|
Tralokinumab (2)
|
Adtralza®
|
LEO Pharma GmbH
|
Skin diseases
|
Atopic dermatitis (AD), 12 to < 18 years
|
|
|
Axicabtagen-Ciloleucel (5)
|
Yescarta®
|
Gilead Sciences GmbH
|
Oncological diseases
ORPHAN
|
Follicular lymphoma (FL), after ≥ 3 prior therapies
|
|
|
Axicabtagen-Ciloleucel (4)
|
Yescarta®
|
Gilead Sciences GmbH
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL) and highly malignant B-cell lymphoma, relapsed within 12 months after first-line therapy or refractory
|
|
|
Daridorexant
|
Quviviq®
|
Idorsia Pharmaceuticals Germany GmbH
|
Mental illnesses
|
Sleep disorders (mental illnesses)
|
|
|
Ravulizumab (4)
|
Ultomiris®
|
Alexion Pharma Germany GmbH
|
Nervous system diseases
|
Myasthenia gravis, AChR antibody+
|
|
|
Olaparib (9, reassessment)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Ovarian carcinoma (OC), fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab
|
|
|
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3)
|
Genvoya®
|
Gilead Sciences GmbH
|
Infectious diseases
|
HIV infection, 2 to < 6 years
|
|
|
Tixagevimab / Cilgavimab
|
Evusheld®
|
AstraZeneca GmbH
|
Infectious diseases
|
COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre
|
|
|
Faricimab (2)
|
Vabysmo®
|
Roche Pharma AG
|
Eye diseases
|
Neovascular age-related macular degeneration (AMD)
|
|
|
Remdesivir (4)
|
Veklury®
|
Gilead Sciences GmbH
|
Infectious diseases
|
COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg)
|
|
|
Remdesivir (3)
|
Veklury®
|
Gilead Sciences GmbH
|
Infectious diseases
|
COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years
|
|
|
Vutrisiran
|
Amvuttra®
|
Alnylam Germany GmbH
|
Metabolic diseases
ORPHAN
|
Hereditary transthyretin amyloidosis (hTTA) with polyneuropathy (stage 1 or 2))
|
|
|
Relugolix
|
Orgovyx®
|
Accord Healthcare GmbH
|
Oncological diseases
|
Prostate carcinoma (PC), advanced, hormone-sensitive
|
|
|
Lonafarnib
|
Zokinvy®
|
EigerBio Europe Ltd
|
Other diseases
ORPHAN
|
Hutchinson-Gilford progeria syndrome or progeroid laminopathy, 12 months and over
|
|
|
Faricimab
|
Vabysmo®
|
Roche Pharma AG
|
Eye diseases
|
Diabetic macular edema (DME)
|
|
|
Lisocabtagen maraleucel
|
Breyanzi®
|
Bristol-Myers Squibb GmbH
|
Oncological diseases
ORPHAN
|
Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma and follicular lymphoma (PMBCL) grade 3B, after ≥ 2 prior therapies
|
|
|
Brexucabtagene-Autoleucel (2)
|
Tecartus®
|
Gilead Sciences GmbH
|
Oncological diseases
ORPHAN
|
B-cell acute lymphoblastic leukaemia (ALL), aged > 26
|
|
|
Pertuzumab / Trastuzumab (4, reassessment)
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy
|
|
|
Selpercatinib (5)
|
Retsevmo®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older
|
|
|
Melphalanflufenamid
|
Pepaxti®
|
Oncopeptides AB
|
Oncological diseases
|
Multiple myeloma (MM) after at least 3 previous therapies, combination with dexamethasone)
|
|
|
Asciminib
|
Scemblix®
|
Novartis Pharma GmbH
|
Oncological diseases
ORPHAN
|
Chronic myeloid leukaemia (CLL), Ph+, after ≥ 2 prior therapies
|
|
|
Olipudase alfa
|
Xenpozyme®
|
Sanofi-Aventis Deutschland
|
Metabolic diseases
ORPHAN
|
Acid sphingomyelinase deficiency (ASDM) type A/B or type B
|
|
|
Difelikefalin
|
Kapruvia®
|
Fresenius Medical Care Nephrologica Deutschland GmbH
|
Skin diseases
|
Pruritus in chronic kidney disease (CKD), haemodialysis patients
|
|
|
Selinexor
|
Nexpovio®
|
Stemline Therapeutics B.V.
|
Oncological diseases
|
Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone
|
|
|
Selinexor (2)
|
Nexpovio®
|
Stemline Therapeutics B.V.
|
Oncological diseases
|
Multiple myeloma (MM) at least 1 prior therapy, combination with bortezomib and dexamethasone
|
|
|
Pertuzumab (4, reassessment)
|
Perjeta®
|
Roche Pharma AG
|
Oncological diseases
|
Breast carcinoma (BC), early with high risk of recurrence, adjuvant therapy, combination with trastuzumab and chemotherapy
|
|
|
Valoctocogene roxaparvovec
|
Roctavian®
|
BioMarin International Ltd.
|
Hematopoietic diseases
ORPHAN
|
Hemophilia A
|
|
|
Burosumab (6)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
ORPHAN
|
FGF23-related hypophosphatemia in tumour-induced osteomalacia
|
|
|
Efgartigimod alfa
|
Vyvgart®
|
Argenx Germany GmbH
|
Nervous system diseases
ORPHAN
|
Myasthenia gravis, AChR antibody+
|
|
|
Eptinezumab
|
Vyepti®
|
Lundbeck GmbH
|
Nervous system diseases
|
Migraine prophylaxis
|
|
|
Olaparib (8)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Breast carcinoma (BC), HER2, BRCA1/2 mutation, pre-treated, high risk of recurrence, adjuvant, monotherapy or combination with chemotherapy.
|
|
|
Upadacitinib (6)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. KG
|
Digestive system diseases
|
Ulcerative colitis (UC), pre-treated
|
|
|
Upadacitinib (5)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. KG
|
Musculoskeletal system diseases
|
Axial spondyloarthritis (AS), non-radiographic
|
|
|
Birkenrindenextrakt
|
Filsuvez®
|
Amryt Pharma GmbH
|
Other diseases
ORPHAN
|
Wound treatment in epidermolysis bullosa (from 6 months))
|
|
|
Ceftolozan / Tazobactam (7)
|
Zerbaxa®
|
MSD Sharp & Dohme GmbH
|
Infectious diseases
|
Bacterial infections, multiple indications, < 18 years of age
|
|
|
Capmatinib
|
Tabrecta®
|
Novartis Pharma GmbH
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients
|
|
|
Eladocagene Exuparvovec
|
Upstaza®
|
PTC Therapeutics International Limited
|
Metabolic diseases
ORPHAN
|
Aromatic L-amino acid decarboxylase (AADC) deficiency, ≥ 18 months
|
|
|
Trastuzumab Deruxtecan (2)
|
Enhertu®
|
Daiichi Sankyo Deutschland GmbH
|
Oncological diseases
|
Breast carcinoma (BC), HER2+, after 1 prior therapy
|
|
|
Trastuzumab Deruxtecan
|
Enhertu®
|
Daiichi Sankyo Deutschland GmbH
|
Oncological diseases
|
Breast carcinoma (BC), HER2+, at least 2 previous therapies
|
|
|
Pembrolizumab (30)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Renal cell carcinoma (RCC), adjuvant, monotherapy, pre-treated patients
|
|
|
Pembrolizumab (29)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Colorectal cancer (CRC)) with MSI-H or with dMMR, after fluoropyrimidine-based combination therapy.
|
|
|
Pembrolizumab (28)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Endometrial carcinoma with MSI-H or with dMMR , pre-treated
|
|
|
Pembrolizumab (27)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Gastric carcinoma with MSI-H or dMMR, pre-treated
|
|
|
Pembrolizumab (26)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Small bowel carcinoma with MSI-H or dMMR, pre-treated
|
|
|
Pembrolizumab (25)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Biliary carcinoma with MSI-H or dMMR, pre-treated
|
|
|
Pembrolizumab (24)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Cervical carcinoma, PD-L1 expression ≥ 1 (CPS), combination with or without bevacizumab
|
|
|
Pembrolizumab (23)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Melanoma, adjuvant therapy, ≥ 12 years, monotherapy
|
|
|
Pembrolizumab (22)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Melanoma, ≥ 12 to < 18 years
|
|
|
Glycopyrronium
|
Axhidrox®
|
Dr. August Wolff GmbH & Co. KG Arzneimittel
|
Other diseases
|
Severe primary axillary hyperhidrosis
|
|
|
Inebilizumab
|
Uplizna®
|
Horizon Therapeutics GmbH
|
Nervous system diseases
|
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
|
|
|
Eravacyclin
|
Xerava®
|
PAION Deutschland GmbH
|
Infectious diseases
|
Reserve antibiotics: Complicated intra-abdominal infections (cIAI)
|
|
|
Atezolizumab (10)
|
Tecentriq®
|
Roche Pharma AG
|
Oncological diseases
|
Non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 % of TC, EGFR/ALK negative, adjuvant therapy after resection and chemotherapy.
|
|
|
Secukinumab (7)
|
Cosentyx®
|
Novartis Pharma GmbH
|
Musculoskeletal system diseases
|
Enthesitis-associated arthritis (EAA)
|
|
|
Secukinumab (8)
|
Cosentyx®
|
Novartis Pharma GmbH
|
Skin diseases
|
Juvenile psoriatic arthritis (PA), ≥ 6 years
|
|
|
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
|
