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Aktuelle Nutzenbewertungsverfahren

Hier finden Sie alle aktuellen Verfahren der Frühen Nutzenbewertung der letzten 12 Monate.

 

Ongoing (preliminary decision published)
Diroximel fumarate (relapsing-remitting multiple sclerosis)
Pembrolizumab (new indication: cervical cancer with PD-L1 expression with a CPS ≥ 1, in combination with or without bevacizumab)
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, ≥ 2 prior therapies)
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, 1 prior therapy)
Eladocagene exuparvovec (aromatic L-amino acid decarboxylase (AADC) deficiency, patients aged ≥ 18 months)
Capmatinib (non-small cell lung cancer (NSCLC), pretreated patients with mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping)
Ceftolozane / tazobactam (new indication: bacterial infections; patients aged < 18 years (antibiotic of last resort))
Birch bark extract (wounds associated with dystrophic and junctional epidermolysis bullosa (EB), patients aged ≥ 6 months)
Upadacitinib (new indication: non-radiographic axial spondyloarthritis)
Upadacitinib (new indication: ulcerative colitis, pretreated patients)
Olaparib (new indication: high risk early breast cancer with BRCA1/2-mutations and HER2-negative as monotherapy or in combination with endocrine therapy for the adjuvant treatment of previously treated patients)
Eptinezumab (new indication: prophylaxis of migraine)
Efgartigimod alfa (Myasthenia Gravis for AChR antibody positive patients)
Burosumab (new indication, 50 M € limit exceeded: FGF23-related hypophosphatemia in tumor-induced osteomalacia)
Valoctocogene roxaparvovec (hemophilia A)
Selpercatinib (new indication: thyroid cancer, RET-mutation, monotherapy, patients aged ≥ 12 years)
Pertuzumab / trastuzumab (re-assessment: early breast cancer, HER2-positive, high risk of recurrence, adjuvant therapy, in combination with chemotherapy)
Pertuzumab (re-assessment: early breast cancer, high risk of recurrence, adjuvant therapy, in combination with trastuzumab and chemotherapy)
Olipudase alfa (acid sphingomyelinase deficiency (ASMD) type A/B or type B)
Melphalan flufenamide (multiple myeloma, ≥ 3 prior therapies, in combination with dexamethasone)
Asciminib (chronic myeloid leukemia, Ph+, ≥ 2 prior therapies)
Selinexor (multiple myeloma, ≥ 4 prior therapies, in combination with dexamethasone)
Selinexor (multiple myeloma, ≥ 1 prior therapy, in combination with bortezomib and dexamethasone)
Difelikefalin (pruritus in patients with chronic kidney disease who are on hemodialysis)
Brexucabtagene autoleucel (new indication: acute lymphoblastic leukemia, patients aged ≥ 26 years)
Completed (final decision published)
17.02.2022
Icosapent ethyl (dislipidemia, pre-treated patients)
17.02.2022
Migalastat (new indication: Fabry disease, patients aged 12 - < 16 years)
17.02.2022
Nivolumab (new indication: oesophageal or gastro-oesophageal junction cancer, pretreated patients, adjuvant)
17.02.2022
Misoprostol (known substance with new data exclusivity: labour induction)
03.02.2022
Selumetinib (neurofibromatosis type 1, patients aged ≥ 3 - < 18 years)
03.02.2022
Daratumumab (new indication: multiple myeloma, ≥ previous therapy(ies), in combination with pomalidomide and dexamethasone)
20.01.2022
Nivolumab (new indication: colorectal cancer (CRC) with microsatellite-instability-high (MSI-H) or mismatch repair-deficient (dMMR), pre-treated patients, in combination with ipilimumab)
20.01.2022
Daratumumab (new indication: systemic light-chain amyloidosis, 1st line, in combination with cyclophosphamide, bortezomib and dexamethasone)
20.01.2022
Cemiplimab (new indication: basal cell carcinoma, metastatic or locally advanced)
20.01.2022
Cemiplimab (new indication: non-small cell lung cancer (NSCLC), 1st line)
20.01.2022
Blinatumomab (new indication: B-precursor acute lymphoblastic leukaemia (ALL), high-risk first relapsed, Ph-, CD19+, patients aged ≥ 1 - < 18 years)
20.01.2022
Teriflunomide (new indication: relapsing remitting multiple sclerosis (RRMS) in patients aged 10-17 years)
06.01.2022
Angiotensin II acetate (hypotension)
06.01.2022
Tralokinumab (atopic dermatitis)
06.01.2022
Empagliflozin (new indication: chronic heart failure)
06.01.2022
Satralizumab (neuromyelitis optica spectrum disorders in anti-aquaporin-4 IgG (AQP4-IgG) seropositive patients ≥ 12 years of age)