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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)
01.09.2022
Tepotinib (non-small cell lung cancer (NSCLC), METex14-skipping mutation, pre-treated patients)
01.09.2022
Lorlatinib (new indication: non-small cell lung cancer (NSCLC), ALK+ mutation, 1st line)
01.09.2022
Brivaracetam (new indication: partial onset seizures in patients with epilepsy, adjunctive therapy, patients aged 2 – < 4 years)
04.08.2022
Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)
04.08.2022
Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and RF mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)
04.08.2022
Ivacaftor (new indication: cystic fibrosis; F508del mutation, heterozygous, and gating mutation; patients aged ≥ 6 - ≤ 11 years; in combination with ivacaftor / tezacaftor / elexacaftor)
04.08.2022
Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (homozygous for F508del mutation))
04.08.2022
Ivacaftor (new indication: cystic fibrosis; in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))
04.08.2022
Sotorasib (non-small cell lung cancer (NSCLC); KRAS G12C mutation; ≥ 1 prior therapies)
04.08.2022
Avacopan (granulomatosis with polyangiitis or microscopic polyangiitis; in combination with rituximab or cyclophosphamide)
04.08.2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous; and other or unknown mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))
04.08.2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous, and RF mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))
04.08.2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; F508del mutation; heterozygous, and gating mutation; patients aged ≥ 6 - ≤ 11 years (in combination with ivacaftor))
04.08.2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; in combination with ivacaftor, patients aged ≥ 6 - ≤ 11 years (homozygous for F508del mutation))
04.08.2022
Ivacaftor / tezacaftor / elexacaftor (new indication: cystic fibrosis; in combination with ivacaftor; patients aged ≥ 6 - ≤ 11 years (heterozygous for F508del and MF mutation))
04.08.2022
Sofosbuvir / velpatasvir (new indication: chronic hepatitis C; patients aged ≥ 3 - 6 years)
21.07.2022
Duvelisib (chronic lymphatic leukemia (CLL), after ≥ 2 prior therapies)
21.07.2022
Duvelisib (follicular lymphoma, after ≥ 2 prior therapies)
21.07.2022
Burosumab (re-assessment, 50 M € limit exceeded: X-linked hypophosphatemia, patients aged ≥ 18 years)
21.07.2022
Burosumab (re-assessment, 50 M € limit exceeded: X-linked hypophosphatemia, patients aged ≥ 1 - < 18 years)
21.07.2022
Isoflurane (known active substance with new data exclusivity: sedation of mechanically ventilated patients during intensive care)
21.07.2022
Calcifediol (known active substance with new data exclusivity: secondary hyperparathyroidism in chronic renal failure)
07.07.2022
Remdesivir (new indication: COVID-19, patients not requiring supplemental oxygen, with increased risk of progressing to severe COVID-19)
07.07.2022
Amivantamab (non-small cell lung cancer (NSCLC), EGFR exon 20 insertion mutations, after platinum-based therapy)
07.07.2022
Abrocitinib (atopic dermatitis)