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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)
Difelikefalin (pruritus in patients with chronic kidney disease who are on hemodialysis)
Lisocabtagene maraleucel (diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3b (FL3B); ≥ 2 prior therapies)
Faricimab (diabetic macular edema (DME))
Lonafarnib (Hutchinson-Gilford progeria syndrome or (processing-deficient) progeroid laminopathy)
Relugolix (advanced hormone-sensitive prostate cancer)
Remdesivir (new indication: COVID-19; patients requiring supplemental oxygen; patients aged ≥ 4 weeks to < 12 years)
Vutrisiran (hereditary transthyretin-mediated amyloidosis with polyneuropathy (stage 1 or 2))
Tixagevimab / cilgavimab (obligation for benefit assessment for the first time: COVID-19; patients not requiring supplemental oxygen; patients aged ≥ 12 years)
Faricimab (neovascular age-related macular degeneration (nAMD))
Remdesivir (new indication: COVID-19; patients not requiring supplemental oxygen; patients aged < 18 years and weighing ≥ 40 kg)
Elvitegravir/Cobicistat/Emtricitabin/Tenofoviralafenamid (new indication: HIV infection, patients aged 2 to < 6 years)
Olaparib (re-assessment: adult patients with advanced (FIGO stages III and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer, homologous recombination deficiency (HRD) positive, maintenance treatment in combination with Bevacizumab)
Ravulizumab (new indication: myasthenia gravis, patients who are anti-acetylcholine receptor (AChR) antibody-positive)
Tezepelumab (bronchial asthma, patients aged ≥ 12 years)
Tralokinumab (new indication: atopic dermatitis, patients aged 12 to < 18 years)
Daridorexant (insomnia)
Maribavir (cytomegalovirus (CMV) infection, refractory)
Olopatadin / mometason (allergic rhinitis, patients aged ≥ 12 years)
Zanubrutinib (news indication: chronic lymphocytic leukemia (CLL), first line treatment)
Zanubrutinib (new indication: chronic lymphocytic leukemia (CLL), for relapsed and/or refractory patients)
Zanubrutinib (new indication: marginal zone lymphoma (MLZ), ≥ 1 prior anti-CD20-antibody-based therapy)
Latanoprost / netarsudil (reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension)
Completed (final decision published)
16.03.2023
Valoctocogene roxaparvovec (hemophilia A)
16.03.2023
Selinexor (multiple myeloma, ≥ 4 prior therapies, in combination with dexamethasone)
16.03.2023
Selinexor (multiple myeloma, ≥ 1 prior therapy, in combination with bortezomib and dexamethasone)
16.03.2023
Melphalan flufenamide (multiple myeloma, ≥ 3 prior therapies, in combination with dexamethasone)
16.03.2023
Asciminib (chronic myeloid leukemia, Ph+, ≥ 2 prior therapies)
16.03.2023
Brexucabtagene autoleucel (new indication: acute lymphoblastic leukemia, patients aged ≥ 26 years)
16.03.2023
Pertuzumab (re-assessment: early breast cancer, high risk of recurrence, adjuvant therapy, in combination with trastuzumab and chemotherapy)
16.03.2023
Pertuzumab / trastuzumab (re-assessment: early breast cancer, HER2-positive, high risk of recurrence, adjuvant therapy, in combination with chemotherapy)
16.03.2023
Selpercatinib (new indication: thyroid cancer, RET-mutation, monotherapy, patients aged ≥ 12 years)
16.03.2023
Olipudase alfa (acid sphingomyelinase deficiency (ASMD) type A/B or type B)
16.02.2023
Birch bark extract (wounds associated with dystrophic and junctional epidermolysis bullosa (EB), patients aged ≥ 6 months)
16.02.2023
Upadacitinib (new indication: non-radiographic axial spondyloarthritis)
16.02.2023
Upadacitinib (new indication: ulcerative colitis, pretreated patients)
16.02.2023
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)
16.02.2023
Eptinezumab (new indication: prophylaxis of migraine)
16.02.2023
Efgartigimod alfa (Myasthenia Gravis for AChR antibody positive patients)
16.02.2023
Burosumab (new indication, 50 M € limit exceeded: FGF23-related hypophosphatemia in tumor-induced osteomalacia)
02.02.2023
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, ≥ 2 prior therapies)
02.02.2023
Trastuzumab Deruxtecan (indication: breast cancer, HER2+, 1 prior therapy)
02.02.2023
Pembrolizumab (new indication: cervical cancer with PD-L1 expression with a CPS ≥ 1, in combination with or without bevacizumab)
02.02.2023
Capmatinib (non-small cell lung cancer (NSCLC), pretreated patients with mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping)
02.02.2023
Ceftolozane / tazobactam (new indication: bacterial infections; patients aged < 18 years (antibiotic of last resort))
02.02.2023
Eladocagene exuparvovec (aromatic L-amino acid decarboxylase (AADC) deficiency, patients aged ≥ 18 months)
19.01.2023
Eravacyclin (antibiotic of last resort: complicated intra-abdominal infections (cIAI))
19.01.2023
Glycopyrronium (known active substance with new document protection (§16): severe primary axillary hyperhidrosis)