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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)
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)
Risankizumab (new indication: Crohn's disease, pre-treated patients)
Bictegravir / emtricitabine / tenofovir alafenamide (new indication: HIV infections, patients aged between 2 and < 18 years
Sutimlimab (cold agglutinin disease (CAD))
Abemaciclib (re-assessment: breast cancer, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, in combination with aromatase inhibitors)
Olaparib (new indication: metastatic castration-resistant prostate cancer (mCRPC) in combination with abiraterone and/or prednisone for patients in whom chemotherapy is not clinically indicated)
Maralixibat (Alagille syndrome (ALGS) patients aged ≥ 2 months
Lutetium (177Lu) vipivotide tetraxetan (progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) for patients who have progressed after treatment with AR pathway inhibition and taxane-based chemotherapy, in combination with androgen deprivation therapy (ADT))
Trastuzumab deruxtecan (new indication: breast cancer; HER2-low; pre-treated patients)
Trastuzumab deruxtecan (new indication: gastric or gastroesophageal junction (GEJ) adenocarcinoma; HER2-positive; after a trastuzumab-based regimen)
Spesolimab (generalized pustular psoriasis (GPP); acute treatment)
Ibrutinib (new indication: chronic lymphocytic leukemia (CLL); first line; in combination with venetoclax)
Sotorasib (re-assessment: non-small cell lung cancer (NSCLC); KRAS G12C mutation; ≥ 1 previous therapy)
Ciltacabtagene autoleucel (multiple myeloma, patients with at least three prior therapies)
Fenfluramine (new indication: Lennox-Gastaut syndrome as an add-on therapy for patients aged ≥ 2 years)
Dapagliflozin (new indication: chronic heart failure with left ventricular ejection fraction (LVEF) > 40 %)
Dolutegravir / abacavir / lamivudine (new indication: HIV infection; ≥ 14 kg and < 12 years of age)
Finerenone (chronic kidney disease associated with type 2 diabetes; stage 3 and 4 with albuminuria)
Finerenone (chronic kidney disease associated with type 2 diabetes; stage 1 and 2 with albuminuria)
Emicizumab (new indication: moderate hemophilia A; without factor VIII inhibitors; severe bleeding phenotype)
Voclosporin (lupus nephritis)
Completed (final decision published)
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)
19.01.2023
Inebilizumab (indication: neuromyelitis optica spectrum disorders (NMOSD) anti-aquasporin-4 immunoglobulin G (AQP4-IgG) seropositive patients)
19.01.2023
Pembrolizumab (new indication: renal cell carcinoma, adjuvant therapy, pretreated patients)
19.01.2023
Pembrolizumab (new indication: colorectal cancer with MSI-H or dMMR tumors for patients treated with fluoropyrimidine-based combination therapy)
19.01.2023
Pembrolizumab (new indication: endometrial carcinoma with MSI-H or dMMR tumors, pretreated patients)
19.01.2023
Pembrolizumab (new indication: gastric cancer with MSI-H or dMMR tumors, pretreated patients)
19.01.2023
Pembrolizumab (new indication: small intestine cancer with MSI-H or dMMR tumors, pretreated patients)
19.01.2023
Pembrolizumab (new indication: biliary cancer with MSI-H or dMMR tumors, pretreated patients)