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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)
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)
Esketamine (re-assessment: treatment-resistant Major Depressive Disorder in combination with a SSRI or SNRI)
Completed (final decision published)
15.06.2023
Latanoprost / netarsudil (reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension)
15.06.2023
Risankizumab (new indication: Crohn's disease, pre-treated patients)
15.06.2023
Sutimlimab (cold agglutinin disease (CAD))
15.06.2023
Bictegravir / emtricitabine / tenofovir alafenamide (new indication: HIV infections, patients aged between 2 and < 18 years)
15.06.2023
Zanubrutinib (news indication: chronic lymphocytic leukemia (CLL), first line treatment)
15.06.2023
Zanubrutinib (new indication: chronic lymphocytic leukemia (CLL), for relapsed and/or refractory patients)
15.06.2023
Zanubrutinib (new indication: marginal zone lymphoma (MLZ), ≥ 1 prior anti-CD20-antibody-based therapy)
15.06.2023
Abemaciclib (re-assessment: breast cancer, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, in combination with aromatase inhibitors)
01.06.2023
Maribavir (cytomegalovirus (CMV) infection, refractory)
01.06.2023
Olopatadin / mometason (allergic rhinitis, patients aged ≥ 12 years)
12.05.2023
Tezepelumab (bronchial asthma, patients aged ≥ 12 years)
12.05.2023
Tralokinumab (new indication: atopic dermatitis, patients aged 12 to < 18 years)
12.05.2023
Daridorexant (insomnia)
20.04.2023
Ravulizumab (new indication: myasthenia gravis, patients who are anti-acetylcholine receptor (AChR) antibody-positive)
20.04.2023
Elvitegravir/Cobicistat/Emtricitabin/Tenofoviralafenamid (new indication: HIV infection, patients aged 2 to < 6 years)
20.04.2023
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)
20.04.2023
Tixagevimab / cilgavimab (obligation for benefit assessment for the first time: COVID-19; patients not requiring supplemental oxygen; patients aged ≥ 12 years)
06.04.2023
Lisocabtagene maraleucel (diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3b (FL3B); ≥ 2 prior therapies)
06.04.2023
Lonafarnib (Hutchinson-Gilford progeria syndrome or (processing-deficient) progeroid laminopathy)
06.04.2023
Relugolix (advanced hormone-sensitive prostate cancer)
06.04.2023
Vutrisiran (hereditary transthyretin-mediated amyloidosis with polyneuropathy (stage 1 or 2))
06.04.2023
Faricimab (diabetic macular edema (DME))
06.04.2023
Faricimab (neovascular age-related macular degeneration (nAMD))
06.04.2023
Remdesivir (new indication: COVID-19; patients requiring supplemental oxygen; patients aged ≥ 4 weeks to < 12 years)
06.04.2023
Remdesivir (new indication: COVID-19; patients not requiring supplemental oxygen; patients aged < 18 years and weighing ≥ 40 kg)