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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)
05.05.2022
Delamanid (revocation of exemption: pulmonary multi-drug resistant tuberculosis, patients ≥ 10 kg)
05.05.2022
Cefiderocol (antibiotic of last resort: infections caused by aerobic gram-negative pathogens)
21.04.2022
Ixazomib (re-assessment: multiple myeloma, ≥ 1 prior therapy(ies), in combination with lenalidomide and dexamethasone)
21.04.2022
Pitolisant (excessive daytime sleepiness (EDS) with obstructive sleep apnoea (OSA) after previous therapy)
07.04.2022
Sofosbuvir / velpatasvir / voxilaprevir (new indication: chronic hepatitis C; adolescents from 12 to < 18 years)
07.04.2022
Albutrepenonacog alfa (re-assessment, 50 M € limit exceeded: hemophilia B; congenital factor IX deficiency)
07.04.2022
Peanut protein as defatted powder of Arachis hypogaea L., semen (peanuts) (peanut allergy; patients aged ≥ 4 years)
18.03.2022
Ravulizumab (new indication: paroxysmal nocturnal haemoglobinuria (PNH); pediatric patients)
18.03.2022
Lumacaftor / ivacaftor (re-assessment: cystic fibrosis; homozygous F508del mutation in CFTR gene; aged ≥ 2 - ≤ 5 years)
18.03.2022
Daratumumab (new scientific evidence (§ 14): newly diagnosed multiple myeloma, in combination with lenalidomide and dexamethasone for patients unsuitable for autologous stem cell transplantation)
18.03.2022
Vosoritide (achondroplasia, patients aged ≥ 2 years)
18.03.2022
Vandetanib (re-assessment: medullary thyroid cancer (MTC))
18.03.2022
Solriamfetol (obligation for benefit assessment for the first time: excessive daytime sleepiness (EDS) with obstructive sleep apnoea (OSA) after previous therapy)
03.03.2022
Bimekizumab (moderate to severe plaque psoriasis)
03.03.2022
Vericiguat (chronic heart failure)
03.03.2022
Odevixibat (progressive familial intrahepatic cholestasis (PFIC) in patients aged ≥ 6 months)
03.03.2022
Tafasitamab (diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide)
03.03.2022
Tofacitinib (new indication: polyarticular juvenile idiopathic arthritis (pJIA), rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis, and juvenile psoriatic arthritis (PsA) in patients aged ≥ 2 years)
03.03.2022
Roxadustat (symptomatic anaemia associated with chronic kidney disease (CKD))
17.02.2022
Upadacitinib (new indication: atopic dermatitis, patients aged ≥ 12 years)
17.02.2022
Dapagliflozin (new indication: chronic kidney disease)
17.02.2022
Relugolix / estradiol / norethisterone acetate (uterine fibroids)
17.02.2022
Tirbanibulin (actinic keratosis (Olsen grade 1))
17.02.2022
Tofacitinib (new scientific evidence (§ 13): rheumatoid arthritis, pretreated patients, monotherapy or in combination with methotrexate)
17.02.2022
Icosapent ethyl (dislipidemia, pre-treated patients)