G-BA procedures on early benefit assessment

Since the AMNOG (Act on the Reform of the Market for Medicinal Products) entered into force on 1 January 2011, a total of xx procedures concerning xx different medicinal products have been initiated by the G-BA. xx of these procedures have been finalised with a resolution (see figure). Currently, there are xx active procedures pursuant to §35a SGB V. Of these, presumably xx decisions are in preparation, the commenting procedure should be underway for xx cases, and xx procedures are listed by the G-BA as initiated.

      A total of XX previously initiated procedures were prematurely terminated or postponed by the G-BA:

      • 9 medicinal products were exempted due to insignificance according to § 12 VerfO:
        • Ceftarolinfosamil (14.03.2012)
        • Chloroprocain (26.07.2013)
        • Defibrotid (14.10.2013)
        • Delamanid (07.03.2014)
        • Dexmedetomidin (13.07.2011)
        • Dinutuximab beta (08.09.2017)
        • Landiololhydrochlorid (12.06.2017)
        • Lutetium-(177Lu)-Oxodotreotid (29.08.201)
        • Piperaquintetraphosphat / Dihydroartemisinin (21.03.2012)
           
      • 2 procedures are suspended:
        • Cefiderocol (16.07.2020)
        • Ceftazidim / Avibactam (31.07.2020)
           
      • 16 procedures were discontinued:
        • Bedaquilin (15.05.2014)
        • Ceftolozan/Tazobactam (Akute Pyelonephritis) (15.03.2020)
        • Ceftolozan/Tazobactam (Komplizierte Harnwegsinfektionen) (15.03.2020)
        • Ceftolozan/Tazobactam (Komplizierte intraabdominelle Infektionen) (15.03.2020)
        • Ceftolozan/Tazobactam (Neues Anwendungsgebiet: Im Krankenhaus erworbene Pneumonie einschließlich beatmungsassoziierter Pneumonie) (15.03.2020)
        • Dabigatranetexilat (01.12.2013)
        • Daratumumab (Multples myelom, Monotherapie) (01.05.2017)
        • Denosumab (Osteoporose, Knochenschwund, Knochenmetastasen) (15.10.2013)
        • Ibrutinib (Morbus Waldenström) (01.08.2015)
        • Ivacaftor (zystische Fibrose ≥ 12 Jahre, Kombination mit Tezacaftor) (01.12.2018)
        • Olmesartanmedoxomil / Amlodipin / Hydrochlorothiazid (15.12.2010)
        • Parathyroidhormon (Osteoporose) (15.10.2013)
        • Prasteron (vulvovaginale Atrophie) (01.05.2019)
        • Retigabin (Epilepsie) (01.05.2013)
        • Rivaroxaban (Prohylaxe/Therapie artherothrombotischer / venothrombotischer Ereignisse) (01.12.2013)
        • Saxagliptin (Diabetes mellitus 2, Monotherapie) (01.09.2013)
           
      • 1 procedure has been postponed:
        • Olaparib (Adenokarzinom des Pankreas, vorbehandelte Patienten)