Potential trends for modifications of AMNOG

The Joint Federal Committee (Gemeinsamer Bundesausschuss – GBA), the German public body responsible for the early benefit assessment, recently held a conference on three years experiences with AMNOG. During this conference Antje Haas, deputy representative of the national association of statutory health insurance funds (GKV-Spitzenverband) within the GBA, outlined how the rules on the early benefit proceedings could be further developed. Please find below a link to Ms. Haas’  presentation:


On slide 15 you will find Ms. Haas’ recommendations which gives you an idea on potential trends for modifications of AMNOG:

  • Incentives/obligation for a periodical reassessment including an update on the additional benefit and subsequent price adjustment
  • New indications shall be subject to the early benefit assessment
  • Reimbursement shall be closely linked to an adequate price = reimbursable amount as of day one
  • Authorisation and method assessment for companion diagnostics – standardisation of the requirements for the use of biomarkers
  • No dossier – mandatory rebate on the price for the appropriate comparator
  • Full assessment procedure for orphan medicinal products above a 30 million threshold
  • Threshold has to be assessed under consideration of the total turnover
  • If necessary, introduction of a definition of the “materiality threshold” to assess the therapeutic improvement

As explained above, these are solely “recommendations” of a representative of the GKV-Spitzenverband and in particular do not represent actual plans of the German legislators to amend the legal provisions governing the early assessment procedure. However, the presentation illustrates the view of one (influential) member of the GBA, in particular in relation to the discussion around the assessment of the benefit of orphan medicinal products. Therefore, it is vital to continuously underline towards HTA bodies that the denial of an additional benefit of an orphan medicinal product authorised under EU law should be put in question within national HTA processes.

Published 1. May 2014 in News Germany