Executive Summary

  • AMNOG introduced mandatory HTA-assessments for new active substances entering the German market from January 2011
    • Alternate routes to market through the G-DRG or NUB system are possible for other treatments
  • The assessment is essentially a comparison of the new drug with the best existing therapy for the same indication (so-called “comparator therapy”), or with best supportive care in case of orphan drugs
  • The GBA provides an additional benefit rating (i.e. the added value) of the drug
  • The reimbursement procedure takes 6 months, starting from the marketing authorisation holder’s dossier submission