Edison healthcare quarterly: German (drug) reformation

The book opens with an overview of the new German drug pricing system (AMNOG) by Dr Michael Aitkenhead. He writes that AMNOG, which sets reimbursed prices based on added benefit over existing therapies, presents a major barrier to market access for new drugs in Europe’s largest market. Recent negative pricing decisions for newly licensed drugs (ie GW Pharma’s Sativex) and the initiation of reviews for already marketed products (DPP-4 inhibitors) have brought AMNOG back into focus. Results of AMNOG benefit assessments to date, which are undertaken by IQWiG/G-BA, suggest four factors are critical for a positive outcome: (1) clinical data versus G-BA’s chosen comparator therapy, (2) supportive evidence based on hard endpoints, (3) trial results including patient sub-groups relevant to G-BA, and (4) negotiations with G-BA once IQWiG’s initial results are published.

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