PHP21 - 2.5 YEARS OF AMNOG IN GERMANY – AN ANALYSIS OF BENEFIT ASSESSMENT AND NET PRICE NEGOTIATION TRENDS

Abstract

In 2011, the AMNOG law changed the price-setting procedure for drugs in Germany. Manufacturers are now required to submit a dossier to the Federal Joint Committee (GBA) for newly launched or, upon specific request, already market products. The GBA decides on the level of additional benefit which impacts the reimbursement price negotiations with German sick funds. The objectives of this study were thus to: 1) identify ways in which manufacturers can optimize the benefit assessment outcomes, 2) analyze correlations between additional benefit, budget impact and negotiated rebate. To achieve objective 1, assessments by the GBA and the IQWiG (Institute for Quality and Efficiency in Healthcare) (source: GBA website) were scanned for key trends. To achieve objective 2, list and post-negotiation prices were extracted from the Lauer-Taxe (German price database). For the 10 agents that had so far completed price negotiations, these were mapped against additional benefit and the budget impact (annual therapy costs as stated in GBA assessment). The results linked to objective 1, which were more qualitative in nature, allowed for the extraction of 5 key learnings for manufacturers to keep in mind. The results associated with objective 2 showed no link between additional benefits granted and negotiated rebate but did reveal price impacting parameters apart from budget impact. Concerning objective 1, the ways in which manufacturers can attempt to optimize benefit outcomes include: 1. Focus on comparator choice, 2. Focus on hard endpoints, 3. Make patient segmentation more solid, 4. Expect independent action of GBA and IQWiG and 5. Accept that there is no methodological standard for the definition of an additional benefit. Regarding objective 2, we concluded that budget impact, influenced primarily by target population size, annual therapy costs and drug price, is an – if not the most important driver in the negotiation.