PHP203 How to Optimise Chances for Successful AMNOG Assessments – Best Practice Approach for German Market Access

Abstract

Since the introduction of AMNOG in January 2011, manufacturers in Germany are required to submit a “benefit dossier” and show additional benefit in relation to a so-called appropriate comparative therapy to the Federal Joint Committee for every NCE in order to gain access to price negotiations. If an additional benefit is shown, the new reimbursed price will be a surplus on the reimbursed comparator price. Market access in Germany changed significantly due to AMNOG and requires early preparation, an interdisciplinary approach and clearly defined internal processes. Market access strategies and processes have to be reviewed in light of the new framework and adapted in order to optimize the chance to be successful in the AMNOG process. Preparation for AMNOG should start as early as in the planning of clinical studies to implement the right questions into the study and not to rely on surrogate drivers. The FJC will respond best to data providing the most credible scientific clinical evidence. Building RCTs powered to capture such information does present important issues for pharmaceutical companies to address. Early planning of clinical studies should be part of an early strategy development for the NCE that can be informed by early phase modeling of the likely outcome of the benefit assessment. Early identification of the patient groups that are most likely to benefit is vital in order to plan for patient (sub-) populations big enough to achieve statistical significant results and positive outcomes in the AMNOG process. An interdisciplinary approach is required at a stage in the product development where there are no common processes and communication paths established between headquarter and affiliates. A best practice approach requires a well defined process including road maps and checklists per stage of product development in form of standard operating procedures in order to optimize market access.