HTA Reforms in Germany: Implications for Pharmaceutical Pricing and Reimbursement in Germany and the EU

Problem Statement: Germany approved a cost-containment bill in the final quarter of 2022. We explored the most significant implications for pharmaceutical pricing and reimbursement in Germany following the approval of the cost-containment law and how the new bill interacts with the new European Regulation on HTA.

Description: We interviewed the former chairperson of the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) Drug Price Arbitration Board Juergen Wasem, and reviewed how the new cost-containment law changes the way price negotiations were traditionally done in Germany. By combining these changes with the process of the new European Regulation, we came to a consensus view on the likely interaction between these new developments within the EU landscape.

Lessons Learned: In Germany, the most significant changes affect the guidelines on free pricing period, free set list price, pricing rules per level of benefit, price-volume agreements, pricing for combination products, wastage, and orphan drug appraisal. The three main factors that are considered for pricing are European prices, the price of comparable compounds in Germany, and the believed monetary value of the additional benefit. We believe that the extent to which Germany will comply with the pan-European regulation will largely depend on whether the EU Regulation implementation working groups sufficiently acknowledge the new German practices. As a result, we may either see a future appraisal landscape in Europe much like that in Germany, or a persistent divergence in the way Member States implement the Regulation. The German approach to evaluating drugs may influence the countries with lower healthcare budgets less, as the question of reimbursement and access remains in the hands of the individual Member States. For these Member States, the results of the Pharmaceutical Strategy of the European Commission may be more relevant.

Stakeholder perspective: Industry, government-affiliated stakeholder