IMPACT OF 2011 GERMAN HEALTH CARE REFORM ON GLOBAL MARKET ACCESS STRATEGIES
Author(s)
Honoré AC1, Marinoni G2, Ando G21IHS, Zurich, Switzerland, 2IHS, London, United Kingdom
OBJECTIVES: This study seeks to evaluate the impact of the 2011 German healthcare reform (AMNOG) on the global pricing and reimbursement landscape and its influence, if any, on global market access strategies. METHODS: Key local regulators were interviewed to understand the scope and mechanism of the mandatory early benefit assessment as well as its implications in terms of pricing and market access on a national and global level. Primary research consisted of in-depth phone interviews with six regulatory stakeholders and industry representatives in Germany. Secondary research was based on data from national and regional healthcare authorities, national statistics offices and IHS Global Insight Healthcare and Pharmaceutical services. RESULTS: AMNOG has put an end to free pricing in Germany by correlating price to added therapeutic benefit scores and opening the reference pricing system to all patented medicines. The total transparency of the early benefit assessment and pricing processes can influence prices not only in Europe but also worldwide. The availability of results from the Federal Joint Committee (G-BA)’s benefit assessment can affect the pricing and reimbursement status of pharmaceuticals worldwide, while international reference pricing can put downward pressure on prices in at least 22 other countries. CONCLUSIONS: The German reform will have an impact beyond the country’s borders. Germany has traditionally been an early pharmaceutical launch market but the end of free pricing and the prospect of lower price levels for products of no and minor-to-moderate added value may require a complete reconsideration of the optimal launch sequence. While AMNOG has revolutionized the pricing and reimbursement landscape in Germany, from a global perspective, the reform is not particularly innovative. Germany’s new pricing process is comparable to the French model whereby perceived degree of innovation directly impacts medicine prices, and comes near to the Swiss and Austrian models.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PHP33
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases