MARKET UPTAKE OF PHARMACEUTICAL INNOVATIONS IN GERMANY - REGULATORY APPROACHES AND ITS CONSEQUENCES

Author(s)

Witte J, Greiner W
School of Public Health, Bielefeld University, Bielefeld, Germany

OBJECTIVES: Regulation of new pharmaceuticals in Germany is characterized by an early benefit assessment process and free pricing within one year after formal approval followed by price negotiations. Both is relevant for market uptake analysis, as there is no direct prescription or reimbursement regulation based on assessment results. Since introduction of the Pharmaceutical Market Restructuring Act in 2011, over 200 benefit assessment procedures have been concluded. Yet, the impact of the results on prescription behavior remains unknown. METHODS: Based on prescription data from a large German sickness fund we examined to what extend the market uptake of pharmaceutical innovations increase in relation to the amount of additional benefit within twelve months after assessment results were published by the Federal Joint Committee (FJC). RESULTS: Our findings indicate that there is no correlation of the amount of additional benefit and likelihood of prescription. Mean overall market uptake one year after FJC-decision is 12.4%. Products with a large benefit (“considerable”) feature a slightly smaller adjusted uptake-rate (14.2%) than those with no approved benefit (14.7%). Medicines with a “minor” benefit show an uptake-rate of 12.6%, whereas those whose benefit is “not quantifiable” show the lowest with 9.8%. For market volume adjusted and unadjusted rates will be presented. Recent examples for interacting factors that might affect the likelihood of early adoption will be discussed. CONCLUSIONS: As prices remain free in the first year of market appearance in Germany, health insurers claimed need for regulation as especially new hepatitis therapies rapidly gained market volume and were responsible for an exceeding increase in expenditures. Results of the pharmaceutical dialogue event indicate, that prospectively a revenue caps could be introduced instead of shortening the timeframe of free pricing. Simulation results on the impact of a revenue cap will be presented to estimate potential coverage of this regulatory approach.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP58

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Prescribing Behavior, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Multiple Diseases

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