DOES THE LEGAL REGULATION OF PROMOTING PHARMACEUTICAL PARALLEL IMPORTS HELPS TO CREATE SAVINGS FOR THE STATUTORY HEALTH INSURANCE (GKV) IN GERMANY?

Author(s)

Leisten M, Brakmann D, Münchberg F, Wiberny S
Janssen-Cilag GmbH, Neuss, Germany

OBJECTIVES: In Germany parallel imports does not only exist due to economic reasons like arbitrage principle, but due to special legislative support. According to law, pharmacies have to fulfil a predetermined import quota to achieve a certain efficiency reserve which should help generating higher savings for the statutory health insurance. Prices of imports are only cost efficient if they are fulfilling a minimum price difference which is 15% or 15 Euro below the prices of originals. The objective is to determine whether imports are price efficient and if they obtain the legally implemented savings. METHODS: This analysis evaluates data from IMS-Database which covers all redeemed GKV receipts. Imports were identified by pharmacy number (PZN). Afterwards they were ordered by Anatomical Therapeutic Chemical (ATC)-Coding and listed separately for GKV-sales and market share. Market share was identified by units sold, sales on basis of manufactures price. Prices were taken from a public price list (Lauer-Taxe). For overall savings publicized data were used (Arzneimittel-Atlas). Evaluation period was 2013. RESULTS: Imports are focussing on special therapeutics, mainly covering Neurologics (ATC1 “N”) and Immunsuppressiva (ATC1 “L”). Both indications received a market share of 38.7% with sales of 2.5 bio. euro. By looking at the top 5 imports with highest sales cost efficient prices according to legal rule are only apparent in 3 of 5 cases (absolute rating) and 1 of 5 cases (relative rating). In general, prices of imports are oriented to prices of originals and sometimes even excess them. Annual savings are 63.5 mio. euro. CONCLUSIONS: Imports are focussing on special therapeutic areas which mainly lead to high margins for importers. Prices are not efficiently according to legal rule so that the expected savings does not result. Therefore the existing regulation of import quota should be disestablished. Imports should regulate themselves by the competition of the market but without additional support by legislation.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP88

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Multiple Diseases

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