German Reimbursement Decisions Will Remain Officially Opaque In New Law
This article was originally published in The Pink Sheet Daily
Far from granting industry a greater say in German reimbursement decisions, amended laws appear to endorse their lack of transparency as a new system kicks in.
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Comparator issues have wrecked reimbursement prospects for the second time for Boehringer/Lilly’s diabetes drug Trajenta in Germany as authorities dispute the utility of a study published in The Lancet comparing the product to the sulphonylurea glimepiride.
Germany’s new early-benefit assessment system for all new drugs launched since Jan. 1, 2011, radically changes the status of Europe’s largest market. It was once a bastion of free (and thus relatively high) pricing, which firms used to signal their drugs’ value to other markets. Now, prices of new drugs will be negotiated between sponsors and the country’s association of statutory sick funds, on the basis of an added-benefit score determined by the G-BA, or Federal Joint Committee. Since those net prices will be made public, and many other countries reference German prices, there’s a real risk of a downward price spiral across Europe.
Decisions by Germany’s drug benefit assessor, IQWiG, to recommend novel prostate cancer treatment Zytiga and reject me-too diabetes treatment Trajenta may allay confusion over just how well the country’s new added value assessment process is working