German Reimbursement Decisions Will Remain Officially Opaque In New Law

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.

There was more bad news for drug firms from Germany Dec. 1, when a new law redefining the relationship between the pharmaceutical industry and the reimbursement authority (G-BA) failed to secure drug firms the degree of influence they have long been seeking. Furthermore, it appeared to endorse, rather than redress, the existing lack of transparency in the G-BA process, according to industry, by granting immunity from external challenges to the auhtority’s decision-makers.

The set-back comes as the G-BA takes on an increasingly influential role in Europe’s largest market. It’s at the center of a new, stringent cost-benefit assessment process (known as AMNOG) that threatens reference pricing for drugs that fail to show compelling additional benefit over existing treatments

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