How Broad Labels May Make Market Access In Germany More Difficult
Companies might have to rethink their German market access strategies if new legislation is passed to informs doctors of the outcome of AMNOG benefit assessments.
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New updates to Germany’s 2011 AMNOG healthcare reform act could lead to more conservative prescribing and benefit assessments for older products. Pricing measures were dropped but will likely resurface after September’s general elections.
Plans to make pharmaceutical prices in Germany confidential are likely to be shelved, but other measures could help companies better navigate price transparency.
The advanced therapies sector is undergoing something of an industrial revolution, but access issues for products coming to market remain, says Miguel Forte, CEO of Bone Therapeutics. However, there are opportunities to create a better environment for the sector, including regulatory change and more harmonization of HTA processes.