European HTAs And Payers On How To Tackle The Evidence Problem
European payers and health technology appraisal organizations have warned that their decision making is being increasingly hampered by evidence gaps. Some solutions may lie in the better use of existing mechanisms, such as scientific advice and managed entry agreements, while others could be introduced through the overhaul of the EU pharmaceutical legislation.
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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.
At a recent webinar payers and health technology appraisal bodies gave further details on what they want included and left out of the European Commission’s overhaul of the EU pharmaceutical legislation. However, speakers voiced some concerns about whether their demands will be met.
European payers have called for fast-track approval pathways and only limited use of conditional approvals in the upcoming reform of the EU’s pharmaceutical legislation. They also want to see data and market protection periods reduced to boost competition.