Direction Of Travel Of EU HTA Regulation Is ‘Disappointing’ For Advanced Therapies

Without further work, the EU-wide joint clinical assessments introduced by the EU regulation on health technology assessments will fail to meet the needs of advanced therapies, warns the Alliance for Regenerative Medicine.

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ATMPs "rowing upstream" against traditional HTA models • Source: Shutterstock

The methods being developed to underpin the joint clinical assessments introduced by the EU Health Technology Assessment (HTA) Regulation are so far disappointing and do not address the specifics of advanced therapies, according to Stephen Majors, director of public affairs at the Alliance for Regenerative Medicine.

ARM is calling for ongoing dialog between the European Commission, the EU member states and industry to ensure that a suitable system that incorporates better methods for indirect comparisons and real-world evidence (RWE) is developed

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