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