While the introduction of joint clinical assessments under the new EU HTA Regulation could be “fruitful,” the bloc should take a more “integrated approach” to enabling access to ATMPs, according to a Belgian HTA expert.
EU-wide joint clinical assessments (JCAs), a key part of the Health Technology Assessment (HTA) Regulation, will not solve all access problems faced by EU citizens who are eligible for treatment with an advanced therapy medicinal product (ATMP).
This is according to Jo De Cock, former general administrator for the Belgian HTA body RIZIV-INAMI, who spoke during a...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
