When developing a medicinal product, two milestones are of importance for making its path to the market: the granting of a marketing authorization from regulatory agencies and the proof of the medicinal product’s usefulness to the healthcare system. The EMA/HTA SA represents an opportunity for the applicant to obtain preliminary feedback and anticipate potential hurdles from both regulatory and market access stakeholders.
HTA Parallel Scientific Advice
A Parallel Scientific Advice (EMA/HTA SA) is a pilot project including the EMA and selected national Health Technology Assessment bodies allowing the applicant to obtain a joint advise on its development plan and price and reimbursement strategy.
HTA Parallel Scientific Advice in the European Union
As the first step to market access, a new medicine requires a marketing authorisation from a medicines regulatory agency. The second step prior to enabling patient access to a new therapeutic option increasingly involves the assessment of its usefulness to the healthcare system that lies with a payer or healthcare-guidance organisation, and the Health Technology Assessment Bodies (HTABs) that advise them.
Since 2010, the EMA has put in place a pilot project of Parallel Scientific Advice (EMA/HTA SA) with the participation of 13 of the HTA bodies that allows developers to receive simultaneous feedback from both regulators and national HTA bodies on their development plans for new medicines. Responsibilities and roles of each stakeholder are defined as follow:
- The EMA provides advices based on the evaluation of efficacy and safety in the context of clinical trials and is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products, including the provision of scientific advice for regulatory ends.
- The national HTA bodies provide advice on the relative efficacy and cost-effectiveness of the new medicinal entity, assessed against all available sources of comparative evidence. They operate at a local or national level under specific local or national rules.