Possible cooperation between regulatory authorities and non-profit medical insurance providers
Recently there has been the first meeting between the European Medicines Agency (EMA) and European Union (EU) healthcare payers. It took place at EMA’s offices in London on the 19th September 2017. These organizations met with the aim of discussing the ways of improving their cooperation in order to facilitate sustainable patients’ access to new medicinal products. This meeting was supposed to be complementary to EMA’s current cooperation with health technology assessment (HTA) bodies and especially with EUnetHTA.
Members of EMA, Association Internationale de la Mutualité, an association of mutuals and other non-profit medical insurance providers, European Social Insurance Platform, Medicine Evaluation Committee and the multi-stakeholder platform Mechanism of Coordinated Access to Orphan Medicinal Products have gathered to discuss how their collaboration may influence the access to medicines for EU citizens.
Before patients will get new medicines, some sequential processes should take place. Firstly, drug developers must receive a marketing authorization. Regulatory authorities such as EMA evaluate the benefits and potential risks of a medicine. The second step is taking pricing and reimbursement decisions by healthcare payers at the national and regional level. HTA bodies also contribute to this process. These organizations take into consideration following factors: therapeutic value, how the medicine will influence healthcare budgets, the seriousness of the disease, existing alternative treatments and other factors.
However, a delay in the second step sometimes happens due to the fact that drug developers are mostly focused on showing the safety, efficacy and quality of their new medicine for regulatory authorities but do not provide enough data for cost-effectiveness evaluation and pricing and reimbursement decisions. Therefore, they should conduct more research at this stage.
EMA believes that effective collaboration between regulatory authorities and non-profit medical insurance providers is a significant approach to address these challenges.