If you think there is a possibility that the medical device you are about to put on the market in France might gain eligibility for reimbursement by the state health insurance, the application process will require that you undertake a medico-economic study. This is a step that calls for preparation.
Why and when to do a medico-economic study?
In view of their value in evaluating the usefulness of the device under typical conditions and in assessing its efficacy in comparison to other available propositions, medico-economic studies have a particular pertinence for the launch of MDs. Indeed, it is for this reason that in France they are an essential prerequisite for the obtention of patient refund eligibility.
Applications for eligibility are submitted after obtention of the CE mark, from two bodies: the “Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) of the Haute autorité de santé” (HAS), which, among other aspects, assesses the clinical interest of the new device, and the Comité Économique des Produits de Santé, which is responsible for setting the refund rate with producers.
A step that requires preparation ahead of the clinical evaluation
Applications for reimbursement eligibility should give advance consideration to the conditions under which it might eventually be covered by the state health insurance system (i.e., be eligible for patient reimbursement). Such consideration should ideally precede the start of the clinical evaluation.
This is why project assistance from KYomed INNOV is such an asset: “We carry out these medico-economic studies in collaboration with our partners. As part of our overall approach, we encourage our clients to think ahead so that their clinical evaluation takes into account the criteria required for the medico-economic component“, explains the head of the Clinical Evaluation of Innovative Devices department.