"Fulfilling your objectives in terms of pricing, reimbursement and market access delays for your regulated health products"
Given the complexity and the constraints linked to the constant renewal of market access procedures for which all firms have to deal with, an adaptation and an optimization of their strategy is needed.
-A solid know-how the management of national or European projects: decoding of the key phases, implementation of roadmaps, setting up of working and expertise groups, monitoring of the objectives
-Support and advice throughout the different administrative, regulatory and medico-economic steps of your dossiers, and that for all types of health product (pharmaceutical, biological, medical equipment and devices...)
-An expertise in the building up of the dossiers intended to the authorities and health policy makers (Transparency Commission , CEPS, CNEDiMTS, ...)
A recognized expertise
Some examples of intervention:
- Challenge of the “Market Access” strategy (price/time)
- Optimization of all regulatory phases (product status, new procedures and management: community pharmacies / hospital, double dispensation "fast track", T2A list and / or retrocession, price deposit, ATU / WMA way if necessary)
- Writing or audit and validation of key folders for gaining access to reimbursement: notes on drug therapeutic interest (Transparency Commission), Medical and technical file (CNEDiMTS) and notes of economic interest (CEPS).
- Validation, justification and reinforcement of the argumentation toward the requested price
- Anticipation of commitments with CEPS (early thinking on the types of commitments, modeling their costs and analysis of the trade-off price / time)
- Lobbying and support in the negotiations with the CEPS
- Development of defensive strategies: renegotiation or reregistration phases, threat on price cutting or dereimbursement, reconsideration of the benefit/risk connection...