The introduction of a new product on the market needs a whole understanding of legislative aspects, mechanisms of reimbursement and access to the market both at the national and regional levels.
We believe that for the market access of medicines and medical devices to be effective, a multi-step approach is required, where the various phases are tightly interconnected:
MARKET ACCESS STRATEGY
The identification of the strategy for market access begins before obtaining authorization, because we think that the timing in parallel with pricing, are the fundamental components of a successful strategic analysis, which is supported by the involvement of the most suitable stakeholders, represented by the most important professional at both national and regional levels.
PRICING AND REIMBURSEMENT
Once the strategy has been identified, we use our skill in the area of pricing and reimbursement, which consists in a preliminary analysis of competitors, and a differentiated approach in cases of medicines and medical devices.
Thanks to our experience over the years, we have the know-how for the preparation of the pricing and reimbursement dossier (P&R), according to Deliberation CIPE 2001.
Moreover, thanks to a collaboration with a network of professionals, we can carry out:
- Epidemiological studies,
- Ad-hoc pharmacoeconomic analysis, from cost-effect studies to Budget Impact Analyses (BIA),
We support pharmaceutical companies also in the preparation of audits at the AIFA. audizioni presso AIFA.
Our activity does not end with reimbursement at the national level, but we are a partner for market access at the regional level, thanks to our knowledge of reimbursement processes that are in force in the various regions.
REGIONAL ACCESS MANAGER (RAM)
With the aim of meeting the needs of start-ups and new pharmaceutical companies, we propose a professional RAM in outsourcing who represents the conjunction between the company and the region, indispensable to create a solid network of knowledge that can monitor regional needs.
We can manage the reimbursement of medical devices through continuous monitoring of regional tenders, preparing the necessary documentation to present for access to the tender, following the whole process to the end.