Market Access
Building robust access strategies, solid health-economic evaluations, and HAS dossiers that withstand scrutiny.
projects delivered
health coalitions created
Who is it for? Pharmaceutical companies, biotechs, and medtechs (medical devices, in vitro diagnostics, e-health solutions) seeking to secure market access and reimbursement for their innovations in France.
The Challenge
In France, obtaining marketing authorization is only the first step: it is reimbursement that determines whether a therapy actually reaches patients. HAS evaluations — ASMR, SMR, health-economic assessments — have become increasingly demanding. The ongoing reform of the evaluation system, new requirements for comparative clinical evidence, and the emergence of advanced therapies (gene therapies, ATMPs) are further complicating the landscape.
At the same time, early access schemes (AAP) open significant opportunities, but require rigorous anticipation of post-listing requirements. Market access teams that do not prepare these dossiers from Phase II onward take a real risk.
Our Approach
We work upstream and throughout the access process, combining regulatory expertise, economic modeling, and a thorough understanding of payer expectations.
Early access strategy. We support the structuring of early access authorization (AAP) dossiers, the identification of priority indications, and the preparation of early dialogues with the HAS. A well-designed AAP strategy is not an end in itself — it is an investment in the definitive reimbursement dossier.
Health-economic evaluations. We build cost-effectiveness and cost-utility models aligned with French standards (HAS methodological guidelines), integrating available data — clinical trials, RWD, registries — and anticipating the questions of health-economic evaluation commission experts.
HAS dossier preparation. We help medical and market access teams structure their listing applications, anticipate objections, and prepare for hearings before the relevant commissions (CT, CEESP). Our knowledge of precedents and HAS expectations significantly strengthens submission quality.
Our Results
Our 7 health coalitions created reflect our ability to bring stakeholders together around shared access challenges. Whether in rare diseases, oncology, or chronic conditions, we have supported teams in securing favorable access conditions for patients who needed them.
Frequently asked questions
Why is a Market Access strategy essential?
A well-defined strategy optimizes the chances of reimbursement and accelerates a product's adoption on the market.
When should market access work begin?
Ideally from the earliest phases of product development, to anticipate the expectations of regulators and payers. An outsourced consultant can support you in this process.
How does an engagement with Digital Pharma Lab start?
We offer a preliminary diagnostic study to analyze your needs and define the best market access strategy together.
