Market Access for Healthcare Products

For over 15 years, we have supported pharmaceutical, medical device and in vitro diagnostic manufacturers in developing their pricing and reimbursement strategies in France and across Europe. Our expertise covers therapeutic areas including oncology and rare diseases.

In France, we prepare pricing and reimbursement dossiers, taking into account the requirements of health technology assessment bodies and payers. This includes applications for inclusion on reimbursement lists for patients covered by statutory health insurance (“Assurés Sociaux“) and/or for use in healthcare institutions (“Agrément Collectivités“), as well as the LPPR, RIHN and NABM pathways for other healthcare products.

Across Europe, we work in collaboration with expert consultants for each category of healthcare product to establish pricing corridors and local market access strategies.

Starting with the development of a price-driven strategy, we cover every stage of the market access process, from preparing reimbursement submissions to negotiating prices. We are therefore involved throughout the entire market access journey in France.

Integrated Market Access

Market Research and Strategic Analysis

We conduct market research and strategic analyses to identify the most effective market access options in France and across Europe.

Before clinical development begins, we assess the pricing and reimbursement potential of healthcare innovations, including as part of due diligence assessments. We provide recommendations on clinical trial design to meet the expectations of health technology assessment bodies and payers.

Our recommendations help anticipate regulatory and payer expectations, potential barriers and reimbursement conditions.

Preparation of Reimbursement Dossiers

For France, we prepare clinical (HAS) and economic (CEPS) dossiers in line with the requirements of the HAS, CEPS and other healthcare stakeholders.

We deliver comprehensive, submission-ready dossiers for the relevant health authorities. Combining strategic analysis with meticulous attention to detail, we draft the key sections of each dossier and incorporate the required technical evidence, including literature reviews, critical appraisal of clinical data and budget impact modelling.

Our objective is to communicate the value of your product effectively and secure the best possible pricing and reimbursement conditions, while delivering dossiers within agreed deadlines.

HTA Hearings and Price Negotiations

We support you in preparing for hearings and negotiations with healthcare decision-makers.

Our strategic perspective enables us to identify the key priorities for hearings with the HAS. Through a targeted approach, we help you anticipate potential objections from health technology assessors, demonstrate your product’s clinical value and maximise the prospects of a favourable assessment ahead of price negotiations.

Ahead of price negotiations with the CEPS, we anticipate potential objections and plan each stage by developing negotiation scenarios. Our experience of more than 20 price negotiations enables us to anticipate the committee’s likely response to each successive pricing proposal.

Market Access

Secure recognition of your product’s clinical value and an appropriate reimbursed price in the French market, while anticipating market access requirements across Europe to develop a coherent international pricing strategy.

Yves Cariou – Senior Market Access Expertise

Yves Cariou (PharmD, MSc) brings over 15 years of experience in market access for innovative healthcare products.

Having worked on more than 200 pricing and reimbursement projects across Europe, Yves has developed extensive, in-depth expertise in clinical and economic assessment in the major EU markets.

He draws on a broad network of key opinion leaders (KOLs) and payers across Europe, particularly in France, as well as his expertise in market research methodologies (qualitative interviews with key opinion leaders, advisory boards, etc.), to develop market access strategies, tactical plans, value propositions and pricing assessments.

Yves also has comprehensive experience of the French healthcare product reimbursement system.

He has prepared pricing and reimbursement dossiers for products in oncology, infectious diseases and rare diseases. He has successfully managed the entire market access process, from dossier preparation through to price negotiations with the relevant health authorities and publication in the French Official Journal, for both medicines and medical devices.

Yves is a member of the jury for the French National Research Agency’s RHU translational research funding programme. He is fluent in French, English and Italian and is based in Brussels.