CAPABILITIES
Market Access
Solving challenges through unrivaled expertise combining strategic mindsets with strong technical capabilities
- Early Access
- HTA ASSESSMENT
- PRICING AND MARKET ACCESS STRATEGY
- PRICING NEGOTIATION
- EARLY DIALOGUE
- SAFEGUARD CONTRIBUTION
Early access
France offers several early access pathways that enable patients to benefit from innovative treatments before full pricing and reimbursement decisions are made — including compassionate use programs, early access authorizations, and direct access. Each of these mechanisms has distinct eligibility criteria, timelines, and strategic considerations.
We help you accelerate patient access to your innovation while managing regulatory complexity and strategic risk.
Strategic assistance
We support you in evaluating the opportunity of leveraging one of these mechanisms by conducting in-depth situation analysis and competitive benchmarking, identifying key challenges & opportunities, defining optimal product positioning and developing a tailored roadmap for early access success
Operational support
We assist with the preparation of pre-submission meetings with the authorities (ANSM, HAS), the development of robust early access dossiers and the facilitation of advisory boards to strenghten the clinical narrative and value proposition of your product
HTA Assessment
The HTA assessment plays a central role in determining market access conditions. Successfully navigating this process requires robust clinical evidence, strategic positioning, and a clear understanding of HAS expectations.
We support you at every stage of the HTA evaluation to maximize the likelihood of a favourable outcome.
Strategic assistance
We help you define the HTA potential of your product through in-depth clinical data analysis, KOL interviews and benchmarking with relevant analogues
Operational support
We deliver hands-on assistance with the development of high-quality HAS dossiers, facilitate advisory boards to refine your product narrative, and offer coaching and guidance in preparation for HAS hearings
Pricing and market access strategy
Defining an effective pricing and market access strategy is a critical step to secure successful entry into the French market. A clear understanding of your product’s price potential is essential to build a viable access pathway – from early access to reimbursement. Aligning pricing objectives with HTA potential, payer expectations, and market dynamics significantly increases the chances of success.
We support you in developing and executing a robust market access strategy tailored to your product’s profile.
Strategic assistance
We guide you in defining your optimal pricing strategy by assessing achievable price conditions (list / net) based on expected HTA outcomes, market environment, and relevant comparator benchmarks
Operational support
We provide hands-on support for the preparation of a robust CEPS dossier, identify relevant economic analogues to strenghten your price justification, and develop tailored Excel models to simulate and compare different pricing agreement scenarios – including potential paybacks (early access)
Pricing negotiation
Pricing negotiation is a critical milestone that directly impacts your commercial success in the French market. To navigate it successfully, it is essential to balance your internal business objectives with the expectations and constraints of the CEPS. The negotiation landscape is constantly evolving – shaped by changing policies, shifting priorities, and updated pricing rules – making strategic preparation more critical than ever.
We assist and guide you throughout the entire pricing negotiation process to help you achieve results that align with your business goals.
Strategic support
We assit you in adapting your pricing strategy to the negotiation context, and offer strategic training and coaching to ensure your team is fully prepared for every stage of the process
Operational support
We supply day-to-day guidance throughout the negotiation, facilitate debrief meetings after each round to refine messaging and strategy, and develop written counter-proposals.
Early dialogue
Early Dialogues with the HAS are a key opportunity for pharmaceutical companies to engage with French health authorities at an early stage of development. These meetings aim to provide recommendations on pivotal study desing and support the generation of evidence that meets HTA standards. Leveraging Early Dialogues can significantly strenghten your product’s future positioning and reduce the risk of HTA misalignment during the HTA assessment.
We help you request and prepare for Early Dialogues with the HAS, ensuring your clinical development plan is aligned with their expectations.
Strategic support
We conduct a comprehensive situation analysis of your current data package, clinical development plan and draft pivotal study protocol to identify key questions that should be addressed during the Early Dialogue
Operational support
We assist with the development of the briefing document and support the preparation of clear responses to clarification requests from HAS
Safeguard contribution
The Safeguard Contribution is a financial mechanism designed to control national pharmaceutical expenditure in France. Regularly revised, it has become a major budgetary tool – making it essential for companies to anticipate its financial impact.
We support you in understanding the mechanism and forecasting your company’s contribution.
Strategic support
We provide ongoing insights and strategic discussions with your teams on the core principles and current – as well as anticipated – developments of the Safeguard Contribution – highlighting critical points of attention
Operational support
We model and estimate the overall safeguard contribution, and forecast the expected financial impact for your company