We assess pricing potential and market size through market research. This market access research helps anticipate how health authorities are likely to assess a medicine, medical device or diagnostic test. It leads to the definition of a pricing corridor: a realistic price range determined by the product’s relative clinical value as perceived by health authorities, together with the other pricing factors specific to each healthcare system. We also assess market size to optimise peak sales potential.
Pricing and Volume Strategy
Market Research: The First Step in Any Market Access Strategy
Through market research drawing on secondary sources (medical literature, clinical guidelines, reimbursement databases, etc.) and primary research (in-depth qualitative interviews with clinical key opinion leaders and payers), we establish the key parameters of your reimbursement strategy:
- The selection of clinically and/or economically relevant comparators;
- The product’s clinical positioning within the treatment pathway, relative to existing therapeutic alternatives;
- The size of the target population eligible for reimbursement;
- The public health and organisational impact;
- Reimbursement conditions already granted to comparable products and the expected incremental clinical benefit (ASMR/ASA);
- Potential barriers identified by health authorities in previous assessments.
Clinical Evidence Assessment and Anticipation of ASMR/ASA Ratings
In France, the relevance of clinical evidence is assessed to determine the strength of the clinical value proposition. The choice of clinically relevant comparator, target population and treatment strategy helps anticipate:
- The level of Improvement in Actual Clinical Benefit (ASMR) for medicines, assessed by the Transparency Committee;
- The level of Improvement in Expected Clinical Benefit (ASA) for medical devices, assessed by the CNEDiMTS.
The level of improvement directly influences the subsequent price or reimbursement tariff negotiation strategy with the CEPS.
Recommendations and Roadmap
Clear recommendations provide the basis for a roadmap setting out all the activities and resources required in France to prepare your reimbursement application. This includes a timetable for each activity, additional evidence and tools to be developed, pricing scenarios and a negotiation plan.
Access to a Panel of Clinical Experts and Payers
Access to a panel of medical experts (clinical key opinion leaders) and economic stakeholders (payers and health technology assessors) enables us to anticipate healthcare system requirements for the reimbursement of your product, whether it is a medicine, medical device or in vitro diagnostic. Potential barriers to market access and, ultimately, prescribing are identified and addressed at an early stage.
Frequently Asked Questions
What is a pricing corridor in healthcare market access?
A pricing corridor is the realistic net price range for a healthcare product, generally determined by national and international price comparators and the product’s clinical and economic value proposition. It is established through market research and provides a framework for negotiations with health authorities.
What are ASMR and ASA?
In France, ASMR (Improvement in Actual Clinical Benefit) is assigned to medicines by the Transparency Committee of the HAS. ASA (Improvement in Expected Clinical Benefit) is the equivalent assessment for medical devices, conducted by the CNEDiMTS. These ratings, ranging from I to V, reflect the level of incremental clinical benefit compared with a relevant comparator and help guide pricing decisions. They are key components of the reimbursement dossier and must be estimated as reliably as possible to support the development of a pricing corridor. This assessment is informed by targeted market research focusing on the determinants of price, including the anticipated ASMR or ASA rating.
When should market access research be conducted?
Ideally, before submitting the regulatory dossier, as soon as the first pivotal clinical data become available. This allows the clinical strategy and choice of comparators to be refined before they are finalised.
Is the pricing corridor guaranteed by the CEPS?
No. It is a strategic estimate developed in advance by the manufacturer to guide negotiations. The final price is determined by agreement with, or decision of, the CEPS following the assessment and negotiation process.