Welcome to Justin Stindt Consultants, an international consulting agency offering in-depth insights into the French market’s pricing and reimbursement pathways. For pharma, biotech and medtech companies aiming to penetrate the French market, understanding the intricate Health Technology Assessment (HTA) appraisals by the HAS and the subsequent price negotiations with the CEPS and/or hospitals is essential. Whether it’s prescription drugs, hospital products, medical devices, or e-health solutions, our team of experts provides tailored advice to navigate these complex pathways. From direct purchase by hospitals to the nuances of medical devices in ambulatory settings, our consultants ensure you’re well-equipped for market entry. Trust Justin Stindt Consultants as your dedicated partner in achieving optimal market positioning and access in France.
Deciphering France's Unique Healthcare Market: A Strategic Guide to Drug Reimbursement and Hospital Approval Pathways
Understanding the Dual Pathways of Prescription Drug Approval and Reimbursement in France: Retail and Hospital Use
For prescription drugs, there are 2 overarching pathways: reimbursement in the retail setting (French: “Homologation Assurés Sociaux”) and approval for hospital use (French: “Homologation Collectivité” or also “Agrément aux collectivités”). Inclusion on either of these lists is contingent on Health Technology Assessment (HTA) appraisal by the HAS and positive recommendation for reimbursement.
Hospital Product Pathways: Direct Purchasing, Liste En Sus, and Retrocession Strategies
For hospital products, there are several additional sub-pathways:
- Direct purchase by hospitals / buying groups: this is the default pathway for medicines used in the hospital setting. Price can be set freely by the manufacturer but purchase needs to be negotiated with hospitals / buying groups which can display high price sensitivity given the DRG system and chronic shortage of resources.
- Liste en sus / Reimbursement on top of DRGs: for innovative medicines which are too expensive to be covered by existing DRGs, inscription on the liste en sus will provide extra funding for hospitals and enable them to pass through cost directly to social security. Eligibility criteria include demonstrating a certain level of added value (ASMR) or having a comparator already on the list. Please contact our consulting team for the most up-to-date eligibility criteria and support in accessing the liste en sus.
- Retrocession list: the retrocession list is for drugs dispensed by hospital pharmacies but intended for use by the patient / caregiver at home. Examples would be oral oncology drugs.
Retail Drug Pricing Dynamics: CEPS Negotiations and ASMR Rating Impact in France
For retail drugs, prices need to be negotiated and agreed with the CEPS before reimbursement is granted. The CEPS takes into account the ASMR Rating (from I to V being the lowest). Drugs receiving an ASMR between I and III will benefit from a price premium compared to French comparators, while lower ratings such as ASMR IV and V will not be allowed a premium and in many cases be required to grant rebates. The framework agreement between the CEPS and industry association LEEM (accord cadre) also includes a number of provisions for orphan drugs.Reimbursement Routes for Medical Devices in the French Healthcare System
There are different reimbursement pathways for medical devices and they depend on the conditions of use of the device. In an ambulatory setting, medical devices (MDs) for the use at the patient’s home may be reimbursed through their inclusion in the LPPR following approval by CNEDiMTS. If they are used during a professional procedure, MDs used outside of any context of hospitalisation are not subject to individualised pricing. The procedure is included in the joint classification of medical procedures (CCAM). Medical devices that are used at healthcare organisations are primarily reimbursed through the diagnosis related groups (DRGs). Lab tests are typically included in the TNB.E-Health in France: Insights into Digital Health Solution Reimbursement
In France, a new fast track pathway PECAN (Prise en Charge Anticipée) for one-year reimbursement of digital health solutions was created in 2023. Decree no. 2023-232 of March 30, 2023, introduces the possibility of early reimbursement for two categories of digital medical devices (DMN):- DMNs for therapeutic purposes, ultimately intended for inclusion on the List of Reimbursable Benefits and Products (LPPR);
- Remote medical monitoring DMNs, ultimately intended for registration on the List of Remote Medical Monitoring Activities (LATM).
Justin Stindt ConsultantS agency delivers expert consulting services on pricing & reimbursement pathways In France.
Our agency offers a strategic assessment of the Pricing & Reimbursement pathways for your asset in France. This will include an overview of the available pathways and specific recommendations which pathway would be optimal for your asset.
If you want to determine the price potential of your product, our consulting firm develops Pricing & Reimbursement strategies.
If you have any questions on Pricing & Reimbursement pathways – France and are looking for a vendor for support in identifying the optimal pathways for your asset, please contact one of our experts.
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