Pricing and Reimbursement Dossiers France: Welcome to Justin Stindt Consultants, a global consulting agency specializing in Transparency Commission and CEPS dossiers. Differentiating a medicine in France is pivotal to optimize pricing and reimbursement. Our agency is adept at navigating the complexities of French pricing and reimbursement decisions, which are rooted in clinical evaluations and price negotiations. With an international team of experts, we provide comprehensive support in dossier submissions to the Transparency Commission (CT) of the French National Authority for Health (HAS). Our team of experts ensures that each submission resonates with payers, emphasizing the added value of the product in an evidence-based manner. Trust Justin Stindt Consultants as your dedicated partner in achieving optimal market positioning and access in France.
Transparency Commission and CEPS Dossiers in the French Market Access Landscape
Differentiating a medicine from its competitors is crucial in France in order to maximise pricing and reimbursement. French pricing and reimbursement (P&R) decisions are two-fold, based on a clinical evaluation and price negotiations. The Transparency Commission (TC) appraises the clinical benefit of all drugs, the Commission d’évaluation économique et de santé publique (CEESP) appraises the cost-effectiveness of certain drugs, and retail drugs and hospitals drugs eligible for extra funding have to agree on a price with the Economic Committee for Health Products (CEPS).
In order to register or maintain the registration of a drug on the lists of reimbursable specialties provided for in articles L. 162-17 of the Social Security Code and L. 5123-2 of the Public Health Code (known as the “liste ville” and “liste collectivités”) a dossier submission to the Transparency Commission (CT) of the French National Authority for Health (Haute Autorité de Santé (HAS)) is required. This dossier is also referred to as Note d’intérêt thérapeutique or NIT.
The medicine’s reimbursement potential is dependent upon the service médical rendu (SMR) rating as assessed by the HAS’ TC. The TC’s role in the P&R procedure is fundamental even after the clinical assessment concludes, given that the amélioration du service médical rendu (ASMR) rating provided by the TC is referred to during price negotiations with pharma, biotech or MedTech firms.
The dossier submitted to the TC must comply with the outline provided by the HAS which our agency has on file both in French and an English translation. Even more so, it is critical to summarize the added value of the product compared to the relevant comparators in an evidence-based and payer-resonating manner. Based on a thorough understanding of the clinical evidence and Health Economics and Outcomes Research (HEOR) methods, our team of experts has helped many clients to write robust and compelling dossiers and successfully drive them through the Health Technology Appraisal (HTA) process with the HAS.
In addition to the NIT, companies also have to submit a pricing dossier to the CEPS, also called the note d’intérêt économique (NIE). It has to include essential information such as the price requested and a sales forecast for the French market.
Our agency has been selected by many pharma, biotech and medtech companies as service provider of choice to write the French P&R dossiers NIT and NIE. Our company leverages French native speakers with extensive experience both in the industry and consulting agencies and a successful track record of P&R dossiers leading to sustainable Pricing & Reimbursement in France.
The pricing & reimbursement submission for medical devices and eHealth products is formed by 3 parts:
- summary and identification of request
- medico-technical dossier
- economic dossier
While the complete dossier (parts 1, 2 and 3) has to be submitted to the CEPS, only parts 1 and 2 have to the be submitted to the CNEDiMTS. The submission to CNEDiMTS has to be done electronically via the SESAME platform. Digital early support or List of medical remote monitoring activities submissions have to be done via the EVATECH platform.
Companies claiming ASA (Amélioration du Service Attendu – expected service improvement) I, II, or III with a significant impact on health insurance expenditure should also submit a dossier to the Commission d’évaluation économique et de santé publique (CEESP). Contact our firm for more information on the submission process, documents, and timings.
Navigating France's Healthcare Market with Justin Stindt Consultants: Expertise in Pricing & Reimbursement Dossiers
Our commitment as a leading consulting agency lies in delivering Health Technology Assessment (HTA) submissions that excel in written excellence, technical precision, and the art of weaving clear, captivating narratives. Our goal is to ensure that each submission forms a cohesive, integrated, evidence-based story, moving away from a mere assortment of distinct clinical and health-economic elements typically found in an evidence package.
At JSC, we are experts in supporting the preparation of pricing and reimbursement dossiers for the French market. Our services include (not limited to):
- Comprehensive project planning with clear timelines and milestones
- Strategic review of drug positioning
- Dossier writing, both French original and English translations
- Dossier validation with Key Opinion Leaders and ex-members of the TC, CEESP ans CEPS
- Submission process guidance and support
- Hearing preparation and support
- Strategic advice and participation in price negotiations
- Effective project management and communication throughout the process
At Justin Stindt Consultants, our team of experts has extensive experience in providing our clients with tailored support to provide French patients access as soon as possible at sustainable pricing and reimbursement conditions. If you are looking for a vendor to support your French Pricing & Reimbursement dossiers NIT and NIE, select a service provider that will go the extra mile to enable HTA endorsement and sustainable pricing for your product.
Contact us today to learn how our consulting agency can tailor our services to meet your unique needs and make your pricing & reimbursement goals a reality.
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