On July 2, 2024, a significant framework agreement was signed between the Economic Committee for Health Products (Comité Économique des Produits de Santé, CEPS) and various industry organisations, including Snitem, UFAT, Entreprises de la Nutrition Clinique, and AFIDEO. Announced by the Ministry of Labor, Health, and Solidarity (Ministère du Travail, de la Santé et des Solidarités) on July 11, 2024, this agreement establishes a new course for the conventional policy governing the pricing and revising of products included in the List of Products and Services (Liste des Produits et Prestations, LPPR).
This article provides an exhaustive look at how this new agreement impacts different stakeholders, including manufacturers of medical devices, pharmaceutical companies, general practitioners (GPs), proceduralists, and patients. The agreement aims to enhance visibility for economic actors, facilitate tariff negotiations, and ensure fair pricing practices across the healthcare sector in France.
Impact on Medical Devices
Formal Negotiation Setup
The new framework establishes a formal negotiation process between CEPS and medical device manufacturers. This structured approach ensures that all proposals are thoroughly reviewed, and supported by detailed documentation covering production costs, clinical benefits, and market analysis.
Initial Proposal
Submission: Manufacturers submit a comprehensive price proposal, including detailed breakdowns of production costs, research and development (R&D) expenses, and clinical evaluation data.
Review by CEPS: CEPS conducts a meticulous review to verify the accuracy of the data and ensure the proposed price aligns with national healthcare budget constraints. This review includes an assessment of the device’s manufacturing costs, R&D investments, and clinical effectiveness.
Negotiation Meetings
Scheduled Discussions: Multiple rounds of discussions are scheduled between CEPS and the manufacturer to thoroughly cover the proposed price, the clinical benefits of the device, comparisons with existing devices, and the projected patient population that will benefit from the device.
Iterative Process: These meetings are often iterative, with both parties presenting counteroffers and justifications. The goal is to reach a mutually acceptable price point that reflects the device’s value while considering economic constraints.
Agreement Finalization
Draft Agreement: Once a consensus is reached, a draft agreement is prepared. This document outlines the agreed price, specific terms of the agreement, and conditions for ongoing evaluation and adjustments.
Signoff: Both CEPS and the manufacturer review and sign the final agreement, making it legally binding. This step formalizes the negotiated terms and ensures both parties are committed to the agreed pricing structure.
Criteria for Price Setting
The negotiation process for setting prices considers several critical factors to ensure fairness and sustainability:
Production Costs
Manufacturing Expenses: Detailed accounting of all costs involved in producing the medical device, including raw materials, labour, and overhead.
Research and Development: Comprehensive breakdown of costs incurred during the R&D phase, covering clinical trials, regulatory compliance, and postmarked surveillance.
Clinical Evaluations: Expenses related to conducting clinical studies that demonstrate the device’s safety and efficacy.
Therapeutic Benefits
Clinical Efficacy: Robust evidence from clinical trials showing the device’s effectiveness in improving patient health outcomes.
Health Outcomes: Data illustrating how the device positively impacts patient health, quality of life, and potential cost savings for the healthcare system by reducing hospitalizations or other interventions.
Comparative Effectiveness: Analysis comparing the new device with existing alternatives to highlight its superior benefits or innovative features.
Market Competition
Existing Alternatives: Thorough analysis of current market offerings, including pricing and market share of similar devices.
Degree of Innovation: Evaluation of how innovative the device is, such as new functionalities, improved design, or addressing previously unmet medical needs.
Market Dynamics: Projections on market demand, patient population size, and expected market adoption of the new device.
Outcome for Medical Devices
Similar to medical devices, the agreement formalises the negotiation process for medicines:
The agreement ensures that device prices reflect their clinical value while balancing economic constraints. Regular reviews and potential adjustments based on real-world evidence are integral to the framework, ensuring ongoing fairness and relevance. This approach fosters a dynamic and responsive pricing environment that can adapt to new data and market conditions.
Impact on Medicines
Price Negotiations
Initial Proposal
Submission: Pharmaceutical companies submit a detailed price proposal supported by comprehensive clinical data and market analysis.
Review by CEPS: CEPS thoroughly reviews the proposal, considering production costs, therapeutic benefits, and market competition.
Negotiation Meetings
Scheduled Discussions: Discussions cover the proposed price, therapeutic benefits, comparisons with existing treatments, and the projected patient population.
Iterative Process: Multiple negotiation rounds may occur to reach a mutually acceptable price, with both parties presenting counteroffers and justifications.
Agreement Finalization
Draft Agreement: A draft agreement is prepared, outlining the agreed price and specific terms.
Signoff: Both parties review and sign the final agreement, making it legally binding.
Criteria for Price Setting
The price-setting criteria for medicines include:
Production Costs
Detailed breakdown of manufacturing and R&D expenses.
Therapeutic Benefits
Clinical efficacy and health outcomes data.
Comparative effectiveness against existing treatments.
Market Competition
Analysis of existing alternatives and their pricing.
Degree of innovation and market dynamics.
Outcome for Medicines
The agreement ensures fair pricing that reflects the medicine’s value while considering economic constraints. Regular price reviews and adjustments are built into the framework to maintain fairness and relevance over time.
Impact on GPs and Proceduralists
Reimbursement Rates
The agreement impacts reimbursement rates for procedures involving medicines and medical devices:
Fair Compensation
Ensures GPs and proceduralists receive fair compensation for procedures.
Establishes a mechanism for regular review and adjustment of reimbursement rates.
Policy Updates
Provides a framework for updating procedural tariffs in response to new medical practices and technologies.
Involves GPs and proceduralists in the feedback loop to ensure policies remain relevant and effective.
Professional Representation
GPs and proceduralists can participate in the Conventional Policy Monitoring Committee (Comité de Suivi de la Politique Conventionnelle, CSPC) discussions through their associations, influencing policy developments relevant to their practice.
Impact on Patients
Access to Advanced Medical Technologies
Patients benefit from the agreement through improved access to advanced medical devices and innovative treatments:
Sustainable Access
Ensures patients have access to high quality medical devices and medicines without undue financial strain on the healthcare system.
Balances affordability with the economic viability of manufacturers.
Improved Health Outcomes
Access to cutting edge medical technologies and treatments can significantly improve health outcomes and quality of life for patients.
Implementation and Monitoring
Conventional Policy Monitoring Committee (CSPC)
The CSPC will oversee the implementation of the agreement, addressing issues and facilitating ongoing dialogue between CEPS and industry stakeholders. The committee will meet at least twice a year, with the first meeting scheduled for September 2024.
Duration and Reviews
The agreement is applicable for three years from the date of signing (July 2, 2024). Regular reviews and potential adjustments based on new data and market dynamics are integral to the framework, ensuring its continued relevance and effectiveness.
Application Form Changes
The application form for listing on the LPPR (Liste des Produits et Prestations Remboursables) will undergo changes to reflect the new requirements of the agreement. These forms can now be found on the Ministry of Health’s official website and through relevant industry portals.
Conclusion
The new framework agreement represents a significant step forward in the regulation and pricing of medical devices and medicines in France. By establishing a structured and transparent negotiation process, it ensures fair pricing, encourages innovation, and improves patient access to essential medical technologies. Regular reviews and the involvement of various stakeholders, including GPs and proceduralists, ensure that the agreement remains dynamic and responsive to evolving healthcare needs.
References
Ministry of Health’s official website: https://sante.gouv.fr
G_NIUS: https://gnius.esante.gouv.fr