Health Technology Assessments (HTAs) in France are a key component of the healthcare system, used to evaluate the clinical efficacy, safety, and cost-effectiveness of new medical technologies, including drugs, devices, and procedures. The HTA process in France is highly structured and involves several key organizations, each with distinct roles and responsibilities.
1. High Authority of Health (Haute Autorité de Santé - HAS)
The High Authority of Health (HAS) is the central body responsible for conducting HTAs in France. Established in 2004, HAS is an independent public authority that oversees the evaluation of healthcare technologies and services. HAS's primary role is to ensure that the French healthcare system delivers high-quality care while remaining financially sustainable.
Within HAS, several departments are directly involved in the HTA process:
- Commission de la Transparence (CT): This Transparency Committee evaluates the clinical efficacy, therapeutic value, and safety of new medicines. The CT assesses the drug's therapeutic benefit, known as "Service Médical Rendu" (SMR), and its added value compared to existing treatments, referred to as "Amélioration du Service Médical Rendu" (ASMR). The outcomes of these assessments influence whether a drug will be reimbursed by the French national health insurance system (Assurance Maladie) and at what rate.
- Commission d'Évaluation Économique et de Santé Publique (CEESP): The CEESP, or Economic and Public Health Evaluation Committee, is responsible for the economic evaluation of new health technologies. This includes cost-effectiveness analysis, budget impact analysis, and the broader public health impact. The CEESP’s evaluations are particularly relevant for determining the price of new drugs and technologies and ensuring they offer good value for money.
2. National Union of Health Insurance Funds (Union Nationale des Caisses d'Assurance Maladie - UNCAM)
UNCAM plays a crucial role in the negotiation of prices and reimbursement levels for new drugs and health technologies following the HTA process. After HAS has assessed the SMR and ASMR, UNCAM negotiates with the manufacturers to determine the reimbursement rates. The reimbursement decisions are based on the HTA outcomes, particularly the ASMR rating, which influences the extent to which a product is reimbursed.
UNCAM's involvement ensures that only technologies that offer significant therapeutic benefits are widely reimbursed by the national health insurance system, balancing innovation with cost control.
3. Economic Committee for Health Products (Comité Économique des Produits de Santé - CEPS)
The Economic Committee for Health Products (CEPS) is responsible for setting the prices of medicines and other health technologies that are reimbursed by the French national health insurance system. After UNCAM and the manufacturer have reached an agreement on reimbursement, CEPS negotiates the final price based on the assessments made by HAS, particularly the ASMR classification and the economic evaluation provided by CEESP.
CEPS aims to strike a balance between ensuring that innovative treatments are accessible to patients and maintaining the financial sustainability of the healthcare system. The final price reflects the therapeutic benefit, cost-effectiveness, and budget impact of the new product.
4. Ministry of Health (Ministère des Solidarités et de la Santé)
The Ministry of Health oversees the entire healthcare system in France, including the HTA process. While the Ministry does not directly conduct HTAs, it sets the overall policy framework and ensures that the HTA process aligns with national health priorities. The Ministry is also responsible for final approval of pricing and reimbursement decisions, based on the recommendations from HAS, UNCAM, and CEPS.
Key Steps in the HTA Process in France:
1. Submission of Dossier:
The process begins when a pharmaceutical company or a medical device manufacturer submits a dossier to the HAS for evaluation. This dossier must include comprehensive data on the clinical efficacy, safety, and economic impact of the health technology. For new drugs, this typically follows the receipt of marketing authorization from the European Medicines Agency (EMA) or ANSM.
2. Clinical Evaluation:
The HAS conducts a clinical evaluation to assess the therapeutic value of the health technology. This is done by the Transparency Committee (Commission de la Transparence), which reviews the clinical data provided in the dossier. The Committee assesses the health technology's Actual Benefit (SMR) and Added Clinical Value (ASMR).
- SMR: This evaluates the overall benefit of the technology, including its efficacy, side effects, and relevance to public health. SMR is graded from "major" to "insufficient."
- ASMR: This assesses the improvement the new technology offers over existing treatments. ASMR is graded from I (major improvement) to V (no improvement).
3. Economic Evaluation:
If the technology is deemed to have an adequate SMR and ASMR, the HAS conducts an economic evaluation through CEESP. This evaluation focuses on the cost-effectiveness of the health technology compared to existing alternatives. The CEESP uses models like cost-utility analysis and budget impact analysis to assess the economic value.
4. Public Consultation and Ethical Consideration:
Before finalizing the assessment, HAS may open a public consultation to gather input from healthcare professionals, patients, and other stakeholders. This phase also includes ethical considerations, especially for technologies with significant societal implications.
5. Final Recommendation:
After completing the clinical and economic evaluations, the Transparency Committee issues a final recommendation regarding the reimbursement status of the technology. For drugs, this recommendation is crucial in determining whether the drug will be included in the list of reimbursable products covered by the French National Health Insurance.
6. Pricing Negotiation:
If the health technology is recommended for reimbursement, the pricing negotiation process begins. The Economic Committee for Health Products (CEPS) negotiates the price with the manufacturer, taking into account the ASMR rating, the results of the economic evaluation, and the expected budget impact.
7. Reimbursement Decision:
Once the price is agreed upon, the technology is included in the reimbursement list. The level of reimbursement by the National Health Insurance varies depending on the SMR rating, with drugs or technologies offering higher SMR generally receiving higher reimbursement rates.
8. Post-Market Surveillance:
Post-market surveillance is conducted to monitor the real-world performance and safety of the health technology. The HAS may request additional data or studies post-launch to confirm the long-term benefits and safety, and to ensure continued reimbursement.
In conclusion, the HTA process in France is rigorous and comprehensive, involving clinical and economic evaluations by the HAS, public and ethical consultations, and negotiations with the CEPS. This process ensures that only health technologies that demonstrate sufficient clinical benefit and economic value are reimbursed by the French healthcare system, contributing to the efficient allocation of healthcare resources while ensuring patient access to effective treatments.