France has a comprehensive and dynamic reimbursement system for in vitro diagnostic tests, which covers a wide range of services, from laboratory tests to genetic tests to companion diagnostic tests. However, obtaining reimbursement for novel diagnostic tests in France can be a complex and lengthy process, involving multiple stakeholders and criteria. In this blog post, we will provide an overview of the reimbursement system for in vitro diagnostic tests in France, and the steps and requirements for applying for the inclusion of a new test in the reimbursement catalogue.
The Reimbursement System for In Vitro Diagnostic Tests in France
The reimbursement system for in vitro diagnostic tests in France is based on three main catalogues, which are updated regularly by the authorities and the health insurance funds, based on the recommendations of the health technology assessment agency and the opinions of the medical biology professionals. These catalogues are:
– The NABM catalogue: This is the official list of medical biology services that are covered by the statutory health insurance in France. It includes codes and tariffs for diverse types of in vitro diagnostic tests, such as laboratory tests, genetic tests, and companion diagnostic tests. The NABM catalogue is funded by the National Health Insurance Fund (CNAM) and the Ministry of Health and represents the majority of the reimbursement for in vitro diagnostic tests in France.
– The RIHN catalogue: This is a list of innovative tests that are not yet included in the NABM catalogue but are considered to have a high potential for improving the diagnosis, the prognosis, or the treatment of diseases. The RIHN catalogue is funded by a separate budget from the Ministry of Health and allows for temporary or conditional reimbursement of innovative tests, for a period of up to three years, during which the manufacturer or the sponsor must provide additional data to support the clinical utility and the economic impact of the test.
– The Supplementary list: This is a list of tests that are under evaluation or awaiting a decision for inclusion in the NABM or the RIHN catalogue. The Supplementary list is also funded by a separate budget from the Ministry of Health and allows for provisional reimbursement of tests that are not yet included in the other catalogues, for a period of up to one year, during which the manufacturer or the sponsor must submit a dossier to the health technology assessment agency for the assessment of the test.
The Application Process for the Inclusion of a New Test in the NABM Catalogue
The application process for the inclusion of a new test in the NABM catalogue is the most common and the most rigorous pathway for obtaining reimbursement for novel diagnostic tests in France. The process involves the following steps and requirements:
– The test must have a CE mark and comply with the European regulations on in vitro diagnostic medical devices.
– The test must have a clear and relevant intended use and target population.
– The test must have a sufficient level of evidence to demonstrate its analytical and clinical validity and utility.
– The test must have a favourable cost-effectiveness ratio and budget impact compared to the existing alternatives.
– The test must have a potential impact on the organisation and quality of care, the patient outcomes, and the public health objectives.
– The test must address an unmet medical need, a diagnostic uncertainty, or a clinical practice gap.
– The manufacturer or the sponsor must submit a dossier to the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) of the National Authority for Health (HAS), which is responsible for assessing the clinical utility, the technical performance, and the economic impact of the test.
The CNEDiMTS then issues a recommendation to the National Union of Health Insurance Funds (UNCAM) and the Ministry of Health, which decide whether to include the test in the NABM catalogue and at what tariff.
– The application dossier must follow the guidelines and the template provided by the HAS. The dossier must include a summary and identification of the application (part 1), a medico-technical dossier (part 2), and an economic dossier (part 3). The medico-technical dossier must demonstrate the clinical utility, the technical performance, and the impact on the organization and quality of care of the test. The economic dossier must provide a cost-effectiveness analysis and a budget impact analysis of the test.
– The application process can take up to 18 months, depending on the complexity and the quality of the dossier. The CNEDiMTS meets every month to examine the applications and issue recommendations. The UNCAM and the Ministry of Health then negotiate the tariff and the conditions of reimbursement, which are published in the Official Journal of the French Republic.
Conclusion
Obtaining reimbursement for novel diagnostic tests in France can be a challenging and time-consuming process, but also a rewarding one, as it can open up new opportunities for innovation and improvement in the field of in vitro diagnostics. The reimbursement system for in vitro diagnostic tests in France is based on three main catalogues, which are updated regularly by the authorities and the health insurance funds, based on the recommendations of the health technology assessment agency and the opinions of the medical biology professionals.
The application process for the inclusion of a new test in the NABM catalogue is the most common and the most rigorous pathway for obtaining reimbursement for novel diagnostic tests in France, and it involves multiple steps and requirements, such as the CE mark, the intended use, the level of evidence, the cost-effectiveness, the budget impact, and the public health impact of the test. The manufacturer or the sponsor must submit a dossier to the CNEDiMTS of the HAS, which then issues a recommendation to the UNCAM and the Ministry of Health, which decide whether to include the test in the NABM catalogue and at what tariff. The application process can take up to 18 months, depending on the complexity and the quality of the dossier.