In France, reimbursable in vitro diagnostic tests (IVD) tests should be included in the Nomenclature des Actes de Biologie Médicale (NABM). Each test has a nationally defined cost weight, which can be translated into reimbursement amounts. These tariffs are used mainly to reimburse IVD tests performed in outpatient settings.
Eligibility of IVD tests for reimbursement is reviewed annually. Typically the decision-making process starts with clinical societies’ and/or national clinical councils’ proposal. The creation of the code involves health technology assessment by HAS. The ultimate coverage decision is made by the National Union of Health Insurance Funds (UNCAM). It takes 3 to 5 years to introduce a NABM code. In a recent White Paper, MTRC has analysed three actual HAS assessments - two favourable and one negative - to identify how evaluators interpret evidence and what factors influence reimbursement decisions most.
By dissecting these cases, the White Paper sheds light on the broader evidence requirements and decision-making framework used by HAS, offering diagnostics manufacturers critical insights into the expectations and potential challenges of securing NABM reimbursement.
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