Positive HAS opinion for regular reimbursement of NGS panels in two indications in France

The Repository of Innovative Procedures outside the Nomenclature of Biology and Anatomopathology (RIHN) provides temporary funding for innovative IVD tests until sufficient evidence is available for inclusion in the Nomenclature of Medical Laboratory Procedures (NABM) for regular reimbursement. Tests included in the RIHN are financed outside the statutory health insurance system through the research and innovation budget (MERRI), which forms part of the MIGAC funds distributed by the Ministry of Health. 

With the RIHN reform starting in 2023, a new List of Innovative Procedures Outside the Nomenclature (LAHN) was introduced, combining tests previously funded via RIHN (the List of innovative tests and the Supplementary List of tests no longer considered innovative). The LAHN is now subject to evaluation by the French National Authority for Health (HAS) to “clean up” outdated entries and free resources for truly innovative tests. 

On October 21, 2025, HAS published the evaluations of the targeted next-generation sequencing (NGS) panels in two indications: multiple myeloma and lung cancer. Based on these HTAs, the HAS published favourable opinions on the registration of tests in the NABM for regular reimbursement.

Targeted NGS panel of molecular alterations in the management of multiple myeloma at the time of diagnosis and in case of relapse received sufficient Actual Benefit (SA) and level II of Clinical Added Value (ASA). The test is performed on a bone marrow biopsy.

Targeted NGS gene panel on circulating tumour DNA (ctDNA, also known as liquid biopsy) in locally advanced or metastatic non-small cell lung cancer (NSCLC, stages IIIB, IIIC, and IV) received sufficient SA and ASA level III in the following clinical situations:

• At diagnosis in treatment-naive patients, for the detection of molecular alterations: In cases of therapeutic emergencies, meaning situations involving a short-term life-threatening risk (respiratory distress, superior vena cava syndrome, compressive pericardial effusion, impaired general condition, etc.) or a short-term functional risk (symptomatic or threatening meningeal or cerebral involvement, spinal cord compression, etc.);
• In cases of disease progression under tyrosine kinase inhibitors: In therapeutic emergency situations (as defined above); When tissue analysis is non-contributive; When tissue analysis cannot be performed.

The composition of relevant panels for both indications is also provided in the document.

Based on HAS opinions, the National Union of Health Insurance Funds (UNCAM) will decide on the introduction of the reimbursement and the tariffs for the tests.

See the details in French here (HTA on NGS in multiple myeloma), and here (HAS opinion on NGS in multiple myeloma), and here(HTA on NGS in lung cancer ), and here (HAS opinion on NGS in lung cancer ).

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.