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 started in 2023, a new List of Innovative Procedures Outside the Nomenclature (LAHN) was introduced, combining tests previously funded via RIHN (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 The LAHN is now subject to evaluation by the French National Authority for Health (HAS) to “clean up” outdated entries and free resources for truly innovative tests.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 July 29, 2025, HAS published the evaluations of the targeted next-generation sequencing (NGS)-based gene panels in two indications: most frequent aminoacidopathies and acute leukaemia. Based on these HTAs, the HAS published favourable opinions on the registration in the NABM (level III of Clinical Added Value, ASA) of the targeted NGS panels in the two clinical indications as provided below. 

Medical management of the most frequent five aminoacidopathies (phenylketonuria and hyperphenylalaninemia, urea cycle disorders, maple syrup urine disease (leucinosis), tyrosinemia type 1, and homocystinuria due to cystathionine β-synthase (CBS) deficiency) in patients: 

• Presenting a biological anomaly suggesting a genetic ethology;
• For whom the initial clinical evaluation did not allow for a precise diagnosis due to an atypical or incomplete presentation;
• For whom a multigenic disorder is possible, as NGS enables simultaneous analysis of multiple genes involved in similar or overlapping clinical presentations. 

Pharmacogenetics of oncology treatments and supportive care for acute leukaemia in the context of consolidation or maintenance chemotherapy with thiopurines, or implementing supportive care in patients with a confirmed diagnosis of acute leukaemia, either before or after initiating chemotherapy. 

There are currently three generic codes relevant for these clinical indications in the LAHN:

• N350 Next-generation sequencing (NGS) package < 20 kb (index case);
• N351 Next-generation sequencing (NGS) package > 20 kb and < 100 kb (index case);
• N352 Next-generation sequencing (NGS) package > 100 kb and < 500 kb (index case).

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 aminoacidopathies), and here (HAS opinion on NGS in aminoacidopathies), and here (HTA on NGS in acute leukaemia), and here (HAS opinion on NGS in acute leukaemia).

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.