HAS evaluated targeted high-throughput sequencing of gene panels in three oncological indications

On August 2, 2024, the French National Authority for Health (HAS) published the evaluations of the targeted high-throughput sequencing of gene panels in the medical management of lung cancer, gastrointestinal stromal tumors, and chronic lymphocytic leukemia. These evaluations are part of a multi-year cycle initiated in response to a request from the General Directorate for Healthcare Services (DGOS) of the French Ministry of Labor, Health and Solidarity (MTSS) to assess the following somatic oncology services:

• N452 High-throughput sequencing (NGS) package < 20 kb;
• N453 High-throughput sequencing (NGS) package > 20 kb and < 100 kb;
• N454 High-throughput sequencing (NGS) package > 100 kb and < 500 kb.

Currently, these procedures are included in the List of IVD tests outside the Nomenclature (Liste des actes hors nomenclatures, AHN, i.e., the merged 2023 RIHN List and the Supplementary List funded outside Statutory Health Insurance via the research and innovation budget). These evaluations aim to decide whether the tests can be granted regular reimbursement within the Statutory Health Insurance and are part of the cleaning up of the current AHN List, allowing for the financing of truly innovative tests.

Based on these HTAs, the HAS published its favorable opinions on the registration in the Nomenclature of Medical Laboratory Procedures (NABM) (level II of Clinical Added Value, ASA) of the targeted high-throughput sequencing of gene panels for the medical management of patients with: 

• Lung cancer with the following indications:at the locally advanced stage, except in emergencies: at the time of diagnosis, in the event of progression after targeted therapy; at the metastatic stage, except in emergencies: at the time of diagnosis, in the event of progression after targeted therapy. In these indications, the gene panel allowing the search for relevant molecular includes the following genes: EGFR, ALK, ROS1, BRAF, RET, and KRAS;

• Gastrointestinal stromal tumors with the following indications: for the sequencing and analysis of the KIT and PDGFRA genes: localized gastrointestinal stromal tumors at intermediate or high-risk of recurrence, locally advanced or metastatic; suspicion of gastrointestinal stromal tumor in a patient whose histology has proven non-contributory to making the diagnosis (complex case); for sequencing and analysis of NTRK1/2/3 genes (RNA): pediatric wild-type gastrointestinal stromal tumors at a locally advanced or metastatic stage;

• Chronic lymphocytic leukemia with the following indications: search for TP53 and IGHV mutations before starting first-line treatment in all patients with symptomatic chronic lymphocytic leukemia; search for TP53 mutation before any change in treatment line in all patients with symptomatic relapse; search for TP53, BTK, and PLCG2 mutations before any change in treatment line in patients with symptomatic relapse after taking Bruton's tyrosine kinase inhibitors; search for TP53 and BCL2 mutations before any change in treatment line in patients with symptomatic relapse after taking BCL2 inhibitors; search for TP53, BTK, PLCG2, and BCL2 mutations before any change in treatment line in patients with symptomatic relapse after taking Bruton's tyrosine kinase inhibitors and BCL2 inhibitors.

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