[Targeted next generation sequencing gene panel in the medical management of chronic lymphocytic leukemia]
Nganbou A, Cardonneil C
Record ID 32018013501
French
Original Title:
Séquençage haut débit ciblé d’un panel de gènes dans la prise en charge médicale de la leucémie lymphoïde chronique
Authors' objectives:
This report aimed to assess the clinical benefit of a targeted next generation sequencing (NGS) gene panel in the management of chronic lymphocytic leukemia in routine care. The objective was to identify the relevant molecular alterations to be tested in chronic lymphocytic leukemia and to define the role of targeted NGS in detecting these alterations.
Authors' results and conclusions:
The analysis of the collected data has shown that targeted NGS:
- has a superior threshold for detecting mutations compared to Sanger sequencing, enabling the detection of subclonal mutations, which have the same clinical impact as clonal mutations;
- demonstrates the importance of testing for resistance mutations to improve prognosis and to adapt targeted therapies.
Authors' recommendations:
The French National Authority for Health (HAS) has recommended that the National Health Insurance reimburse targeted next generation sequencing gene panel testing in the following cases:
- TP53 and IGHV mutation testing before initiating first line treatment in all patients with symptomatic chronic lymphocytic leukemia;
- TP53 mutation testing before treatment modification for all patients with symptomatic relapse;
- TP53, BTK and PLCG2 mutation testing before treatment modification in patients with symptomatic relapse after receiving Bruton’s tyrosine kinase inhibitors;
- TP53 and BCL2 mutation testing before treatment modification in patients with symptomatic relapse after receiving BCL2 inhibitors;
- TP53, BTK, PLCG2 and BCL2 mutation testing before any change of treatment line in patients with symptomatic relapse after receiving Bruton’s tyrosine kinase inhibitors and BCL2 inhibitors.
Authors' methods:
The evaluation method was based on: (1) a critical analysis of systematic reviews, meta-analyses, and clinical practice guidelines identified through a systematic search and selected based on explicit criteria; (2) the identification of (a) clinically relevant evidence of molecular alterations, assessed using the OncoKB and TOPOGRAPH classification systems, and (b) approvals from the French National Authority for Health Transparency Committee, or when unavailable, compassionate use decisions given by the French National Agency for Medicines and Health Products Safety for relevant targeted therapies; and (3) consultation with an expert; and (4) stakeholders’ consultation (healthcare professionals, patients and users organizations), as well as the opinion of public health institutions.
Authors' identified further research:
The French National Authority for Health notes that the composition of the targeted next generation sequencing gene panel may evolve following favorable assessments of new gene alterations. These evaluations will be conducted in a dynamic manner in response to advances in scientific knowledge such as the identification of new relevant evidence and/or the publication of new approvals by French National Authority for Health Transparency Committee, and where applicable, compassionate use decisions by the French National Agency for Medicines and Health Products Safety.
Details
Project Status:
Completed
URL for protocol:
Non applicable
Year Published:
2024
URL for published report:
https://www.has-sante.fr/upload/docs/application/pdf/2024-07/rapport_shd_llc.pdf
Requestor:
Healthcare professionals, patients/users, public health institutions and manufacturers
URL for additional information:
https://www.has-sante.fr/upload/docs/application/pdf/2024-07/annexe_shd_llc.pdf
English language abstract:
There is no English language summary available
Publication Type:
Rapid Review
Country:
France
Pubmed ID:
Non applicable
DOI:
Non applicable
MeSH Terms
- Leukemia, Lymphocytic, Chronic, B-Cell
- High-Throughput Nucleotide Sequencing
- Disease Management
- Mutation
Keywords
- Chronic lymphocytic leukemia
- NGS
- Oncogenomics
- Mutation
- Sequence Analysis
Contact
Organisation Name:
Haute Autorité de Santé
Contact Address:
2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;
Contact Name:
has.seap.secretariat@has-sante.fr
Contact Email:
has.seap.secretariat@has-sante.fr
Copyright:
<p>Haute Autorite de Sante/French National Authority for Health (HAS)</p>
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.