[Next generation sequencing gene panel for medical lung cancer care]

Hachem M, Carbonneil C
Record ID 32018013275
French
Original Title: Séquençage haut débit ciblé d’un panel de gènes dans la prise en charge médicale du cancer du poumon: recherche des altérations moléculaires somatiques
Authors' objectives: The objective of this assessment was to determine the benefit of using a next generation sequencing (NGS) gene panel for the clinical management of non-small cell lung cancer (NSCLC) patients, in routine clinical practice. The aim was (1) to assess the diagnostic performance of NGS, (2) to identify the molecular alterations of interest and (3) to define the role of NGS in the therapeutic care for NSCLC patients.
Authors' results and conclusions: The assessment of the evidence and data demonstrated that next generation sequencing gene panel testing: • is highly concordant with the comparators (Kappa coefficient of 0.884); • can detect additional targetable molecular alterations (marginal increase in the detection capacity of 2%); • makes better use of the tumour tissue; and • the clinical utility of the targeted gene panel has been demonstrated by the benefits provided by targeted therapies.
Authors' recommendations: The French National Authority for Health has recommended funding the next generation sequencing gene panel procedure by the National Health Insurance for patients with locally advanced and metastatic non-small cell lung cancer, following diagnosis or in cases of progression, excluding any emergency situations
Authors' methods: The method used for this assessment was based on (1) a critical analysis of systematic reviews and meta-analyses and clinical practice guidelines identified by a systematic search based on PICO criteria; (2) the identification (a) of the level of evidence of the clinical actionability of molecular targets as set out by the European Society for Medical Oncology scale - ESCAT, (b) of targeted therapies included on the list of reimbursable drugs assessed by the Transparency Committee of the French National Authority for Health , or drugs that have compassionate use authorisations issued by the French National Agency for Medicines and Health Products Safety (ANSM); and (3) stakeholder consultations (relevant professional bodies and patient and consumer organisations), as well as public health institutions.
Authors' identified further research: The French National Authority for Health points out that the composition of the next generation sequencing gene panel may be subject to change, in accordance with favourable assessments of new gene alterations. These new assessments shall be conducted in a dynamic manner in response to developments in scientific knowledge (identification of new relevant evidence and/or publication of new French National Authority for Health Transparency Committee advice and/or, compassionate use authorisations issued by the French National Agency for Medicines and Health Products Safety). An additional HAS assessment is in progress to establish the relevance of liquid biopsy use in the above-mentioned indications.
Details
Project Status: Completed
Year Published: 2024
Requestor: Healthcare professionals, patients/consumers, manufacturers, public health institutions.
English language abstract: There is no English language summary available
Publication Type: Rapid Review
Country: France
MeSH Terms
  • Sequence Analysis
  • Molecular Targeted Therapy
  • High-Throughput Nucleotide Sequencing
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Genetic Testing
  • Molecular Diagnostic Techniques
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.