[Report: circulating tumour DNA (liquid biopsy)-based EGFR exon 20 T790M mutation detection in advanced non-small cell lung cancer after previous EGFR-directed therapy]
Tchekanda E, Mortier T
Record ID 32018002362
French
Original Title:
Avis: Détection de la mutation T790M de l’exon 20 du gène EGFR dans le cancer du poumon résistant aux inhibiteurs de l’EGFR sur ADN tumoral circulant (biopsie liquide)
Authors' objectives:
Approximately 60% of NSCLC patients treated with a 1st- or 2nd generation TKI will develop the EGFR-T790M resistance mutation and
require a change in therapy. Although a test used to detect this mutation
from a tissue biopsy is listed in the Répertoire québécois et système de
mesure des procédures de biologie médicale (hereinafter the
"Répertoire"), the present request concerns the detection of the EGFRT790M mutation in samples obtained by liquid biopsy, an alternative
specimen collection method that enables the patient to avoid a tissue
biopsy and the associated risks, and to obtain a change in therapy more
quickly.
Authors' results and conclusions:
RESULTS: (1.Diagnostic performance): According to the Health Quality Ontario assessment report published in
2020, the concordance rate for EGFR-T790M mutation detection results
between liquid biopsy and tissue biopsy ranges from 50% to 96%. The
sensitivity and specificity, negative predictive value (NPV) and positive
predictive value (PPV) are 68% [46%-88%], 86% [62%-99%], 61% and
89%, respectively. The use of droplet digital PCR (ddPCR) appears to
increase the rate of positive detection of the EGFR-T790M mutation by
liquid biopsy. (2. Patient
perspective) : According to the HQO report, patients perceived liquid biopsy as a faster
and more convenient approach because they would not have to wait
several weeks to get an appointment for a tissue biopsy, which could
require a trip to a specialized centre that might be further away. They
also expressed fear and even panic about the tissue sample collection
procedure, in which a large-gauge needle is used. (3. Economic
evaluation ): Liquid biopsy as a triage test is less expensive and more effective than
tissue biopsy in detecting the EGFR-T790M mutation. However, when
the clinical benefits and costs of the subsequent treatments are factored
in, the incremental cost-utility ratio is high, in part because of
osimertinib's non-cost-effectiveness.
Since the listing of this drug as a 1st-line therapy in the formularies, the
liquid biopsy-eligible population has been steadily decreasing. The
current number of people receiving 1st- or 2nd-generation TKIs was
estimated to be 32, based on RAMQ data, and 40 if patients with private
insurance are included. These analyses estimate the laboratory savings
at $460, but they anticipate that 5 additional patients could receive
osimertinib, for a net budget impact of approximately $537,000 over the
next 3 years. (4. Position of the
experts consulted): The experts consulted support the use of liquid biopsy in the context
defined by the requester. They did not raise any specific issues, apart
from the limited relevance of this test, given the recent listing of
osimertinib as a 1st-line therapy. The rapid emergence of a large number
of indications for liquid biopsy appears to be imminent and would
constitute a technological and oncologic revolution.
Authors' recommendations:
Based on the deliberation, by the CSABM’s members, of all the
evidence, including the perspective of the experts consulted, INESSS
recommends that circulating tumour DNA-based EGFR-T790M
mutation detection be included in the Répertoire.
Authors' methods:
The assessment process included a rapid review of the scientific and
grey literature, and consultations with experts and other stakeholders.
An assessment report on the relevance of using liquid biopsy in the
same context as this request was published by Health Quality Ontario
(HQO) in March 2020. The report includes an assessment of its
diagnostic performance, clinical utility, safety, cost-effectiveness and
budget impact, and an assessment of patient preferences and values.
The HQO report was deemed to be of good methodological quality and
is the main source of data for the present assessment.
Details
Project Status:
Completed
Year Published:
2022
Requestor:
Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
Canada
Province:
Quebec
MeSH Terms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Liquid Biopsy
- Circulating Tumor DNA
Contact
Organisation Name:
Institut national d'excellence en sante et en services sociaux
Contact Address:
L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369
Contact Name:
demande@inesss.qc.ca
Contact Email:
demande@inesss.qc.ca
Copyright:
Gouvernement du Québec
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.