Original Title: Dosage sanguin de l’imatinib et de son métabolite actif par chromatographie liquide de haute performance couplée à la spectrométrie de masse en tandem (HPLC-MS/MS)

Authors' objectives: The Institut national d'excellence en santé et en services sociaux (INESSS) has received a request to include a new test in the Répertoire québécois et système de mesure des procédures de biologie médicale (hereinafter referred to as the “Répertoire”), in accordance with the evaluation mechanism for new medical biology tests. The mandate entrusted was to evaluate the relevance of including in the Répertoire the blood levels testing of imatinib and its active metabolite (norimatinib) by high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Blood levels testing for imatinib complements the requirements of the product monograph and the indications for payment accepted by public or private insurers.

Authors' results and conclusions: RESULTS (#1POPULATION PERSPECTIVE): In Québec, imatinib is mainly used for the treatment of chronic myeloid leukemia (CML), Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and gastrointestinal stromal tumour (GIST). • CML, ALL and GIST are rare diseases. The prognosis for CML is generally good, while three-year overall survival for ALL remains at 45% in adults. Five-year survival for GIST is 85% for all stages combined. (#2 CLINICAL PERSPECTIVE-CLINICAL VALIDITY): The ability of imatinib Cmin to predict a positive response is uncertain for patients with GIST or ALL due to little or no data. • The ability of imatinib Cmin to predict adverse events is uncertain for ALL, given the lack of data. (#2 CLINICAL PERSPECTIVE-CLINICAL UTILITY): The utility of monitoring norimatinib levels is uncertain due to lack of data. • The number of imatinib blood concentration measurements a patient should have remains uncertain and may vary according to the clinical context. (#3 ORGANIZATIONAL PERSPECTIVE): The results of the analysis could change the trajectory of care for some patients. (#4 SOCIOCULTURAL PERSPECTIVE): Some learned societies acknowledge that the therapeutic drug monitoring of imatinib and norimatinib could be of interest in certain sub-populations or in specific clinical contexts. (#5 ECONOMIC PERSPECTIVE): Efficiency studies selected for CML and GIST suggest that therapeutic drug monitoring of imatinib may be a more cost-effective strategy than administration without such follow-up. • No cost-effectiveness studies of both imatinib and norimatinib, or of the ALL population, were identified.

Authors' recommendations: INESSS recommends that the Minister introduce blood testing for imatinib and its active metabolite by HPLC-MS/MS in the Répertoire québécois et système de mesure des procédures de biologie médicale. In the perspective of creating value for patients with chronic myeloid leukemia (CML), gastrointestinal stromal tumours (GIST) or acute lymphoblastic leukemia (ALL), and for the healthcare system, INESSS specifies that measurement of imatinib and its active metabolite should be used in the following context: - in cases of unexplained suboptimal clinical response or unexpected toxicity to imatinib; - in the event of polypharmacy with a risk of drug interactions. The test must meet the requirements of ISO 15189.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-de-limatinib-et-de-son-metabolite-actif-par-chromatographie-liquide-de-haute-performance-couplee-a-la-spectrometrie-de-masse-en-tandem-hplc-ms-ms.html

Year Published: 2025

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-de-limatinib-et-de-son-metabolite-actif-par-chromatographie-liquide-de-haute-performance-couplee-a-la-spectrometrie-de-masse-en-tandem-hplc-ms-ms.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

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: L'Institut national d'excellence en sante et en services sociaux (INESSS)