Original Title: Dosage sérique des antipsychotiques par chromatographie liquide de haute performance couplée à la spectrométrie de masse en tandem (HPLC-MS/MS)

Authors' objectives: A request to add a new test to the Répertoire québécois et système de mesure des procédures de biologie médicale (hereinafter the “Répertoire”) has been submitted to the Institut national d’excellence en santé et en services sociaux (INESSS) in accordance with the evaluation mechanism for new medical laboratory tests. The mandate given was to assess the relevance of quantifying antipsychotics using high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) in the context of therapeutic drug monitoring (TDM) for certain psychotic and mood disorders. Given that this request concerns antipsychotics for which the test does not appear in the Répertoire, the Ministère de la Santé et des Services sociaux (MSSS) considers that the relevance of this test should be assessed from a provincial perspective.

Authors' results and conclusions: RESULTS (#1 SOCIOCULTURAL DIMENSION): Learned societies recommend therapeutic monitoring for most antipsychotics based on different levels of evidence. Therapeutic monitoring of certain antipsychotics is recommended as the standard of care, whereas for others, it may be useful in certain clinical situations. (#2 POPULATIONAL DIMENSION): Psychotic disorders and mood disorders are chronic illnesses that affect the individual’s daily life. The timely measurement of antipsychotic levels may contribute to sound individualized clinical decisions. This would improve, among other things, the treatment’s efficacy, tolerability, acceptability and reliability. • There are still equity issues in Québec that affect people with psychotic and mood disorders, who do not seem to receive optimal care in many situations. (#3 CLINICAL DIMENSION): The current available scientific data indicate that a number of factors, such as age, ethnicity and dosage form, can influence plasma antipsychotic concentrations. • Interindividual variations in antipsychotic levels are associated with a greater likelihood of having subtherapeutic or undetectable concentrations. Supratherapeutic levels, which can increase the probability of adverse effects or toxicities, can be detected as well. (#4 ORGANIZATIONAL DIMENSION): Multiplex HPLC-MS/MS assay can help in the processing of the samples, reduce test costs and improve the turnaround time for the measurement of drugs that are used less often. (#5 ECONOMIC DIMENSION): The weighted value of each test is 86.43. It is possible that the weighted value will fluctuate according to the number of requests sent to the laboratory. Furthermore, this request volume will depend on the test turnaround time. • Including the proposed tests in the Répertoire could generate, during the first 3 years, additional costs of approximately $2000 to $125,000. The sensitivity analyses performed show that the net variation could be from -$3500 to $7500 (scenario 1) and from approximately $18,500 to $280,000 (scenario 2).

Authors' recommendations: In light of the findings based on the five value dimensions, INESSS recommends that the Minister add HPLC-MS/MS quantification of antipsychotics in the Répertoire. To maximize the anticipated clinical utility, INESSS states that the following conditions are necessary for implementing the proposed test:  For urgent requests, an overall turnaround time (from specimen collection to results reporting) should be about 48 hours. For other requests, a turnaround time of up to 7 workdays would be acceptable.  Given the small number of antipsychotics to be added, designating a single facility, the Centre de toxicologie du Québec (CTQ), would suffice for the time being if it is able to offer the quantification services within the desired turnaround times. It would be important to plan specimen transport so that the tests are accessible throughout the province and to ensure efficient transmittal of the results directly to the SIL-P and the DSQ.

Authors' methods: The evaluation process included a review of the scientific literature, a search of the grey literature, and consultations with clinicians and other stakeholders. The methodology was based on seven evaluation questions covering the five dimensions in INESSS’s framework for determining the value of interventions. A review of the economic literature concerning the cost-effectiveness of the HPLC-MS/MS quantification of antipsychotics was conducted. A budget impact analysis examining the costs associated with adding HPLC-MS/MS quantification of antipsychotics to the Répertoire was performed. Costs were projected over a three-year period from a healthcare system perspective. All of the scientific, contextual and experiential data were interpreted and were synthesized into findings in order to guide the Standing Deliberative Committee - Diagnostic Approaches and Screening (CDP-ADD)’s deliberative process for the purpose of developing recommendations.

Project Status: Completed

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

Year Published: 2024

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-serique-des-antipsychotiques-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)