Synchronized evaluation process for companion diagnostic tests
Background
Personalized medicine and its associated research are booming. The advent of more and more targeted treatments calls for the use of biomedical testing to identify people who could potentially benefit from them. INESSS therefore seeks to implement all of the processes required to ensure that the companion test for a listed drug with recognized therapeutic value can be available in a timely fashion, where applicable.
INESSS defines a companion test as any biomedical analysis whose results are intended to select a population (based on its status or on a recognized predictive marker) that could benefit from a specific treatment (targeted therapy), to monitor it, or to anticipate its foreseeable adverse effects.
The test is thus considered as seen as "companion" to the treatment.
Synchronized evaluation process for companion tests
The goal in implementing an evaluation process for companion tests is to ensure the Direction de la biovigilance et de la biologie médicale (DBBM) of the MSSS is informed in a timely fashion that a medical biology analysis is associated with a drug being evaluated by INESSS. Consequently, when a notice is sent to the Minister recommending the listing of a drug associated with a companion test, the authorities responsible for adapting laboratory services can take the necessary steps to ensure the availability of said analysis upon listing of the drug.
The synchronized evaluation process for companion tests is linked to the INESSS Evaluation of drugs for listing purposes process. If applicable, manufacturers are required to inform INESSS, in the Mandatory advance notice, that a test has been associated with the drug referred to in the application for evaluation for listing purposes. In addition to this mandatory advance notice, the manufacturer will need to file a Submission for companion tests evaluation with INESSS. The synchronized evaluation process for companion tests applies only to tests accompanying a drug under evaluation for listing purposes. For all requests to add a test not related to a drug under evaluation to the Répertoire québécois et système de mesure des procédures de biologie médicale, the Assessment mechanism for medical biology tests at INESSS apply.
Assessment procedure for companion tests
The approach to the evaluation of companion tests associated with drugs evaluated for listing purposes was updated in January 2024. Its goals are to promote a more systematic and transparent approach to companion test evaluation mechanisms, to enable stakeholders to adapt to precision medicine practices, to contribute to the evolution of knowledge and to maintain innovative approaches inspired by best practices.
Assessment procedure for companion tests (January 2024)
This document explains how companion tests are evaluated at INESSS. Its purpose is to outline the evaluation approach for a new process in personalized medicine and pharmacogenomics.