Since the FDA approved the first gene therapy in 2017, Canadian patients, health care providers, and decision-makers have been anticipating the arrival of chimeric antigen receptor (CAR) T-cell therapies in Canada. During this time, CADTH has been considering how to effectively and rigorously assess the clinical effectiveness and value that these therapies may bring to patients and the health care system.
Today, we are pleased to provide further details about how our reviews of CAR T-cell therapies will proceed.
Review Process
CAR T-cell therapies are ushering in a new approach to treating cancer and other serious conditions. Given the unique aspects of these health technologies, CADTH will review CAR T-cell therapies through its health technology assessment process for medical devices and clinical interventions, and not through its pan-Canadian Oncology Drug Review (pCODR) or Common Drug Review (CDR).
This approach is being implemented in direct response to feedback from federal, provincial, and territorial Ministries of Health and the Canadian Association of Provincial Cancer Agencies (CAPCA), and is consistent with that being taken by several other health technology assessment bodies, including the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec.
Assessments will be led by CADTH, with recommendations, advice, and guidance from the Health Technology Expert Review Panel (HTERP). HTERP’s current member composition will be supplemented with individuals who have the applicable clinical expertise and who are leading the implementation of CAR T-cell program planning provincially.
Transparency, collaboration, and stakeholder engagement are central to each assessment that CADTH undertakes, and our appraisals of CAR T-cell therapies will be no different. Stakeholders, including patient groups and registered clinicians, will have the opportunity to provide their insight and perspective on these new treatments. For indications specific to cancer, we will also work closely with the Canadian Association of Provincial Cancer Agencies to ensure that any operational and implementation issues are effectively addressed.
Our assessments of CAR T-cell therapies will include a clinical and health economics review, patient and clinician input, manufacturer input, and a comprehensive review of implementation considerations. Reports for each component of the review will be released publicly on the CADTH website. There will be opportunities for feedback on interim versions of these reports.
