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.
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.
What are CAR T-Cell Therapies?
CAR T-cell therapies are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so that they will attack cancer cells.1 The general approach for CAR T-cell therapy is similar to ex vivo methods for cell-based therapies.2 Blood from a vein in the patient’s arm flows through a tube to an apheresis machine, which removes the white blood cells, including the T cells, and sends the rest of the blood back to the patient. Then, the gene for a special receptor called a chimeric antigen receptor (CAR) is inserted into the T cells in the laboratory. The CAR T cells are grown in the laboratory and then given to the patient by infusion, and then bind to an antigen on the cancer cells and kill them.3
Please direct any questions regarding this review process to email@example.com.
1 NCI Dictionary of Cancer Terms. [Internet]. US: National Cancer Institute; [cited 2018 April 3]. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy
2 Gene Therapy: An Overview of Approved and Pipeline Technologies [Internet]. Ottawa: CADTH; 2018 March. [cited 2018 April 3]. Available from: https://cadth.ca/sites/default/files/pdf/eh0068_gene_therapy.pdf
3 NCI Dictionary of Cancer Terms. [Internet]. US: National Cancer Institute; [cited 2018 April 3]. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy