Improving Our Assessments of Drugs With Companion Diagnostic Tests 

As part of our ongoing initiative to improve and modernize our reimbursement review program, Canada’s Drug Agency is introducing the first phase of process improvements related to companion diagnostics.  

A companion diagnostic is a class of medical device used alongside a drug that is essential for the safe and effective use of the corresponding drug or biologic product. These tests can detect biomarkers that may predict a more favourable response to a particular therapy and can be used to help tailor individualized treatment. 

Currently, a drug sponsor must include clinical and economic considerations related to companion diagnostics in their applicable reimbursement review submission. To date, the review process has included an evaluation of the clinical utility of the diagnostic test(s), and the evidence has been presented in a clinical review report appendix. 

The improvements we are introducing enhance this process and are effective immediately. They include: 

• Improved presubmission phase forms: We updated the presubmission briefing template and advance notification templates so we can gather additional information about new drugs that may have implications for diagnostic testing resources and/or impacts on other aspects of the health care system.  
• Improved report structure: We will now give our review of companion diagnostic tests more prominence by producing a separate Testing Procedure Assessment Report for drugs or drug regimens that impact diagnostic testing resources rather than embedding this information in a clinical review report appendix.
• Expanded opportunity for comments: We updated the Sponsor Comments on Draft Reports template so that drug sponsors with applications that have a companion diagnostic have more space to comment specifically on the draft Testing Procedure Assessment Report.
• A dedicated testing procedures team: A newly formed team focused on precision medicine within our Medical Devices and Clinical Interventions portfolio will conduct reviews of companion diagnostics. 

An Evolving Process 

We first launched a process to assess companion diagnostics in 2017; since that time, the landscape has evolved substantially and the field of precision medicine, which relies on companion diagnostic tests to inform targeted treatment decisions, has grown. There is a large pipeline of complex drugs and drug regimens that require diagnostic and other testing evidence to inform treatment decisions. The arrival of these products in the Canadian market will impact the provincial and territorial health systems’ medical imaging and diagnostic resources.

We anticipate launching a new and expanded review process that may include testing procedure assessments for products that do not have a specific companion diagnostic test but pose additional implementation considerations and for which jurisdictional decision-makers would benefit from a pan-Canadian evidence review process. These reviews may include, for example, clinical and economic considerations related to complementary diagnostic testing, impacts on medical imaging resources, or the expanded use of existing diagnostic testing modalities. 

We look forward to continued dialogue on these matters with the pharmaceutical, life sciences, and medical device industries; patient partner groups; clinical societies; and our health system partners.