The Canadian Agency for Drugs and Technologies in Health (CADTH) has invited stakeholders to provide comments and feedback on its proposed process for the assessment of companion diagnostics, which is integrated through the Common Drug Review and Pan-Canadian Oncology Drug Review programmes.
According to the CADTH Proposed Process for the Assessment of Companion Diagnostics, "[c]ompanion diagnostics are laboratory tests that aim to measure the expression of a specific biomarker [and] guide optimal clinical management by identifying subpopulations of patients who are most likely to benefit from a given drug". The proposed process would include the CADTH evaluating a submitted drug and its associated companion diagnostic together, and would not delay the currently established timelines to complete a review or increase the current fees for reviewing a drug application.
The CADTH proposal is expected to be implemented on or after April 3 2017, and the deadline for stakeholders to submit comments and feedback is January 13 2017.
For further information on this topic please contact Andrew Mandlsohn at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or by email ([email protected]).The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.