Posted by Michael Wonder on 13 Jun 2017
Integrating companion diagnostics into CDR and pCODR reviews
13 June 2017 - In November 2016, CADTH invited stakeholder comments and feedback on a proposed process for the assessment of companion diagnostics through the CDR and pCODR programs.
Feedback was received from three industry associations, four drug manufacturers, 10 government agencies, three patient advocacy groups, one hospital, one health care professional, and six members from the CADTH expert drug committees.
In general, respondents acknowledged the need for a pan-Canadian process for the assessment of companion diagnostics, and were supportive of CADTH’s efforts to address this gap. Some respondents sought details of relevant changes to procedures, submission guidelines, and templates. There was some uncertainty around the impact on current drug review timelines and the impact on the current CDR/pCODR recommendations framework. All respondents supported CADTH’s continued engagement with patients, clinicians, and participating jurisdictions.
