Pangaea Express - Health Technology Assessment of Drugs with Companion Diagnostics

July 4, 2017

By Marla Weingarten

CADTH has reviewed all the stakeholder input regarding the process for the Health Technology Assessment of Drugs With Companion Diagnostics that was first presented back in November 2016. CADTH has now posted its final process for the Assessment of Drugs with Companion Diagnostics through the CADTH Common Drug Review (CDR) and the CADTH pan-Canadian Oncology Drug Review (pCODR) programs that will apply to all submissions and resubmissions filed on or after October 11, 2017. (This will take effect for all CADTH Pre-submission Information Requirements Forms received as of June 13, 2017.)

CADTH is going ahead with its proposed process and requiring that both drug and the companion diagnostic are submitted together.

“Of note, CADTH will not be conducting independent assessments of companion diagnostics, either as single or multiple (class) technologies; instead, CADTH’s overarching objective is to explicitly and consistently investigate factors relevant to any required biomarker testing that would inform the implementation of associated drugs under review through the CADTH CDR and pCODR programs.”

CADTH will implement the following requirements:

  • Provide a reference list and copies of articles that highlight the clinical utility of the companion diagnostics under review. In this context, clinical utility refers to evidence of improved health outcomes as a result of biomarker testing. If no references are provided, a statement will be required to confirm that a search has been undertaken but no references have been located.

  • Explicitly incorporate relevant costs and consequences (e.g., rates of true- and false-positives, and true- and false-negatives) of any required biomarker testing into the pharmacoeconomic evaluations. The source(s) of information and any assumptions made regarding this aspect of the analysis will also be required.

  • Disclose all prices for companion diagnostics included in the submissions in all applicable CDR and pCODR review reports and recommendations documents posted on the CADTH website.

  • Provide budget impact analyses for drugs and companion diagnostics in combination and separately, as some jurisdictions fund the two health technologies through separate mechanisms.

For more information, please contact Marla Weingarten, Consultant, The Pangaea Group