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Introducing New Patient Input Template and Integrating Companion Diagnostic Assessment Into CADTH’s Drug Review Programs

Published on: June 13, 2017
Result type: News

CADTH would like to thank all stakeholders who responded to the consultation on the proposed changes to:

  • the patient input template for the CADTH Common Drug Review (CDR) and the CADTH pan-Canadian Oncology Drug Review (pCODR)
  • the proposal to integrate the assessment of companion diagnostics through the CADTH CDR and CADTH pCODR processes.

1. New Patient Input Template for CDR and pCODR Programs

In September 2016, CADTH invited stakeholder comments and feedback on proposed revisions to the patient input template for the CDR and pCODR programs. The joint template builds on CADTH’s and its drug expert committee’s experiences of receiving and using more than 546 patient input submissions. CADTH would like to thank all the stakeholders who commented on the proposed joint CDR and pCODR patient input template. CADTH received feedback from patient groups, pharmaceutical companies, and members of CADTH’s drug expert committees — the Canadian Drug Expert Committee (CDEC) and the pCODR Expert Review Committee (pERC). Specifically, we would like to acknowledge the thoughtful feedback submitted by patient groups. We recognize that patient groups are well-placed to identify which template prompts are most relevant to their specific disease area and the drug under review; in response, we then try to frame the responses around the most relevant prompts.

The finalized joint template is now available for use. It replaces the existing patient input templates. Patient groups should be using the finalized joint template for patient input for drug reviews that are submitted to the CDR and pCODR programs on or after September 1, 2017.

The key changes made by CADTH in response to stakeholder feedback received are, as follows:

  • clarity provided on what is needed to report information gathering
  • re-introduced questions on disease experience
  • focused questions on improved outcomes
  • simplified the required conflict of interest declarations.

In addition, we have added a section for patient groups to use when the drug under review has an associated companion diagnostic test. The template also includes a separate section to complete if the drug under review is a biosimilar (also known as a subsequent entry biologic).

To support groups contributing patient input and to better understand how their input is used, CADTH has added and updated patient input supporting materials, which are available on the CADTH website.

2. Integrating Companion Diagnostics Into CDR and pCODR Reviews

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.

After careful consideration of all the feedback received, and in collaboration with the participating jurisdictions, CADTH has developed a process for the assessment of drugs with companion diagnostics that will apply to all submissions and resubmissions filed on or after October 11, 2017. Note that this will take effect for all CADTH Pre-submission Information Requirements Forms received as of June 13, 2017. For more details about the new requirements for companion diagnostics, please refer to our summary on Health Technology Assessment of Drugs with Companion Diagnostics at CADTH, as well as the respective CDR and pCODR Procedures and Submission Guidelines.

Should you have any questions regarding the aforementioned information, please contact us at requests@cadth.ca.