CADTH’s Pharmaceutical Reviews Updates are used to communicate new CDR and pCODR drug review process updates to the public. PDCI has outlined below the key highlights from the most recent update. For more information, please consult the CADTH website.

1.  CADTH released new updates to economic Category 1 Requirements that will come into effect for all standard review submissions filed on or after March 2, 2020. Major changes include:

• Economic requirement changes:
  • Base-case analysis to reflect Health Canada-approved indication for all submissions (CDR and pCODR). Scenario analyses should be presented if there are relevant subgroups within the reimbursement criteria.
  • All economic models must be submitted in Microsoft Excel.
  • CADTH will no longer accept economic models if the model run time for the base-case analysis and key scenario analyses exceeds one business day (eight hours).
  • The probabilistic analysis must be stable over multiple model runs. A congruence test must be provided to identify the appropriate number of iterations required for convergence to be reached.

2. Effective for all submissions filed on or after March 2, 2020, all single drug review processes will include the following Category 1 requirements:

• A pan-Canadian budget impact analysis (BIA) model, report and supporting documentation.
• Complete clinical study reports (CSRs) for all pivotal studies and other relevant studies that address key clinical issue. Final or interim CSRs must be provided in full and include complete study protocol and analysis plan.
• A templated table summarizing reimbursement status for all relevant comparator drug products across Canada.

Other updates include:

• New CADTH Process for Cell and Gene Therapies:
  • Submission requirements include:
    • Clinical, economic and administrative submission requirements same as CADTH’s single drug review process.
    • pan-Canadian BIA.
    • Implementation plan template.
• Updated CADTH Fee Guidelines to include interim process for plasma protein products and cell and gene therapies.
• Conflict of Interest Policies changes effective for all calls for patient input and registered clinical input issued on or after January 2, 2020.
• New Pharmaceutical Advisory Committee (PAC): a new advisory body to provide strategic advice to CADTH on drug related issues. This committee is formed through the merger of the Drug Policy Advisory Committee (DPAC) and the pCODR Advisory Committee.
• Effective immediately: CADTH is aligning terminology in the single drug review processes for CDR and pCODR.
• Reminder: manufactures are overlooking sources of information (already disclosed in documents posted by other HTAs and/or regulatory authorities) when requesting redactions from CADTH reports.
• The slides from the annual CADTH Medical Device and Drug Portfolio Information Sessions, held on November 25, 2019, are available here.

Contact Ara Salazar, Director of Market Access, to learn more about how these changes may affect your upcoming submissions.