CADTH’s Pharmaceutical Reviews Updates are used to communicate new CDR and pCODR drug review processes updates to the public. PDCI has outlined below the key highlights from the most recent update. For more information on this review, please consult the CADTH’s website.
CADTH has three new consultations inviting stakeholder’s comments and feedback on the following proposals:
These proposed changes may have an impact on the reimbursement submission processes. PDCI is preparing responses and an in-depth analysis of the implications of the consultations that will be shared publicly to the industry by our TargetPharma.
These proposed changes may have an impact on your upcoming submissions. To provide your feedback, use the feedback template on the CADTH website and submit by 5:00pm EDT on Friday, September 13, 2019.
Three Additional CADTH Program Updates are Highlighted Below:
- Decision to allow for suspension rather than mandatory withdrawal will be made on a case-by-case basis and applicants must have consented to the information-sharing process between CADTH and Health Canada
- Health Canada’s rationale for NOD/NON and anticipated timelines for addressing issues will determine need for suspension
- The following information is required in order for CADTH to lift the suspension:
- Brief summary of the issue and how the manufacturer is planning to resolve the issue
- New clinical data filed to Health Canada
- Advance Notification Form is required a minimum of 6 weeks when issue is likely to be resolved and NOC issued
- The process requirements has been updated in the Procedure and Submission Guidelines for the CADTH Common Drug Review
- The base case and all scenario analyses must be conducted probabilistically
- A breakdown by costs and by quality-adjusted life-years must be reported based on the probabilistic results in the base-case and, if applicable, scenario analysis
- If there is more than one comparator included, the probabilistic analysis should run all comparators simultaneously or be conducted in a way that ensures that the same input parameter values are considered within each simulation. Pairwise analyses assuming different efficacy assumptions for a common comparator are not appropriate