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.
In this Pharmaceutical Reviews Update, CADTH made program updates by clarifying economic requirements, consolidating procedural documents for the pCODR process, and updating the procedural documents for CDR and Interim Plasma Protein Product Review processes.
1. The description of economic and pricing requirements for drugs reviewed through CDR, pCODR and the Interim Plasma Protein Product Review processes have been updated to provide greater clarity for manufacturers:
- Relevant parametric distributions should be presented when an economic model includes survival data.
- Time horizon for budget impact analyses are to include a baseline year followed by a three-year forecast period from the proposed listing date. The cost breakdown should also include dispensing fees and mark-ups.
- Reminder that confidentially submitted prices are not accepted by CADTH in submissions or resubmissions through thte single drug review processes.
- Budget impact information submitted for category 2 requirements should align with those submitted as part of category 1 requirements.
2. A new document has been drafted that consolidates separate documents relating to the pCODR process titled Procedures for the CADTH pan-Canadian Oncology Drug Review. Key changes include:
- The limit of four sponsor attendees in checkpoint meetings has been lifted and these meetings will now only occur via teleconference.
- The new process for the submission and review of cell and gene therapies is now included.
- Sponsors are no longer required to provide the Template for pCODR Structured Summary of Economic Information for Disclosure upon filing a submission or resubmission.
- A single declaration letter now replaces the Letter Authorizing Unrestricted Sharing of Information and the Signed declaration that all unpublished studies have been disclosed.
- Specification that a Health Canada consent form now replaces the Letter of Authorization allowing Health Canada to Share Information with pCODR for submissions filed on a pre-NOC basis.
- Templates for pCODR category 1 requirements are now being made available on the CADTH website.
3. The Procedures for the CADTH Common Drug Review and Interim Plasma Protein Product Review document now provides greater clarity regarding new economic requirements. There are currently no changes to the current category 2 requirements for CDR submissions as a result of the new pan-Canadian budget impact analysis requirement for category 1.
Contact Ara Salazar, Director of Market Access, to learn more about how these changes may affect your upcoming submissions.