CADTH’s Pharmaceutical Reviews Updates are used to communicate new Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (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. Consultation on CADTH’s Drug Reimbursement Review Procedures
CADTH is seeking stakeholder feedback on its revised procedures aligning CADTH’s CDR, Interim Plasma Protein Products, and pCODR submission requirements and processes. Complete details can be found in the Summary of Proposed Procedures for CADTH Drug Reimbursement Reviews.

Stakeholders are invited to submit feedback using the Survey Monkey feedback template by 5:00 p.m. EDT on August 10, 2020.

2. Consultation on Health Canada, CADTH, and INESSS Aligned Review
The Aligned Reviews Between Health Canada and Health Technology Assessment (HTA) Organizations process is currently optional for sponsors filing HTA submissions on a pre-NOC basis. Health Canada, CADTH, and INESSS have conducted an initial evaluation of the process and seek stakeholder feedback on proposals to: 

• Make information-sharing mandatory for all HTA submissions filed pre-NOC, and
• Revise the consent letter to reduce the need for Health Canada to distribute information separately to CADTH and INESSS.

Details can be found in the Proposed Enhancements to the Health Canada, CADTH, and INESSS Aligned Review Processes.  Stakeholder feedback is invited via the Survey Monkey feedback template by 5:00 p.m. EDT on August 10, 2020.

3. New Process for Drugs with Expanded Health Systems Implications
CADTH will be applying an expanded review process to products that are not necessarily well-suited to CADTH’s drug reimbursement review process. Eligible interventions may include novel products likely to pose substantial system-wide implementation challenges (e.g., complex administration process, significant pre- and post-treatment requirements, and the need for coordination across broader health care system). 
Interventions will be selected for evaluation on a case by case basis in consultation with CADTH’s advisory committees. For more information, please consult the CADTH Process for Drugs with Expanded Health System Implications

4. Changes to Provisional Algorithm Process for Oncology Drugs
Revisions to the provisional algorithm process for oncology drugs include: 

• New proposed place in therapy template,
• New timelines for establishing provisional algorithms,
• New process for manufacturer engagement,
• New review template for communicating provisional algorithm.

For more information, please consult the CADTH Pharmaceutical Review Update – Issue 16.

5. Minor Adjustments to Economic Requirements
Updates include adjustments to the descriptions of economic evaluation requirements related to the congruence test and to the presentation of parametric distributions when using survival data. The updates also include adjustments to the description of budget impact analysis requirements related to the breakdown of costs by perspective, and to the flexibility of the model to apply to any CADTH-participating drug plans.

The Procedures for the CADTH Common Drug Review and Interim Plasma Protein Product Review and the Procedures for the CADTH pan-Canadian Oncology Drug Review have been updated to reflect the above information. 

6. Revised Fee Schedule 
CADTH has published a revised Fee Schedule for CADTH Pharmaceutical Reviews. Key changes include:

• Discontinuation of Schedule B: Submissions for drugs with new indications and re-submissions received on or after June 30th, 2020 will be subject to Schedule A. 
• Schedule D will apply for requests for reconsideration filed by industry sponsors for pCODR reviews submissions and resubmissions targeting the October 2020 pERC meeting.
• A new Schedule F has been added for drugs which will be reviewed through the new CADTH Process for Drugs with Expanded Health System Implications. 

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