CADTH Pharmaceutical Reviews Update — Issue 15

Canada's Drug Agency Program Updates

1. COVID-19 Update

Canada's Drug Agency continues to support health care decision-makers throughout this challenging period. We have established a new website with information related to COVID-19 from Canada's Drug Agency and other respected organizations.

Canada's Drug Agency has successfully shifted to a virtual office and have the tools in place to continue delivering our programs and services. Further, we continue to monitor our operations to identify potential disruptions to our core business activities and we will promptly notify our stakeholders if we anticipate delays. Please consult the questions and answers for more details and if you have additional questions, contact us at [email protected].

2. Consultations on Canada's Drug Agency Drug Review Procedures Postponed

Canada's Drug Agency will be postponing the planned consultations on our aligned drug review processes due to the COVID-19 pandemic. Stakeholders will be notified once an appropriate time frame for this consultation has been identified.

3. New Expert Review Committee for Plasma Protein Products

Canada's Drug Agency and Canadian Blood Services announced the establishment of the Interim Plasma Protein Product review process in November 2019. Canada's Drug Agency issued a call for nominations to identify members for the new Canadian Plasma Protein Product Expert Committee (CPEC) in January 2020. Canada's Drug Agency and Canadian Blood Services are pleased to announce that the new members of this committee have been selected. Please refer to the following communication for details.

4. Revised Procedure for the Sponsor Review of Canada's Drug Agency pCODR Reports

The Procedures for the Canada's Drug Agency pan-Canadian Oncology Drug Review have been revised and sponsors will now be provided with a copy of the complete Canada's Drug Agency Pharmacoeconomic Report in addition to the executive summary that will be posted on the Canada's Drug Agency website. This revision has been made based on feedback from sponsors who have indicated that a copy of the complete report would assist them when validating the handling of non-disclosable information and the identification of errors before the executive summary of the report is posted.

5. Clarification of Requirements for Budget Impact Analysis

Canada's Drug Agency has made a minor adjustment to the description of the requirements for the pan-Canadian Budget Impact Analysis to emphasize that sponsors are required to include copies of all supporting documentation as part of category 1 requirements. The Procedures for the Canada's Drug Agency Common Drug Review and Interim Plasma Protein Product Review and the Procedures for the Canada's Drug Agency pan-Canadian Oncology Drug Review have been updated to reflect these revisions.

6. Clarification of Stakeholder Feedback on pCODR Expert Review Committee Initial Recommendations

In response to inquiries from stakeholders, Canada's Drug Agency has added additional text to the Procedures for the Canada's Drug Agency pan-Canadian Oncology Drug Review to clarify the stakeholder feedback process on the pERC initial recommendation.

7. Updated Fees for Canada's Drug Agency Pharmaceutical Reviews

Canada's Drug Agency has updated the Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews. The updated document includes the annual fee adjustment based on the Consumer Price Index.

8. Quarterly Update to the Canadian Drug Expert Committee (CDEC) Meeting Schedule

Canada's Drug Agency has updated the CDEC meeting schedule. This schedule is updated quarterly to allow stakeholders to plan for upcoming submissions.