CADTH Pharmaceutical Reviews Update — Issue 12

Canada's Drug Agency Program Updates

1. New Canada's Drug Agency Process for Cell and Gene Therapies

Canada's Drug Agency has undertaken an internal review of our processes for drugs and devices, and established a revised process for the review of cell and gene therapies that leverages the strengths of both programs. This new process will offer stakeholders the benefits of firm performance targets and well-established processes for conducting reviews and issuing recommendations for drug products, with the additional ethical and implementation considerations that are an important strength of the Canada's Drug Agency medical devices processes. The following document provides a brief overview of the new process:

• Canada's Drug Agency Review Process for Cell and Gene Therapies

2. Updated Fee Guidelines

Canada's Drug Agency has updated the Fee Schedules for Canada's Drug Agency Pharmaceutical Reviews to accommodate the following changes:

• new interim process for plasma protein products
• new process for cell and gene therapies.

3. Pending Updates to the Canada's Drug Agency Category 1 Requirements

3.1 Economic requirements

Canada's Drug Agency will be implementing revisions to the economic category 1 requirements for all standard review submissions filed on or after March 2, 2020. These revisions will include the following:

• Canada's Drug Agency will require sponsors to submit a base-case analysis that would reflect the Health Canada– approved indication for all submissions (including those for oncology drugs). If there are relevant subgroups within the specific reimbursement criteria requested by the sponsor, these should be provided as scenario analyses
• a pan-Canadian budget impact analysis and report will be required for all submissions
• economic models must be programmed in Microsoft Excel
• the submitted economic model must have a reasonable run time. If the model run time for the base-case analysis and key scenario analyses exceeds one business day (eight hours), Canada's Drug Agency will consider it to be excessive and will not accept it.
• 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.

Canada's Drug Agency is providing advance notification of these pending revisions to allow time for sponsors to plan accordingly. Any sponsors with questions regarding these requirements should contact Canada's Drug Agency ([email protected]) with the complete details of their questions.

3.2 New Category 1 Requirements

In August 2019, Canada's Drug Agency consulted on a proposal to revise the category 1 requirements for our single drug review processes. Effective for all submissions filed on or after March 2, 2020, the Canada's Drug Agency single drug review processes will include the following additional category 1 requirements:

• Complete clinical study reports for all pivotal studies as well as other studies that address key clinical issues. Final or interim clinical study reports must be provided in full and include both the complete study protocol and analysis plan.
• A table summarizing the reimbursement status of all relevant comparator drugs. This information must be provided using the following standardized template.
• A pan-Canadian budget impact analysis report, model, and supporting documentation.

Canada's Drug Agency also consulted on the inclusion of a systematic literature review as a category 1 requirement for all submissions and resubmissions that are filed for review through the standard review processes. Canada's Drug Agency is continuing to develop the guidance documentation for that proposed revision to the process and anticipants announcing further details in the months to follow.

4. Canada's Drug Agency Conflict of Interest Policies

To increase transparency and promote alignment across our drug review processes, Canada's Drug Agency will no longer redact any conflict of interest information from patient group input or registered clinician input submissions that are filed for drugs being reviewed through the Canada's Drug Agency pan-Canadian Oncology Drug Review (pCODR) process. This change will be effective for all calls for patient input and registered clinical input issued on or after January 2, 2020.

5. New Pharmaceutical Advisory Committee

Canada's Drug Agency is pleased to announce the formation of the Pharmaceutical Advisory Committee, a new advisory body that will provide strategic advice to Canada's Drug Agency on drug-related issues and topics. This committee has been formed through the merger the Drug Policy Advisory Committee and the pCODR Advisory Committee. Consolidation of these committees will offer efficiency for both Canada's Drug Agency and the participating jurisdictions. Canada's Drug Agency wishes to thank all jurisdictional representatives who served on the previous advisory committees for their contributions.

6. Reminder: Canada's Drug Agency Redaction Policy

Canada's Drug Agency has found that sponsors are routinely requesting the redaction of information that has already been disclosed in documents posted by other health technology assessment agencies and/or regulatory authorities. Specifically, Canada's Drug Agency has noted that sponsors are frequently overlooking the following sources of information when requesting the redaction of information from Canada's Drug Agency reports:

• the complete committee papers that are published by the National Institute of Health and Care Excellence (NICE) in the United Kingdom
• the disclosure of dossier modules by the Federal Joint Committee (Gemeinsamer Bundesausschuss) in Germany
• study detail results and details posted on clinicaltrials.gov.

Requesting redaction of information that has been publicly disclosed results in an inefficient use of resources for both Canada's Drug Agency and the sponsor.

7. Alignment of Terminology

Canada's Drug Agency is aligning the terminology in the single drug review processes as follows:

• submissions that are withdrawn and re-filed in the pCODR process will no longer be classified as resubmissions by Canada's Drug Agency and will be classified as submissions. Resubmissions will only apply in situations where Canada's Drug Agency has completed a review and issued a final recommendation for the drug and indication under review.
• Canada's Drug Agency will now use the term ‘accepted for review’ rather than ‘deemed complete’ for pCODR submissions and resubmissions. This is reflected in the Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews.
• Canada's Drug Agency has aligned milestone 1 for its Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) processes in the Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews (initiation of review is now used as milestone 1).
• submissions filed before market authorization by Health Canada will be simply be referred to as pre-Notice of Compliance (NOC) submissions and those filed after market authorization will be referred to as post-NOC submission (there will no longer be a distinction between NOC or NOC/c [with conditions] in the description of submission types).

These revisions are effective immediately and will be reflected on the Canada's Drug Agency website and in the procedural documentation for the single drug review processes.

8. Canada's Drug Agency Drug Portfolio Information Session

The annual Canada's Drug Agency Medical Device and Drug Portfolio Information Sessions were held on November 25, 2019. The event provided attendees with information about priority initiatives and process changes from the Canada's Drug Agency medical device and drug portfolios. If you are interested in more information, the slides are available here and the presentations are available on the Canada's Drug Agency YouTube page.