CADTH Pharmaceutical Reviews Update — Issue 8

Updates for Patients and Communities

Re-posting Calls for Patient Input

Canada's Drug Agency has received some inquiries regarding how and when patient groups are re-engaged in the Canada's Drug Agency Common Drug Review (CDR) process following an initial call for patient input. In the case of a pending submission or resubmission, Canada's Drug Agency will repost the call for patient input in the following circumstances:

• the pending submission or resubmission has been substantially delayed following the issuance of the initial call for patient input (typically a delay of six months or longer)
• the pending submission or resubmissions was withdrawn after the call for patient input was issued and is subsequently refiled by the applicant.

In most instances, patient groups may want to simply resubmit their earlier input. Canada's Drug Agency appreciates that this may require some additional effort for patient groups, but feels that re-posting the call for patient input in the above-noted circumstances is important for the following reasons: it ensures that the patient group input reflects the current perspective from the patient group(s) who initially responded; and it provides an opportunity for any additional groups to contribute to the Canada's Drug Agency review process.

In the case of a request for advice, Canada's Drug Agency posts a call for patient input and reaches out directly to all patient groups who provided input on the original Canada's Drug Agency review of the drug.

Canada's Drug Agency Program Updates

Biosimilars No Longer Reviewed through the Canada's Drug Agency CDR and pCODR Processes

When Canada's Drug Agency launched a new, streamlined biosimilar review process in February 2018, we committed to evaluating the impact and utility of the new process after approximately one year. Canada's Drug Agency recently completed this internal evaluation, which included consultation with public drug plans and the pan-Canadian Pharmaceutical Alliance (pCPA). As a result, Canada's Drug Agency is pleased to announce that there is no longer a need for Canada's Drug Agency to continue offering the streamlined biosimilar review process. There are no changes to the current pCPA negotiation process anticipated as a result of the decision by Canada's Drug Agency.

As of June 1, 2019, Canada's Drug Agency will be stopping work on any biosimilar reviews that would have been completed after June 1, 2019.

This decision was made based for several compelling reasons, including the fact that the current streamlined biosimilar review process may delay access to new biosimilar treatments. Stopping the biosimilar review process will allow Canada's Drug Agency to redeploy its limited resources that are being used to administer the biosimilar process to other drug reviews and program-related issues.

Effective immediately, submissions for biosimilars should be filed directly with the jurisdictions and pCPA. There may be rare circumstances where a Canada's Drug Agency review may be required for a biosimilar (e.g., the reference product was not reviewed by Canada's Drug Agency or a drug plan); Canada's Drug Agency and the drug plans would consider these on a case-by-case basis. Any manufacturers with questions regarding eligibility for biosimilar submissions should contact Canada's Drug Agency ([email protected]).

Important notes:

• Any manufacturers with ongoing biosimilar reviews that will not be completed by June 1, 2019 will receive a refund for the application fee.
• Manufacturers with pending biosimilars have been notified of these revisions to the review process and advised not to file submissions with Canada's Drug Agency.

Pan-Canadian Oncology Drug Review

1. Update on the Proposal to Integrate Key Functions of the Cancer Drug Implementation Advisory Committee Into the Canada's Drug Agency pan-Canadian Oncology Drug Review (pCODR) Process

On February 28, 2019, Canada's Drug Agency — in collaboration with the Canadian Association of Provincial Cancer Agencies — issued a consultation proposal to integrate key functions of the Cancer Drug Implementation Advisory Committee into the Canada's Drug Agency pCODR process. We would like to thank all stakeholders who responded to the consultation. Canada's Drug Agency continues to assess all stakeholder feedback and is taking a balanced approach to ensure that the application of these comments would be made in the best interest of patients and the public.

We are working to target an implementation date of July 1, 2019, whereby any pre-submission information form received by the pCODR program on or after July 1, 2019 will incorporate the proposed implementation functions. Canada's Drug Agency will issue a notice prior to the implementation of any applicable changes to Canada's Drug Agency pCODR procedures and guidelines, so as to reduce the impact of timing on those working on submissions to the process. Revised processes and guideline documents should be publicly available on the Canada's Drug Agency website on June 12, 2019.

Common Drug Review

2. Updated Redaction Request Process

Canada's Drug Agency has encountered several challenges with the existing redaction request process for the clinical and pharmacoeconomic review reports, including the following:

• with manufacturers submitting additional redaction requests at the time they are sent the reports to validate the redactions that were previously requested (i.e., additional confidential information that was not initially identified when reviewing the draft reports)
• with the need for an additional review by manufacturers to identify confidential information that may have been added to the clinical and/or pharmacoeconomic report, based on manufacturer comments to Canada's Drug Agency
• with the need for an additional review by manufacturers to identify confidential information that may have been added based on finalized category 1 requirements (in the case of a submission filed on a pre-Notice of Compliance (NOC) basis).

As noted in the Canada's Drug Agency August 2018 consultation on posting manufacturer comments, the agency is interested in ensuring that the redaction process avoids the need for multiple redaction requests. As such, Canada's Drug Agency has revised the CDR procedure to shift the timing of the redaction request process to after the Canada's Drug Agency Drug Expert Committee (CDEC) Final Recommendation has been issued. This will allow manufacturers the opportunity to review and request redactions from the final Canada's Drug Agency review reports, eliminating the issues noted previously, and making the process more efficient for both Canada's Drug Agency and manufacturers.

This new process is effective for all submissions, resubmissions, and requests for advice that were filed on or after May 1, 2019.

Details regarding the new redaction process for CDR documents have been incorporated into an updated version of the Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review.

3. Updated Advance Notification Process

Canada's Drug Agency has recently encountered an increasing number of situations where applicants are not providing details of the economic evaluation when filing advance notification forms. This information is required in order for Canada's Drug Agency to prepare resources for the pending submission or resubmission. Canada's Drug Agency appreciates that this information may be incomplete when the advance notification form is initially filed; however, manufacturers are not following up with the complete details prior to filing the submission or resubmission.

Effective immediately, if the economic information is incomplete when initially submitting the advanced notification form, this information should be updated as soon as possible and submitted to Canada's Drug Agency no later than two weeks prior to filing the submission or resubmission.

4. Updated Clinical Review Templates

Canada's Drug Agency has updated the template used for the clinical reports prepared for standard reviews. Revisions include a new stakeholder input section that will summarize information from patient groups and clinicians earlier in the report, and moving evidence from non-randomized studies and indirect comparisons from the appendices into the main body of the report. Please see the link that follows for a sample of the new Canada's Drug Agency template:

• Canada's Drug Agency Common Drug Review Clinical Review Report Template.

5. Canadian Blood Services

Canada's Drug Agency is pleased to announce that a representative from Canadian Blood Services (CBS) has been added as an observer to the DPAC Formulary Working Group. The addition of CBS to this working group will allow Canada's Drug Agency, CBS, and the public drug plans to further collaborate, sharing information on drug topics that are of interest to all parties. The DPAC Formulary Working Group list has been updated to reflect this change.

6. Updated Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review

The Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review has been updated with the following revisions:

• the removal of details of the biosimilar review process
• details regarding the additional embargo period for the CDEC recommendations that are substantially revised during a request for reconsideration and/or request for clarification (previously communicated in Canada's Drug Agency Pharmaceutical Reviews Update – Issue 7)
• details regarding the new process for requesting the redaction of confidential information included in Canada's Drug Agency reports
• additional clarification included in the confidentiality guidelines regarding the sharing of information with members of the Institut national d'excellence en santé et en services sociaux (INESSS) expert review committee, who are participating in the discussion with the joint Canada's Drug Agency-INESSS clinical panels
• additional details regarding how and when patient groups are re-engaged in the CDR process following an initial call for patient input
• additional details regarding the pharmacoeconomic review process used by Canada's Drug Agency.

Applicants who have questions about specific requirements may contact Canada's Drug Agency for guidance on submission preparation by emailing [email protected].