CADTH Pharmaceutical Reviews Update — Issue 25

See Pharmaceutical Reviews Update ― Issue 25 for important news and information regarding CADTH’s drug review programs. Highlights from this issue include:

• patient and clinician group input
• sponsor review of drug program feedback for confidential information
• feasibility of adoption reimbursement conditions
• new information during the reconsideration phase
• clarifications and revisions for economic requirements.

Update for Patients and Communities

When you submit patient input to CADTH, our pharmaceutical review team prepares a summary of all the submissions received from patient groups. We send it to you to confirm that it’s accurate. We then add the summary to our Clinical Report and your original input is posted separately on our website.

Moving forward, we will no longer be summarizing your input to CADTH. Instead, we will add your original patient input, written in your own words, directly into our Clinical Report. With your full input included in the report, we will end sharing it as a separate document on our website. Expert committee members will continue to receive your full patient input and we will continue to reach out to you when a committee or review team member has follow-up questions for you. If you have any comments or questions about this change, please contact [email protected] or call CADTH at 1 866 988 1444.

Thank you for taking the time to read and comment on patient input summaries over the years and for the continued work you put into the patient input and feedback on draft recommendations that you submit to CADTH.

CADTH Program Updates

1. Patient and Clinician Group Input

CADTH will be phasing out the CADTH-authored detailed summaries of patient group input and clinician group input in our clinical reports and will be including the actual input that has been received from the groups within our reports. CADTH will continue to provide brief summaries of this input in the executive summary of the clinical report and in the recommendation documents. As with the current process, CADTH will continue to reflect on this input throughout all phases of the review, including in the appraisal and interpretation section of the reports and recommendations.

These revisions are being implemented for the following reasons:

• to provide the sponsor with all patient group and clinician group input at the time the sponsor is providing comments to CADTH on the draft review report(s)
• to place greater emphasis on the individual submissions from patient groups and ensure that the patient voice is accurately reflected in the CADTH reports
• to reduce duplication of effort for processing the input from clinical specialists, help manage situations where clinician groups file input later in the process, and simplify the overall reports by focusing on areas where there is consensus or a divergence of opinions from the specialists.

As a result of these changes, the Procedures for CADTH Reimbursement Reviews have been updated to reflect that CADTH will no longer distribute a summary of the input to the patient groups for their review and will no longer post the patient group input and clinician group input as a separate document (it will be fully integrated into the clinical report). In order to accommodate delayed filing of stakeholder input and situations where the CADTH templates have not been used or incorrectly used (e.g., failure to provide input in the correct file format), sponsors may receive a separate document with the consolidated stakeholder input, together with the draft review report(s). The reports and stakeholder input will subsequently be merged by CADTH.

2. Feasibility of Adoption Reimbursement Conditions

CADTH is currently undertaking a review of the deliberative processes used by its expert committees. As an interim step toward alignment, CADTH has added “Feasibility of adoption into the health system” as a category of the reimbursement condition within the Procedures for CADTH Reimbursement Reviews. This category of the reimbursement condition provides an assessment of the ease with which the drug can be adopted into the overall health care and cancer care systems. The feasibility of adoption may be noted in the following scenarios:

• economic feasibility may be noted when there are concerns regarding the affordability of the drug under review based on the budget impact assessment
• organizational feasibility may be noted when there are concerns regarding the ability of the health system to adopt the drug under review based on an assessment of health system enablers and barriers to implementation, as identified by the participating drug programs, inclusive of all elements: operational, capital, human resources, legislative, and regulatory requirements.

These conditions have been used effectively within the pan-Canadian Oncology Dug Review Expert Review Committee (pERC) deliberative process and will be expanded to all reimbursement reviews effective for drugs targeting the October 2021 expert committee meetings.

3. Reviewing Drug Program Feedback on Draft Recommendation for Confidential Information

At the time of issuing the final recommendation, CADTH will be providing the sponsor with a copy of the stakeholder feedback that was received on the draft recommendation for the purposes of identifying any potentially confidential information that may have been included in the feedback from the participating drug programs. This is offered as an additional measure in the event that the drug programs have considered confidential information within the unredacted draft recommendation when providing input to CADTH. This new step in the procedure will streamline the posting process and avoid the need for case-by-case discussions with the sponsor if the drug programs have referenced data in the feedback, which could be considered confidential by the sponsor. CADTH’s procedures remain unchanged in other aspects and all feedback from the sponsor must be disclosable and will be posted on the CADTH website.

4. New Information in the Reconsideration Phase

Effective immediately, CADTH has revised the reconsideration process to allow sponsors to provide new information in selected circumstances. The decision to allow new information during the reconsideration process will be made solely by CADTH, based on the following considerations:

• the new information has been provided to try and address an important gap in the evidence that has been identified by the CADTH expert committee
• the sponsor confirms in writing that the new information was not available during the review phase of the CADTH reimbursement review process (i.e., it could not have been included in the initial application without substantially delaying the overall review process and was not available at the time of providing comments on the draft CADTH reports)
• the expert committee has concluded that the drug under review has the potential to address an important unmet medical need
• the drug under review was reviewed by Health Canada through an expedited review pathway (e.g., priority review)
• the sponsor provides the new information in a format that allows CADTH to complete a review and appraisal of the data (e.g., in accordance with the CONSORT reporting guidelines).

As the inclusion of new information during the reconsideration process cannot reasonably be anticipated by CADTH, the timelines for managing these situations will be established on a case-by-case basis. Any sponsors who feel they have new information that may address a clear gap in the evidence that has been identified by the CADTH expert committee should identify the new information within the reconsideration request template when submitting the request.

5. Revised Economics Requirements and Additional Clarifications

CADTH has revised the economic requirements section of the Procedures for CADTH Reimbursement Reviews, as follows:

• CADTH is now requiring sponsors to state the version of Excel that is required to run the economic model (including sub-version and specific update information). This revision will assist in minimizing issues when CADTH is running the economic models filed by sponsors.
• CADTH has provided additional clarification regarding the requirements for model distributions (e.g., Weibull, Gompertz, and so forth) to denote that these should be provided as 1-piece distributions in models unless an appropriate rationale for a piecewise analysis has been provided by the sponsor.
• CADTH has provided additional clarification on the base case population for the budget impact analysis (i.e., per the Health Canada indication).