CADTH Pharmaceutical Reviews Update — Issue 35

See Pharmaceutical Reviews Update ― Issue 35 for important news and information regarding CADTH’s drug review programs. Highlights from this issue include:

• CADTH consultation on time-limited reimbursement recommendations

• Revised timing for issuing the call for patient and clinician Input

• important reminders about the sponsor summary of clinical evidence template

• instructions for inviting CADTH to attend Health Canada meetings

• reminder about revisions to the expert committee schedule.

CADTH Program Updates

1.    Consultation on Time-Limited Reimbursement Recommendations

CADTH is inviting stakeholder feedback on a proposal to introduce time-limited reimbursement recommendations. These are recommendations that would be issued in favour of reimbursement in a manner that is time-limited and contingent upon a future reassessment of additional evidence that addresses the uncertainty with the comparative clinical benefit and cost-effectiveness for the drug or drug regimen under review. Complete details of the proposed procedures, along with a summary document, are provided in CADTH Consultation: Proposed Process for Time-limited Reimbursement Recommendations.

To provide comments on the proposal, please use the feedback template. Feedback must be received by CADTH by 5:00 p.m. ET on May 1, 2023. For feedback to be considered, you must identify yourself to CADTH. Only 1 response per organization will be considered. If you have any questions about the feedback process, please email CADTH.

We thank you in advance for your interest in CADTH’s drug reimbursement review process.

2.    Revised Timing for Call for Patient and Clinician Input 

Effective immediately, the call for patient group input and clinician group input will be posted 29 business days in advance of the anticipated filing date for all applications (instead of 20 business days). There are no changes to the amount of time that the calls for input will be open. Patient groups and clinician groups will continue to have a total of 35 business days (from the date the call for input is issued in the weekly update) for preparing and submitting their input. This revision has been made to allow CADTH to receive input from patients and clinicians earlier in the review process. This change introduces important administrative efficiencies and allows CADTH to maximize the available time for each review. 

3.    Reminders: Sponsor Summary of Clinical Evidence Template

3. 1.  Summarizing Indirect Comparisons
   Sponsors are reminded that, in accordance with the template instructions and the Procedures for CADTH Reimbursement Reviews, all indirect comparisons included in an application must be summarized within section 4 of the sponsor summary of clinical evidence template. CADTH has encountered situations where sponsors have been including data from indirect comparisons within the submitted economic model that are not summarized within the indirect comparison section of the sponsor summary of clinical evidence template. These applications will not be accepted for review until the sponsor provides a revised sponsor summary of clinical evidence template that includes a summary of all of the indirect comparisons included in the application.

3. 2.  Sponsors Must Complete Section 2
   Sponsors are reminder that section 2 of the sponsor summary of clinical evidence template must be completed. In section 2, the sponsor must summarize the individual study methods and results for the pivotal trials as well as other studies that meet the systematic literature review protocol. It is not acceptable to skip section 2 and complete only section 4 of the template (i.e., the summary of indirect treatment comparisons). If you have questions regarding this template, please contact [email protected].

4.    Invitations from Industry to Attend Health Canada Pre-Submission or Pipeline Meetings 

CADTH welcomes opportunities to observe Health Canada presubmission meetings, pipeline meetings, or preclinical trial application consultation meetings. To streamline the process and reduce the administrative burden for sponsors, we ask that industry please note the following instructions:

Sending an Initial Request to CADTH

Where to send the initial request: To ensure proper tracking and triage of the meeting request, please ensure that the request for CADTH attendance is sent only to [email protected]. 

What information must be included: To ensure appropriate attendance at the meeting, please include the following information in the initial request to CADTH:

• meeting date and time 
• meeting location (i.e., confirmation that virtual attendance is acceptable)
• for presubmission meetings: the drug name and proposed indication
• for pipeline meetings: please note if the presentations will focus on a particular therapeutic area (e.g., oncology drugs)
• when the sponsor requires the list of CADTH attendees. 

Sending the Meeting Invitations 

Once CADTH has confirmed the list of attendees, please send the meeting invitation directly to the individuals identified by CADTH.

Uploading Meeting Materials

CADTH provides sponsors with a secure portal (the Pharmaceutical Submissions SharePoint site) to upload confidential meeting materials for presubmission and pipeline meetings. Please follow the instructions outlined in the Pharmaceutical Submissions SharePoint Site Set-Up Guide to request access to the site. Sponsors should request access to the Pharmaceutical Submissions SharePoint site 10 business days before the intended date of uploading the meeting materials so that CADTH can set up the secure area for the sponsor’s submission. In the event that this timeline cannot be met, please contact CADTH ([email protected]) as soon as possible to ensure the meeting materials can be submitted without delay.

CADTH Participation in the Meetings

At meetings organized by Health Canada, CADTH will observe the presentations and discussions. Sponsors with questions regarding the reimbursement review process should contact CADTH directly and arrange a presubmission meeting to have a detailed discussion about a pending application. 

5.    Reminder: Revisions to Expert Committee Schedule

Sponsors are reminded that CADTH posted an updated expert committee meeting schedule in December 2022 to reflect minor revisions to the date ranges for submission windows. Sponsors should carefully review the revised schedule and ensure that their planned advance notification and filing dates align with the updated submissions windows. 

To help sponsors target applications to a preferred expert committee meeting date, CADTH has added an additional column to the expert committee schedule that communicates the last day that a sponsor can provide advance notification to target the next available expert committee meeting. CADTH encourages sponsors to provide as much advance notice as possible to facilitate resource planning and budgeting for the pharmaceutical review programs. The last possible date for providing advance notice should not be viewed as the preferred target date for fulfilling the advance notice requirement.     

If you have questions regarding the revised schedule, please contact [email protected].