CADTH Pharmaceutical Reviews Update — Issue 32 

See Pharmaceutical Reviews Update ― Issue 32 for important news and information regarding CADTH’s drug review programs. Highlights from this issue include: 

• changes to the process for requesting redactions 
• new standardized dates and times for pre-submission and reconsideration meetings  
• clarification of pharmacoeconomic requirements 
• Consultation on real-world evidence reporting guidance 
• CADTH Symposium call for abstracts 
• CADTH Information Session 

CADTH Program Updates 

1. New Process for Requesting the Redaction of Confidential Information  
   CADTH has revised the process for sponsors to request the redaction of confidential information in CADTH reports. Effective immediately, sponsors will now be required to highlight confidential information in a word document as opposed to a PDF file. Sponsors will now receive a word document with tracked changes locked and will be requested to highlight confidential information in yellow. Other than the change in file format, there are no other changes to the redaction request process. In accordance with the existing process, the sponsor must continue to identify confidential information using a identification of confidential information form and CADTH will provide responses. Sponsors must not alter any of the text in the CADTH report (this will result in the document not being accepted by CADTH and returned to the sponsor for revision). 
    

2. New Standardized Dates and Times for Meetings with Industry 
   Effective as of January 2023, CADTH is introducing standardized dates and times for pre-submission meetings and reconsideration meetings. This change will help streamline the process and ease the administrative burden for CADTH and industry. CADTH will now offer these meetings only in the following timeslots (no exceptions will be made):  
    

   First week of the month:	Monday: 9:30 a.m. to 11:00 a.m. ET   Thursday: 1:00 p.m. to 2:30 p.m. ET  Friday: 1:00 p.m. to 2:30 p.m. ET
   Second week of the month	Monday: 9:30 a.m. to 11:00 a.m. ET   Friday: 1:00 p.m. to 2:30 p.m.ET
   Third week of the month:	Monday: 9:30 a.m. to 11:00 a.m. ET   Thursday: 1:00 p.m. to 2:30 p.m. ET  Friday: 1:00 p.m.to 2:30 p.m. ET
   Fourth week of month:	Monday: 9:30 a.m. to 11:00 a.m. ET   Friday: 1:00 p.m. to 2:30 p.m. ET

   
   Each meeting will remain as a maximum of 1 hour. Meeting slots will be assigned on a first-come, first-served basis. The pre-submission meeting and reconsideration request forms have been modified to accommodate the new standardized times for these meeting. As always, sponsors are encouraged to arrange pre-submission meetings well in advance of the targeted date for filing the application.
    

3. Clarification of Pharmacoeconomic Application Guidelines CADTH has revised the Procedures for CADTH Reimbursement Reviews to add clarifications regarding the using of the unit costs within the economic model and budget impact models, and the provision of disaggregated life-years, quality-adjusted life-years (QALYs), and costs within the economic model. 

CADTH Launches Consultation on Real-World Evidence Reporting Guidance 

Today, CADTH, on behalf of the Real-World Evidence Steering Committee, launched a public consultation to solicit feedback on a pan-Canadian guidance document that will inform the use of real-world evidence (RWE) that may be submitted for consideration in regulatory and reimbursement decision-making. 

The purpose of the guidance document is to highlight best practices for reporting, as well as important methodological considerations that can help to standardize RWE submissions and maximize their relevance for regulators and HTA bodies in Canada. Importantly, the proposed guidance aligns with existing RWE guidance from international regulators and HTA bodies, while providing strong consideration of the pan-Canadian health care environment. 

As part of the engagement process, an online consultation opens November 10, 2022, and runs until January 6, 2023. CADTH will also host a webinar for stakeholders on December 2, 2022. The webinar will describe the process used to develop the guidance and the type of feedback that CADTH is seeking. It will also provide a forum for stakeholders to ask questions about the consultation process.  

CADTH Events 

1. CADTH Symposium Call for Abstracts 
   CADTH is now accepting abstracts for workshops, panels, breakfast sessions, oral presentations, and posters for the 2023 CADTH Symposium to be held from Tuesday, May 16 to Thursday, May 18, 2023. 
   Submission deadline: 5:00 p.m. ET on Friday, December 16, 2022. 
   
   The 2023 Symposium is a 3-day hybrid event that will provide both in-person and virtual attendance options. The in-person program will take place at the Shaw Centre in Ottawa, Ontario. 
   
   The 2023 theme is Shaping Future-Ready Health Systems. Registration will open in early 2023. Questions may be sent to [email protected]. 
   
   Abstracts must be submitted online via the Symposium website.  
    
2. Hold the Date - CADTH Information Session 
   Event Date: Thursday, December 8, 2022 
   Time: 1:00 p.m. to 4:00 p.m. ET 
   The annual CADTH Information Session is an opportunity for all interested stakeholders to get the latest information about CADTH’s priority initiatives and process changes, including a report on progress since the launch of CADTH’s Strategic Plan for 2022–2025. A highlight of the session is the Open Forum, where attendees can direct questions to CADTH President and CEO Suzanne McGurn and other senior staff. 
   
   There is no charge to attend this virtual session, but advance registration is required. 
   
   Questions may be sent to [email protected].