The Canadian Agency for Drugs and Technologies in Health (CADTH) has published Issue 28 of its Pharmaceutical Reviews Update. Below PDCI has summarized the updates and clarifications, and provided implications for manufacturers. CADTH’s update also includes two consultations open until April 14, one concerning a streamlined drug class review process that could result in revised CADTH recommendations.  

New Application Requirement: Summary of Clinical Evidence Template (Section 5.2) 
Following a 2019 consultation, CADTH will implement a new application requirement called the Summary of Clinical Evidence Template which will apply for both standard and complex review applications.  The new requirement will be effective for applications received on or after October 17th (for oncology drugs) and on or after October 31st (for non-oncology drugs). 

Key information:   

• The template has five sections for the sponsor to summarize key clinical information for the drug under review.  
• Sponsors will be required to conduct a systematic literature review (SLR) of the beneficial and harmful effects of the drug for the indication under review in accordance with instructions provided in Section 2 of the template. Note that an SLR will not be required for tailored review process applications. 
• A Research Information Systems (RIS) file must be included in the application with all references cited in the template 
• Information provided by the sponsor in the template will be used by the CADTH review teams to prepare the Clinical Review Report. It will not be shared publicly on the CADTH website in its submitted form. 

This procedural revision will have significant implications for sponsors planning new drug submissions to CADTH. The information now required from the manufacturer in the Summary of Clinical Evidence template is currently produced by CADTH staff through a resource-intensive process that includes the development of a systematic review protocol with input and validation from external experts, the development and execution of a search strategy by medical librarians, and the screening, identification, extraction, and interpretation of clinical trial data by dedicated reviewers. CADTH is launching this procedural revision to alleviate internal resourcing constraints due to the increasing volume of submissions, and to align with international HTA processes. Sponsors will need to ensure that their submitted SLR meets the standards set out by CADTH. 

Clarifications and Revisions 

1. Reconsideration Process: CADTH will not accept reconsideration requests related to the rationale underlying price conditions noted in the recommendation. CADTH’s view is that these rationale are based on the findings of the CADTH economic report (as opposed to the committee’s recommendation), and because the sponsor has already had an opportunity to review and comment on the pharmacoeconomic report prior to the expert committee meeting.  
2. Pharmacoeconomic Application Guidelines (updated section 5.6): CADTH has clarified that only 1 economic evaluation can be included per CADTH review of a single indication. Specifically, CADTH will not accept: 

• More than 1 economic model for the review of a single indication
• Submission of both a cost-minimization analysis and cost-utility analysis for the review of a single indication 

1. Confidentiality Guidelines (Appendix 1): CADTH has provided additional clarity on the acceptance of redaction requests including a new summary table outlining common sources of information and whether the information is considered confidential by CADTH.  
2. Reimbursement Status of Comparators Updated Template (Section 5.8): Revised to accommodate drugs reviewed through the interim plasma protein process.  

Stakeholder Feedback  
CADTH is seeking feedback by April 14, 2022 on:

• a proposed new pharmaceutical review process that would allow reimbursement recommendations in select cases where there is no sponsor to file an application.  
• a streamlined approach that would offer an expedited alternative to the current therapeutic review process.  The proposed process would allow for class reviews to take place in 4-6 months (instead of the current 9-12 months), and as with standard therapeutic class reviews, may result in revised reimbursement recommendations. 

Please see CADTH’s Pharmaceutical Reviews Update – Issue 28 for more information 

Please contact Ara Salazar, Director, Market Access at ara.salazar@pdci.ca for any questions or further information.