CADTH Pharmaceutical Reviews Update — Issue 43

Program Updates  

 1. Budget Impact Analysis Consultation 

CADTH is taking steps to help drug sponsors enhance the budget impact analyses (BIAs) that are included in the submissions they file with our Drug Reimbursement Review program. At the 2023 CADTH Symposium, we introduced a BIA tool to help drug sponsors with the economic component of their submission, and that tool is now available for stakeholder feedback. Read CADTH’s consultation announcement to access the BIA tool and for complete details on how to participate. The consultation period will be open from January 25, 2024, to February 22, 2024.

Notably, the BIA tool is a template that drug sponsors may use to prepare their analyses that are submitted to CADTH, but they are not required to use this template. The draft version is posted for public consultation and feedback purposes only; it should not be used to inform policy decisions at this time.

2. New Streamlined CADTH Economic Reports   

CADTH communicated in June 2023 that we are examining opportunities to introduce a proportionate approach to reimbursement reviews based on complexity. To explore approaches to a more efficient review process, CADTH has identified situations where a streamlined approach to the CADTH economic review can be introduced. 

Effective immediately, a new streamlined economic review report may be applied in situations where the sponsor has filed a cost-utility analysis and the drug under review is unlikely to provide greater health benefits (i.e., efficacy or improved harms) compared to currently reimbursed comparator(s) based on sponsor-submitted clinical information. CADTH will conduct a streamlined economic review for these applications, with the following approach: 

• The CADTH economic report will focus on the comparative clinical information filed by the sponsor and whether it has demonstrated that the drug under review has similar health benefits compared to currently reimbursed comparator(s) (i.e., no evidence of superior efficacy or improved harms). 
• CADTH may not conduct reanalyses of the sponsor’s economic model in situations where CADTH determines that the criteria for a cost minimization analysis (CMA) are met (i.e., there is already a reimbursed drug for the same indication, or a drug demonstrates similar clinical effects compared to the most appropriate comparators).
• The conclusions of the CADTH economic report will be simplified for stakeholders, noting that there is insufficient evidence to support a price greater than currently reimbursed comparators.

This process change is an initial step toward a more proportionate approach to reimbursement reviews based on complexity. CADTH is in the process of developing a comprehensive plan to address the proportion approach initiative. Stakeholders will be apprised of the details and consulted on the proposed approach later this year. 

3. Revised Criteria for Submission of Cost Minimization Analyses 

As an additional part of the ongoing work on establishing a proportionate approach to reimbursement reviews, CADTH has revised the criteria for the submission of a cost minimization analysis (CMA), specifically removing the criterion that CMA must demonstrate cost savings relative to appropriate comparators using the disclosable prices in the CADTH submission. These changes are reflected in an updated copy of the Procedures for CADTH Reimbursement Reviews.  

4. Updated Processes for Meetings With CADTH and Industry 

4.1 Attendees at Reconsideration Meetings 

Effective immediately, sponsors may invite patient representatives to attend reconsideration meetings with CADTH. Extending the invitation to patient representatives will be optional and at the discretion of the sponsor. As the meetings may include the discussion of confidentially submitted information, sponsors are responsible for ensuring that all participants agree to maintain confidentiality of the proceedings. 

4.2 Extending the Duration for Pipeline Meetings 

CADTH is pleased to announce that pipeline meetings will be extended to 90 minutes to allow for more in-depth discussion with industry. This change is effective immediately and is reflected in updated procedures and applicable templates. 

5. Provisional Funding Algorithms 

When CADTH initiates an update to existing provisional algorithms, we will now communicate this information in the Weekly Summary newsletter. The update will include the target date for feedback on the draft report. Complete details on the provisional funding algorithm process are found in section 13 of the CADTH Procedures for Reimbursement Reviews. Subscribe to receive future issues of the Weekly Summary newsletter.