On June 5, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced a series of process improvements it plans to explore or add to its drug reimbursement review process. These changes – aimed at gaining efficiencies, reducing timelines and improving transparency – include:

• Effective June 8, 2023: Addition of pipeline meetings with drug sponsors
• Addition of pipeline meetings with drug sponsors
• Development of a budget impact analysis (BIA) template
• Streamlining review requirements for certain drug products
• Exploring advancement of innovative concepts such as outcome-based agreements (OBA) and incorporating new evidence midstream during a review
• Adding in-review meetings for certain drugs
• Introducing a proportionate approach to Reimbursement Reviews based on complexity
• For drugs with broad system implications, introducing implementation advice panels for diagnostics
• Increasing transparency and alignment with international practice in committee deliberations
• For select oncology drugs, delivering provisional funding algorithms in parallel with Reimbursement Reviews
• Piloting a new formulary management committee under which some of the new processes will be trialed.

CADTH also announced Industry Fees will increase by both an inflationary amount (approximately 6%) and an amount to enable the process improvements described. Effective July 17, 2023:

1.  Standard Review Fees are $98,670, representing an increase of $22,770
2.  CADTH Scientific Advice services are $80,000 to $125,000, representing an increase of $15,000 to $25,000 in the fee range

CADTH anticipates implementing these changes in the near term and will engage with key stakeholders on next steps. PDCI will report as more details become available on roll-out of these potential changes and any associated stakeholder consultations.

For more information on these changes, please see CADTH’s Announcement or contact PDCI’s Ara Salazar, Director, Market Access at ara.salazar@pdci.ca.

CADTH’s announcement follows other recent CADTH updates aimed at advancing the use of real-world evidence (RWE) in Canadian regulatory and health technology assessment, and improving transparency by adopting the GRADE approach for CADTH’s Reimbursement Reviews.

On May 16, 2023, CADTH published its final Guidance for Reporting Real-World Evidence, detailing best practices for reporting RWE and highlighting methodological considerations to help standardize RWE submissions and maximize relevance of its use by Canadian regulatory and HTA bodies. This document follows a consultation on draft guidance in which CADTH received input from 54 stakeholders. A Response to Stakeholder Feedback document summarizes the changes that have now been incorporated.  Overall, the final guidance updates provide improved clarity and more details on RWE reporting to address stakeholder feedback. Specifically,

• The RWE definition has been aligned with Health Canada’s RWE definition
• The submission checklist includes 96 items to be reported on (up from 92 items in the draft Guidance). 
• A new section titled Implementation Considerations has been added, which outlines how and where this document can be used now and in the future
• Transparency remains a key theme and is viewed as instrumental to providing Canadian regulators and HTA agencies with the information required to inform decision-making. 

CADTH has now adopted the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach for communicating the level of certainty of a body of evidence within CADTH Reimbursement Reviews. This rating tool will be used to assess various types of evidence, not just clinical trials. It’s implementation is aligned with CADTH’s goal towards greater transparency and evidence-based decision making. The GRADE approach will be implemented for  

• all non-oncology drug applications received on or after April 5, 2023 
• all oncology drug applications received on or after April 26, 2023

A new table in the Executive Summary section will present this information in a standardized format. It will not change how the evidence is assessed by the CADTH review teams; rather, it is CADTH’s hope that GRADE will provide greater consistency, transparency, and structure in how the assessments are communicated. Uncertainties remain with the implementation of the GRADE approach and any potential downstream implications(e.g., on payer reimbursement negotiations and decisions). PDCI will continue to monitor and assess the potential effects for submission sponsors.

For more information on RWE or the GRADE Approach, please contact PDCI’s Nabil Tadros, Director, Clinical Consulting at Nabil.Tadros@pdci.ca.