Development of a Multi-Criteria Decision Analysis Rating Tool to Prioritize Real-World Evidence Questions for the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration.

The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration developed an MCDA rating tool to assess and prioritize potential post-market real-world evidence (RWE) questions/uncertainties emerging from public drug funding decisions in Canada. In collaboration with a group of multidisciplinary stakeholders from across Canada, the rating tool was developed following a three-step process: (1) selection of criteria to assess the importance and feasibility of an RWE question; (2) development of rating scales, application of weights and calculating aggregate scores; and (3) validation testing. An initial MCDA rating tool was developed, composed of seven criteria, divided into two groups. Group A criteria assess the importance of an RWE question by examining the (1) drug's perceived clinical benefit, (2) magnitude of uncertainty identified, and (3) relevance of the uncertainty to decision-makers. Group B criteria assess the feasibility of conducting an RWE analysis including the (1) feasibility of identifying a comparator, (2) ability to identify cases, (3) availability of comprehensive data, and (4) availability of necessary expertise and methodology. Future directions include partnering with the Canadian Agency for Drugs and Technology in Health's Provincial Advisory Group for further tool refinement and to gain insight into incorporating the tool into drug funding deliberations.

Considerations for Developing a Reassessment Process: Report from the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration's Reassessment and Uptake Working Group.

The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration was established to develop a framework for generating and using real-world evidence (RWE) to inform the reassessment of cancer drugs following initial health technology assessment (HTA). The Reassessment and Uptake Working Group (RWG) is one of the five established CanREValue Working Groups. The RWG aims to develop considerations for incorporating RWE for HTA reassessment and strategies for using RWE to reassess drug funding decisions. Between February 2018 and December 2019, the RWG attended four teleconferences (with follow-up surveys) and two in-person meetings to discuss recommendations for the development of a reassessment process and potential barriers and facilitators. Modified Delphi methods were used to gather input. A draft report of recommendations (to December 2018) was shared for public consultation (December 2019 to January 2020). Initial considerations for developing a reassessment process were proposed. Specifically, reassessment can be initiated by diverse stakeholders, including decision makers from public drug plans or industry stakeholders. The reassessment process should be modelled after existing deliberation and recommendation frameworks used by HTA agencies. Proposed reassessment outcome categories include maintaining status quo, revisiting funding criteria, renegotiating price, or disinvesting. Overall, these initial considerations will serve as the basis for future advancements by the Collaboration.

A Practical Methodology for Disaggregating the Drivers of Drug Costs Using Administrative Data.

BACKGROUND: Prescription drug expenditures represent a significant component of health care costs in Canada, with estimates of $28.8 billion spent in 2014. Identifying the major cost drivers and the effect they have on prescription drug expenditures allows policy makers and researchers to interpret current cost pressures and anticipate future expenditure levels. OBJECTIVES: To identify the major drivers of prescription drug costs and to develop a methodology to disaggregate the impact of each of the individual drivers. METHODS: The methodology proposed in this study uses the Laspeyres approach for cost decomposition. This approach isolates the effect of the change in a specific factor (e.g., price) by holding the other factor(s) (e.g., quantity) constant at the base-period value. The Laspeyres approach is expanded to a multi-factorial framework to isolate and quantify several factors that drive prescription drug cost. Three broad categories of effects are considered: volume, price and drug-mix effects. For each category, important sub-effects are quantified. RESULTS: This study presents a new and comprehensive methodology for decomposing the change in prescription drug costs over time including step-by-step demonstrations of how the formulas were derived. CONCLUSIONS: This methodology has practical applications for health policy decision makers and can aid researchers in conducting cost driver analyses. The methodology can be adjusted depending on the purpose and analytical depth of the research and data availability.