Table A1.

Initial set of MCDA criteria.

Criteria
Group A—Criteria to Assess the Importance of the RWE Question or Uncertainty Identified
Drug’s perceived incremental benefit: Extent of perceived net clinical benefit of the therapy compared to existing options (accounting for quality of evidence, unmet need, and any other contextual factors). The ‘perceived’ net clinical benefit is based on the currently available evidence.
Magnitude of uncertainty identified: Magnitude of the uncertainty identified in cancer drug funding deliberations (the uncertainty can be about toxicity, clinical effectiveness, quality-of-life, treatment pattern, generalizability of benefits, costs, etc.)
Impact of uncertainty: Potential impact of the uncertainty on the balance between incremental benefits and incremental costs
Relevance to payer: Consider the potential effect of the identified uncertainty on funding status, funding pathways, budget-impact analysis, etc.
Group B—Criteria to Assess the Likelihood of Finding an Answer to the RWE question or Resolving the Identified Uncertainty
Sample size: Extent to which it is likely that there will be enough patients to have a sufficient sample size
Comparator: Likelihood that a relevant Canadian comparator population can be identified. A ‘relevant’ comparator is a group that has been treated according to current Canadian standard of care regimen.
Time: Likelihood that there is enough time to accrue and follow patients for the outcomes of interest
Data: Likelihood that there will be available and relatively complete data for cohort receiving therapy and the comparator, including data for important patient and clinical characteristics to ensure comparability between groups, as well as measure and relevant outcomes
Expertise: Availability of expertise to conduct the RWE analysis
Methodology: Availability of appropriate methodology (with consideration given to current data availability and the clinical context)