Table 1.
Updated MCDA Rating Tool Criteria.
| Criteria |
|---|
| Group A—Criteria to Assess the Importance of the RWE Question |
| Drug’s perceived incremental benefit: Extent of perceived net clinical benefit of the therapy compared to existing options based upon clinical evidence (accounting for quality of evidence, unmet patient need, and any other contextual factors) |
| Magnitude of uncertainty: 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 total incremental benefits and/or total incremental costs (balance between incremental benefits and incremental costs) compared to relevant Canadian comparator treatment |
| Relevance of uncertainty: Relevance to decision-makers (for example, consider the potential effect of the identified uncertainty on funding status, funding pathways, budget-impact, etc.) |
| Group B—Criteria to Assess the Likelihood of Finding an Answer to the RWE question |
| Comparator: Likelihood that a relevant Canadian comparator population of sufficient sample size can be identified within a reasonable time frame (i.e., within time to be relevant to the funding decision) |
| Sample size: Extent to which it is likely that there will be enough patients to have a sufficient sample size within a reasonable time frame (i.e., within time to be relevant to the funding decision) |
| Data: Likelihood that there will be available, high quality and complete data for the cohort receiving the therapy of interest and the comparator, including data for important patient and clinical characteristics to ensure comparability between groups, as well as 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) |
Abbreviations: ICER: incremental cost-effectiveness ratio; pCODR: pan-Canadian Oncology Drug Review; RWE: real-world evidence.