CADTH undertook reanalyses to address limitations in the sponsor’s submission, including using an appropriate value for the rate of ranolazine response, correcting health-state resource costs, adopting a wider range of possible utility values, and extending the analysis to a lifetime horizon.
CADTH was unable to address several important limitations associated with the model structure. Notably, the sponsor’s model considered only the frequency of angina symptoms and did not consider symptom severity, a clinically relevant marker of treatment response. It is unclear whether the small incremental quality-adjusted life-year (QALY) gains would provide meaningful benefit to patients. Given these limitations, the uncertainty regarding the strength of the comparative effectiveness evidence, and the generalizability of the pivotal trial evidence to a Canadian population, the comparative clinical effectiveness of ranolazine is highly uncertain. The cost-effectiveness of ranolazine is therefore also uncertain.
Version: Final (with redactions)
Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
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About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system.
