Pharmacoeconomic review report : (HLS Therapeutics Inc.) : indication : prevention of cardiovascular events in statin-treated patients. Icosapent ethyl (Vascepa) / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

Canadian Agency for Drugs and Technologies in Health, author, issuing body.

Language:

English

Subjects (All):

Cost effectiveness.

Physical Description:

1 online resource (29 pages) : illustrations

Edition:

Version: Final.

Place of Publication:

Ottawa (ON) : Canadian Agency for Drugs and Technologies in Health, 2020.

Summary:

Icosapent ethyl (Vascepa) is indicated for reduction of cardiovascular events (CVEs; e.g., cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides and established cardiovascular disease (CVD), or with diabetes and at least one other cardiovascular risk factor. Icosapent ethyl is available in 1 g capsules with a recommended daily dose of 4 g, taken as two 1 g capsules twice daily. At the sponsor-submitted price of 2.45 per 1 g capsule, the annual cost of treatment is 3,577 per patient. The sponsor's reimbursement request was in accordance with its Health Canada indication. The sponsor submitted a cost-utility analysis based on a Markov state-transition model that assessed the costs and quality-adjusted life-years (QALYs) of treatment with icosapent ethyl in addition to statin therapy compared to statin therapy alone. The analysis was conducted over a 20-year time horizon from the Canadian public health care payer perspective, with costs and QALYs discounted at 1.5%. Patients entered the model in the "CVE-free" health state and remained in that state until experiencing either a non-fatal or fatal CVE (including CVE-related death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and unstable angina). Survivors of a non-fatal CVE would enter and remain in a "post-non-fatal CVE" health state in the following model cycles, where they could experience subsequent non-fatal CVEs or fatal CVEs. A baseline risk of non-cardiovascular death was applied in the model. Data from the statins-alone arm of the REDUCE-IT trial, extrapolated using parametric survival methods, was used to inform the baseline model transition from the CVE-free state to the post-non-fatal CVE state. Relative treatment effects and costs for icosapent ethyl plus statins were applied for the first five years of the model time horizon, with relative treatment effects based on the hazard ratios (HRs) derived from the REDUCE-IT trial comparing time to first primary end point for each CVE included in the model in patients treated with icosapent ethyl plus statins compared to statins alone. In the sponsor's base case, icosapent ethyl plus statin therapy was associated with higher costs (12,523) and more QALYs (0.29) than statin therapy alone, resulting in an incremental cost-utility ratio (ICUR) of 42,797 per QALY gained.

Notes:

Description based on publisher supplied metadata and other sources.