Cost-effectiveness of Icosapent Ethyl for High-risk Patients With Hypertriglyceridemia Despite Statin Treatment.

MedStar author(s):
Citation: JAMA Network Open. 5(2):e2148172, 2022 02 01.PMID: 35157055Institution: MedStar Health Research Institute | MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Research Support, Non-U.S. Gov'tSubject headings: *Cost-Benefit Analysis | *Eicosapentaenoic Acid/ec [Economics] | *Eicosapentaenoic Acid/tu [Therapeutic Use] | *Hydroxymethylglutaryl-CoA Reductase Inhibitors/ec [Economics] | *Hydroxymethylglutaryl-CoA Reductase Inhibitors/tu [Therapeutic Use] | *Hyperlipidemias/dt [Drug Therapy] | *Hyperlipidemias/ec [Economics] | Aged | Eicosapentaenoic Acid/aa [Analogs & Derivatives] | Female | Humans | Male | Middle Aged | Risk FactorsYear: 2022Name of journal: JAMA network openAbstract: Conclusions and Relevance: This study suggests that, both in-trial and over the lifetime, IPE offers better cardiovascular outcomes than standard care in REDUCE-IT participants at common willingness-to-pay thresholds.Design, Setting, and Participants: An in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018. Analyses were performed from a US health care sector perspective. Statistical analysis was performed from March 1, 2018, to October 31, 2021.Importance: The Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins.Interventions: Patients were randomly assigned to IPE, 4 g/d, or placebo and were followed up for a median of 4.9 years (IQR, 3.5-5.3 years). The cost of IPE was Main Outcomes and Measures: Main outcomes were incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness.Objective: To estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment.Results: A total of 4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive IPE, and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive standard care. Treatment with IPE yielded more QALYs than standard care both in trial (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and over a lifetime projection (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In-trial, total health care costs were higher with IPE using either SSR cost (All authors: Andrade K, Ballantyne CM, Bellows BK, Bhatt DL, Boden WE, Bress AP, Brinton EA, Derington CG, Dolman S, Jacobson TA, Johnson J, King JB, Kolm P, Miller M, Steg PG, Tajeu GS, Tardif JC, Weintraub WS, Zhang ZOriginally published: JAMA Network Open. 5(2):e2148172, 2022 02 01.Fiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-02-22
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Journal Article MedStar Authors Catalog Article 35157055 Available 35157055

Conclusions and Relevance: This study suggests that, both in-trial and over the lifetime, IPE offers better cardiovascular outcomes than standard care in REDUCE-IT participants at common willingness-to-pay thresholds.

Design, Setting, and Participants: An in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018. Analyses were performed from a US health care sector perspective. Statistical analysis was performed from March 1, 2018, to October 31, 2021.

Importance: The Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins.

Interventions: Patients were randomly assigned to IPE, 4 g/d, or placebo and were followed up for a median of 4.9 years (IQR, 3.5-5.3 years). The cost of IPE was .16 per day after rebates using SSR Health net cost (SSR cost) and .28 per day with wholesale acquisition cost (WAC).

Main Outcomes and Measures: Main outcomes were incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness.

Objective: To estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment.

Results: A total of 4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive IPE, and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive standard care. Treatment with IPE yielded more QALYs than standard care both in trial (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and over a lifetime projection (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In-trial, total health care costs were higher with IPE using either SSR cost ( 8786) or WAC ( 4544) than with standard care ( 7273; mean difference from SSR cost, 513 [95% CI, 55- 870]; mean difference from WAC, 271 [95% CI, 911- 630]). Icosapent ethyl cost 2311 per QALY gained using SSR cost and 07218 per QALY gained using WAC. Over a lifetime, IPE was projected to be cost saving when using SSR cost ( 95276) compared with standard care ( 97064; mean difference, - 788 [95% CI, - 735 to 159]) but to have higher costs when using WAC ( 02830) compared with standard care (mean difference, 766 [95% CI, 094- 0438]). Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than 0000 per QALY gained when using SSR cost and a 72.5% probability of costing less than 0000 per QALY gained when using WAC.

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