OBJECTIVES

: Alirocumab, a monoclonal antibody specific to PCSK9, is approved in Japan as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). The objective is to estimate the budget impact of alirocumab use in adult patients with HeFH or clinical ASCVD who are on statins and require additional lowering of LDL-C to <70 mg/dL in Japan.

METHODS

: A budget impact model was developed to understand pharmacy costs of therapy with statins ± other lipid-modifying therapy (LMT) over a 3-year projection period for 2 scenarios: 1) alirocumab available as an add-on therapy to statins; 2) alirocumab not available. Input parameters were derived from randomized controlled trials, epidemiologic studies, and real-world database analyses.

RESULTS

: In Japan, alirocumab utilization rate has been estimated to be 5% at 3 years. The increase in per member per month (PMPM) will be estimated in year 1 and year 3. In the US budget impact model, the PMPM was $0.46 in the first year and $1.36 in the third year. The model and accompanying results will be adapted to the Japan market. Sensitivity analyses, with maximum alirocumab utilization rate (e.g. 10% after 3 years) and the increase in pharmacy costs will be estimated per patient per year. Results sensitive to assumptions regarding the utilization of alirocumab such as patient eligibility criteria, and the model time frame will be identified. Cost offset based on ODYSSEY OUTCOMES trial data will be included.

CONCLUSIONS

: The introduction of alirocumab as a potential add-on therapy to statin for patients with ASCVD or HeFH requiring additional LDL-C lowering and its impact on the health care system in targeted PCSK9i prescribed patients will be presented.