OBJECTIVES:

Alirocumab has been approved in Japan in 2016 for the treatment of high CV risk adults who require additional LDL-C lowering. Assessing effectiveness may be informative for formulary decision-makers.

METHODS

: A lifetime Markov model with annual cycle length was developed to estimate the incremental impact of alirocumab therapy on top of standard of care (SoC) vs. SoC alone in patients with LDL-C >= 70mg/dL and clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). Baseline characteristics and CV event risks will be estimated using the Japanese Medical Data Vision database, administrative claims data. In the model, patients could remain stable or progress to subsequent CV events such as acute coronary syndrome (ACS), coronary revascularization, ischemic stroke, CV death, or non-CV death. Each outcome was assigned a utility weight and cost, based on published sources. Results from the ODYSSEY OUTCOMES Trial will be used to estimate reductions in CV event risk. Alirocumab drug cost will be based on a list price of 550,752 JPY per year. The outcomes of interest in each arm included lifetime costs and quality adjusted life years (QALYs), as well as the incremental cost effectiveness ratio (ICER) of cost per QALY gained.

RESULTS

: Demographic information including patient comorbidities will be shared along with baseline LDL-C and CV event rates in both the treatment and comparative arms from the model after updates with the ODYSSEY OUTCOMES Trial data and local CV event rate from local real-world database analyses, utility and local Japanese cost information by June. Life time costs in the two treatments arms along with lifetime QALYs with incremental cost effectiveness ratios will be presented.

CONCLUSIONS

: Accounting for real world drug costs incurred, alirocumab therapy may be cost-effective for specific patient groups as the ICER falls within published acceptable WTP range.