OBJECTIVES

Inclisiran is a first-in-class, small-interfering ribonucleic acid (siRNA) that has been recently submitted to the Food and Drug Administration (FDA) for approval for the treatment of atherosclerotic cardiovascular disease (ASCVD) in patients with low-density lipoprotein (LDL) ≥70 mg/dL despite being on maximally tolerated statin therapy. We created a Markov model to estimate a range of value-based prices for inclisiran compared to currently available therapies: ezetimibe and the proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9s).

METHODS

Our Markov state-transition model used a health-system payer perspective to compare three strategies: (1) ezetimibe, (2) PCSK9s, (3) inclisiran. We used inputs from the ORION-10 and FOURIER trials, and relevant literature. We modeled a lifetime horizon using a 3% discount rate for costs and quality-adjusted life-years (QALYs). To estimate the thresholds for which inclisiran would be considered cost effective, we adopted a willingness-to-pay threshold of $150,000 per QALY.

RESULTS

Inclisiran therapy is projected to provide 11.49 QALYs. Following a $150,000 willingness-to-pay threshold, a projected value-based price benchmark for inclisiran would be $4,701 annually or $392 per month when compared to ezetimibe, and $9,995 or $833 per month when compared to PCSK9 monoclonal antibodies.

CONCLUSIONS

The annual cost of first-in-class inclisiran for clinical ASCVD patients would need to fall between $4,701 - $9.995 for it to be considered cost-effective compared to current strategies. Value-based pricing benchmarks will be key to informing stakeholders in negotiating pricing arrangements for providing accessibility to inclisiran as a novel treatment option.