Newer cholesterol-lowering agents: What you must know

Effective, but expensive. At its current list price of approximately $14,000 per year,⁹ evolocumab, added to standard therapy in patients with ASCVD, exceeds the generally accepted cost-effectiveness threshold of $150,000 per quality-adjusted life year (QALY) achieved.²⁰ Similar analysis in patients with HeFH estimated a cost of $503,000 per QALY achieved with evolocumab.²¹ The outcomes of cost-effectiveness analyses hinge on the event rate in the study population and the threshold for initiating therapy. For the FOURIER trial participants, with an annual event rate of 4.2 per 100 patient-years, a net annual price of approximately $6700 would be necessary to meet a $150,000 per QALY threshold.²²

At 2015 prices, the addition of PCSK9 inhibitor therapy for all eligible patients would reduce cardiovascular care costs by an estimated $29 billion over 5 years but would also increase drug costs by an estimated $592 billion, representing a 38% increase over 2015 prescription drug expenditures.²¹ Treatment of less than 20 million US adults with evolocumab at the cost of this single drug would match the entire cost for all other prescription pharmaceuticals for all diseases in the United States combined.²³

In 2012, 27.9% of US adults ages 40 years and older were taking prescribed lipid-lowering treatment; 23.2% were taking only statins.²⁴ If the 2013 American College of Cardiology/American Heart Association cholesterol treatment guidelines²⁵ were fully implemented, an estimated additional 24.3% of the US population would be treated with statins.²⁶ Full implementation of the more conservative USPSTF guidelines would result in an additional 15.8% of the US population initiating statin therapy.²⁶ The same cost-effectiveness analysis evaluating evolocumab use estimated that initiating statins in these high-risk populations not currently using statins would save $12 billion in cardiovascular care over 5 years.²¹

Adding a PCSK9 inhibitor to statin therapy consistently decreases LDL-C levels further by around 60%.

Until the cost of PCSK9 inhibitors decreases to a justifiable level and outcomes of longer term studies are available, consider prescribing other adjunctive treatments for patients who have not achieved LDL-C goals with statin therapy alone. Generally, reserve use of PCSK9 inhibitors for the highest-risk adults: those with HeFH or clinical ASCVD who must further lower LDL-C levels. Some insurers, including Medicare, are covering PCSK9 inhibitors, but many patients have difficulty obtaining coverage.²⁷

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