Medicare Use of the Leading PCSK9 Inhibitor Has More Than Doubled Since 2023. Now an Oral Option Arrives.

September is National Cholesterol Education Month, an annual observance focused on raising awareness of high blood cholesterol and its role in cardiovascular disease. The timing comes as the treatment landscape for elevated low-density lipoprotein cholesterol (LDL-C) continues to expand, with new drugs offering different ways to target PCSK9, a protein involved in regulating the body’s clearance of LDL-C.

About one in four U.S. adults has high levels of LDL-C, the type of cholesterol that contributes to plaque buildup in arteries and increases the risk of heart attack and stroke. Yet CDC data show that just 54.5% of U.S. adults who could benefit from cholesterol-lowering medication were taking it during 2013–2014. In March 2026, the American College of Cardiology and American Heart Association issued updated dyslipidemia guidelines that emphasize earlier treatment and lower LDL-C targets for people at higher cardiovascular risk.

Statins remain the foundation of LDL-C-lowering treatment, but they do not adequately lower cholesterol for everyone. Other treatment options include ezetimibe, bempedoic acid and PCSK9-targeting therapies. 

In July, the FDA approved Merck’s Lipfendra (enlicitide) as the first oral PCSK9 inhibitor. It is indicated as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia. Patients take it once daily as a tablet, marking the first oral option in a treatment category that previously consisted of injectable therapies, either self-administered or administered by a health care professional.

Merck set Lipfendra’s wholesale acquisition cost at about $315 for a 30-day supply, or roughly $3,800 annually. That is about half the cost of those injectable PCSK9 inhibitors already on the market. 

Lipfendra is the fifth FDA-approved PCSK9-targeted therapy since PCSK9 emerged as a potential therapeutic target in 2005. 

Amgen’s Repatha (evolocumab) received FDA approval in August 2015. It has become the leading PCSK9 inhibitor under Medicare Part D, according to CareSet’s analysis of CMS Chronic Conditions Data Warehouse data. In June 2026, more than 274,250 Medicare beneficiaries used Repatha, up from roughly 105,970 in January 2023.

The growth has coincided with an expansion of the drug’s FDA-approved population. In August 2025, the FDA broadened Repatha’s indication to include adults at increased risk for major cardiovascular events because of uncontrolled LDL-C, removing the previous requirement that patients have established cardiovascular disease.

Another major PCSK9 inhibitor under Part D is Regeneron and Sanofi’s Praluent (alirocumab), which was approved in July 2015. The number of Medicare beneficiaries using Praluent fluctuated around 40,000, with a slight decrease in 2024 and 2025. As of June 2026, about 43,730 beneficiaries were taking the medication. 

In 2026, Blue Cross Blue Shield of Michigan changed its Medicare formulary, replacing Repatha with Praluent as its preferred covered PCSK9 inhibitor. To ensure an uninterrupted transition, prior authorizations were pre-loaded for patients currently taking Repatha.

Approved in December 2025, Lerochol (lerodalcibep-liga) is the newest self-injected PCSK9 inhibitor. The monthly injectable can be administered at home and has extended room-temperature stability. LIB Therapeutics also offers a $199 monthly cash-pay program for patients who obtain the drug through its designated pharmacy.

Leqvio (inclisiran), meanwhile, is administered by a health care professional rather than self-injected at home. Following its FDA approval in December 2021, the number of Medicare beneficiaries using the treatment increased from 2,170 in January 2023 to 14,060 in December 2025, according to CareSet’s analysis.

Growth continued after a July 2025 FDA label expansion allowing Leqvio to be used as monotherapy, along with diet and exercise, to reduce LDL-C in adults with hypercholesterolemia. Previously, the drug’s label called for its use in addition to a statin or other LDL-lowering therapy.

Gross Medicare Part B spending on Leqvio totaled $449.2 million in 2025, compared with $143.7 million in 2023, according to CareSet’s analysis.