FDA Approves Cholesterol-Lowering Drug That Will Go Up Against PCSK9s

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol.

Dosing of the small interfering RNA (siRNA) therapy is via a subcutaneous injection by a health care professional with an initial dose, another dose three months later and then every six months. The cost for the first year of treatment is $9,750 and $6,500 for subsequent years. The company says the drug will be available in early 2022.

The cost is slightly higher than those of the two competing therapies, both PCSK9 inhibitors: Amgen Inc.’s Repatha (evolocumab) and Regeneron Pharmaceuticals, Inc.’s Praluent (alirocumab) are both right around $5,850 annually. Those drugs also have more frequent dosing, although patients can administer the products themselves via subcutaneous injection.

For the Managed Care Biologics and Injectables Index: Q3 2020, between Aug. 25, 2020, and Sept. 28, 2020, Zitter Insights polled 51 commercial payers covering 127.5 million lives. Respondents cited Leqvio’s route of administration, cost, safety and efficacy as their top factors in preferring the drug over Praluent and Repatha (see chart).

Payers representing 61% of lives said they were likely to cover Leqvio’s use only in people on maximally tolerated statin therapy. To prefer Leqvio over the PCSK9s, payers were seeking a wholesale acquisition cost that is 47% below that of both drugs.

Zitter Insights and AIS Health are both MMIT companies.

During the same time frame, Zitter Insights surveyed 50 cardiologists. Almost two-thirds said they would prescribe Leqvio for hypercholesterolemia, and 52% said they would prescribe it over PCSK9 inhibitors.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.

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