FDA Approves Sub-Q Tx for LDL Control – Leqvio

Last week the FDA approved Leqvio, from Novartis Pharmaceuticals. Leqvio is a first-in-class, RNAi sub-Q therapy indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).

The startup dose is given via subcutaneous injection by a healthcare professional. The next dose is given after 3 months with subsequent doses every 6 months. Before starting Leqvio the patient should be on a diet to lower cholesterol and a statin.

Novartis priced Leqvio at $3,250 per dose in the U.S., meaning the first year of treatment will cost $9,750 and subsequent years $6,500. That range falls in line with the current list prices of two existing PCSK9 therapies—around $5,400 to $5,850 for Amgen’s Repatha and Regeneron’s Praluent.

As an in-office procedure, Leqvio injections will be covered under the Medicare Part B. But, coverage through Part B could be an advantage for Leqvio over Repatha and Praluent. Physicians will be reimbursed for Leqvio ASP plus 6%. The other two drugs are covered by Part D under the pharmacy benefit.

Given the relatively large patient population and relatively low cost for a specialty drug, it is unlikely that Leqvio will be channeled through a limited distribution specialty pharmacy program. Leqvio qualifies as a specialty pharmacy therapy mainly because it ‘fits’ the specialty class of therapy carved out by Repatha and Praluent.


FDA approves add-on therapy to lower cholesterol among certain high-risk adults

FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Leqvio works to reduce circulating levels of LDL-C, commonly known as “bad cholesterol.”

Leqvio is approved at a 284 mg dose administered as an initial under-the skin injection, a second dose at three months, and continued treatment once every six months after that point.

Diseases or Conditions
HeFH is a life-threatening condition in which patients have a mutation in a small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high levels of LDL-C. People with HeFH generally have cholesterol levels two to three times higher than normal. These individuals are at increased risk of cardiovascular events, such as heart attack, stroke, and coronary artery disease. HeFH occurs in approximately 1 in 250 individuals.

ASCVD involves the buildup of cholesterol plaque in arteries. Approximately 18.3 million American adults (8%) have ASCVD. Clinical ASCVD is an umbrella term and includes conditions such as acute coronary syndromes (sudden, reduced blood flow to the heart), peripheral arterial disease, heart attack and stroke.

Effectiveness
The effectiveness of Leqvio was studied in three randomized, double-blind, placebo-controlled trials that enrolled 3,457 adults with HeFH or clinical ASCVD. Enrolled participants were taking maximally tolerated statin therapy but required additional LDL-C lowering based on their risk for cardiovascular events. In all three studies, the main effectiveness outcome measure was the percent change in LDL-C from the beginning of the trial to day 510 (month 17). In each trial, participants received under-the-skin injections of either 284 mg Leqvio or a placebo on four separate days: day 1, day 90 (month 3), day 270 (month 9), and day 450 (month 15).

Study 1 enrolled 1,561 adults with ASCVD. At day 510, the Leqvio group had an average LDL-C decrease of 51% whereas the placebo group had an average LDL-C increase of 1%. Study 2 enrolled 1,414 adults with ASCVD. At day 510, the Leqvio group had an average LDL-C decrease of 46% whereas the placebo group had an average LDL-C increase of 4%. Study 3 enrolled 482 adults with HeFH. At day 510, the Leqvio group had an average LDL-C decrease of 40% whereas the placebo group had an average LDL-C increase of 8%.

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