MMIT Reality Check on Heterozygous Familial Hypercholesterolemia

Payer Coverage:

A review of market access for treatments of adults with heterozygous familial hypercholesterolemia (HeFH) shows that under the pharmacy benefit, about 65% of the lives under commercial formularies are covered with utilization management restrictions. Around 45% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 38% of the lives under commercial policies are covered with utilization management restrictions. About 7% of the lives under health exchange policies have access to at least one of the drugs without utilization management restrictions.

For about 30% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 42% require multiple steps. Around 82% of payer-controlled pharmacy benefit covered lives require prior authorization, with 42% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Leqvio

In December 2021, the FDA approved Novartis Pharmaceuticals Corp.’s Leqvio (inclisiran) 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 284 mg dose, another dose three months later and then every six months. The cost for the first year of treatment is $9,750.00 and $6,500.00 for subsequent years. The company says the drug will be available in early 2022.

FDA Approves Novartis 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: Amgen Inc.’s Repatha (evolocumab) and Regeneron Pharmaceuticals, Inc.’s Praluent (alirocumab).

FDA Gives Repatha Additional Indications

In September 2021, the FDA gave two additional indications to Amgen Inc.’s Repatha (evolocumab): (1) as an add-on treatment to diet and other low-density lipoprotein cholesterol-lowering therapies for people at least 10 years old with heterozygous familial hypercholesterolemia to reduce LDL-C and (2) as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia in people at least 10 years old. The agency initially approved the PCSK9 inhibitor on Aug. 27, 2015. Recommended dosing is 420 mg per month by subcutaneous injection. The drug’s monthly wholesale acquisition cost is $476.55.

Key Findings:

Market Events Drive Changes

In December 2021, the FDA approved Novartis Pharmaceuticals Corp.’s Leqvio (inclisiran) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol. In September, the agency gave two additional indications to Amgen Inc.’s Repatha (evolocumab): (1) as an add-on treatment to diet and other low-density lipoprotein cholesterol-lowering therapies for people at least 10 years old with HeFH to reduce LDL-C and (2) as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia in people at least 10 years old.

Competitive Market Landscape

Esperion Therapeutics, Inc.’s Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) were launched into a cholesterol market that was static for years and remains dominated by statins. The indication has seen a couple of new entrants, and the launch for Leqvio, which can be dosed just twice a year after an initial loading period, is expected to mount a strong challenge to Repatha and Regeneron’s Praluent (alirocumab), which have both failed to live up to initial blockbuster sales predictions.

Pharmacy, Medical Benefit Implications

Coverage is highly restricted with multiple steps and a laundry list of prior-authorization restrictions. All products are covered under the pharmacy benefit, but some also have medical coverage, which is rarely used by health care providers or the pharma companies.

Key Players in Market:

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• Reality Check