Debate Rages Around Costly New High Cholesterol Drugs

PCSK9 inhibitors could cost up to $23.3 billion nationally if widely prescribed.

The latest budget challenging specialty drug is expected to be approved within days, as stakeholders across the industry brace for the impact of a new class of cholesterol-lowering medications.

PCSK9 inhibitors (Proprotein Convertase Subtilisin/Kexin type 9), which seek to reduce low density lipoprotein (LDL) cholesterol, could cost the US health care system up to $23.3 billion annually, according to pharmacy benefit manager Prime Therapeutics. Praluent by Regeneron & Sanofi, and Repatha by Amgen are expected to be approved shortly by the FDA.

Unlike current statins that are taken orally and have less costly generic alternatives, PCSK9 inhibitors are self-injected monoclonal antibodies that block the PCSK9 protein from inhibiting removal of LDL from the liver. The drugs are expected to cost between $7,000 and $12,000 annually.

“While these new drugs offer hope to those who aren’t able to effectively manage their cholesterol with existing therapy, they need to be affordable,” said Patrick Gleason, PharmD, director of health outcomes at Prime. “Just to treat those with familial hypercholesterolemia alone, these drugs could cost the US health system billions of dollars per year, and as much as $23.3 billion to treat all potential people who could receive the drug. It’s also reasonable to assume that some prescribers will be interested in using these drugs for additional people with high cholesterol. Contributing to the high cost is the fact that these drugs are considered maintenance medicines, so people would expect to take them for many years.”

Prime estimates the drugs could add between $0.93 and $6.71 per member per month (PMPM) to commercial insurance coverage costs and up to $15.66 PMPM to Medicare coverage costs depending on the conditions PCSK9 inhibitors are approved to treat. If the drugs were prescribed to 40% of approximately 600,000 Americans with abnormally high cholesterol levels that statins don’t reduce, it could add an additional $2.1 billion annually in new costs.

PCSK9 inhibitors are expected to be approved to treat more than 200,000 Americans with familial hypercholesterolemia, a rare genetic condition leading to abnormally high cholesterol levels that are unable to be managed with traditional statins. The inhibitors may also be approved for statin intolerant people or those unable to achieve an expected cholesterol decrease from statins, which could include up to approximately 2.3 million Americans.

Express Scripts Chief Medical Officer Steve Miller told the Washington Post that PCSK9 inhibitors have the potential to be the biggest category in the history of pharmaceutical drugs. Miller added his company could pursue the same approach it took with high cost hepatitis C drugs, when it exclusively offered Viekira Pak after a discount from the manufacturer as a result of the cost for competitor drug Sovaldi.

“We have made it very clear to them that we’re willing to go exclusive with one drug or the other, if they don’t competitively price these drugs,” Miller told the Post.

Prime estimates that if PCSK9 inhibitors are approved just for people with familial hypercholesterolemia who are intolerant or resistant to traditional statins, that just 0.11% of commercially insured members could receive the drugs at a cost of $0.93 PMPM. However, if they were approved for all people who are statin intolerant or resistant, 0.81% of members could receive the drugs at a cost of $6.71 PMPM.

Prime concluded utilization management tactics that include prior authorization and quantity limits may be necessary to manage costs.

“If PCSK9 inhibitors are approved by the FDA, it is critical that we have the right level of utilization management in place to help ensure that these medicines are used in those high-risk members where therapy is most warranted,” said Pete Clagett, senior vice president of integrated care and specialty at Prime. “If not managed appropriately, the costs of PCSK9s could have a dramatic impact on overall drug spend starting later this summer. In a couple years, PCSK9s could cost America the equivalent of $73 per person per year.”