For Now, Pharmacy Managers Just Say No to High-Cost PCSK9 Cholesterol Drugs

FDA’s approval of Amgen’s evolocumab (Repatha) late yesterday was fairly anticlimactic by the time the news came down shortly after 5 p.m. The news came an hour later: the drug’s price of $14,100 a year, was only $500 less than alirocumab (Praluent), the Sanofi-Regeneron therapy approved a month prior.

The announcement quashed speculation that Amgen might seek to publicly position itself as the lower-cost PCSK9 inhibitor as both drug makers head into talks with major health plans and pharmacy benefit managers (PBMs), who will ultimately control which patients gain access to these powerful new weapons against high cholesterol.

It didn’t take long for the nation’s 2 top PBMs, ExpressScripts and CVS Health, to offer responses. In sum, both said they would generally not be covering these drugs until they clear pharmacy and therapeutics (P&T) committees. Both vowed to get the best deal possible for their customers.

The approvals are nearly identical. Both drugs gained approval to treat heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease, such as heart attacks and strokes, where maximally tolerated statins are not doing enough to lower low-density lipoprotein (LDL) cholesterol. Evolocumab received an additional indication for homozygous familial hypercholesterolemia.

ExpressScripts’ Chief Medical Officer Steve Miller, MD, said in a statement late last night that until the P&T process is complete, the drug can only be obtained through an exception process that will restrict PCSK9 inhibitors to those who meet the strictest terms of the FDA recommendations.

He called on manufacturers to work with PBMs on favorable pricing to avoid exclusions, saying, “We would only exclude one of these products if our P&T committee determines that the product we cover is at least clinically equivalent to the one we exclude. And only then would we exclude one of these products if that exclusion would deliver significant savings for our clients and patients.”

CVS was less specific yesterday, but it essentially opened negotiations August 10 when it said it would not bother to try to price alirocumab until its competitor cleared the FDA. And CVS called for a return to more specific clinical guidelines than those adopted in 2013, which expanded the pool of patients who could receive statins.

“As per our standard approach, new-to-market products are not included on the formulary until they are reviewed by the CVS/Caremark Pharmacy and Therapeutics Committee and recommended for inclusion,” the company said in a statement.

“Based on the evaluation of the P&T committee we will evaluate the inclusion and position of both Repatha and Praluent on our formulary. In addition, consistent with past practices, CVS/Caremark will actively negotiate with the drug manufacturers in an effort to control costs for patients and payers.

Both Sanofi-Regeneron and Amgen have vowed to work with health plans and PBMs on discounts and to set up programs for needy patients who otherwise would lack access to the drugs. But with the annual prices of both coming in well above early estimates of $7000 to $12,000, managed care plans and PBMs are not pleased.

There has been some speculation that those with the familial hypercholesterolemia conditions would have a comparatively easier time gaining access, given their limited treatment options and the small number of patients involved. CVS’ statement said that even after the formulary process is complete, controlling costs means that patients must first try statins, “reserving the new drugs primarily for patients with rare genetic conditions.”

Drug makers and PBM leaders clearly see the pricing equation differently. In announcing Praluent’s price last month, its sponsors said it was inexpensive relative to other monoclonal antibodies and that pricing took into account the cost of heart disease to the US healthcare system. PBMs, by contrast, fear a day when this high-priced therapy could be seen as a routine alternative to a low-cost standby, stains.

The current FDA approval is not the problem, and everyone knows it. Unlike European regulators, FDA limited the scope of its approval for now while it awaits the results of long-term cardiovascular outcomes trials, which it has required since the mid-2000s to avoid letting dangerous products flood the market. While it may take until 201 for the full results of these trials to be presented, Amgen is already touting plans to present some data next week at a conference in London. Of the 2 sponsors, Amgen made the stronger push at the FDA advisory committee level and at recent scientific meetings to eventually extend availability to patients who can’t tolerate statins.

Both drugs are injectable monoclonal antibodies that block proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that when missing or limited causes LDL cholesterol levels to drop by 55% to 60%, depending on the condition and whether it is used in combination with other therapy, such as metformin.

The high cost of the PCSK9 inhibitor class drew the attention of the Campaign for Sustainable Rx Pricing, a Washington, DC-based group that seeks to educator lawmakers and the public about solutions to rein in the cost of new drugs. “The approval of Repatha is another example of a breakthrough medication with a too high price tag,” said John Rother, president of the National Coalition on Health Care and the campaign’s leader. “With several game-changing medications in the pipeline, we need to address the underlying issue of how these prices are set form the start before they hit the market.”