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For Now, PBMs Just Say No to High-Cost PCSK9 Inhibitors

Mary K. Caffrey
When prices of the first 2 entrants of this new class of cholesterol-lowering drugs came in well above expectations, leading PBMs announced plans to limit who could gain access and sent a clear message to the drug makers: get ready to negotiate.
When the FDA approved the first 2 PCSK9 inhibitors this summer, there was plenty of attention from health plans and cardiologists alike to scope of the labels, especially relative to what European regulators allowed for these breakthrough cholesterol drugs. But when the approvals came down for alirocumab (Praluent) on July 24, 2015, and for evolocumab (Repatha) on August 27, 2015, the next question was: what will they cost?1-3

First, Sanofi-Regeneron set the price of alirocumab at $14,600 a year for both the 75-mg and 150-mg injections—a eye-popping $40 a day.4 Then, despite speculation that Amgen might price evolocumab well below its competitor, the second drug came in at $14,100 a year for its 140-mg injection.5 Both drugs are given twice a month, although evolocumab plans to have a 420-mg monthly dose available next year.

The first entrants in this long-awaited class of monoclonal antibodies, which reduced low-density lipoprotein (LDL) cholesterol up to 60% in clinical trials, arrived well above the $7000 to $12,000 annual cost that analysts predicted.6 ExpressScripts, the nation’s largest pharmacy benefits manager (PBM), and CVS Health, the second-largest, had spent months before the FDA actions making it clear they intended to leverage the presence of 2 drugs to demand savings for their clients, and ultimately, consumers.6-8

As the prices were set reaction from the 2 PBMs came quickly: get ready to negotiate.

CVS Health announced August 10, 2015, after alirocumab was approved and a decision on evolocumab was pending, that the PBM would not bother to talk to Sanofi-Regeneron about setting discounts until alirocumab had a competitor.9 This move came after alirocumab’s sponsors paid $67.5 million to transfer an orphan drug voucher to jump ahead of Amgen in the approval process.10 CVS Health Chief Medical Officer Troyen Brennan, MD, MPH, told Reuters that CVS would have a management program that would take into account a patient’s history of heart dis-ease, diabetes, cardiovascular risk fac-tors, and experience with statins before authorizing use of a PCSK9 inhibitor.9

What the FDA Approved. The PBMs are aided by the fact that labels for alirocumab and evolocumab are nearly identical. Both PCSK9 inhibitors are authorized to treat heterozygous familial hypercho-lesterolemia and atherosclerotic cardio-vascular disease, such as heart attacks and strokes, where maximally tolerated statins are not doing enough to lower LDL cholesterol. Evolocumab received an additional indication for homozygous familial hypercholesterolemia.2,3 While the US approvals do not cover patients who simply can’t tolerate statins, which Europeans regulators allowed, they do cover enough high-risk heart disease patients that market estimates have varied from 6 to 10 million patients a year.11

It doesn’t appear those with hypercholesterolemia will have too many problems gaining access to the drug, and CVS has indicated as much, both in an email to Evidence-Based Diabetes Management and in public comments referencing those with “rare genetic conditions.”12 Those with high-risk heart disease will be expected to exhaust all treatment options before gaining access, however.

ExpressScripts’ Chief Medical Officer Steve Miller, MD, in a statement issued the evening of the evolocumab approval, said that the drug class could become “the most costly therapy our country has seen.” Until the pharmacy and ther- apeutics (P&T) committee completes its review in September, the drug would only be available through an exception process that will restrict PCSK9 inhibi-tors to those who meet the strictest terms of the FDA recommendations.13

Manufacturers could avoid exclusions by working with PBMs on favorable pricing. Miller said: “We would only exclude one of these products if our P&T commit-tee 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 exclu-sion would deliver significant savings for our clients and patients.”13

CVS was less specific after the evolocumab approval, but the company inferred that most patients would have to wait until after the P&T committee had reviewed both therapies and price nego-tiations had occurred. “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.14

“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.14

Both Sanofi-Regeneron and Amgen promised that health plans and PBMs will receive discounts from the whole-sale price and that programs will be created for needy patients who otherwise would lack access to the drugs. But the standoff that appeared to be shaping up in late August distressed some who observed that never before had it been so clear that payers and pharmacy managers, not doctors or even the FDA, were deciding when a drug would be appropriate. And this was happening because of price, despite the therapeutic potential.

John LaMattina, a senior partner at PureTech Ventures and a Forbes contributor, wrote, “The payers are making no mention of extending the lives of patients with CV [cardiovascular] disease nor the impact of reducing heart attacks and strokes to healthcare costs. This doesn’t seem to be a major concern to them. Limiting their own costs, however, is paramount. Welcome to the new world of medicine.”15

Different Points of View. Drug makers and PBM leaders clearly see the pric-ing equation differently. In announcing Praluent’s price, Sanofi-Regeneron 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.4 PBMs, by contrast, fear a day when this high-priced therapy could be seen as a routine alternative to a low-cost stand-by, statins.7,8,15

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 cardio-vascular outcomes trials, which it has required since the mid-2000s to avoid letting dangerous products flood the market. While it may take until 2017 for the full results of these trials to be presented, Amgen was already touting plans to present some data at a conference days after the FDA approval of evolocumab. Of the 2 sponsors, Amgen made the stronger push at the FDA ad-visory committee level and at recent scientific meetings to eventually extend availability to patients who can’t toler-ate statins.10,16

Both drugs work by blocking proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that when missing 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.


 
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