In the jockeying for share in the brand-new market for the specialized PCSK9 cholesterol-lowering meds, Amgen ($AMGN) has picked up an edge over Sanofi by nailing a formulary exclusive with CVS. To get that preferred spot, Amgen has again agreed to tie the price of the drug to its effectiveness.
The pharmacy benefits manager announced today that Amgen's Repatha will be the one and only PCSK9 inhibitor to be offered in the CVS commercial formularies to treat patients with a hereditary form of high cholesterol, and those at high risk of heart problems who haven't responded to aggressive statin therapy.
"We believe patients should have access to the right medication, at the right time and for the right reason," CVS Chief Medical Officer Troyen A. Brennan said in a statement. "We have determined that choosing a single PCSK9 inhibitor for our commercial formularies allows us to get the best price possible for clients and preserves our commitment to deliver the best care available."
And Amgen's Anthony C. Hooper, executive vice president of Global Commercial Operations for the company, explained how that happened. "Value-based partnerships are a key area of focus for Amgen, and Repatha gave us a great opportunity to offer value based contracts that address payers' concerns by linking the net price of Repatha to expected LDL cholesterol reductions and anticipated appropriate patient utilization.
The drugmaker worked the same kind of deal to nab an exclusive from the Harvard Pilgrim health plan. That agreement was inked earlier this month.
By striking its exclusive with Amgen, CVS ($CVS) set itself apart from competitor Express Scripts ($ESRX) which last month surprised analysts by making room for both Sanofi ($SNY) and Regeneron's ($REGN) Praluent and Amgen's ($AMGN) Repatha on its preferred formulary. It said that with the discounts and strict limits on who could get the treatments, it felt it could afford to offer both.
Like the new hepatitis C drugs, whose prices led PBMs to start the exclusives craze as a way to extract larger discounts, PBMs have expressed concerns about what the costs of PCSK9 will mean for their budgets. Repatha runs about $14,100 a year and Praluent costs about $14,600, much higher than the cost of taking a generic statin to treat high cholesterol. But the FDA didn't approve the two drugs as treatment options for people who can't tolerate statins, something the PBMs had fretted might happen.
The CVS agreement gives the drugmaker a lift after the National Institute for Health and Care Excellence (NICE) last week turned the drug down for approval in preliminary draft guidance. The U.K.'s cost watchdog not only said its cost was too high but took issue with evidence of its benefits. It said there's no proof that it can actually prevent angina, heart attacks and strokes, and won't be known until data from an outcomes study are available in second half of 2016.
A preliminary denial is standard operating procedure as a way for NICE to get leverage in price negotiations. Amgen has already indicated that its price in the U.K. would be much lower than in the U.S. It has said it would charge £340.20 for a 28-day supply of the med in Britain, or about $520. That stacks up to about $6,780 per year, lower than what it is offering in Europe. In Austria, for instance, the price is set at about 7,300 euros, or $8,220.
- here's Amgen's announcement
- and the CVS release
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