CVS isn't stopping with PCSK9 discount demands. It wants concessions from ACC/AHA, too

CVS Health ($CVS) has no intention of shelling out more than it has to on the new PCSK9 drugs. It's been saying so for more than a year--and now, it has taken a double-barreled shot at the next-gen cholesterol fighters.

Following up on a gloomy Journal of the American Medical Association (JAMA) report last year, CVS execs have published a new manifesto, calling on the American College of Cardiology and the American Heart Association to revamp their cholesterol-treatment guidelines. The 2013 treatment advice tossed out numerical targets for "bad" LDL cholesterol, in favor of a more qualitative assessment of heart risks.

CVS wants them to change right back. And it fully admits its selfish reasons: Without the numerical targets, doctors would have more leeway to prescribe pricey new PCSK9s rather than the vastly cheaper, largely generic statins that have been standard treatments for decades now.

CVS Chief Medical Officer Troyen Brennan

And that, of course, could frustrate CVS' attempts to control access to the new class. "As we work to encourage cost-effective use of these new cholesterol-lowering medications … guidelines that incorporate specific LDL targets would be important to help determine where PCSK9 inhibitors best fit," CVS Chief Medical Officer Troyen Brennan said in a statement, adding that CVS wants guidelines that offer "clear guidance" for doctors and "enable effective utilization management programs to help control healthcare costs."

In the meantime, CVS is holding off on covering Sanofi ($SNY) and Regeneron's ($REGN) first-in-class med Praluent, approved last month, Brennan told Reuters. Amgen's ($AMGN) direct rival, Repatha, is up for FDA approval later this month, and CVS wants to wait and see the language on Repatha's official label, which will define the size of the population recommended for therapy. It's no doubt waiting to see how Amgen's prices Repatha, too; Sanofi and Regeneron put a $14,600 tag on their med, somewhat higher than most analysts had expected. That price applies to both doses of Praluent, despite previous predictions that the companies would use a lower price on the lower dose to gain favor with payers.

CVS and its fellow pharmacy benefits manager Express Scripts ($ESRX), as well as other payers, fought a similar fight with Gilead Sciences ($GILD) and AbbVie ($ABBV) over their hepatitis C medication costs. Stuck with Gilead's $1,000-per-pill drug Sovaldi till AbbVie's Viekira Pak was approved, payers tried to keep a lid on spending by restricting coverage only for the sickest patients. After AbbVie's rival hit the scene, there was a quick scramble for exclusive formulary placement in return for big discounts.

CVS and Express Scripts have been promising a similar scrap with the PCSK9 drugs, given that their benefits are similar and their prices high. Last month, Express Scripts President Tim Wentworth said the new meds are poised to "wreak havoc" on drug spending, and promised that patients would face a high bar for coverage approval--not to mention pit Sanofi/Regeneron against Amgen for big discounts.

CVS has put a price tag on that havoc: $150 billion over 10 years, according to a JAMA article published last year. That apocalyptic figure depended on a broad definition of eligibility--one that likely won't come close to real-world use. But as a rhetorical device, it struck the note CVS wanted. And the events of the past two days demonstrate--for the drug companies and, importantly, for CVS clients--that the PBM is almost hysterical in its seriousness about controlling PCSK9 spending.

Two questions now: Whether the ACC and AHA would bow to payer pressure and change its guidelines on cholesterol management. The guidelines have drawn fire elsewhere for lack of specificity, so the groups would have a way to save face, but then again, they might just balk at the very idea. Doctors don't like to be pushed around, and CVS could be over-reaching here.

Also, just how far are Sanofi/Regeneron and Amgen willing to go to win payer coverage for the new meds? The drugmakers do have leverage of their own; doctors are excited about the new drugs, and patients will want them. They could try to paint the PBMs as bad guys more worried about their own bottom lines than about patient care.

- see the CVS release
- get more from Reuters

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