With New Cholesterol Drugs, Should Managed Care Brace Itself for the Next Sovaldi?

There was no mistaking the excitement at this weekend’s meeting of the American College of Cardiology over a new class of therapy, the PCSK9 inhibitors, which dramatically reduce low-density lipoprotein (LDL) cholesterol levels while also cutting by half the risk of cardiovascular events. Two drugs in this class await FDA approval and could hit the market by this summer.

But while scientists gushed there is “no floor” for lowering LDL cholesterol for which there isn’t a benefit, the reporters who questioned Marc Sabatine, MD, MPH, of Brigham and Women’s Hospital and presenter of Sunday’s results on Amgen’s evolocumab, had different concerns. How much is this drug going to cost? And if it costs more than statins, will patients take it for awhile, until LDL levels drop, or will they take it forever?

Sabatine wouldn’t comment on price, saying those questions rest with manufacturers. Formulary managers and payers are already asking those same questions, however, in the wake of last year’s watershed moment with Sovaldi. When the $1000-a-day pill for hepatitis C virus hit the market in early 2014, both commercial payers and state Medicaid directors were left wondering how their balance sheets would absorb such a hit.

A year later, formulary managers who spoke with The American Journal of Managed Care last month said that competition with other HCV drugs has allowed payers to achieve large discounts for a drug that was biggest driver in last year’s 13.4% drug spending increase. But the formulary managers said that the PCSK9 class could represent something even more alarming.

While Sovaldi is an eye-popping $84,000 for a 12-week treatment course, the drug does represent a one-time expenditure to cure HCV, which can bring much higher long-term medical costs including liver transplants. PCSK9 inhibitors, by contrast, are something else entirely—a high-powered, but higher cost treatment for a chronic disease previously treated by low-cost statins. The possible transfer of treatment from generics to a specialty therapy, for an unspecified period of time, is uncharted territory.

Sabatine did address those concerns Sunday. “I don’t view these as potential competitors to statins,” Sabatine said. “Statins are the foundation.” PCSK9 inhibitors such as evolocumab can help patients who cannot tolerate statins and those who have been unable to lower their LDL cholesterol on current therapies. PCSK9 inhibitors can also aid those affected by a genetic condition called familial hypercholesterolemia.

Both Sabatine and a commentator at the press conference, Eric D. Petersen, MD, of Duke University, acknowledged that decisions about who takes this new drug class will involve a balance among the physician groups that set clinical guidelines, payers, and formulary managers. Already, however, analysts and the formulary giant Express Scripts say the fact that 2 versions are in the pipeline will ensure that the Sovaldi experience will not be duplicated. Amgen’s evolocumab, to be marketed as Repatha, is due for an FDA decision by August, while Sanofi-Regeneron’s alirocumab, to be marketed as Praluent, filed for priority review and will get a decision in July. Still, forecasts call for the PCSK9 class to generate $2 billion a year in sales at their peak.

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