FDA decisions expected soon on pricey new cholesterol drugs

The Food and Drug Administration may issue approval decisions this month and next for two cholesterollowering drugs that could drive the nation’s drug costs even higher.

The FDA is expected to decide by late July whether to OK Sanofi’s and Regeneron’s cholesterol medication Praulent, with a decision about whether to approve Amgen’s Repatha expected by the end of August.

The two drugs belong to a new class of injectables called PCSK9 inhibitors. Studies show the biologic products reduce levels of low-density lipoproteins by as much as 60% when used in conjunction with statin drugs.

Last month, FDA advisory committees voted to recommend limited approval for both Repatha and Praulent for patients with familial hypercholesterolemia, which affects an estimated 600,000 Americans. But the drugs also may be used for patients who can’t reduce their LDL adequately with statins, or who can’t take statins because of side effects.

An analysis by pharmacy benefits manager Prime Therapeutics estimated the per-patient cost for PCSK9 inhibitors between $7,000 and $12,000 a year. It’s projected that PCSK9 inhibitors could cost the country up to $23 billion annually.

An article published in Health Affairs in February said the costs associated with PCSK9 inhibitors could easily eclipse those of Gilead Sciences’ hepatitis C drug Sovaldi, which was priced at $84,000 when first introduced. “Managed pharmacy care, indeed the healthcare system, has never seen a challenge like this to our resilience in absorbing costs,” the authors concluded.