The Formulary Files

PCSK9 inhibitors on the way


Krishna Rutvij Patel, PharmD

Think Sovaldi’s causing headaches? Hepatitis C isn’t the only disease where dramatic treatments, and the vexing coverage decisions that come with them, occur. PCSK9 inhibitors for dyslipidemia are poised to enter the market next year.

Amgen filed for FDA approval for its PCSK9 inhibitor in August, while Sanofi and Regeneron Pharmaceuticals, working together, released encouraging studies in August on their next generation of cholesterol-lowering drugs.

Effective yet expensive specialty drugs competing in an arena filled with generic statins will force formulary decision makers to determine which patients would be most appropriate for PCSK9 inhibitors. But is that entirely in their hands? So much in health care comes down to physician buy-in.

Leerink Partners, a health care investment company, surveyed 100 cardiologists, endocrinologists, and primary care physicians to gauge how they plan to handle PCSK9 inhibitors.

The physicians estimate that about 40% of patients with dyslipidemia are candidates for PCSK9 inhibitors, as they would be the ones who either cannot tolerate statins or do not achieve adequate LDL lowering with statins.

Outlook for PCSK9 inhibitors

Based on a survey of 100 cardiologists, endocrinologists, and primary care physicians, 40% of the yellow+red segments will likely be prescribed PCSK9 inhibitors

Source: Leerink Partners

Then the question is: Why won’t 100% of the yellow + red segments in the graphic at left be prescribed PCSK9 inhibitors? Here are some thoughts.

When statins lack efficacy, that would warrant a switch to PCSK9 inhibitors. However, there are several reasons why lack of efficacy may not be the reason for failure to reach the goal. These reasons include:

  • Statin dose hasn’t been optimized
  • Patient is nonadherent to statins
  • Patient does not follow proper diet/exercise protocol, which would further reduce LDL levels
  • Patient won’t be able to afford PCSK9 inhibitors
  • Patient is apprehensive about injections