Just as payers are contending with the prospect of paying for the next generation of direct-acting antiviral agents to treat patients with hepatitis C, the next wave of pricey medications is set to hit the market. PCSK9 inhibitors are the latest class of drugs being developed to dramatically lower cholesterol levels in patients who don’t tolerate statins or whose cholesterol levels cannot be adequately controlled with older medications. PCSK9 inhibitors work differently from statins by targeting a protein that interferes with the body’s ability to eliminate low-density lipoprotein (LDL) cholesterol from the blood.
PCSK9 inhibitors are injectable drugs, so they will cost more than oral statins. And since they will have patent protection, they will be more expensive than the cheaper generic statins some patients use. PCSK9 inhibitors are estimated to cost at least $10,000 per year; some may cost up to $1500 per prescription. Multiply that times the number of Americans with high cholesterol who will need to take the drugs for a lifetime and you can see why payers and pharmacy benefits managers are concerned about the burden these drugs will place on healthcare budgets.
Biologics License Applications have been filed with the Food and Drug Administration for evolocumab (Amgen) and alirocumab (Sanofi and Regeneron); Prescription Drug User Fee Act action dates are Aug. 27, 2015 and July 24, 2015, respectively. Bococizumab (Pfizer) is further behind in commercial development, with phase III trials in progress. We’ll continue to monitor these medications and let you know if the evidence suggests these specialty products deliver better results than their predecessors so that you can decide whether they justify their higher price tags.