Express Scripts adds PCSK9 inhibitors to National Preferred Formulary

Express Scripts’ announcement comes amid growing concerns about a range of new drugs that could be helpful for millions of Americans, yet may bust health care budgets for private insurers as well as government programs, such as Medicare and Medicaid.

“We think this is really an innovative approach, and we think it’s going to take great care of patients”, said Dr. Steve Miller, Express Scripts’ chief medical officer.

Having 2 drugs hit the market at once no doubt helped negotiations, and the expected arrival of more entrants into this class will create more opportunities for price controls.

With a combination of discounts and a rigorous utilization management program for both Praluent and Repatha, Express Scripts’ National Preferred Formulary clients collectively will spend approximately $750 million on PCSK9 inhibitors in 2016, far lower than industry forecasts.

“We are delighted that Express Scripts has chosen to preserve physician and patient treatment choice for patients …”, said Anthony C. Hooper, executive vice president for global commercial operations at Amgen, in a written statement. Praluent was approved in July with Repatha gaining approval a month later. Praluent and Repatha belong to a new class of drugs called PCSK9 inhibitors, biologic medications that in clinic studies are supposed to lower low-density lipoprotein cholesterol levels by as much as 60% compared with a placebo over a year.

During clinical trials, patients receiving both of these drugs, plus statins, saw remarkable reductions in their bad cholesterol levels. For the large majority of the more than 70 million people with high cholesterol, statins are the clinically appropriate, tried-and-true therapy. More than 73 million USA adults, or almost one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. The drug was being tested on patients with human papillomavirus-associated cancers.

Among the measures implemented by the PBM is 24-hour access to specialist pharmacists and nurses who will make sure patients know how to use the drugs properly in order to comply with the therapy and achieve the best possible outcome. Last year, Express Scripts had refused coverage to Gilead Sciences, Inc.’s (NASDAQ:GILD) $1,000-a-day hepatitis C drug Harvoni, in favor of a heavily discounted rival pill Viekira Pak by AbbVie Inc. Miller said Tuesday Express Scripts is seeking to limit price increases on the other drugs it covers as well. Other pharmacy benefit firms then used similar negotiating tactics with the two drug makers and the reported price, with discounts, for the treatments has dropped by nearly half.

Express Scripts said its agreements with PCSK9 drugmakers include rebates, restrictions on who can receive the therapy, protections against price increases and a spending cap.

Still, “it’s never been done that aggressively on such a high-profile, high-expense drug”, said Rother. “No. Did they get the level of discount they wanted? No”.