Express Scripts Sues Small Drug Manufacturer

Update 6/23:

Kaléo announced today that it has countersued and filed a response to the lawsuit:

“Kaléo is disappointed that Express Scripts chose to bring a lawsuit against us. Not only does kaléo intend to vigorously defend ourselves against these claims, we have countersued to recover payments we made for excessive rebates and administrative fees that were improperly invoiced, received, and retained by Express Scripts in breach of its contract with kaléo," said Kaléo in a statement.

"Affordable and unrestricted access, for patients who are prescribed our potentially lifesaving product, is our number one priority. Patients deserve fair access to medicines that offer technological innovations that address their medical needs without burdensome paperwork or high out-of-pocket costs. Kaléo is committed to ensuring that patients with commercial insurance, or those facing financial hardship, can affordably obtain our potentially lifesaving product.”

Original Story:

Express Scripts has filed a lawsuit against Kaléo, a small pharmaceutical manufacturer, over charges related to Kaléo’s naloxone injector, Evzio.

Kaléo allegedly owes Express Scripts $14.5 million in fees and rebates, according to the New York Times. The PBM has also dropped Evzio from its preferred list.

The price of Evzio quintupled last year and, according to the Times, as the price increased, so did Express Scripts’ administrative fees. In January of last year, two Evzio injectors cost $937.50 and Express Scripts billed about $25,000 in administrative fees that month. In April Evzio’s price was $4,687.50 and the fees jumped to nearly $130,000, which was in addition to other rebates charged, and totaled about $14 million.

Related article: A Big Shift for a Major PBM

A spokesperson for Express Scripts told Drug Topics that “We filed this lawsuit to get money that is rightfully owed our clients. Kaléo owes rebates and administrative fees that we share with our clients and we are working to get that money back.”

In a statement provided to Drug Topics, DrugKaléo CEO Spencer Williamson said “This is a baseless suit and we will respond accordingly. Affordable and unrestricted access, for patients who are prescribed our potentially lifesaving product, is our number one priority. Patients deserve fair access to medicines that offer technological innovations that address their medical needs without burdensome paperwork or high out-of-pocket costs.”

Williamson added, “Kaléo is committed to ensuring that patients with commercial insurance, or those facing financial hardship, can affordably obtain our potentially lifesaving product.”

According to the Times, Kaléo raised the price of Evzio to cover patient-assistance programs. Kaléo covers out-of-pocket costs for those with private insurance and provides the drug for free to uninsured patients who make less than $100,000 annually.

In 2015, Express Scripts sued Horizon Pharma over unpaid fees. Horizon paid Express Scripts $65 million to settle the case.