- Kaléo Pharma says Express Scripts owes it more than $5 million for breaching rebate contracts related to the overdose medication Evzio (naloxone HCl injection), according to a recently filed countersuit.
- The pharmacy benefit manager (PBM) "actively prevented patients from accessing Evzio by implementing onerous prior authorization and step edit requirements that made it difficult for Kaléo to get Evzio to patients in need and, ultimately, adding Evzio to its 'exclusion list' and effectively preventing many of its health plan clients from covering Evzio," the drugmaker stated in documents submitted to the U.S. District Court for the Eastern District of Missouri.
- The countersuit is a lob back at Express Scripts, which in May claimed that Kaléo needed to fork over $14.5 million in unpaid rebates and administrative fees for Evzio that spanned from April 2016 to January 2017.
The relationship between pharmaceutical companies and PBMs is adversarial by nature, but has come under increased strain in recent months as lawmakers and consumers push for more transparency about high-cost medications.
Kaléo is one drugmaker at the center of that push. In early February, 31 senators sent a letter to the company's CEO Spencer Williamson expressing their concern over the "startling price hike" of Evzio since it hit the U.S. market in 2014. The company has also received criticism for the $4,500 list price of its epinephrine autoinjector and EpiPen competitor Auvi-Q.
The debate over the price of Evzio comes as the opioid epidemic in the U.S. has hit a peak, with 91 Americans dying everyday from opioid overdose, according to the Centers for Disease Control and Prevention.
In its countersuit, Kaléo disclosed that the initial wholesale acquisition cost set for a two-pack of the opioid overdose autoinjectors was $575. That price increased to $3,750 in early 2016, however, as part of a new model that the drugmaker said it turned to in an effort to bypass artificial blocks that Express Scripts put in place to limit Evzio uptake. The rationale was that the higher price would allow the company to employ various co-pay and patient assistance initiatives.
"Kaleo’s new pricing strategy worked," the company said in a document filed on June 22, adding that it "saw an immediate and dramatic increase in utilization and patient access to Evzio almost overnight, and the prescription fill percentage (i.e., the rate at which patients were able to fill prescriptions for Evzio) dramatically increased."
At the core of the current court battle, however, is which party violated the two rebate agreements that were at the cornerstone of their initial 2014 pact. Both sides say the other is at fault.
"We want Kaléo to honor its written contracts and not shirk its obligation to pay the rebates and fees it owes," an Express Scripts spokesman said in an email to BioPharma Dive. "Kaléo’s business strategies — its baseless exponential price increases on its drugs and its failure to satisfy its contractual obligations to Express Scripts under the terms of its rebate agreements — are geared towards increasing its own profits and undermining the efforts by pharmacy benefit managers and other payers to reduce the cost of prescription drugs."
Kaléo pharma did not immediately respond to BioPharma Dive's request for comment.