FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Senators Request Details on Kaléo’s Pricing Model for Overdose Drug Evzio

Feb. 16, 2017

A group of 31 Democratic senators have asked Kaléo to provide details on pricing of the company’s opioid overdose treatment Evzio, requesting documents on production costs and donation programs.

Kaléo raised the price of Evzio — a combination drug-device that delivers naloxone for use in emergencies — from $690, the price when the FDA first approved the product in 2014, to $4,500. The surge in price comes as Congress works to address the opioid epidemic by providing first responders the “live-saving” treatment, the senators said.

In the letter to the company’s CEO, the senators ask for the company to explain why it adjusted the list price of the drug — a value that Kaléo contends is not a “true gauge” of Evzio’s cost to consumers, because the company offers discounts and coupons to offset the list price. Through these programs, patients have paid a “low or even zero cost share,” the company said.

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