Kaléo to offer lower-priced opioid antidote

Pharmaceutical company Kaléo announced Wednesday that it will offer a generic version of its opioid antidote Evzio for $178 for a carton containing two single-dose auto-injector pens.

Evzio was approved by the US Food and Drug Administration in April 2014 under an expedited review for “the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.” In these instances, it can quickly reverse the effects of opioids.

The active ingredient, naloxone, comes in an auto-injector pen that is administered into a muscle and easy to use by bystanders or family members who are not medically trained. Evzio is different from other naloxone products because it gives verbal instructions to the user.

The price for the life-saving drug was initially set at $575 in July 2014, but was increased as high as $4,100 in January 2017, a US Senate subcommittee investigation found last month.

The investigation by the Permanent Subcommittee on Investigations, which is under the Committee on Homeland Security and Governmental Affairs, uncovered how Kaléo “exploited the opioid crisis by increasing the price of its naloxone drug Evzio by more than 600 percent by 2016,” according to Chairman Rob Portman, a Republican of Ohio.

The subcommittee’s report said the higher cost was a result of a new distribution model to “capitalize on the opportunity of opioid overdoses at epidemic levels.”

“This news is a positive step forward and I’m hopeful that it will increase access to naloxone, a critically-important overdose reversal drug that has saved tens of thousands of lives,” Portman said of Wednesday’s announcement.

The company said the new generic will be available through its subsidiary, IJ Therapeutics, in mid-2019.

In the meantime, the same $178 price is available immediately for government agencies, first responders and other health care providers through a new public access pricing program.

According to Kaléo, some patients with commercial health insurance plans already qualify to get Evzio at no out-of-pocket cost.

“The lower list price of the authorized generic will offer a more affordable and cost-effective solution for Medicare Part D patients and plans,” the company said.

The subcommittee investigation found that the price increases by Kaléo cost taxpayers more than $142 million as of November 18, “just in the last four years, despite the fact that less costly versions of naloxone exist.”

Delaware Sen. Tom Carper, a Democrat who led the Senate investigation with Portman, said this is a step in the right direction. “Life-saving drugs should not be out of reach for those that need them most, especially in the midst of a deadly public health crisis.”

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