Can a $4,500 epinephrine injector challenge Mylan's scandal-plagued EpiPen?

Looking to take on beleaguered EpiPen giant Mylan, privately held Kaléo will roll out its competing autoinjector next month at a price of $0 for most patients.

The catch? The product’s list price is $4,500 for a two-pack—an amount much higher than that of its established rival, CEO Spencer Williamson told reporters on a conference call Thursday. Kaléo’s Auvi-Q AffordAbility program is designed to ensure that patients won’t pay anywhere near that amount, though.

Patients with commercial insurance, including those on high-deductible plans, can access the Kaléo product at an out-of-pocket cost of $0, Williamson said. When an insurer moves to “block” Auvi-Q, the company will step in and step in and pay for that patient’s access. The plan is designed to provide those in need with a new option, he said. Uninsured patients can buy an Auvi-Q two-pack at a cash price of $360.

Multiple insurance plans have signed on to cover Auvi-Q at its $4,500 list price, the Kaléo helmsman told reporters, but he declined to name any. When asked whether the product will actually cost the healthcare system more than any competing rival, Williamson said Kaléo believes “the most important price is the price to the patient.”

Some insurance plans place a value on offering choices and new technology, Williamson said, so he believes the list of those who opt to cover Auvi-Q will "continue to grow."

EpiPen’s list price is about $600 for a two-pack, and Mylan recently launched an authorized generic at half of that price.

“The drug pricing and payer system is broken,” Williamson said Thursday. “It is increasingly hard for people to afford prescription medicines. Unfortunately, the way the current system works, stakeholders often prioritize economics over what is best for the patient.”

With its epinephrine autoinjector, Kaléo will look to challenge a much larger company that’s weathered months of bad publicity and investigations over repeated price hikes on EpiPen. As a result of that controversy, one analyst recently predicted EpiPen’s sales will fall significantly to $300 million in 2018 from $1.1 billion in 2016.

But Mylan has a plan to grow EpiPen's reach by supporting “entity prescription” legislation that allows businesses such as restaurants and hotels to purchase and store the lifesaving injectors. It’s also planning to offer products directly through its own pharmacy to avoid pharma middlemen, who Mylan CEO Heather Bresch has said account for a significant amount of EpiPen’s cost.

Sanofi, which previously marketed Auvi-Q through a partnership with Kaléo, voluntarily recalled the product back in November 2015 for dosing problems. The French pharma later canceled the deal and returned the rights to Kaléo, jeopardizing the product’s future.

To bring its product back to market, Richmond, Virginia-based Kaléo “immediately got to work” on its manufacturing line, which is now fully automated, co-founder Eric Edwards said Thursday.

“We did not announce availability … until we felt very confident that this recall was addressed,” he said.

The company is not alone in looking to challenge EpiPen. Adamis recently filed for approval of its injector after an FDA rejection prompted former partner Teva to abandon the project and transfer away the rights.