A notable brand name competitor to the EpiPen will be available for purchase in early February, with a pricing strategy that's great for patients but may upset insurers.
The Auvi-Q, a “talking” epinephrine auto-injector, will return to the market on Feb. 14, and Richmond, Va.-based drugmaker Kaléo said that any American with commercial insurance—even high-deductible plans—will pay $0 out of pocket for the device. Households with an income of less than $100,000 will get it free, and any other noninsured patients will pay $360—half the cash price of the brand-name EpiPen and $60 more expensive than Mylan's new generic EpiPen.
It's been widely reported that the actual list price for Auvi-Q is $4,500, which will be the starting point for insurers to negotiate discounts and rebates. It appears Kaléo will foot the bill for patients with commercial insurers that choose not to cover the Auvi-Q.
It's a bold move that could offer serious competition to Mylan and its EpiPen products, which have no such guarantee of a $0 cost for commercially insured patients. Previous reports have suggested the Auvi-Q had a market share of only 10% when it was available.
"We wish we didn't have to do this, but the system is set up in a way that without this bold move, patients wouldn't get access and be able to afford Auvi-Q," Kaléo CEO Spencer Williamson told CNBC Thursday. "We're confident the model provides access and affordability, and that it is a sustainable model."
Kaléo has developed a similar device that delivers naloxone, the drug that can temporarily reverse the effects of opioid overdoses. That device also has a list price of $4,500 for two injectors, and has a $0 copay card, but the terms and conditions of that program note that “maximum reimbursement limits apply,” without stating those limits.
Kaléo announced last fall that it would rededevelop Auvi-Q after it was taken off the market in 2015. The device was produced through a licensing agreement between Kaléo and France-based drugmaker Sanofi, which was forced to recall the device in 2015—just two years after it was launched—because it repeatedly delivered inaccurate doses to patients. Kaléo terminated that agreement in February.
Auvi-Q is an innovator drug, not a generic version of the EpiPen. It has a voice prompt system that talks its user through the process of delivering epinephrine in a manner somewhat similar to the EpiPen.
Kaléo said last year that it reassessed its manufacturing processes and invested in new technology and quality systems to ensure the reintroduced device would work properly. The reliability required to produce a competitive epinephrine auto-injectorsis one of the biggest obstacles keeping manufacturers from entering the market.
Israel-based Teva Pharmaceutical Industries has tried for the past couple years to get Food and Drug Administration approval for a generic version of the EpiPen, but so far has been unsuccessful, in part due to Mylan's petitioning against the product.