Kaléo to re-launch emergency allergy treatment Auvi-Q in US next month under "first-of-its-kind" pricing scheme

Kaléo said Thursday that the previously announced US re-launch of its Auvi-Q (epinephrine) auto-injector for the treatment of life-threatening allergic reactions is slated for February 14. The company added that as part of a "first-of-its-kind" access programme, Auvi-Q will be available to patients with commercial insurance, including those with high-deductible plans, at no cost out-of-pocket. Meanwhile, the cash price for Auvi-Q is $360 for those without government or commercial insurance, but will be free for uninsured patients whose annual household income is less than $100 000. 

CEO Spencer Williamson said "we met with patients and physicians and listened to the very real challenges in the current healthcare environment with obtaining access to affordable medicines." The executive remarked that no competing branded or generic device "will cost a commercially insured patient less out-of-pocket than Auvi-Q." 

Under the programme, Auvi-Q will be listed at $4500 for a two-pack, more than seven-fold higher than the $609 list price for Mylan's EpiPen (epinephrine), which recently also became available as an authorised generic for about $300 a twin pack. "The reason [Auvi-Q's] list price is high is it's the only way we can make sure patients have access and can get it for $0," Williamson said, adding that no insurer will pay full price due to discounts and rebates. 

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Bernstein analyst Ronny Gal suggested that even with a 30-percent or 40-percent discount to insurers, Kaléo would continue to generate a profit as "you're still getting $3000 for a product that probably cost them under $100 to make." Gal also predicted that enough insurers would likely pay full price, or close enough to it, to offset what the company pledges to spend in patient assistance. "The entire game is to charge an enormous amount of money to insurers and have those insurers cross-subsidise everybody else," the analyst said, adding "this is where pharma is going…the trick right now is how to try to isolate the patient from the pain while being able to charge more and more."

Meanwhile, Adam Fein of Pembroke Consulting said "frankly it sounds a lot like a Valeant [Pharmaceuticals] strategy, where you set a very high list price and you only capture the reimbursement on a very small percentage of prescriptions." He suggested "it's almost an outdated strategy that seems designed to invite controversy." However, Williamson rejected the criticisms, saying "we are very encouraged by the number of plans that we believe are going to cover Auvi-Q." The CEO also rebuffed comparisons between Kaléo's pricing plan and the tactics of Valeant. 

Auvi-Q, which was initially cleared by the FDA in 2012, was pulled from the market in 2015 due to issues with the injection mechanism that could have resulted in incorrect dosage delivery. Kaléo regained US and Canadian rights to the product from Sanofi last year. 

Earlier this month, CVS Health announced that it would sell Impax Laboratories' FDA-approved authorised generic for Adrenaclick (epinephrine) at a cash price of $110 per two-pack, with out-of-pocket costs potentially reduced down to $10 as patients "in most cases" are expected to qualify for a manufacturer's discount. 

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