- Kaleo Pharma, maker of EpiPen alternative Auvi-Q, is facing political pressure for steep price increases on its opioid overdose treatment Evzio, a device containing naloxone.
- U.S. Senator Amy Klobuchar, D-MN, sent a letter to Kaleo on Feb. 3, demanding the company explain why it had increased the price of a two-pack of Evzio to $4,500 from $690 over the past three years.
- Kaleo is also facing scrutiny — and pushback from payers — for setting Auvi-Q's list price at $4,500, even though it is putting in place patient assistance programs for lower-income customers.
Senator Klobuchar's letter is yet another example of the kind of political pressure drugmakers can expect to face for sharp price increases on prescription drugs.
Criticism of rising drug prices has come from both sides of the aisle on Capitol Hill over the past several years. And pharma stocks took a hit in early January when President Trump accused the industry of "getting away with murder."
A recent sit down between Trump and some top pharma executives struck a more muted tone on pricing. But even so, pricing scrutiny looks set to continue unabated in 2017.
Klobuchar particularly keyed in on Kaleo's more than 500% price increase for Evzio.
"This price increase is worrisome. Due to the severity of the opioid epidemic and Evzio’s life-saving attributes, it is critical that your products remain affordable to Americans."
The Minnesota Senator asked Kaleo to explain its rationale for the price increase and detail how the cost of manufacturing has changed during that period — a political vulnerability even if most drug prices are not usually determined solely by cost of goods.
Public health advocates worry that dramatically rising naloxone prices will make opioid overdose treatments less accessible at a time when Americans are dying from opioid overdoses in record numbers. Such deaths totaled 33,000 in 2015, according to data from the Centers for Disease Control and Prevention (CDC).
And Kaleo's Evzio commands a not insignificant share of the retail naloxone market — nearly 20% according to estimates by the Food and Drug Administration for July 2015 through June 2016.
Klobuchar also asked for more information on the decision making behind the price of Auvi-Q, which Kaleo is launching nationwide on Feb. 14.
"Your price of $4,500 for a two-pack is especially disturbing, as more competition should mean lower — rather than higher — prices for epinephrine injectors," wrote Klobuchar in the letter, referencing Mylan's dominant EpiPen brand.
Last year, Mylan had been castigated for its $600 list price point for a two-pack of EpiPen, particularly since Mylan had a virtually monopoly. The entry of Kaleo's Auvi-Q changes that, but as Klobuchar points out, the system doesn't seem to benefit from the added competition.
Klobuchar, like some of her Democratic colleagues, has been active in introducing legislation aimed at tackling rising drug costs.