A lawsuit against Colorado’s EpiPen access law can move to trial. The law went into effect last January, making epinephrine auto-injectors for people with severe allergies much cheaper.
It brought the average cost of an EpiPen two-pack down from $600 to $60 each, setting a hard cap for both people with insurance and creating an affordability program for uninsured people with a prescription for the injectors.
Dr. Rohit Katial of Denver’s National Jewish Health said access to the medicine can and does save lives when people have an anaphylactic reaction to things like bee stings, nuts or shellfish.
“You just don’t know when you’re going to have an accidental exposure or get stung if you’re outdoors, especially here in Colorado, where people hike and do mountain activities,” Katial said.
According to legislators, there are approximately 565,824 people with life-threatening food allergies in the state. That’s more than the entire population of Colorado Springs.
“The EpiPen, in most guidelines, is the first medication that should be administered for anaphylaxis. It buys you time to get to a healthcare facility for more durable care or monitoring or additional epinephrine, along with other medications to really treat the reaction.”
EpiPens are sold in two-packs because some people have very severe reactions resulting in a rapid breakdown of the epinephrine. “The initial injection can sometimes be enough to get you time to get to an emergency department, but if it’s a very severe reaction, folks may need a second one to buy some additional time. One is not always enough,” Katial said.
However, just before the law hit the books, Tel Aviv-based Teva Pharmaceuticals, a company that sells generic 2-pack epinephrine injectors for about $300 a pop, sued the state, arguing the affordability program is a violation of the Fifth Amendment taking clause — a rule that requires the government to pay “just compensation” if it takes private property for public consumption.
Colorado countered, saying the law is about economic regulation and isn’t the same thing as the government seizing property.
That fall, Amneal Pharmaceuticals, another EpiPen manufacturer, also sued Colorado in federal court, asking a judge to block the law on the same grounds.
The judge denied the company’s requests for a preliminary injunction and also rejected the state’s bid to dismiss the case.
This month, Teva’s lawsuit went up for appeal first, and the 10th Circuit Court ruled it can move forward.
“We affirm the district court’s denial of Defendants’ motion to dismiss based on Eleventh Amendment immunity and remand this case to the district court for further proceedings,” wrote Senior Judge Bobby R. Baldock in the Sept. 5 order.
The announcement does not end or pause the law, but it does clear the way for both companies to take their case to trial in district court.
In the meantime, the price cap will stay in place.
If the manufacturers win, uninsured Coloradans would likely lose the $60 EpiPen option first — because pharmacies wouldn’t be guaranteed a reimbursement — while the $60 cap for people with insurance would probably remain, at least initially, until courts or lawmakers say otherwise.
“I would imagine it’s folks that aren’t insured or fully insured or don’t have appropriate drug coverage plans, but it’s much more nuanced and complex than that,” Katial said. “Someone could be insured but just not afford the cost. So it could be the entire gamut. I think at a minimum it would definitely impact uninsured folks or those that don’t have appropriate drug plan coverage.”
If Teva wins, the state could ask for a stay while it appeals or moves to rush a legislative fix.
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