Senator Richard Blumenthal (D) is calling on the manufacturer of epinephrine injectors known as EpiPens to explain the prices being charged for the lifesaving devices that are essential to allergy sufferers. In a tweet, Blumenthal wrote on August 22, “I’m demanding that Mylan lower the price of its EpiPenfor all Americans that rely on it for their health and safety.”
The price of EpiPens has increased in recent years and is the last remaining epinephrine injector left on the US market, according to Consumer Reports. Good RX, which is cited by Consumer Reports, currently lists the price of EpiPens at approximately $600 in pharmacies. As children return to fall classes, some parents are finding the price to be prohibitive. Mylan Pharmaceuticals purchased the rights to produce EpiPens from pharmaceutical giant Merck. At that time, the cash price hovered around $50, according to the Annals of Allergy, Asthma and Immunology. Each EpiPen has about $1 of epinephrine, according to Bloomberg reports.
By way of contrast, the CanadaDrugPharmacy website lists an adult-size epinephrine device at $205, delivering 0.5 milligrams.
For Americans who are receiving Medicaid, who include those on Social Security’s Supplemental Security Income (SSI) and other welfare recipients, the total cost is covered. But Americans who are working and cover their own insurance are sometimes paying out of pocket for the device. Private insurers require patients to pay into a deductible before paying the entire cost or partial cost of an EpiPen.
Allergy expert Dr. James R. Baker, who is CEO and chief medical officer of Food Allergy Research & Education – an advocacy group – said it is not welfare and low-income recipients who are shelling out for EpiPens, but Americans who have high-deductible health plans. He told ABC News recently, "These patients are faced with a bill for several thousand dollars for several epinephrine auto-injectors if they have not already fulfilled their out-of-pocket requirement under their health plan." Baker added, "This can be devastating for many families who do not have financial reserves." Baker also said that he has heard of families going to the extreme of "stretching EpiPens to save money."
In many cases, using an EpiPen can save the life of the victims of bee and wasp stings, or those who have ingested foods to which they have allergies.
There's no reason an EpiPen, which costs Mylan just a few dollars to make, should cost families more than $600. https://t.co/rVWUlMxD0Q— Bernie Sanders (@SenSanders) August 18, 2016
"Anecdotal reports to us suggest that for some families it’s not unusual to split two-packs of auto-injectors, keep epinephrine auto-injectors past their expiration dates, or delay or ultimately not refill their prescriptions," said Baker. "This is an enormous patient safety issue." Mylan Pharmaceuticals stated that it has given away 700,000 free EpiPens to 65,000 schools since 2012, in addition to discount coupons for those finding difficulty paying for them. It has not commented on the retail cost of the devices.
Sen. Chuck Grassley (R-I) recently wrote to Mylan CEO Heather Bresch, saying: “In the case of EpiPens, I am concerned that the substantial price increase could limit access to a much-needed medication,” adding, “In addition, it could create an unsafe situation for patients as people, untrained in medical procedures, are incentivized to make their own kits from raw materials.” He called on her to explain the price increases. Bresch is the daughter of Sen. Joe Manchin (D-WV).
In a statement, Mylan said, “ensuring access to epinephrine--the only first-line treatment for anaphylaxis--is a core part of our mission.” Mylan stated that almost 80% of commercially insured patients on the company’s patient assistance program got the med at no cost in 2015. In a statement, Mylan said, "With changes in the healthcare insurance landscape, an increasing number of people and families are enrolled in high dehigh-deductible plans, and deductible amounts continue to rise." Company officials said additionally, "This shift has presented new challenges for consumers, and they are bearing more of the cost,” while adding that it is working with payors and customers to meet patients’ needs.
Wells Fargo’s David Maris said this June that several price hikes that Mylan introduced this year are effectively “beacons for scrutiny.”
Mylan is now facing the possibility of government investigations. Among those scrutinizing Mylan and the 400% price hike of EpiPens is Sen. Amy Klobuchar (D-MN). She wants the Senate Judiciary Committee and Federal Trade Commission to investigate. Republican Sen. Chuck Grassley of Iowa and independent Sen. Bernie Sanders of Vermont are also critical. Sanders recently tweeted, “There is no reason an EpiPen, which costs Mylan just a few dollars to make, should cost families more than $600." Klobochar has some skin in the game: her daughter uses EpiPens.
In a letter to Federal Trade Commission chair Edith Ramirez, Klobuchar demanded an investigation into Mylan's pricing. She wrote: "Although the antitrust laws do not prohibit price gouging, regardless of how unseemly it may be, they do prohibit the use of unreasonable restraints of trade to facilitate or protect a price increase. The FTC should investigate whether Mylan Pharmaceuticals engaged in activity, such as using incentives or exclusionary contracts with insurers, distributors, or pharmacies, to deny an alternative product access to the market."
Klobuchar stated that in 2009, an EpiPen two-pack cost $100. Today, they go for $500 to $600. "This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap,” Klobuchar said in a statement. Klobuchar cited Sanofi, which suspended its Auvi-Q rival to EpiPen after a recall, and Teva, which has been tried to market a competing device. In March, the FDA rejected a generic made by Teva, due to “certain major deficiencies,” which the company says would cause “significant” delays. And in November, Sanofi ran into injector problems.
But the scrutiny is not limited to EpiPens. In June, senators called on Pfizer, Mylan, Amphastar, Adapt Pharma, and Kaleo to explain price increases for naxolone, a drug that is used to reverse the effects of opioids. This month, President Barack Obama signed into law the Comprehensive Addiction and Recovery Act, which is poised to mean a significant uptick in the use of opioid replacements to treat drug addiction. In the House and Senate, it received widespread bipartisan support before it was tendered to the White House.