Study: Patients Forgo EpiPen Treatment Due to High Cost

For the past few months, patients, providers, and advocacy groups have criticized Mylan for the high out-of-pocket cost of the EpiPen (epinephrine injection). A new study published by JAMA Internal Medicine found that out-of-pocket spending soared for the EpiPen since 2007; however, the manufacturer counters that it has offered significant savings programs to offset the high cost.

Since a majority of EpiPen users are insured, the study authors included data from 191.2 million enrollees in the Truven MarketScan Commercial Claims and Encounters database from 2007 to 2014. Included in the study were patients aged 0 to 64 who received private insurance from more than 100 employers.

The study authors wrote that aggressive pricing combined with inadequate insurance policies caused a 124% increase in annual out-of-pocket spending on the EpiPen during this timeframe. The increase of spending from $33.80 to $75.50 per year persisted, despite a small change in fills for the device, according to the study.

Due to the high costs of the EpiPen, the authors speculate that some patients may choose to go without the life-saving treatment.

"The major concern is that these increases may lead patients to forego filling EpiPen prescriptions due to cost, since having an EpiPen can mean the difference between life and death when serious allergic reactions occur," said lead study author Kao-Ping Chua, MD, PhD. "I have met families in the pediatric emergency department who have told me that cost prevents them from replacing their child's expired EpiPen every year. I also know a patient with a history of serious allergic reactions who only gets an EpiPen when her relative fills a prescription for an EpiPen 2-pack and shares the extra 1 with her."

EpiPen is the most commonly used epinephrine auto-injector, despite competition on the market. Some patients with severe allergies carry the device with them at all times, but cost has become a barrier for many.

After Mylan obtained the EpiPen in 2007, the price increased from $94 to $609, which has caused significant backlash. In response, Mylan recently launched a $300 generic version of the device to reduce patient concerns. However, the authors believe that the $300 price tag is still too high for many patients, according to the study.

“Mylan's introduction of a generic alternative is not a real solution to the affordability problem,” Dr Chua said. “Many patients will still have substantial out-of-pocket spending for generic EpiPen because of the cost-sharing their insurance plan requires.”

The authors urge patients and physicians to call for affordable pricing for life-saving treatments and sufficient insurance coverage, according to the study.

"The bottom line is that drug manufacturers and insurers should not force individuals and families to pay high amounts out-of-pocket for life-saving drugs like EpiPen,” said study senior author Rena Conti, PhD. “These pricing practices erode patient and public health. Patients, physicians, and policymakers should advocate for fair pricing and adequate insurance coverage of life-saving emergency drugs.”

To address the high cost, Mylan has launched multiple savings programs, which substantially drives down the cost of the EpiPen for a majority of patients with severe allergies, according to the company. Since the study did not explore the discounts used outside of insurance, some patients’ out-of-pocket costs may be much lower than discovered.

“Mylan has taken immediate action to ensure that everyone who needs an EpiPen Auto Injector is able to get one. In January 2017, nearly 90% of consumers who received EpiPen Auto-Injector or its authorized generic had an out-of-pocket cost of less than $50. This is in comparison to nearly 80% of patients paying less than $50 for their EpiPen Auto-Injector during the same timeframe last year,” Mylan said in a statement to The American Journal of Pharmacy Benefits. “The authorized generic for EpiPen Auto-Injector has the lowest wholesale acquisition cost of all epinephrine auto-injectors on the market.”

Since EpiPen is the most common epipenephrine autoinjector, it is expected that out-of-pocket speding on the drug would increase along with the population.

“Mylan has been an engaged and committed participant in the severe allergy community over the past years,” Mylan said. “As a result of collective community efforts to increase anaphylaxis awareness, preparedness and access to treatment, the number of EpiPen Auto-Injector patients has increased by 80% since 2008.”

Mylan also notes that since its acquisition of the EpiPen, the healthcare structure has changed significantly. These changes have left patients responsible for more out-of-pocket costs for a majority of prescription drugs, not just EpiPen.

“Additionally, it’s important to note that the way consumers pay for their healthcare has changed dramatically over the past few years,” Mylan told AJPB. “The stark reality is that a sharp rise in high deductible health plans has exposed more consumers to higher out-of-pocket costs for their medications. As noted in the study, ‘coverage policies also played a role’ in out-of-pocket spending.”