US senators, including Senator Chuck Grassley (R-Iowa) and Senator Richard Blumenthal (D-CT), are calling for lower pricing for Mylan's EpiPen (epinephrine injection) Auto-Injector, which is used for the emergency treatment of life-threatening allergic reactions (anaphylaxis). Mylan's EpiPen leads the company's specialty product portfolio, accounting for $1 billion of the total $1.2 billion global 2015 sales in specialty revenues.

Senator Grassley asked a series of questions about the pricing, including what analyses were conducted in determining the price, Mylan's advertising budget for the EpiPen in the first half of 2016 as well as 2015, an explanation of the features the company said have improved the product and its value, whether the company offers patient-assistance programs, and whether the company has school-assistance programs for providing the drug.

“In the case of EpiPens, I am concerned that the substantial price increase could limit access to a much-needed medication,” Senator Grassley wrote to Heather Bresch, chief executive officer of Mylan. “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.”

Senator Blumenthal has called on Mylan to lower the price of EpiPen to an affordable, accessible level, citing that the rising price threatens to put the product out of reach for families, schools, and first responders. The senator noted that the price jumped by 480% since 2009.

In response, Mylan said in a company statement on Aug. 22, 2016: “Mylan has worked tirelessly over the past several years advocating for increased anaphylaxis awareness, preparedness, and access to treatment for those living with potentially life-threatening (severe) allergies. Ensuring access to epinephrine – the only first-line treatment for anaphylaxis – is a core part of our mission.”

Mylan further noted that changes in the healthcare insurance landscape have resulted in higher burden costs on consumers, who are increasingly enrolled in high deductible health plans in which deductible amounts continue to rise. Mylan has said it is committed to working with customers and payors to find solutions to meet the needs of patients and families. The company said it has been advocating for increased anaphylaxis awareness, preparedness, and access to treatment for those living with potentially life-threatening (severe) allergies. The company emphasized that ensuring access to epinephrine, the active ingredient in its EpiPen product, is a core part of the company's mission.

Mylan has implemented programs over the past several years to support access to treatment, including its My EpiPen Savings Card, a patient- assistance program, and the EpiPen4Schools program which provides free EpiPen Auto-Injectors to US schools,, In 2015, nearly 80% of commercially insured patients using the My EpiPen Savings Card received EpiPen Auto-Injector for $0. Since the start of the EpiPen4Schools initiative in 2012, more than 700,000 free EpiPen Auto-Injectors have been distributed, and more than 65,000 schools have participated in the program, noted Mylan.

On August 25, 2016, Mylan announced it is taking immediate action to further enhance access to EpiPen by expanding already existing programs in recognition of those patients who are facing the burden of higher out-of-pocket costs. The company is reducing the patient cost of EpiPen Auto-Injector through the use of a savings card that will cover up to $300 for the EpiPen 2-Pak. For patients who were previously paying the full amount of the company’s list price for EpiPen, this effectively reduces their out-of-pocket cost exposure by 50%. Mylan also is doubling the eligibility for its patient-assistance program, which will eliminate out-of-pocket costs for uninsured and under-insured patients and families as well. Specifically, Mylan is doubling eligibility for its patient-assistance program to 400% of the federal poverty level. This means a family of four making up to $97,200 would pay nothing out of pocket for their EpiPen Auto-Injector. Further, Mylan will continue to offer the EpiPen4Schools program. Mylan also is opening a pathway so that patients can order EpiPen Auto-Injector directly from the company, thereby reducing the cost. These programs will apply to EpiPen and EpiPen Jr (epinephrine injection, USP) Auto-Injectors.

Mylan CEO Heather Bresch said in the company statement on August 25, 2016, “We have been a long-term, committed partner to the allergy community and are taking immediate action to help ensure that everyone who needs an EpiPen Auto-Injector gets one. We recognize the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter. Patients deserve increased price transparency and affordable care, particularly as the system shifts significant costs to them. However, price is only one part of the problem that we are addressing with today’s actions. All involved must also take steps to help meaningfully address the US healthcare crisis, and we are committed to do our part to drive change in collaboration with policymakers, payors, patients, and healthcare professionals.”

The above story was originally published on August 23, 2016 and was later updated with information on August 25, 2015 to reflect additional company information issued on August 25, 2016.

Source: Mylan (August 22, 2016 release) and Mylan (August 25, 2016 release).