How physicians can help patients cope with EpiPen price spike
Last month, EpiPen manufacturer Mylan has acknowledged the significant increase in the price of the popular epinephrine autoinjector since it acquired the device in 2007, and announced a new generic option that will still cost more than the previous price of the brand name product.
Physicians, medical associations, politicians and patients have all criticized Mylan's actions in what is seen as the latest price spike of a high-demand drug by a pharmaceutical monopoly.
Purvi Parikh, MD, an allergist and immunologist and spokesperson for the Allergy & Asthma Network, told Healio Internal Medicine that the price increase would affect patient adherence and their safety.
"Unfortunately, this is a reality for patients in that the price increase combined with high insurance deductibles has forced them to choose between medication and basic necessities such as food and housing," she said. "Many have foregone the EpiPen or gotten less than is recommended to save money.”
Parikh acknowledged that some patients will have no option but to use an EpiPen that has expired.
"The danger is that the efficacy and potency of the medication decreases over time so it may not work as you would hope in the case of a life-threatening reaction," she said. "If no other option exists, we still recommend using the expired one, as it is still better than no epinephrine.”
How physicians can support patients
Parikh did note, however, that there are several ways that physicians can help patients cope with the price increase.
"Physicians can help by making patients aware of cost-saving programs by Mylan as well as other organizations such as the Allergy & Asthma Network and the American College of Allergy, Asthma and Immunology," she said. "Physicians can also help advocate to the government and insurance entities to get the medication placed on preventative drug lists so they are not susceptible to high deductibles."
Tonya Winders, CEO and president of the Allergy & Asthma Network, shared more options for patients who are struggling to afford the medication.
"Patients with commercial insurance should use the coupon/discount card, which will reduce their payment by up to $300," she said. "Patients without commercial insurance who qualify for Medicaid should receive their EpiPen for $0 out of pocket. Families that have no insurance should access either the generic Adrenaclick or generic EpiPen when it's available. It is always wise to use GoodRX.com to determine which retail pharmacy outlet offers the best pricing in your area."
Winders also noted that the only other approved epinephrine autoinjector is the generic Adrenaclick, but it is only available in limited markets.
What does the generic option mean?
In a press release issued this past week, Mylan announced that it would launch a generic version of their EpiPen in the next several weeks.
"We understand the deep frustration and concerns associated with the cost of EpiPen to the patient, and have always shared the public's desire to ensure that this important product be accessible to anyone who needs it,” Heather Bresch, Mylan CEO, said in the release. “Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response, which required the cooperation of our partner. However, because of the complexity and opaqueness of today's branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option. Generic drugs have a long, proven track record of delivering significant savings to both patients and the overall health care system. The launch of a generic EpiPen, which follows the steps we took last week on the brand to immediately reduce patients' out-of-pocket costs, will offer a long-term solution to further reduce costs and ease the burden and complexity of the process on the patient."
Rachel Sachs, an associate professor at the Washington University in St. Louis School of Law, explained that Mylan could have several reasons for launching a new generic, aside from public relations.
"By bringing the first generic EpiPen to market, Mylan has now planted its flag in the generics space," she wrote in a blog entry for The Petrie-Flam Center at Harvard Law School. "Although epinephrine (the drug inside the EpiPen) is now generic and cheap to produce and sell, companies do seem to find it difficult to replicate the device portion of the EpiPen, with Sanofi’s product recently removed from the market due to dosing issues and Teva’s application for a generic denied by the FDA with no public explanation just a few months ago. Mylan has now benchmarked a new price for those products if they return — they must price below $300 for a two-pack to compete effectively with Mylan."
Sachs also speculated whether Mylan was attempting to maintain its significant portion of the market with the brand name EpiPen.
"I wonder whether their generic will be fully substitutable by pharmacists, a question which may depend on the state laws involved (and which Mylan has lobbied to influence)," she wrote. "I wonder whether the EpiPen comes with training or other easy-to-use tools that will be missing from the generic, and as long as Mylan provides copay coupons only for the branded product, parents facing equivalent copays in either situation will choose the branded EpiPen. I wonder whether Mylan will not offer discounts off the list price for the generic (except those required by law for Medicaid), meaning that the actual prices paid by insurers will be roughly comparable. And finally, because a significant portion of EpiPen purchasing happens during the back-to-school season, Mylan has done little harm to its revenues this year. It is only next year that this product may affect their bottom line."
Parikh said that various factors go into pricing, such as production costs and inflation, which may account for why the newly-announced generic will be more expensive than the EpiPen has been previously.
"For this reason, the company needs to be transparent about the pricing and their actual costs in manufacturing the medication and explain why there is still a cost differential," she said. "Also, another factor in this discussion is the fact that insurance companies are now placing the entire cost on patients through high deductibles, whereas before more of the medications were covered, so with rising costs and inflation, the price differential was not as hard on the patient."
Calling for change
Several medical organizations have called for drug pricing transparency following Mylan's actions.
Andrew W. Gurman , MD, president of the AMA, condemned the cost increase.
"With Americans across the country sending their children back to school this month, many parents and schools are encountering sticker shock over the cost of EpiPens,” he said in a statement. “Although the product is unchanged since 2009, the cost has skyrocketed by more than 400% during that period. The AMA has long urged the pharmaceutical industry to exercise reasonable restraint in drug pricing, and, with lives on the line, we urge the manufacturer to do all it can to rein in these exorbitant costs. With many parents required to buy two or more sets of EpiPens just to keep their children safe, the high cost of these devices may either keep them out of reach of people in need or force some families to choose between EpiPens and other essentials. The AMA will continue to promote market-based strategies to achieve access to and affordability of health care goods and services."
The American Academy of Allergy, Asthma & Immunology called the issue of access "a matter of life and death."
"There is no reasonable alternative to this medication for these people, who may die if they do not have injectable epinephrine immediately available at home and work (or school) when anaphylaxis occurs," Thomas B. Casale, MD, FAAAAI, AAAAI Executive Vice President, said in the release. "Skyrocketing costs for autoinjectable epinephrine products place an unacceptable burden on our patients, and we vigorously support all efforts to address this urgent issue as quickly as possible."
The American Academy of Pediatrics noted that these increases place a large burden on families and keep them from accessing lifesaving care, which can put children in danger.
"At least one in 20 children in the U.S. has a known food allergy," Benard Dreyer, MD, FAAP, president of AAP, said in a release. "As these children head back to school this month, it's critically important they have immediate access to lifesaving epinephrine. Prompt treatment with epinephrine lowers a child's risk of hospitalization and death. The most practical and convenient way to administer this medication is through an auto-injector, like EpiPen."
He continued: "Urgent solutions are needed. Now is the time for all interested stakeholders — families, doctors, manufacturers, distributors, payers and government agencies like the FDA — to act quickly to alleviate the financial hardships faced by families."
Richard Bruno, MD, MPH, the resident member of the American Academy of Family Physicians Board of Directors, urged providers to support both state and federal legislation aimed at making medications more affordable.
"Following these proposals through to enactment is vitally important to ensure the health and financial well-being of Americans," he said in a blog post.
Bruno also called for more transparency regarding the financial interests and backgrounds of those who control drug access.
"As family physicians, we have the opportunity to advocate for our patients' expanded access to affordable medicines, and as an organization, we can amplify that sentiment throughout the house of medicine and to state and federal governments, as well as to corporations that control much of what impacts the patients we serve."
Sachs wrote that we should not "think of ‘price-controls’ as a four-letter word."
"Price controls come in many forms, and we have many of them operating in the law right now," she said. "We could act to prevent price increases over time, a step that has been taken in Medicaid already. We could nudge providers to care about prices through projects like the proposed Part B demo. Giving Medicare both negotiating authority and formulary-setting power would qualify as ‘price controls,’ in my view."
She acknowledged that prices could still increase and that price control might impact innovation, but change is necessary.
"[T]he outrage over actions like Mylan’s must come with a prescription for change," Sachs concluded. "If not, it is a matter of when, not if, this will happen again." – by Chelsea Frajerman Pardes
Disclosures: Parikh and Winders report no relevant financial disclosures.