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Epinephrine cost, education remain crucial obstacles in school health
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According to the CDC, from 1997 to 2011, the prevalence of food allergy in children increased by 50%, while the prevalence of peanut or tree nut allergies has more than tripled — an increase commensurate with the rise in childhood hospitalizations for anaphylaxis.
Nationwide, the prevalence of anaphylaxis is estimated to be as high as 2% among children, according to Wesley Sublett, MD, MPH, FACAAI, from Family Allergy and Asthma in Louisville, Ky.
“While 2% doesn’t sound like a lot, if you consider all the schoolchildren who have been diagnosed with food allergies, there are probably about two children in every classroom across the United States who have food allergies and are potentially at risk for anaphylaxis,” he said in an interview with Infectious Diseases in Children.
Photo by Beaverton School District
As the only recommended first-line treatment for anaphylaxis, prompt epinephrine use has been shown to reduce or prevent hospitalization and reduce mortality risks associated with anaphylaxis. However, according to a study by Robinson and colleagues in the Annals of Allergy, Asthma and Immunology, less than half of children who experience anaphylaxis receive epinephrine prior to arrival in an ED.
In an effort to improve access to emergency epinephrine in schools and curtail anaphylaxis-related hospitalizations, in November 2013, President Barack Obama signed the School Access to Emergency Epinephrine Act into law.
The law provides additional funding through the Department of Health and Human Services, but only if schools are able to maintain an emergency supply of epinephrine auto-injectors (EAIs), have trained personnel to administer them, and can create plans for administration during school hours. Although this legislation has encouraged increased accessibility of epinephrine, availability is only one piece in the larger puzzle of anaphylaxis prevention.
The drastic rise in EAI costs over the past 5 years, coupled with poor education on the proper use of epinephrine among families with children who have food allergies, continue to hamper adequate management of food allergies and, thus, sustained incidence of anaphylaxis-related hospitalizations among children.
To gain insight into how increasing epinephrine costs and widespread epinephrine availability have changed the landscape of allergy management, Infectious Diseases in Children spoke with allergy experts, school nurses and pediatricians about what can be done to counsel students regarding epinephrine to better prevent anaphylaxis.
Consumer options
In the U.S., children at risk for anaphylaxis have three brands of auto-injectors to choose from: EpiPen (Mylan), AUVI-Q (Kaleo) and Adrenaclick (Amedra Pharmaceuticals). Although all assist in administering either 0.15 mg or 0.3 mg doses of epinephrine, each product differs in design, size and mode of drug delivery.
“Although all available auto-injector devices are clinically effective, there are subtle differences in how these products are used, and some children or parents may be more familiar or comfortable with one particular product and might not want to change,” Edward A. Bell, PharmD, BCPS, from the Drake University College of Pharmacy and Health Sciences, told Infectious Diseases in Children. “However, these devices all have the same drug and the same dose — it is just a matter of how they are formulated and how the drug is administered.”
The EpiPen auto-injector remains a household name that has become nearly synonymous with epinephrine, most notably due to extensive lobbying by Mylan for the passage of the School Access to Emergency Epinephrine Act, as well as the popularity of its EpiPen4Schools program.
With simple, color-coded directions for both children and caregivers, the EpiPen will audibly ‘click’ when administered correctly, at which point, the needle should remain in place for 3 seconds to ensure dosage delivery.
Following widespread public outcry – and an appearance before the House Oversight and Government Reform Committee – over the dramatic price increases of their EpiPen auto-injector, in December 2016, Mylan released an authorized generic at half of the price, yet with identical drug formulation and device functionality.
More than a year after its recall for potentially inaccurate dosage delivery, the AUVI-Q auto-injectors returned to the U.S. market in February 2017, offering a compact design as well as step-by-step voice instructions that guide a user through the injection process. As directed, the AUVI-Q is positioned against the thigh and held in place for 5 seconds while the dosage is delivered.
Lastly, long-time EAI Adrenaclick — and its authorized generic — has continued to provide a less-expensive alternative for consumers compared with other auto-injector competitors. Printed with color-coded and numbered instructions along the side of the device for ease of delivery, Adrenaclick utilizes the same press-and-hold technique as other auto-injectors, and requires 10 seconds for complete dose delivery.
“I actively tell patients that there are generic epinephrine options available, and that is what I prescribe,” Andrew Murphy, MD, FAAAAI, a member of the American Academy of Allergy, Asthma and Immunology Anaphylaxis Committee, said in an interview. “I leave it up to the patient or parent to discuss the cost of these options with their pharmacist and look at their insurance to see what works best for them.”
Despite the access provided by the Affordable Care Act, 27.3 million U.S. residents remain uninsured and — along with low-income consumers — are either forced to ‘shop’ for more affordable options or risk their health to avoid paying for a brand name auto-injector.
“This is a problem. There are individuals that cannot afford an auto-injector, and they don’t tell me that they cannot get one,” Gary Rachelefsky, MD, FAAP, FAAAAI, professor of allergy and immunology at the David Geffen School of Medicine at UCLA, said. “They are embarrassed, so I have to make an effort to follow up and make sure that they have received the medication that they need.”
Auto-injectors: Dollars and sense
“Cost of epinephrine auto-injectors is definitely an issue with all of our patients, especially those with high-deductible health care plans,” Sublett told Infectious Diseases in Children. “While some auto-injector devices offer rebates to reduce costs, including generics, and copay cards are now available to reduce prices for patients, cost remains a significant driver of health care selection.”
According to a 2012 analysis published in the Journal of Allergy and Clinical Immunology, the mean wholesale price of any single EAI increased 147% between 1986 ($35.59) and 2011 ($87.92).
Although EpiPen has borne the brunt of public scrutiny from consumers and legislators alike for its stark price increases — the retail price of EpiPen has increased more than 500% since acquired by Mylan in 2007 — prices have continued to rise for all EAIs currently on the market.
Upon its return to the market, the retail price of an AUVI-Q auto-injector was listed as $4,500 for two auto-injectors, an amount nearly 8 times higher than its EpiPen competitor that sparked the pricing controversy. However, through its AUVI-Q AffordAbility program, Kaléo has guaranteed that patients with commercial insurance will pay no out-of-pocket costs for their auto-injectors, and the company will provide the auto-injectors for free to households with no insurance and an income of less than $100,000. For those without insurance who do not qualify to receive Auvi-Q for free, Kaleo has set a cash price of $360.
In a similar effort to curb costs, earlier this year both CVS Pharmacy and Kmart Pharmacy sharply reduced their price for the generic Adrenaclick; according to company releases, CVS has set a cash price of $110 for Adrenaclick, while Kmart offered a price of $199.99 with no out-of-pocket costs for commercially-insured customers.
During her testimony before the House Oversight and Government Reform Committee in September 2016, Heather Bresch, CEO of Mylan, claimed that one component of the substantial price increase was the cost of additional research to prolong epinephrine shelf life as well as product design advancements, including safety features that prevent accidental sticks. Bresch also asked the committee to consider both the success and expense of the EpiPen4Schools program, which has promoted anaphylaxis awareness and provided 700,000 free EpiPen devices to more than 66,000 schools over the past 4 years alone.
“I don’t see a justification for the continuing rise of this drug. A 0.3 mg dose of epinephrine itself is probably less than a dollar in the vials,” Murphy said. “While I understand that there is a cost associated with the injector, I don’t understand how a drug can increase some absurd percentage over the past few years. I certainly don’t understand charging $4,500 for epinephrine with a mechanical device that talks to you.”
While physician groups, Congress, and the pharmaceutical industry work to address skyrocketing costs for auto-injectable epinephrine, the American College of Allergy, Asthma and Immunology encourages patients to discuss affordability issues with their allergists.
“I have spoken with allergists who will simply write a prescription for ‘epi auto-injector name or brand’,” Bell said. “The prescription can then be brought to the pharmacy and the pharmacist determines — based on the patient’s insurance coverage — what they can get, and will then try to get the lowest cost product for their patient.”
Taking stock in schools
The financial incentives offered by the School Access to Emergency Epinephrine Act greatly encouraged states nationwide to adopt policies that allow schools to supply undesignated — not prescribed to any single student — EAIs. According to Food Allergy Research & Education, since 2010, the number of states that allow or require schools to house and administer undesignated EAIs has grown from eight to 48.
Nina Fekaris, MS, BSN, RN, NCSN, president of the National Association of School Nurses and a school nurse for the Beaverton School District in Oregon, noted that while stock epinephrine programs have been beneficial for anaphylaxis prevention, it remains an unfunded legal mandate that has required many school districts to become creative with budgeting.
“A large school district could spend thousands of dollars to provide epinephrine for every building,” Fekaris told Infectious Diseases in Children. “It is one of those things we have to provide, so the money has to come from somewhere. While we have used programs like EpiPen4Schools in the past, we have also had to pay for epinephrine out of our health services budget, which means there is less money for professional development for school nurses and other equipment such as blood pressure cuffs, thermometers and other devices.”
Furthermore, a study by Steffens and colleagues in Prehospital Emergency Care found that in Michigan — one of 12 states that require schools to stock EAIs — 23 anaphylactic events occurred within public schools in 2014, yet only 30.4% of these cases used epinephrine supplied by the school.
While stock epinephrine programs — such as EpiPen4Schools or the newly released “Q Your School” program from Kaléo — can greatly mitigate costs through free EAIs, storage units, training videos and devices as well as anaphylaxis educational materials, availability of epinephrine is still overshadowed by the lack of knowledge in administering it.
“Between parents, health care providers and the school, we try to work hard in helping students be prepared,” Fekaris said. “We can teach patients all the skills and to recognize their symptoms, but when push comes to shove, most of my students are simply too scared to administer their medication. Many parents think that if children have the medication available, then they will be fine, when in actuality the child could be afraid to administer the medication because they have never had to.”
Murphy noted a compounding concern: the availability of personnel able to administer epinephrine in a school setting.
“One of the key obstacles of administering epinephrine in schools has been the fear of actually using the epinephrine; another is identifying a student who needs it,” Murphy said in an interview. “In the past, I have seen instances where the symptoms of anaphylaxis went unnoticed and a child received a Benadryl instead. Furthermore, adequate staffing becomes an issue: some schools don’t have school nurses, while others do, but on a rotating basis in which they are in school one day but not the next.”
Managing the problem
At the patient level, the pediatrician and/or allergist should be heavily involved in education not only on their allergy, but also the signs and symptoms of anaphylaxis as well as self-administration of epinephrine.
“I think the children are better educated than the parents,” Rachelefsky told Infectious Diseases in Children. “I know most 8-year-old children are capable of self-administering epinephrine if they are taught, or at least capable of telling an adult how to do it. The doctor has to spend time teaching the patient. If we can teach diabetics how to measure their blood sugar and administer insulin, why can’t we do that with epinephrine?”
In fact, in a study published in the Journal of Allergy and Clinical Immunology: In Practice, Shemesh and colleagues found that practicing self-administration in a supervised setting not only reduced their anxiety levels, but reduced parental worry as well.
One way to ensure education has been thoroughly given is through the collaborative creation of a written action plan, according to the AAP. These plans can increase education on anaphylaxis, reduce the frequency and severity of reactions, increase the potential use of EAIs and reduce overall anxiety experienced by children with food allergies as well as their caregivers.
“Providing children with an action plan for how to use their epinephrine auto-injectors is incredibly important,” Sublett said in an interview. “In addition to instruction on how to identify their triggers and proper avoidance of those triggers, a written action plan provides these patients and their caregivers with a written form of what they need to do if they experience anaphylaxis.”
In particular, the AAP noted that potential anaphylaxis in the school setting should be included in conversations with patients and parents when building an action plan, and that plan should also be individualized for use by school personnel.
“It is important to include the parents in the conversation about what is viable for the school to do and the appropriate accommodations a school can make,” Fekaris said. “We want everyone to be aware of potential allergies that children might have and to be able to recognize those symptoms. Ensuring that every parent — not only the parents of students with food allergies — is informed about the needs of these students is essential to preventing anaphylaxis.”
Ultimately, Bell noted that the most important education a child and their family can receive is comprehensive information about their allergy; when that is known, treatment and prevention of anaphylaxis becomes much more streamlined.“What is most important is that an accurate diagnosis needs to be made, typically by an allergist through patient history with skin testing,” Bell said. “If it’s determined that a child has a significant allergy that causes anaphylaxis, a prescription for an auto-injector will be made, and the child should be taught how to appropriately use it. Once that has been done, the allergist and pediatrician have done their job.” – by Katherine Bortz
- References:
- Alonso T, et al. Clin Exp Allergy. 2015. doi: 10.1111/cea.12418.
- Robinson M, et al. Ann Allergy Asthma Immunol. 2017. doi: 10.1016/j.anal.2017.06.001.
- Steffens C, et al. Prehosp Emerg Care. 2017. doi: 10.1080/10903127.2017.1308610.
- Sicherer SH, et al. Pediatrics. 2017. doi: 10.1542/peds.2016-4006.
- Wang J, et al. Pediatrics. 2017. doi: 10.1542/peds.2016-4005.
- Westermann-Clark E, et al. J Allergy Clun Immunol. 2012. doi: 10.1016/j.jaci.2012.06.018.
- For more information:
- Edward A. Bell, PharmD, BCPS, can be reached at the Drake University College of Pharmacy and Health Sciences, 2507 University Avenue, Des Moines, IA 50311; email: ed.bell@drake.edu.
- Nina Fekaris, MS, BSN, RN, NCSN, can be reached at the National Association of School Nurses, 1100 Wayne Avenue, Suite 925, Silver Springs, MD 20910; email: nfekaris@nasn.org.
- Andrew Murphy, MD, FAAAAI, can be reached at the Asthma, Allergy & Sinus Center, 1065 Andrew Drive, West Chester, PA 19380; email: awmurphymd@aol.com.
- Gary Rachelefsky, MD, FAAP, FAAAI, can be reached at the University of California, Los Angeles, David Geffen School of Medicine, 10833 Le Conte Ave, Los Angeles, CA 90024; email: grachelefsky@mednet.ucla.edu.
- Wesley Sublett, MD, MPH, FAAAAI, can be reached at the Family Allergy & Asthma, 9800 Shelbyville Rd, Suite 220, Louisville, KY 40223; email: wsublett@familyallergy.com.
Disclosure: Bell, Fekaris, Murphy and Rachelefsky report no relevant financial disclosures. Sublett reports previous financial support from Mylan Pharmaceuticals and Kaléo Pharmaceuticals.