By Noel De León Sifonte, JHBL Staff Member
About 32 million Americans have a food allergy, which is a common trigger for anaphylaxis, a severe allergic reaction that is potentially fatal.[1] Epinephrine is the first line of defense against anaphylaxis, and therefore, epinephrine auto-injectors are vitally important medical products for people with food allergies. However, epinephrine auto-injectors are very expensive.[2]
Anaphylaxis affects people of all ages, but children and those who have asthma or atopic eczema are at a greater risk of developing anaphylaxis.[3] Without an epinephrine auto-injector like EpiPen, to prevent a person from going into anaphylactic shock, medical professionals must use a syringe and needle to manually deliver epinephrine, also known as adrenaline.[4] Medical administration of adrenaline helps regulate organ function.[5] Therefore, administering epinephrine into a person in anaphylactic shock immediately and simultaneously helps reduce throat swelling, open airways, raise blood pressure, and prevent further release of histamine in that person’s body.[6] Nonetheless, anaphylaxis may occur within a short time of exposure to the allergen, possibly causing death within 15 minutes.[7] Consequently, an individual without an epinephrine auto-injector may die before reaching a medical professional to administer epinephrine.
Epinephrine auto-injectors, with their user-friendly instructions, were created to give any individual the chance to administer a dosage of epinephrine quickly and effectively to a person with anaphylaxis. [8] An epinephrine auto-injector is a medical device with a spring-loaded needle that, when firmly pressed against a person’s thigh, injects a fixed dosage of adrenaline.[9] Despite this product’s importance to a person who may experience anaphylaxis, it is often prohibitively expensive.
While there are multiple epinephrine auto-injectors, the original and most commonly known epinephrine auto-injector is EpiPen.[10] Originally, two EpiPens cost less than $100, but Viatris, formerly known as Mylan, acquired the right to sell the product in 2007, and increased the price of EpiPens by more than 400%.[11] Furthermore, Viatris stopped selling EpiPens individually and switched to selling them in pairs, forcing consumers to buy these more expensive twin packages if they wanted to acquire an EpiPen.[12] Viatris successfully increased the price of EpiPen by creating a monopoly. Viatris created this monopoly by filing new patents and purchasing other auto-injector companies to extend their exclusive control over EpiPens.[13]
While Viatris and other companies have attempted to reduce the price of their epinephrine auto-injectors, the prices remain very high.[14] Even if an individual can afford one auto-injector, they may not be able to afford another one. Consequently, many depend on using expired epinephrine auto-injectors.[15] While it may be best to use an expired epinephrine auto-injector when nothing else is available, there is no guarantee that it will work as effectively.[16] By maintaining restrictive prices on epinephrine auto-injectors, companies like Viatris have implicitly classified epinephrine as a luxury medication. However, epinephrine is not a luxury; it is the only life-saving medicine for anaphylaxis.[17]
Thankfully, states are beginning to regulate epinephrine auto-injectors to make them more affordable. At the beginning of this year, New Hampshire was the only state that capped the price of epinephrine auto-injectors.[18] However, other states began following New Hampshire’s example. [19] For instance, earlier this year, the Colorado and Illinois legislatures passed price caps on epinephrine auto-injectors that limited these products to a maximum of $60 per twin package.[20] Similarly, the Minnesota legislature passed a limit of $50 per epinephrine auto-injector rather than per twin package.[21] The Rhode Island legislature enacted a law requiring health insurers to cover the cost of one twin package epinephrine auto-injector per year.[22] Moreover, New Jersey will now limit the price of these medical devices to $25, but only per 30-day supply.[23]
Despite some state legislatures’ willingness to regulate the price of epinephrine auto-injectors, most states have no such regulations.[24] On the other hand, the federal government putting a price cap on insulin earlier this year may indicate a shift in regulating medicine prices.[25] For example, when the federal government limited the price of insulin, Eli Lilly, one of the largest manufacturers of insulin, announced that they would reduce the price of insulin by 70%.[26] Some argue that this was a strategic move to stay ahead of the curve in the market.[27] Nonetheless, Eli Lilly’s decision may possibly set a new standard for pricing life-saving medication.[28]
There are no current indications that Viatris or the other companies will commit to such a similar or drastic reduction of their epinephrine auto-injectors. Moreover, there are no indications that the federal government will cap the price of epinephrine auto-injectors anytime soon. However, the federal government’s decision to cap the price of another life-saving medication alongside Eli Lilly’s announcement may encourage other state legislatures or companies to follow suit in regards with epinephrine auto-injectors.[29] Furthermore, Viatris may reduce the price of EpiPens, similar to Eli Lilly’s reduction of the price of insulin, once more generic versions of epinephrine auto-injectors become available at reduced prices. Nevertheless, until the companies drastically reduce their products’ prices, or the federal government intervenes, State legislatures imposing restrictions on pricing is the most assured and effective method to ensure accessibility and affordability of epinephrine auto-injectors.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
Noel De León Sifonte, originally from San Juan, Puerto Rico, received his Bachelor of Art in Theology from Boston College in 2022 and is currently a second-year law student at Suffolk University Law School.
[1] Facts and Statistics for the U.S., FARE, https://www.foodallergy.org/sites/default/files/2020-06/FARE%20Food%20Allergy%20Facts%20and%20Stats%20rev%202020-06-04.pdf [https://perma.cc/FYT7-S9VE] (detailing number of individuals with different allergies).
[2] Dylan Scott, Can we solve the EpiPen cost crisis?, Vox (Aug. 4, 2023), https://www.vox.com/policy/23658275/epipen-cost-price-how-much [https://perma.cc/8WKR-WCXU].
[3] Anaphylaxis, NHS inform, https://www.nhsinform.scot/illnesses-and-conditions/immune-system/anaphylaxis/ [https://perma.cc/SB9F-XPRU].
[4] What is Epinephrine?, Allergy & Asthma Network, https://allergyasthmanetwork.org/anaphylaxis/ [https://perma.cc/R4U5-LAUQ].
[5] Id.
[6] Id.
[7] What is Anaphylaxis?, Allergy & Asthma Network, https://allergyasthmanetwork.org/anaphylaxis/ [https://perma.cc/JRR4-7JNJ].
[8] See Mylan, How to use an EpiPen (epinephrine injection, USP) Auto-Injector, EpiPen, https://www.epipen.com/-/media/files/epipen/howtouseepipenautoinjector.pdf [https://perma.cc/T4AD-35PN] (detailing instructions for using EpiPen).
[9] See id. Epi Pens Explained, LeBonheur (Sept. 8, 2015), https://www.lebonheur.org/blogs/practical-parenting/epi-pens-explained [https://perma.cc/JRR4-7JNJ].
[10] See Benjamin Gordon, Evolution of Epinephrine, Allergy Amulet (Aug. 9, 2022), https://www.allergyamulet.com/blog/the-evolution-of-epinephrine [https://perma.cc/A54R-9TKC]; see also Ginger Skinner, Cheaper Epinephrine: Spend Way Less With This EpiPen Alternative, Consumer Reps. (Jan. 12, 2017), https://www.consumerreports.org/epinephrine/cheaper-epinephrine-spend-way-less-with-this-epipen-alternative/#:~:text=Generic%20Adrenaclick%20contains%20epinephrine%2C%20the,tip%20into%20your%20outer%20thigh. [https://perma.cc/CS2Q-UAWB] (noting Adrenaclick requires removing two grey caps when EpiPen requires removing one blue cap); Auvi-Q vs. EpiPen, NY Allergy & Sinus Ctr. (Jun. 1, 2018), https://www.nyallergy.com/auvi-q-vs-epipen/#:~:text=Auvi%2DQ%20poses%20many%20benefits,with%20an%20auto%2Dretractable%20needle. [https://perma.cc/UF2Z-KYJ9] (noting Auvi-Q has voice instructions and auto-retractable needle).
[11] See Aubri L. Swank, The Pricelessness of Life vs. Profiting from Illness: A Call for Change to the Pricing Model for Lifesaving Drugs in the United States, 61 Duq. L. Rev. 261, 270 (2023); Marsh, supra note 2.
[12] Id. Yet, many have speculated that the epinephrine alongside the medical device costs less than a total of $15. Id.
[13] Id.
[14] Swank, supra note 11, at 271.
[15] See Ginger Skinner, What You Need to Know About Expired EpiPens, Consumer Reps. (Aug. 26, 2016), https://www.consumerreports.org/drugs/expired-epipens-what-you-need-to-know/ [https://perma.cc/CZ2Y-9HHF]. Epinephrine auto-injectors expire after 12 to 18 months or if the medicine is pink, brown, cloudy or has solid particles. Id.
[16] See Daniel More, Using an Expired EpiPen for Allergic Reactions, Verywell Health (Sept. 8, 2022), https://www.verywellhealth.com/expired-epipen-82701 [https://perma.cc/LL6Z-GQZG] (noting that research shows less epinephrine in expired EpiPens compared to non-expired EpiPens)
[17] What is Anaphylaxis?, supra note 7.
[18] See Wendy Mondello, Epinephrine Price Caps: Who Will Win and Who Will Pay?, Allergic Living (Aug. 19, 2023), https://www.allergicliving.com/2023/08/19/epinephrine-price-caps-who-will-win-and-who-will-pay/#:~:text=Signed%3A%20May%202023%2C%20takes%20effect%3A%20January%202025.,%24100%20per%2030%2Dday%20supply [https://perma.cc/HVX3-L5LV].
[19] Mackenzie Bean, States Take Aim at EpiPen Costs, Berker’s Hosp. Rev. https://www.beckershospitalreview.com/pharmacy/states-take-aim-at-epipen-costs.html [https://perma.cc/94MG-XGHB].
[20] Senator Halpin Caps the Price of EpiPens to $60, Ill. Senate Democrats (Oct. 19, 2023), https://www.illinoissenatedemocrats.com/caucus-news/80-senator-mike-halpin-news/5121-senator-halpin-caps-the-price-of-epipens-to-60 [https://perma.cc/29MK-BKC6]; Mondello, supra note 18. Other states, such as Vermont, and Missouri have introduced bills regarding limiting these medical devices with similar variations but have not been signed at this moment. See Mondello, supra note 18.
[21] Mondello, supra note 18.
[22] Id.
[23] Id.
[24] See id. (detailing only eight states that have enacted or introduced legislation limiting prices of epinephrine auto-injectors).
[25] See Grace Fernandez, Why Eli Lilly’s Insulin Price Cap Announcement Matters, John Hopkins (Mar. 13, 2023), https://publichealth.jhu.edu/2023/eli-lilly-lowers-insulin-prices [https://perma.cc/29MK-BKC6].
[26] Id.
[27] See id. (expressing that generics will soon become available and may sell their product at lower prices).
[28] See id.
[29] Cf. id. (noting other companies have followed in Eli Lilly’s footsteps and reduced price of insulin).