Epinephrine autoinjectors provide life-saving therapy for individuals with allergic reactions such as anaphylaxis to foods, insects, or medications. These autoinjectors are used when an individual is experiencing life-threatening symptoms and can help improve their breathing, reduce hives, and decrease the amount of swelling in the throat and on the face. However, the cost of these autoinjectors, especially the EpiPen, has increased significantly over the past decade (Westermann-Clark et al., 2018).
EpiPens were developed in the 1970s and approved by the Food and Drug Administration in 1987 (Westermann-Clark et al., 2018), and the average wholesale price for an EpiPen 2-pack from 2001-2007 was roughly $100-$150 dollars until EpiPen was acquired by Mylan, a pharmaceutical company, in 2007. Since Mylan’s acquirement of EpiPen, the cost for the 2-pack autoinjector has increased 545%, from $113.27 to $730.33 (Westermann-Clark et al., 2018). You read right; it costs $730.33 for a prescription to save a life.
These EpiPens are prescribed by a physician of the patient, but they are not readily available worldwide or completely covered by insurance. However, alternative epinephrine self-administration prescriptions are being introduced into the market for individuals who cannot afford or have access to the autoinjectors. These self-administration prescriptions include a prefilled syringe of epinephrine that is stored in an eyeglass or pencil case that can be injected into an individual who is experiencing life-threatening symptoms to delay potential death (Pepper et al., 2017). However, many additional factors limit newer products, such as this self-administering epinephrine, to enter the market due to Mylan’s EpiPen. The first factor impeding new epinephrine administering products is the name recognition of Mylan’s EpiPen. Many individuals recognize EpiPen and are familiar with its administration process. Thus, it is more readily available at pharmacies and trusted by individuals. The second factor is with each new device introduced to the market there is new training needed for each device. For example, an autoinjector from Impax Generics requires the removal of two caps before administration compared to the one in the EpiPen. This may be detrimental in a life or death allergic reaction. Lastly, insurance coverages for each autoinjector in the market are different (Westermann-Clark et al., 2018). Therefore, not every insurance will cover these autoinjectors, and as stated earlier, not many of these autoinjectors are available worldwide. As stated by Westermann-Clark et al, in addition to insurance coverage variability, there are socioeconomic factors that play a role in a patient even obtaining autoinjectors (2018). As described in their article, children from high-income homes are 8.35 times more likely to be prescribed autoinjectors compared to children from low-income homes. In addition, children enrolled in Medicaid are also less likely to receive administration of epinephrine from these autoinjectors before arriving at the emergency room which is highly detrimental when attempting to save a patient with severe allergies such as anaphylactic shock (Westermann-Clark et al., 2018). These factors make it difficult for the introduction and use of newer autoinjector devices compared to the already well-known and established EpiPen.
The rising cost of Epipens and limited autoinjector availability worldwide have made it difficult for patients to obtain and afford this prescription that could save their lives. There are alternative epinephrine self-administration coming into the market, however, many factors impede their use and prescription over Mylan’s EpiPen. If you know of an individual with life-threatening allergies, or you yourself experience them these have been ongoing issues over the past few years. So, I ask you how much would you pay to save your life?
References:
Pepper, A. N., Westermann-Clark, E., & Lockey, R. F. (2017). The High Cost of Epinephrine Autoinjectors and Possible Alternatives. The Journal of Allergy and Clinical Immunology: In Practice, 5(3), 665–668.e1. https://doi.org/10.1016/j.jaip.2016.12.018
Westermann-Clark, E., Pepper, A. N., & Lockey, R. F. (2018). Economic considerations in the treatment of systemic allergic reactions. Journal of Asthma and Allergy, Volume 11, 153–158. https://doi.org/10.2147/jaa.s159851
Hey Vi!
ReplyDeleteGreat analysis of the ethics and problems surrounding epi-pens. I have worked frequently with participants at my backpacking job that would have to pay this $300 out of pocket if they did not have epipens. Instead, a lot of the camps used vials of epinephrine to minimize cost.
I wanted to know more about other options available. This article mentioned about 10 different options of other Epi-injectors. And while some of these are less expensive, they bring up questions about how long they have been on the market and people's overall ability to use them. I find it frustrating that a major limiting factor (as you mentioned) is the public's ability to use the device. While it is key, it seems like Mylan's monopoly and society underestimates our ability to learn a new device. For example, AED devices differ between brands, by a common voice activator provides clear directions. I also want to mentioned that I noticed similar ethics that remind me of insulin prices. Why is it that we are able to unify decisions for something like an AED and not for insulin and epinephrine.
http://www.whenpeanutsattack.com/food-allergy-treatment/epinephrine-autoinjectors-compared-epipen-auvi-q/
Hi Vi! I really enjoyed your post, especially because the cost of medications is such a prevalent issue. Another thing that I thought of while reading your post was how outrageously expensive insulin is. As I am sure you know, insulin is an essential medication for people who have Type 1 or Type 2 diabetes. Type 1 being people who don’t produce insulin and Type 2 being those who are insulin resistant. As we have learned in physiology and biochemistry that means that these people are unable to maintain normal glucose levels which can lead to a whole host of other health issues including cardiovascular disease, dietbetic ketoacidosis, and blindness. While there are several factors that can contribute to non adherence to insulin medication, one of the biggest is the cost.
ReplyDeleteI read a study that administered a survey to patients who lived in New Haven, Connecticut and the surrounding areas all with Type 1 or Type 2 diabetes who had had insulin prescribed to them within the last 6 months. They found that 1 in 4 patients reported cost-related insulin underuse. (Herket, et al, 2019). I remember working as a medical assistant and some of our hardest patients to treat were the ones who weren’t insulin compliant due to not being able to afford the medication. A recent journal article released by Forbes reports that insulin costs are increasing by 15% annually. Even the insulins that are supposed to be more affordable are still $175-$300 per vial (Cohen, 2021). Most patients need at least 2-3 vials per month and if you do the math that ends up to be anywhere between $6,300 - $10,800 a year! The point of taking insulin is to keep a person’s blood glucose levels within normal range, thus preventing further health issues later in life that could lead to even more expensive out of pocket costs. But for a lot of people not taking the medication is worth the risk because of all the short term things that are affected by spending that much money on something that “could” be.
I would say that this takes into account all four of the biomedical ethical principles: justice, autonomy, beneficence, and nonmaleficence. How does one treat a patient when the medication that is available isn’t affordable for a majority of the population? How can one argue that the treatment is worth the cost when there are so many other factors at play? And back to your point, how much should someone have to pay to save their life?
Cohen, J. (2021, January 5). Insulin's out-of-pocket cost burden to diabetic patients continues to rise despite reduced net costs to pbms. Forbes. Retrieved November 16, 2021, from https://www.forbes.com/sites/joshuacohen/2021/01/05/insulins-out-of-pocket-cost-burden-to-diabetic-patients-continues-to-rise-despite-reduced-net-costs-to-pbms/.
Herkert, D., Vijayakumar, P., Luo, J., Schwartz, J. I., Rabin, T. L., DeFilippo, E., & Lipska, K. J. (2019). Cost-Related Insulin Underuse Among Patients With Diabetes. JAMA internal medicine, 179(1), 112–114. https://doi.org/10.1001/jamainternmed.2018.5008