Frustration Leads to New Epinephrine Injectors
Manufacturers are releasing their own products to meet demand amid the EpiPen shortage.
As the epinephrine shortage continues, medical professionals, parents, and students are becoming increasingly frustrated. EpiPen, the leading brand of epinephrine autoinjectors to treat anaphylaxis, has been in short supply since late 2017.1 With no end in sight, other manufacturers have rolled out their own epinephrine injectors.
Anaphylaxis is most often a reaction to foods, insect stings, latex, and medications. It occurs when the immune system overreacts to an allergen by releasing chemicals, which cause allergy symptoms. Those with allergies or asthma are at an increased risk of anaphylaxis, as well as those who have experienced an anaphylactic attack.2
The first line of treatment for anaphylaxis is intramuscular epinephrine, most frequently seen in auto-injectors.3 Available brand names include Adrenaclick, Auvi-Q, and EpiPen. There are several generic alternatives, as well.
There is still no timeline of when the supply issues are expected to resolve. Meridian Technologies, a Pfizer Inc subsidiary and the manufacturer of EpiPen and the Mylan generic equivalents, cites limited capacity at the manufacturing facility as cause for the shortages. The company's original statement said the shortages would be temporary.4
In the session, "US Pharmaceutical Trends, Issues, and Outlook for NACDS TSE" at the 2019 NACDS Total Store Expo, Doug Long, vice president of industry relations at IQVIA, predicted that because generic dollar price deflation has not flattened out, shortages may increase.
Generic prices are down by 11.6%, after rising 15% in October of 2014, according to the data from IQVIA. At their lowest point in October 2017, generic prices were down 12.9%.
Because the marketplace for generics is not friendly to manufacturers and wholesalers, Long said, fewer generic drugs are being launched than there are FDA approvals. As of December 2018, of 723 approvals, just 36.1% were launched. This disparity can be attributed to multiple factors, Long said, adding that when it comes to epinephrine injectors, one factor may be Mylan's domination of the market with its EpiPen brand.
Abbreviated new drug applications have increased in recent years, rising from 409 in 2014 to 781 in 2018. However, company withdrawals of applications have also increased. There were 14 withdrawals in 2014, 21 in 2016, and 18 in 2017.
Although Mylan continues to hold about 90% of the epinephrine autoinjector market, alternatives have been fighting to get a foodhold amid the shortage. Physicians and pharmacists have been advised to prescribe and dispense alternative brands wherever possible, but as a result, stocks of the alternatives are also threateningly low.1 Alternative epinephrine auto-injectors are available in 0.3-mg adult doses and 0.15-mg pediatric doses.
Auto-injectors are not the sole entrants to the market, however. Symjepi injectors function like a syringe in which the administrator depresses a plunger to administer the medication.4 The injector was launched in retail locations in the United States in July 2019, after being available in hospitals since January.
All these options, however, come with steep price tags. Without coupons or insurance, EpiPen prices have soared to $600 for a pack of 2.5 Auvi-Q also has significant out-of-pocket costs at the cash price, but Kaleo has implemented a $0 out-of-pocket cost for commercially insured patients on the Auvi-Q website through its direct delivery service.5 The cost for the Symjepi 0.3-mg injectable kit is about $280 for a supply of 2 for cash-paying customers.6
Although other alternatives are continuing to enter the market, the epinephrine shortage is still worrisome because of costs and the fact that the school year has begun.
- The Lancet Child Adolescent Health. The EpiPen shortage: how has it come to this? The Lancet Child Adolesc Health. 2018;2(12):839. doi: 10.1016/s2352-4642(18)30344-4.
- Anaphylaxis. The American Academy of Allergy, Asthma, & Immunology website. aaaai.org/conditions-and-treatments/allergies/anaphylaxis. Accessed September 2, 2019.
- Simons FE, Ardusso LR, Bilo MB, et al; World Allergy Organization. World Allergy Organization guidelines for the assessment and management of anaphylaxis. World Allergy Organ J. 2011;4(2):13-37. doi: 10.1097/WOX.0b013e318211496c.
- Smith G, Matti M. FAQs about the 2018 epinephrine shortages. Allergic Living. August 24, 2018. allergicliving.com/2018/08/22/faqs-about-the-2018-epinephrine-shortages/. Published September 13, 2018.
- Anderson L. EpiPen costs and alternatives: what are your best options? Drugs.com website. drugs.com/article/epipen-cost-alternatives.html. Accessed September 2, 2019.
- Symjepi prices, coupons and patient assistance programs. Drugs.com. drugs.com/price-guide/symjepi. Accessed September 2, 2019.