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New generic version of EpiPen (epinephrine) approved

by
Optum for Workers' Compensation
| Aug 24, 2018

Last year, we told you about the launch of the first authorized generic version of EpiPen®. On August 16, 2018 the U.S. Food and Drug Administration (FDA) approved Teva’s generic versions of EpiPen and EpiPen Jr (epinephrine) auto-injectors for use in adults and pediatric patients weighing more than thirty-three pounds.

Teva has been approved to promote its generic epinephrine auto-injector in 0.3 mg and 0.15 mg dosage strengths and will be applying full resources to launch the auto-injectors in the coming months. Although the launch date and cost of Teva’s generic auto-injector are unknown at this time, generic medications are typically lower in cost to their brand counterparts thus offering cost savings to consumers. And while the dispensing of these types of epinephrine-containing products is not routine for claims in workers’ compensation and auto-related injuries, it can occur.

Currently, epinephrine auto-injector products are allowed on our standard cardiovascular and inflammation formularies and require prior authorization on all other standard formularies. Coverage for these products on custom client formularies will vary.

The FDA has also approved several other epinephrine auto-injector products to treat anaphylaxis, including Adrenaclick® and Auvi-Q®. In addition, authorized generic versions of EpiPen and Adrenaclick are available and marketed without the brand names.

Epinephrine is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, medications, diagnostic testing substances and other allergens, as well as idiopathic (unknown cause) or exercise-induced anaphylaxis. Anaphylaxis, a serious, life-threatening allergic reaction, requires immediate medical treatment, which may include an injection of epinephrine and a trip to a hospital emergency room. If not treated properly, anaphylaxis can be fatal. In conjunction with the administration of epinephrine auto-injector, the patient should seek immediate medical or hospital care.

For more information on generic medications and authorized generics, please read our latest edition of Clinical Info Newsletter. If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. Teva [press release]. Statement: United States Food and Drug Administration approves Teva’s generic epinephrine injection auto-injector. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=251945&p=irol-newsArticle&ID=2363944. Accessed August 17, 2018.
  2. U.S. Food and Drug Administration. FDA News release. FDA approves first generic version of EpiPen. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617173.htm Accessed August 16, 2018.


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