Evzio auto-injector and its generic equivalent have been discontinued from the market

October 30, 2020 · Clinical Team

Evzio auto-injector and naloxone auto-injector have been discontinued and will no longer be available, according to kaléo Inc. (kaléo). According to information Optum has obtained from kaléo, previously dispensed Evzio and its authorized generic are still safe to use until their expiration dates. In addition, pharmacies may dispense current stock, but future refills will not likely be available. After kaléo notified the U.S. Food and Drug Administration (FDA), the FDA’s Orange Book was updated to reflect a discontinued marketing status. At this time, information about Evzio and its authorized generic will continue to be available on kaléo’s website as there is unexpired product still in the market.

Impact on workers’ compensation and auto no-fault

Naloxone is a reversal agent for use in patients with a suspected opioid analgesic overdose. To ensure continuation of care, if a claimant has been prescribed Evzio auto-injector or naloxone auto-injector, his or her prescriber should review the claimant’s current medication therapy over the next several weeks to determine if ongoing naloxone therapy is required. If continued use is still necessary, an alternative naloxone treatment, such as Narcan® Nasal Spray, should be considered.

Upon review of our transactional data, there was a minimal impact on our book of business. We will be providing impact assessments to our clients through our account managers and clinical liaisons.

Impact on Optum Settlement Solutions

Although the generic auto-injector was significantly less expensive than brand-name Evzio, kaléo opted to discontinue production of these products. As such, Evzio auto-injector and naloxone auto-injector were deactivated in RED BOOK® on September 4, 2020, and are no longer included in the Workers’ Compensation Medicare Set-Aside Portal (WCMSAP) as of October 2020. There are still other options available for rescue therapy for opioid overdose; Narcan Nasal Spray is the most commonly prescribed opioid reversal medication in the workers’ compensation industry, due to its low cost and ease of administration. Going forward, available naloxone formulations include:

Medication	NDC	Average Wholesale Price
Narcan Nasal Spray (2-pack)	69547-0353-02	$150 (per package)
Naloxone solution for injection* (various strengths and volumes available)	(various)	$9.90 - $19 (per mL)
Naloxone solution for injection with mucosal atomization device, adapted for intranasal administration	(off-label)	N/A (not recommended)

* Naloxone solution for injection requires drawing up the solution into a syringe prior to administration; therefore, this form of administration is more often used by health systems and emergency responders and is less often prescribed to individual patients and/or their caregivers.

If you would like to contact kaléo for additional information, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612. Information contained in this publication is provided “as is” for informational purposes only and is not intended to constitute medical advice.

Sources:
1. Kaléo, Inc. Richmond, VA. Available at: https://kaleo.com/archived-news/. Accessed on October 26, 2020.
2. IBM Micromedex® RED BOOK® [database online]. Truven Health Analytics®, an IBM Company. Accessed on October 12, 2020.
3. Personal communication (written). Kaléo Medical Information. Richmond, VA 23219. October 20, 2020.
4. U.S. Food and Drug Administration. Orange Book September 2020 Changes List. October 9, 2020. Available at: https://www.fda.gov/media/142901/download. Accessed on October 26, 2020.
5. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed on October 26, 2020.