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More Naloxone options for opioid analgesic overdose

February 10, 2022 · Clinical Team

New medication approval – ZIMHI™ (naloxone hydrochloride injection)

In October 2021, the U.S. Food and Drug Administration (FDA) approved a higher-dose naloxone hydrochloride (HCl) injection - ZIMHI™ (5 mg/0.5 mL) - to treat opioid analgesic overdose. ZIMHI is designed to be administered in the muscle (intramuscular) or under the skin (subcutaneous) using a single-dose, prefilled syringe that delivers 5 mg of naloxone HCl solution.

This follows the FDA approval Kloxxado™ (8 mg), another higher-dose naloxone nasal spray, which we previously discussed on our blog. Like Kloxxado, ZIMHI is another tool to help combat the surge in overdose deaths due to opioid analgesics, particularly since stronger opioid analgesics or higher morphine equivalent doses may require multiple doses of the lower-dose naloxone products to reverse an overdose.   
 

Impact on workers’ compensation and auto no-fault industry

According to treatment guidelines, naloxone nasal spray and naloxone injectable are considered first-line treatment options when naloxone is necessary. For this reason, our Pharmacy and Therapeutics (P&T) Committee allows naloxone (e.g., Narcan© Nasal Spray, Kloxxado Nasal Spray) on our formularies where the use of opioid analgesics may be appropriate, including the global workers’ compensation, auto and standard injury-based formularies. ZIMHI will be evaluated in the near future to assess its formulary status on our standard plans.
 

Impact on Optum Settlement Solutions clients

According to RED BOOK, the average wholesale price (AWP) of ZIMHI is $75.00 per prefilled syringe. This is the same AWP as Narcan Nasal Spray and Kloxxado Nasal Spray, each priced as $75.00 per nasal spray device. The Centers for Medicare and Medicaid Services (CMS) allocates naloxone products for opioid overdose reversal at one unit (syringe or nasal spray device) per year.
 

New generic approval - naloxone nasal spray

In December, the first generic equivalents to the brand-name Narcan Nasal Spray (naloxone HCl 4 mg) became available, with two manufacturers receiving approval for their products.
The current lowest AWP of new generic naloxone nasal spray is $70.31 per nasal spray device, an approximate 6% reduction compared to the AWP of brand-name Narcan Nasal Spray. We anticipate further reductions in generic AWPs as more generic manufacturers enter the market.

Overall, the new generic naloxone nasal spray and the new ZIMHI product are not significantly impactful to workers’ compensation Medicare Set-Asides (WCMSAs).

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. Adamis Pharmaceutical Corporation. Adamis Receives FDA Approval for ZIMHI. Press Release. October 18, 2021. Available
at ZIMHI_Approval_Press-Release.pdf. Accessed on January 14, 2022.
2. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016. MMWR Recomm Rep 2016;65:1-49.
3. ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Last review/update on December 17, 2021.
4. Zimhi™ (naloxone HCl injection) [package insert]. San Diego, CA: Adamis Pharmaceuticals Corporation; October 2021.
5. IBM Micromedex® RED BOOK® [database online]. Truven Health Analytics®, an IBM Company. Accessed on February 7, 2022.
6. WCMSA Portal – Available at https://www.cob.cms.hhs.gov/WCMSA/login. Accessed on February 7, 2022.

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