More Naloxone options for opioid analgesic overdose
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.