FDA Grants Approval for Generic Narcan (naloxone HCL) Nasal Spray

FDA, Opioids, Rx/Pharmacy on May 6, 2019
Posted by Jean S. Goldstein, JD, CMSP

Recently, the FDA approved the first generic Narcan nasal spray to treat opioid overdose.  Narcan temporarily reverses the effects of opioid analgesics and is essentially an antidote for opioid overdose.  While generics of the injectable version of this medication, Evzio, have been available for quite some time, a generic of the nasal spray has not.  The nasal spray is a more user-friendly method by which to deliver the medication, and also is specifically aimed at providing this live-saving drug to those without medical training. 

You may recall we first began seeing naloxone included in CMS approved Workers’ Compensation Medicare Set-Asides (WCMSAs) back in 2016.  At that time, with just a mere recommendation, mention, or one time fill of naloxone, it was extremely likely that medication would be included over a claimant’s entire life expectancy.  At approximately $2K for each pre-filled syringe, the financial impact on a claim was quite significant if included.  While the benefits of the medication have always outweighed the costs; physician recommendations for this medication also create concern in workers’ compensation cases, particularly in those cases where opioid weaning has not been discussed or addressed.  Fortunately, over the last several years, we have found that in many cases, with proper clinical assessments and intervention, evidenced based clinical guidelines may be implemented to discover any available alternatives to the prescribing of opioids over an individual’s lifespan; such that we have measurably seen a reduction in the amount of WCMSAs for which opioids are being prescribed over a Claimant’s entire life expectancy.

The approval of the generic nasal spray has further been viewed as the FDA’s first step to facilitate an over-the-counter naloxone product and its goal in increasing the availability of naloxone products intended for use in the community.  This mission certainly goes hand in hand with the U.S. Department of Health and Human Services’ 5-Point Strategy to Combat the Opioids Crisis, as previously discussed here on our blog. This five-point strategy includes: better addiction prevention, treatment, and recovery services; better data; better pain management; better targeting of overdose reversing drugs; and better research.

The impact of the FDA’s approval of generic Narcan spray will not immediately impact WCMSAs.  First, because generic medications are often delayed from reaching the marketplace, until at least trials have been run, and of course other business considerations and aspects may impact how quickly this product becomes available.  Secondly, and perhaps most importantly, for those WCMSAs submitted to CMS for review, proof of the generic having been provided or explicitly having the doctor state that generic is recommended will absolutely be required in order to have the generic Narcan spray allocated by the Workers’ Compensation Review Contractor.  Lastly, the most significant impact may readily be seen if an over-the-counter (OTC) product is made available, such that Narcan/naloxone may not be included in WCMSAs if readily available as an OTC.  

While it is certainly great news that Narcan spray will be readily available in the near future and at a lesser cost, we are hopeful that we will continue to see a measurable decline in opioid use, such that the need for these antidotes is eradicated.