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What you need to know about naloxone

by Mary McNitt | May 16, 2019

March 14, 2019 
by Erin Kuecker, Pharm.D.

What is naloxone?
Naloxone is an opioid antagonist that displaces opioids from receptors in the brain, reversing the effects of opioid analgesics, including their life-threatening effects. Naloxone is commercially available by nasal spray (i.e., Narcan® Nasal Spray), solution for injection and an auto-injector (i.e., Evzio®). Currently, naloxone products are only available by prescription. Naloxone is not a controlled substance and has no abuse potential. It has no direct role in the treatment of pain or other industrial conditions; it is used exclusively for the treatment of a known or suspected opioid overdose.

How it works
Once administered, naloxone usually takes effect within two to five minutes, and its effects last 30 to 90 minutes. Because the life-threatening symptoms of opioid overdose can return after the reversal effects of naloxone have worn off, especially in those who overdose on long-acting opioid analgesics (e.g., OxyContin® and methadone), emergency medical care is still required after administration of naloxone. Therefore, emergency medical response should be summoned in all cases of an opioid analgesic overdose, regardless of naloxone availability.

Why are we seeing naloxone products more often in workers’ compensation claims?
Because naloxone is a prescription-only product, naloxone access was historically limited to those who were prescribed naloxone directly by a licensed prescriber in a prescriber-patient relationship with the individual receiving the prescription, and who had a legitimate medical need for the prescription. And, like other prescription medications, naloxone was only available by a pharmacy or dispensing prescriber to those with a prescription issued directly in their name. However, increased awareness of the opioid crisis over the past several years has driven changes in policy, regulation and clinical practice regarding prescribing opioid analgesics and the prevention and treatment of opioid analgesic overdoses. These changes have increased access to naloxone.

As the life-saving treatment for reversing an opioid analgesic overdose, naloxone products are now available to use by multiple sources. In addition to emergency responders, naloxone is also available to family and friends of an opioid analgesic user and to laypeople and professionals as a non-patient-specific prescription. Expanded pharmacist distribution using various approaches (depending on the state), may include standing physician orders as well as protocol orders authorized by state boards of health or boards of pharmacy.

Naloxone access laws are quickly changing
In January 2001, no state had any form of naloxone access law, but by July 2017, all 50 states and the District of Columbia had enacted some form of naloxone access law. The terms of naloxone access laws vary widely by state, but all have broadened the availability of naloxone to those not directly prescribed a naloxone product. Learn more about overdose prevention laws here.

Some states have mandated that patients prescribed opioid analgesics, and who meet certain criteria, also receive a prescription for a naloxone product. This is termed “naloxone co-prescribing.” Currently, these mandates exist in ArizonaFloridaRhode IslandVermont and Virginia.

Other states have issued guidance regarding naloxone co-prescribing but have not mandated this practice. In Colorado and North Carolina, prescribers “should consider” co-prescribing naloxone for those meeting certain criteria. In Ohio and California, prescribers are “required to offer” naloxone to certain patients, and in Utah, prescribers “should offer” naloxone to patients meeting certain criteria.

Addressing the cost of naloxone
Although easier to access, the cost of naloxone products is a potential barrier and may increase settlement and Medicare Set-Aside (MSA) costs for workers’ compensation claims, especially if the more costly auto-injector is prescribed.

Medication name

NDC number

Average Wholesale Price

Narcan Nasal Spray (2-pack)

69547-0353-02

$150 (per package)

Evzio Auto-Injector (2-pack)

60842-0051-01

$4,920 (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

N/A


*Kaléo, the manufacturer of Evzio, is now providing reduced Evzio pricing to government agencies, first responders, health departments, and other qualifying groups at a rate of $178 per package; this pricing is not available to carriers. **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 or lay third-party administrators.

The FDA has recently established a procedure for more rapid approval of over-the-counter (OTC) naloxone products. This is designed to encourage drug manufacturers to pursue approval and begin marketing these products in order to expand accessibility. This topic was discussed in our January 24, 2019, blog post titled, “FDA creates faster way to access over-the-counter naloxone products to treat opioid overdoses.” For now, naloxone products remain prescription-only. Costs for naloxone products may decrease in the future with the release of OTC naloxone formulations. Until this occurs, Narcan Nasal Spray is the most cost-effective, user-friendly formulation of naloxone.

Optum will continue to inform the industry of drug labeling changes, classifications and other regulatory changes with naloxone that may affect Medicare Set-Asides.

Sources:

  1. Lim JK, Braberg JP, Davis CS, et al. Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists. J Addict Med. 2016 Sep; 10(5): 300-308. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5049966/
  2. Preventing the Consequences of Opioid Overdose: Understanding Naloxone Access Laws. Substance Abuse and Mental Health Services Administration (SAMHSA) Center for the Application of Prevention Technologies task order. Reference Document #HHSS283201200024I/HHSS28342002T. 20 Jan 2018. Available at: https://www.samhsa.gov/capt/sites/default/files/resources/naloxone-access-laws-tool.pdf

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