Here are three strategies that the federal government should consider to ensure that naloxone is truly accessible

Editor’s Note: This week, the White House Commission on Combating Drug Addiction and the Opioid Crisis released an interim report with recommendations for federal action to reduce the impact of opioid addiction in our country. Only one of the recommendations directly addresses naloxone access: “Provide model legislation for states to allow naloxone dispensing via standing orders, as well as requiring the prescribing of naloxone with high-risk opioid prescriptions; we must equip all law enforcement in the United States with naloxone to save lives.”

This post argues that state-level standing orders haven’t achieved the true goal, which is to put naloxone into the hands of everyone who might witness an overdose, with special focus on people who use opioids themselves. Here are three additional recommendations that the White House Commission should consider to reduce the cost of naloxone and improve access to it. 

By May of 2017, all 50 states and the District of Columbia had passed legislation designed to improve layperson naloxone access. However, significant shortfalls in access continue to persist due to inadequate distribution and prohibitive costs.

Greater access and less expensive naloxone is by no means a solution to the opioid epidemic, but it is a key part. Remember: in the event of an opioid overdose, naloxone is the only medication approved by the FDA to revive the individual.

Price as a Barrier to Naloxone Availability

The cost of naloxone, even generic naloxone, has skyrocketed in recent years. According to the New England Journal of Medicine, the generic injectable naloxone has increased 129% since 2012 and now costs roughly $40 per kit, while the auto-injector has increased by approximately 552% since 2014 and is listed at $4,500 per kit (though is often covered by insurance).

These price hikes by pharmaceutical manufacturers have created a challenge for people who want naloxone, regardless of insurance coverage. For those with commercial coverage, there is significant variation in health insurance co-pays ($40 or more is not unusual). With respect to Medicaid prior authorizations, as of 2016 at least 26 states had (at least one formulation) of naloxone available through the preferred drug list. However, not all state managed care organizations will cover take-home naloxone. Therefore, Medicaid patients may be inhibited from picking up a precautionary naloxone take-home kit.

For Many, Access Isn’t Easy

Although all 50 states have passed legislation intended to improve layperson naloxone access, and 40 states have implemented Good Samaritan policies, these policies alone are insufficient to save the 91 lives lost per day across the United States to opioid overdose.

In about half of states, naloxone is not explicitly authorized for out-of-pharmacy distribution. This means community and harm reduction organizations, which are capable of reaching populations of high-risk individuals, are not able to obtain and distribute naloxone in some states.

This puts the onus on the individual. Unfortunately, we know that many people desperately need naloxone, but are not able to complete the series of steps necessary to receive naloxone from a pharmacy. To illustrate:

1. A person seeking naloxone finds a pharmacy in their area that operates under a standing order.

2. The pharmacy has naloxone in stock, preferably multiple formulations.

3. The pharmacy determines the co-pay for the individual.

4. If the client does not have insurance, variability in naloxone price is substantial.

5. Training is disseminated by pharmacy staff to ensure the naloxone recipient understands how to administer the medication.

For many, this process is a rigamarole.

Making the Needed Policy Changes

The White House Opioid Commission would be wise to focus on increasing access and availability of naloxone while also reducing the cost. Here are three strategies that the Commission should seriously consider to ensure that naloxone is truly accessible throughout communities.

#1 Increasing New Drug Applications for Generic Naloxone

The FDA could consider waiving fees for Abbreviated New Drug Applications, an application used to approve generic versions of drugs. Furthermore, the FDA could prioritize review of naloxone applications. These changes could prompt an increase in applications and therefore encourage competition among manufacturers to reduce the consumer price.

#2 Invoking Government Patent Use

The Department of Health and Human Services could determine that reducing opioid overdose requires a government patent use.

Invoking this policy would allow the federal government to pay reasonable royalties to patent holders of brand name naloxone (Evzio and NARCAN) and direct the increased utilization of generic naloxone. Through bulk, government purchases of generic naloxone, prices for laypeople will go down. Many states already bulk purchase other prescription drugs; naloxone should be included.

#3 Relabeling of Naloxone for Over-the-Counter Access

Relabeling will likely reduce the cost of naloxone, as additional manufacturers will be attracted to the market. The relative ease for the FDA to approve naloxone as an over-the-counter (OTC) drug should be at the top of the Commission’s recommendations. Relabeling of naloxone as an OTC drug would clear up the legal ambiguities that remain in some states for layperson- and community-based distribution of naloxone.

For over 20 years, Italy has permitted OTC naloxone access and in 2015, Australia also began selling naloxone as an OTC product. When the FDA took public comment on naloxone uptake and use in 2015, strong arguments were made in favor of OTC approval. One question, however, was if an OTC label would have ample space to communicate the steps to utilize naloxone for overdose reversal.

Naloxone is Needed Now

Broader access to naloxone for laypersons is safe, reduces overdose deaths, and is a cost-effective intervention. If state and federal agencies want to make a difference in saving the lives people who use opioids, naloxone needs to become affordable and accessible to all of us.

 

 

Miranda Gottlieb works for the State of Florida to reduce opioid-related overdose. Miranda is a scholar of drug policy and a weekend scuba diver. She is a native New Mexican and a graduate of the University of Tennessee. In the fall, Miranda will begin graduate work at Tsinghua University in Beijing, China to study international drug law.