The Opioid Crisis: What is the Government Doing About It? Part 4 – Increasing the Availability of Overdose-Reversing Drugs

FDA, Opioids, Rx/Pharmacy on December 17, 2018
Posted by Complex Claims Division

This blog series is devoted to better understanding the efforts our Federal government is undertaking to combat the opioid epidemic in America. Earlier this year, the Department of Health and Human Services (HHS) announced a five-part strategy that will be utilized to combat the opioid epidemic. In previous posts, we have focused on the first three parts of the strategy which include (1) increasing availability to addiction treatment services; (2) improvements in public health data and reporting as a means to drive more effective solutions for the ever-expanding opioid crisis and (3) the promotion of healthy, evidence-based methods of pain management.

In this post, we’ll examine the fourth prong of HHS’ five-part strategy, which focuses on increasing the availability of overdose-reversing drugs. There’s no question that naloxone (Narcan®) is quite effective at reversing the effects of opioids.  Naloxone is available as an injection or a nasal spray but regardless of the formulation, naloxone works by binding to opioid receptors in the brain. By binding to opioid receptors, it blocks opioids from binding there, which can reverse the effects of an overdose. Once administered, naloxone begins to exert its effect within 2 to 5 minutes. If the patient doesn’t wake up within 3 minutes of receiving a dose of naloxone, it is recommended to give a second dose. It is also very important to administer rescue breaths while waiting for the patient to wake up, to ensure that the patient has adequate amounts of oxygen delivered to the brain. Naloxone will reverse the effects of an opioid overdose for anywhere from 30 to 90 minutes. While naloxone’s efficacy has never been in doubt, access to naloxone has been a challenge.

In April 2018, the Surgeon General released an advisory statement on naloxone and opioid overdose, in which he recommended expanded access to naloxone to include the following groups of people: patients currently taking high doses of opioids as prescribed for pain, individuals misusing prescription opioids, individuals using illicit opioids such as heroin or fentanyl, health care practitioners, family and friends of people who have an opioid use disorder and community members who come into contact with people at risk for opioid overdose. For these groups of people, it was emphasized that having access to naloxone and knowing how to use it could save a life.

The Surgeon General’s statement has contributed to what’s been referred to as a “take home” movement for naloxone. This movement is similar to what we see with EpiPen for parents of children with life-threatening allergies, e.g. parents keep an EpiPen at home and another one at school in the event the child experiences an allergic reaction. Expanded access laws for naloxone, which have now been adopted in all 50 states, allow nonmedical personnel to possess naloxone and administer it to individuals who appear to be experiencing an opioid overdose without fear of legal or criminal consequences.

Federal funding has been made available to further efforts geared toward improving access to naloxone. In 2017, the Health Resources and Services Administration awarded $17.1 million to 55 poison control centers across the United States, to aid their efforts in preventing and providing treatment recommendations for opioid poisonings. The funding was also used to publish a report which captured lessons learned from opioid overdose in rural areas. In 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) allocated $44.7 million in funding to help equip first-responders with sufficient amounts of naloxone. In 2018, SAMHSA announced the availability of $4.7 million to be used in part to expand access to overdose-reversing agents in healthcare settings and also to establish protocols which will connect patients who have experienced an overdose with timely and appropriate treatment. SAMHSA also intended to award 5 grants valued at $200,000 each to healthcare settings in order to continue these treatment protocols.  We see an example of this funding at work in Pennsylvania, where the decision has been made to give doses of Narcan nasal spray away at 80 locations across the state on December 13th. Giveaway locations include many libraries and public health offices, with naloxone being distributed from 11:00am to 7:00pm.

The President has made expanded naloxone access a continuing priority in the 2019 federal budget by allocating $74 million in new investments to this endeavor.

As discussed in our prior blog posts, (https://www.medval.com/2016/09/01/naloxone-the-antidote-and-the-effect-on-cms-approvals/  and https://www.medval.com/2017/05/04/hhs-grants-to-fight-opioid-addiction-how-could-the-grants-impact-your-msa/) naloxone inclusion (particularly in the form of Evzio) in a Medicare Set-Aside allocation, can have a dramatic impact on the total MSA amount when included for the entire life expectancy. Given the focus of the HHS and the April 2018 advisory statement of the Surgeon General, we will continue to monitor the impact of naloxone inclusion in Medicare Set-Aside allocations.