[The Addiction Legal Resource Team is proud to unveil a three-part series on Naloxone, a drug that reverses the effects of an overdose. While the role of Naloxone as a tool to combat the opioid crisis is undisputed, this series does not intend to address every aspect of the drug. Instead, the ALRT is releasing three different pieces that will explore how this drug may be used as a tool to fight the opioid crisis. This is the final post in that series.]
By Travis Murray
In response to the opioid epidemic in the Commonwealth, the Physician General of Pennsylvania issued a standing order for people to purchase naloxone from pharmacies in 2014 that was laid out in a Dear Pharmacist Letter. Naloxone is a prescription medication indicated for the reversal of opioid toxicity. Naloxone works quickly to reverse overdose symptoms, but repeated doses of naloxone are often necessary. The standing order’s goal was to decrease opioid-related deaths by increasing naloxone accessibility. However, in the years since the standing order has been in effect, the price has risen sharply. Those without medical assistance or private insurance may have to pay out-of-pocket drug costs or rely on emergency services or limited free naloxone distribution days.
Narcan® and Evzio® are the only two branded naloxone agents on the market for the reversal of fatal opioid toxicity. Narcan® is available in an easy-to-use intranasal spray, and Evzio® is an auto-injector, making both easy to administer by an individual to unconscious overdose victims. By mandate, both the naloxone nasal spray and the injection are covered without a prior authorization for recipients of Pennsylvania medical assistance (MA). However, people who are not policy-holders are not covered. Therefore, if an MA patient indicates at any time in the pharmacy that the naloxone is for someone else, the pharmacist may be unable to bill the insurance for the medication. Then, if the person wishes to purchase naloxone, he or she must pay out-of-pocket, and prices can range from hundreds to thousands of dollars per dose. For some patients, this may not be enough naloxone to keep the patient alive until emergency services arrive. While chemical dependence and addiction can affect any person, especially those with environmental and genetic risk factors, opioid deaths affects those with lower socioeconomic status disproportionately. Without insurance, a major population that would require access to naloxone may be unable to purchase the medication.
This standing order has seen an increase in naloxone purchases in Pennsylvania, both by private citizens and municipalities, but has unintended consequences of payers insuring non-policy holders and the state is likely trying to limit paying for people who are not covered. For pharmacists, it raises an ethical question of knowingly dispensing and billing a medication to a person who will use the medication on another person. Regarding the high prices of branded naloxone, pharmacy benefit managers (PBMs) have contributed to increased prices for naloxone and many other prescription drugs. PBMs, in theory, are a middleman between drug manufacturers and Medicaid plans and other payers to negotiate and create health formularies, often via rebates. Most PBMs charge administrative fees that get passed on to the insurers and pharmacies that fill the prescription. Pharmacies do not independently contract with insurance plans and often accept these plans or risk forfeiting patients. High drug prices are essential for drug companies to be able to generate a profit from its investment in creating the product. In the end, individuals who wish to purchase the medication and do not have insurance or medical assistance could be unable to afford it.
Solutions to Accessibility Issues
Community pharmacies are trying to make the medication more accessible to patients by dispensing the significantly cheaper generic naloxone solution for injection. The naloxone solution in the syringe is actually safe for intranasal use, and pharmacies have been dispensing them without needles for this route. Some states have taken approaches with other life-saving medications to control costs that may have some applicability. Recently, Colorado limited the maximum price for vials of insulin. Other states have taken PBMs head-on and pushed for their abolition for their responsibility in soaring prescription drug costs. Ohio’s Attorney General has sued OptumRx and CVS Caremark. Pennsylvania has a bill currently in the works to bring payment transparency among PBMs, managed care organizations, and pharmacies in PA General Assembly HB-569. Sometimes even the best intentions can have unintended consequences, and naloxone is not immune to the plague of rising drug costs. Years out from generic formulations of Narcan® and Evzio®, there is much to be done to make naloxone more readily accessible and to protect pharmacists from difficult ethical situations.