By Stephen P. Wood
Naloxone is an opioid-receptor antagonist. In other words, it has the ability to displace an opioid from the receptor site, and essentially reverse its activity to save overdose victims. However, a significant increase in the cost of naloxone has put it out of reach of the people who need it most.
Naloxone was first patented in 1961 by Mozes J. Lewenstein and Jack Fishman, initially as a medication to reverse constipation in patients receiving opioids. Its use for reversal of opioid overdose was approved by the US FDA in 1971. Naloxone comes in several forms, including a solution for intravenous and intramuscular use, a nasal spray formulation, and can also be used in tablet form as an abuse deterrent.
Currently there are seven patents that protect naloxone in its branded formulations, primarily marketed as Narcan and Ezvio. These patent protections extend to the year 2035. However, the protections are not for the drug, whose patent expired long ago, but for the “novel” delivery devices for naloxone, such as nasal actuators and auto-injectors.
Naloxone has been historically inexpensive and pharmaceutical companies really didn’t care much about it. Only six pharmaceutical companies even made the drug prior to 2014. It wasn’t until the onset of the opioid epidemic, and public health initiatives that allowed public access to this drug, that prices began to soar.
Naloxone’s wholesale, generic cost is around $20.00 for a single dose. By comparison, the cost of a two-injector kit under the brand name Evzio is $4,000.00. This represents a stunning 680 percent increase from the drug’s original price in 2014. Meanwhile, the numbers of deaths from opioid overdose continued to rise. Narcan brand nasal spray is slightly cheaper, coming in around $140.00 per dose. However, overdose reversal may require several doses, adding to its cost.
Speaking of novel, how novel is a nasal actuator anyways?
Access to these drugs is mostly limited to those with health insurance, and even then, most require a co-pay. The data substantiates that consumers cannot afford and are not buying the drug. In the midst of the epidemic, sales increased from 2.8 million annually, to only 3.2 million from 2009 to 2015. Simply put, those most at risk can’t afford this lifesaving drug.
These price increases came when the opioid epidemic was at its peak, and they came without any explanation. There have been actions in several states to limit these increases, but little in the way of federal regulation to enforce them, despite recommendations by the CDC to expand access. Many states have tried to meet that challenge, through pharmacy standing orders, pharmacist prescriptive authority or community distribution. These are novel means to increase access, but until the cost is contained, they are not likely to make an impact in increasing access and use. Considering the success of community-based naloxone programs, access is an imperative.
Speaking of novel, how novel is a nasal actuator anyways? Other drugs such as decongestants and topical steroids use similar delivery methods and sell for no more than $10 to $20 dollars per unit. An atomizer device that can be just as efficacious a means of drug-delivery sells for around $7.00.
So, where is the extra $130 worth of expenses coming from?
The same can be said of auto-injectors, which have been around since the 1970’s and were invented to deliver anti-nerve agent drugs during the Cold War. These involve little more than plastic casing, a pressure-activated spring, and a needle. The EpiPen scandal demonstrated that the exorbitant cost is not justifiable, yet here we are again, without much public outcry.
Frankly, it’s a bold move by these companies, and one that shouldn’t go without notice.
The exorbitant cost of these drugs crosses an ethical boundary as well. Ethical sales principles ensure that the cost of an item can be justified, and that the buyer is not being exploited. There has been no evidence to date to support the increased cost of either naloxone product. Furthermore, any parent with a child, any spouse, friend or even a neighbor of someone with substance abuse disorder would pay any price to save their loved one’s life. To take advantage of that is simply unethical and detrimental to society.
It is true that the companies offering naloxone as either a nasal spray or an auto-injector have provided free kits, price-reduced kits and other incentives to communities and service providers.
Kalia, the manufacturer of Efzio, offers the drug for without a co-pay for those with commercial insurance, and has donated close to 250,000 free kits. Pfizer has been similarly generous, providing over one million dollars in grants for opioid overdose programs. At the same time however, Adapt pharmaceuticals, maker of the Narcan nasal spray, has pushed for the FDA to require stricter regulations on naloxone marketing and in 2018 sued Teva, the maker of a generic alternative for patent infringement.
What we should be doing is making drug companies more transparent with regard to manufacturing costs.
This is all about money. Naloxone has gone from a $21 million dollar a year industry prior to 2014, to a booming $274 million dollar take per year since 2015. There is no doubt: pharmaceutical companies are making money off the opioid epidemic. Additionally, those who need this drug the most, often don’t have access to it. They are the under- or uninsured, so waving a co-pay is moot.
There are plenty of opportunities to reduce costs. Several authorities have asked for induction of federal law 28 U.S.C. section 1498, which would allow the United States to contract with a manufacturer to act on their behalf to create a less costly product. However, this still puts the onus of the cost on the tax payer. The pharmaceutical industry brought us the opioids that sparked this epidemic, heavily marketing oxycontin and oxycodone, which retail at around $1.25 a pill. What could possibly justify the antidote costing upwards of 3,600 percent more? There is no justification for this and policy makers need to draw their attention to this scamming of the general public in a time of crisis.
What we should be doing is making drug companies more transparent with regard to manufacturing costs. There needs to be clear data that the delivery of naloxone by a simple, ubiquitous nasal actuator or an auto-injector designed during the Cold War bears the extensive costs that these manufacturers have put on them. With data, the drug prices will invariably be lower, and can be adjusted to the actual cost, dismantling the profiteering occurring at the expense of the lives of our countries citizens.
Naloxone should be available to anyone who needs it: EMS, emergency departments, schools, clinics, and the public. This cost should be offset by the manufacturers charging these exorbitant prices in the first place. In addition, there can be incentives for pharmaceutical companies to produce more affordable products. This burden however, should not be shouldered by the public, whose tax dollars have already been spent on other ineffective programs. This is a time for policy makers and pharmaceutical companies alike to step to the plate and deliver. This is about saving lives — and that should not have a profit margin.