Sara Ratner, President of Government Programs, Nomi Health.
Opioid antagonists are medications that can block the effects of opioids and have been employed to save lives. One brand of antagonist, Naloxone, will soon be available over the counter (OTC), but its availability will not be widened if drug manufacturers set the price too high. But there is more that every business in the supply chain can do to ensure everyone has access to these critical tools in the fight against addiction. I believe having this medication available but not fully accessible to all is unacceptable.
While other medications also act as opioid antagonists, the focus of this article is on Naloxone because of its recent approval as an OTC medication. After being distributed as a prescription for more than 50 years, this recent approval advances the battle against opioid use disorder. This important move transforms Naloxone into another emergency tool, like defibrillators and fire extinguishers, and simplifies efforts to dispense the medication while removing barriers such as limited availability, prior authorization requirements and quantity caps.
We are at an inflection point with over 46 million people suffering from a substance use disorder and 9.2 million people 12 and older reporting misusing opiods. The CDC reports 66.8% of drug overdose deaths had at least one potential opportunity for intervention, and almost half of fatal overdoses had a bystander present. With overdose deaths reaching an all-time high in 2021, everyone needs to know the medication’s availability, how to use it and where to buy it.
But accessibility is contingent on patient affordability, and the OTC price will be much more expensive than the current cost with insurance. For millions of people on Medicaid, it will simply be too expensive.
The Challenge
The OTC price of Naloxone (typically distributed with two doses) for Medicaid and uninsured patients will vary based on several factors and more than two doses may be required to survive an overdose, depending on the strength of the opioids and potential for fentanyl lacing.
Opioid overdoses continue to be a leading cause of death for people 55 and younger, even as Naloxone distribution has trended upward, increasing 88% over the past few years. Ironically, the medicine that counteracts an overdose will often be more expensive than the addictive substances themselves. For example, prescription hydrocodone is often more affordable than ibuprofen, with copays as low as $0.
Unless the cost of Naloxone comes down, the tremendous cost of addiction—socially, culturally, and economically—will continue to rise.
Increasing Access to Naloxone Saves Lives
All aspects of the healthcare sector have a stake in this, including healthcare payers, employers, providers, pharmaceutical manufacturers and patients. These stakeholders will similarly save substantial costs through lifesaving medication, preventing future healthcare costs, productivity loss and even criminal justice costs. There are five steps we must take to address this growing crisis.
1. Create a National Drug Rebate Program
Manufacturers should consider entering into a Medicaid national drug rebate agreement with the Secretary of the Department of Health and Human Services. The Medicaid Drug Rebate Program is a program that includes Centers for Medicare & Medicaid Services, state Medicaid agencies and participating drug manufacturers that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. Approximately 780 drug manufacturers currently participate in this program. All 50 states and the District of Columbia cover prescription drugs under the program. However, this statutorily dictated program is complex to administer with different state requirements. It can also reduce access to pharmaceuticals since, by participating in the MDRP program, a state must cover all prescription drugs as a condition of participation. This could cause states to opt-out in favor of a closed formulary to prevent having to pay all FDA-approved drugs. Those impacted most by this are low-income beneficiaries.
2. Increase Online Availability of Naloxone
Medicaid programs should make Naloxone publicly available through a range of channels, including online, reduces the stigma of buying Naloxone in public. The laws and ability to access Naloxone vary by state, and ZIP code should not determine your lifespan. My company, Nomi Health, just launched a new online delivery platform for Naloxone in Utah and Nebraska. This is a difficult process considering the patchwork pharmacy licensing, prescribing and distribution requirements. This may limit other market entrants that would allow expanded access.
3. Shatter the Stigma
Price isn’t the only barrier; stigma also hinders access. When Naloxone is available online and in convenience stores, vending machines and grocery stores, the drug can get into the hands of more people who need it but may feel uncomfortable talking to their pharmacist or others.
4. Identify and Deploy Research-Based Solutions
There is a need for more research-based solutions to address the opioid crisis, along with continued federal and state funding for substance abuse treatment and prevention programs, including opioid-response initiatives that support and fund Naloxone distribution. Ending the epidemic will require evidence-based treatment, high-quality scientific research and a team of professionals and organizations working to leverage best practices, relying on the latest innovative research and expertise of medical and public health professionals along with the unique needs of each individual requiring treatment. History has demonstrated that research-based initiatives can support market solutions and change. For example, studies of insurance plans that implemented value-based insurance design helped influence policymakers to incorporate these designs into the Affordable Care Act. In addition, research has also been the impetus for employer change in health benefits and spending. Support for these research efforts can further expand access to prevention and treatment programs.
5. Lower The Cost
This medication will be too expensive for major segments of the patient population. Less than $100 may, for some, seem like a small price to pay to save a life, but it’s out of reach for many, especially those that cannot afford basic life needs (i.e., food, housing, transportation). The pharmacy industry needs to ensure affordability so everyone at risk of overdose has an equal chance of survival. These companies should be working with health plans, employers and pharmacy benefit managers (PBMs) to understand the elasticity threshold for affordability so that their populations can purchase this medication when it goes OTC. In addition, evidence and experience support that expanded supply can cause prices to decrease. As a result, government support for expedited drug approval can help drive market supply to stabilize lower OTC costs.
Access to health care is a basic human right. Cost is a critical determinant of access. I believe we must ensure opioid antagonists like naloxone get into the hands of those who need it most.
The information provided here is not intended as medical advice, diagnosis or treatment. Always consult with a qualified healthcare provider for advice concerning your specific situation.
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