Preparing for the Possible Reclassification of Marijuana: Potential Impacts on Pharmacy Benefits
The Department of Justice (DOJ) is investigating the classification of marijuana, with the possibility of moving it from Schedule I to Schedule III of the Controlled Substances Act (CSA). This shift is in line with the Department of Health and Human Services’ (HHS) view that marijuana has legitimate medical applications and a lower potential for abuse compared to other Schedule I and II substances.1
The reclassification of marijuana from Schedule I to Schedule III could bring significant changes to the pharmacy benefits landscape. Coupled with the Medical Marijuana and Cannabidiol Research Expansion Act, which was approved in December 2022, payers must understand and prepare for these potential impacts.
Background
Marijuana has been classified as a Schedule I substance since the enactment of the CSA in 1970. Other drugs in this class include heroin, LSD, and ecstasy. Marijuana contains Δ9-THC—also known as dronabinol—which has been found to produce rewarding effects consistent with long-term nonmedical use and abuse. The Food and Drug Administration (FDA) has approved two drug products containing dronabinol: Marinol (Schedule III, 1985) and Syndros (Schedule II, 2016), for specific medical uses.2
In late 2022, the Medical Marijuana and Cannabidiol Research Expansion Act was approved, opening the doors for extensive research on marijuana and cannabidiol, potentially leading to rapid advancements in marijuana-based therapies.3 This is significant, as one of the requirements under the CSA for determining a drug’s schedule is whether the drug has a “currently accepted medical use” (CAMU) in the U.S. The other factors are (1) potential for abuse and (2) safety while under medical supervision or psychological or physical dependence that could result from abuse of the drug.4
Drugs in schedule II include cocaine, methamphetamine, methadone, oxycodone and fentanyl and are considered less abusive than schedule I drugs. Those drugs managed under schedule III, which is the category proposed for marijuana, include products containing less than 90 milligrams of codeine per dosage unit, ketamine and anabolic steroids. Schedule III drugs have an accepted medical use and are prescribed as medication.5 If approved, marijuana would be regulated similarly to other Schedule III drugs, with specific controls and additional regulations as needed to meet U.S. treaty obligations. However, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to applicable criminal charges under the CSA.
Currently, 38 States and the District of Columbia have enacted laws allowing individuals to use marijuana under certain circumstances for medical purposes.6 This creates a complex landscape where outside of Federal and State-sanctioned medical use of marijuana, individuals are using marijuana on their own initiative for medical, as well as nonmedical, purposes. However, as a schedule I drug, marijuana is illegal under U.S. federal law. If reclassified to schedule III, it would still be federally illegal, but in a class with prescription drugs that have a lower potential for abuse and have accepted medical application. Additionally, it would apply only to marijuana as the plant and derivatives of the plant, and synthetic THC would remain in schedule I.7
In addition, marijuana would remain subject to applicable provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). For example, under the FDCA, a drug containing a substance within the CSA’s definition of “marijuana” would need FDA approval to be lawfully “introduce[d] or deliver[ed] for introduction into interstate commerce,” unless an investigational new drug (IND) is in effect for that drug. To date, although there have been INDs for drugs containing a substance within the CSA’s definition of “marijuana,” no such drugs have been approved by FDA.8
Although no professional medical organization currently recommends use of marijuana, HHS concluded after reviewing several studies that there was some credible scientific support that marijuana could be used to effectively treat pain, anorexia, and nausea and vomiting and that using medical marijuana to treat these conditions did not pose “unacceptably high safety risks.”9
Possible Implications for Pharmacy Benefits
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Preparing for Change
The DOJ is currently seeking public comments on the proposed reclassification. Payers should actively participate in this dialogue and prepare for the potential changes. By staying informed and proactive, payers can effectively manage the transition and continue to provide high-quality, compliant, and cost-effective pharmacy benefits.
SlateRx aims to equip you with the knowledge and insights needed to navigate the evolving regulatory environment and its impact on pharmacy benefits. Stay informed, stay prepared, and ensure your organization is ready for the future of medical marijuana coverage and the advancements in marijuana and cannabidiol research.
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