The pharmaceutical landscape is constantly changing. Could medical marijuana — now legalized in many US states — emerge as a new frontier therapy for various health conditions? For years, while the consulting community has long assisted payors in managing physician-prescribed medications, the potential benefits of medical marijuana treatments have only recently begun to receive greater attention and interest. Despite its potential benefits, there remains limited published material on the topic. This article explores the evolution of medical marijuana, its current Food & Drug Administration (FDA)-approved uses and considerations for patients, and the future possibilities of this non-traditional therapy.
Understanding medical marijuana
Initially associated with recreational use, marijuana has been shown to carry potential pharmaceutical benefits. However, despite being legal for either medicinal or personal use in nearly 40 states in the US, marijuana remains classified as a Schedule 1 drug on the federal level.
Cannabis, a plant comprising three species, has been used as a medicinal treatment stemming back to 2700 B.C. in eastern societies.1 The term "marijuana" refers to the dried flowers and leaves of the cannabis plant containing a large amount of tetrahydrocannabinol (THC), the product responsible for the effects on a person's mental state.2 The term "cannabis" refers to products derived from the plant, Cannabis sativa, which contains over 500 chemical substances.3 It's important to note that medical marijuana shares the same characteristics and chemicals found in recreational marijuana but is used for medical purposes.4
Current legal status in the US
While most states' laws now allow legal purchase of cannabis products for medical or recreational use (more than 80% including the District of Columbia), it remains illegal under federal law.6 Consumable food items containing substances found in cannabis, such as cannabinoids (THC) or cannabidiol (CBD), cannot be sold in interstate commerce under federal law and are also subject to individual states' laws and regulations.3
Under state laws that permit such use, access to medical marijuana generally requires a written recommendation from a licensed physician for qualifying conditions. However, not all physicians in states where medical usage is legal are willing to prescribe it for qualifying patients, and approved conditions vary by state.4
FDA-approved cannabis products
As of 2024, only a few cannabis products have FDA approval. These approved therapies include Epidiolex (which is CBD) and three synthetic cannabis-related drugs: Marinol, Syndros and Cesamet.7
- Epidiolex, an oral solution approved in 2018, has been deemed safe and effective by the FDA for treating seizures associated with Lennox-Gastaut or Dravet syndrome in patients aged 2 and older.7, 8
- Marinol and Syndros are approved for managing chemotherapy-induced nausea in cancer patients and treating anorexia in AIDS patients.
- Cesamet is only approved for chemotherapy-induced nausea.
The FDA recognizes the current prescribing practices in states where cannabis dispensing is legal for various conditions such as severe pain, multiple sclerosis, glaucoma, extreme weight loss and post-traumatic stress disorder (PTSD), among others. However, until recently, there's been limited clinical evidence supporting the efficacy of using medical marijuana to treat these conditions or their related symptoms. Like mainstream prescription medications, cannabis products for unapproved off-label conditions may carry unpredictable or unintentional consequences and potentially serious safety risks.
Recent developments
In late 2022, President Joe Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act, removing previous barriers to cannabis research on a federal level.9 Despite maintaining its Schedule 1 status, the Act opened the door to understanding the medicinal properties of cannabis and its potential therapeutic uses, which were previously unknown.
This research, coupled with a potential rescheduling of marijuana, could benefit payors by potentially avoiding additional prescription or medical costs resulting from increased off-label use of medical marijuana in commercial populations.
The effects of this cannabis research are already being felt. In mid-2023, a letter from Health & Human Services (HHS) Assistant Secretary for Health Administration Rachel Levine to the Drug Enforcement Agency (DEA) supported reclassifying marijuana as a Schedule III product, similar to "drugs with a moderate to low potential for physical and psychological dependence."10
Additionally, documentation the FDA released in early 2024 "reflects HHS' evaluation of the scientific and medical evidence and its scheduling recommendation." The FDA Controlled Substance Staff (CSS) noted that marijuana represents a lower potential risk for abuse than other Schedule I and II substances and shares withdrawal symptoms similar to those associated with chronic use of FDA-approved products such as Marinol and Syndros that use synthetic THC.10
Physiological response and acceptance
Understanding the complete and complex physiological response to cannabis consumption is crucial for its broader acceptance in the medical community. Concerns about side effects and potential abuse aren't unique to cannabis; they also exist with other FDA-approved medications. Regular ingestion of physician-prescribed or over-the-counter medications can lead to side effects that range from skin irritation, nausea, and drowsiness to life-threatening anaphylactic reactions.11
Similarly, the potential for abuse in legally prescribed medications extends far beyond cannabis. Other FDA-approved prescriptions — such as opioids like oxycodone, hydrocodone and morphine — have been well documented for their severe risk of abuse, dependence and harmful side effects, yet saw a significant increase in prescribing trends over the past decade.12 Interestingly, opioids are approved to treat pain related to cancer as well as chronic pain, conditions that medical marijuana could potentially address with further research.12
According to the most recent FDA letter to the DEA, there's "some credible level of scientific support" for marijuana use for pain relief and nausea from chemotherapy. However, its safety and effectiveness have yet to be established.10 When looking at its use in older adults or those with comorbidities who are already treated with multiple medications, there's still much to understand when introducing marijuana to the list of consumed substances and how those chemicals interact.13