As payers, making evidence-based decisions about which treatments to cover is key to ensuring patients receive the right level of care in an overburdened healthcare system, while avoiding undue medical costs. A recent survey of US payers suggests there are misperceptions surrounding cannabis-based products used as medicine that could lead to unintended consequences in patient care.1
At the same time, pressure is increasing in some states among lawmakers and members of the healthcare community to mandate coverage for “medical marijuana,” which is not FDA approved and may cause patients more harm than good. There is also the question of medical liability and who is responsible if harm does occur. Without the oversight and checks and balances of the current prescription drug approval and regulatory process led by the FDA, covering “medical marijuana” could open the flood gates for exponential healthcare costs. In order to address these issues, it’s important to separate fact from fiction.
A survey of US pharmacists and medical directors (n=49) found that 63% rated their knowledge of the endocannabinoid system as low or extremely low, demonstrating the need for more information and education on cannabis and cannabis-related products used as medicine.1
Myth: Testing standards of state-regulated cannabis products sold at dispensaries are uniform and controlled by the FDA.
Fact: Cannabis-based products, including those sold at retail dispensaries for both recreational and medical use are not approved by the FDA. Outside one cannabis plant-derived and three synthetic cannabis-related prescription drugs that have obtained FDA approval,2 no other cannabinoid-based product is legally recognized under federal law for medical use, including “medical marijuana.” This means quality testing of these products is left to the discretion of individual states. These testing standards vary by state; some are more stringent than others and do not include a requirement to provide safety or efficacy for a given condition. It’s important to remember that cannabis-based products that have not undergone the FDA approval process, even those sold in state licensed dispensaries, should never be equated with or considered substitutes for FDA-approved prescription medicines.3
Myth: The amount of THC in hemp and CBD products is not intoxicating and does not impact cognitive function.
Fact: The amount of THC matters, and products with 0.3% THC by dry weight can actually cause intoxication and impact cognition. This is why the FDA has drafted regulatory guidance for industry that provides recommendations on the best methods for calculating THC levels in products.4 The regulatory pathway ensures cannabis-based therapies are developed for a specific population in the right dosage amounts, which are determined by rigorous, placebo-controlled, clinical trials with appropriate patient populations.
Myth: Both THC and CBD have high abuse and dependence potential.
Fact: Studies have shown that THC, when ingested in high amounts, may increase the risk of dependence in some individuals.5 CBD does not bind to receptors in the brain that produce a euphoric effect and clinically it has demonstrated a low potential for dependence in humans.6 However, CBD can have other side effects such as sleepiness and diarrhea and in some cases impact liver function.7 Continued research is needed to understand the benefits and risks of both. The FDA has stated that it will pursue real world data on CBD use and safety, as it plays a critical role in addressing current knowledge gaps.8 The best way to realize the therapeutic potential for cannabinoids, including THC and CBD, while protecting patient safety is the FDA’s regulatory pathway. Robust, randomized clinical studies of a cannabis-based treatment is the best way to evaluate the appropriate use and dose for specific patient populations.
1Data on File (VV-MED-23063). Palo Alto, CA: Palo Alto, CA: Jazz Pharmaceuticals, Inc.
2FDA and Cannabis: Research and Drug Approval Process, U.S. Food & Drug Administration, available at https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process. Accessed June 24, 2021.
3The State of Cannabinoid Testing, Covering Cannabinoids, available at https://www.cannabinoidclinical.com/fda-regulation-cannabinoids . Accessed June 24, 2021.
4Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry. U.S. Food & Drug Administration. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cannabis-and-cannabis-derived-compounds-quality-considerations-clinical-research-guidance-industry. June 2020. Accessed August 17, 2021.
5Is Marijuana Addictive, Marijuana Research Report, available at https://www.drugabuse.gov/publications/research-reports/marijuana/marijuana-addictive. Accessed June 24, 2021
6“CBD: Is it Addictive?” Medical News Today. September 2020. Available at https://www.medicalnewstoday.com/articles/is-cbd-addictive. Accessed August 17, 2021.
7What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. U.S. Food & Drug Administration. Available at https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis. Accessed August 17, 2021.
8Better Data for Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products, U.S. Food & Drug Administration, accessible at https://www.fda.gov/news-events/fda-voices/better-data-better-understanding-use-and-safety-profile-cannabidiol-cbd-products. Accessed June 24, 2021