Imagine reimbursing a medical product thought to have potential health benefits but also risks, without randomized, placebo-controlled clinical data to substantiate the balance between the two. For payers, this scenario may seem absurd; but the reality is this exact issue is being debated in some states seeking coverage and reimbursement mandates for cannabis-derived products such as medical marijuana.1
To date, the evidence surrounding the presumed benefits of cannabis for a variety of medical conditions is mostly based on observational studies or anecdotal evidence. While patients may initially think reimbursement of medical cannabis is a win, the potential risk to public health could be significant. If these legislative measures pass, payers will be forced to provide coverage for products that have not gone through the FDA approval process to understand the benefit-risk profile, appropriate dosing for specific conditions, and potential drug-drug interactions.
Payers commit significant resources to the Pharmacy and Therapeutics Committee (P&T) process to thoroughly evaluate the quality, safety, and efficacy of FDA-approved products, as well as, the cost of those products to members. The lack of randomized, placebo-controlled clinical data surrounding non-FDA-approved cannabis-derived products would significantly challenge this P&T process. In addition, there are operational issues that could arise from coverage of non-FDA approved cannabis-based products due to the absence of a National Drug Code (NDC) to adjudicate claims and implement utilization management programs. Furthermore, if an issue or recall occurs with a certain batch of a medical cannabis product, it would be difficult to determine member impact if it is outside the claims system. In the long run, this could potentially increase health risks for members as well as escalate cost and financial risk for payers.
Understanding the benefit versus risk profile of any drug before considering its use in a patient population is critical; but that just isn’t happening with cannabis. Many payers have implemented policies for cannabis products and consider non-FDA approved formulations as investigational thus, not covered. But some state legislators are trying to challenge these policies. In a recent statement, the FDA noted they are exploring a number of ways to address the gaps in scientific data around the cannabidiol (CBD) industry and the implications on public health and safety. These include “encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners.”2
While these investments are needed, the lack of regulatory oversight for products being touted as medicinal ‒ not to mention inconsistent standards of purity, quality and potency ‒ poses a real threat to patients. Furthermore, reimbursement of medical marijuana can set a precedent for other products, such as the herbal extract kratom and psychedelics like MDMA and psilocybin.3
Considering the extensive time and investment required to complete a rigorous pharmaceutical research program and FDA approval process (see Figure 1), against much looser and variable state regulations for medical cannabis growth and distribution, it's understandable why some cannabis companies attempt to bypass this approach. However, to ensure patient safety it is also abundantly clear how essential randomized, placebo-controlled clinical data are to making sound decisions about treating serious health conditions. As payers, demanding data and ensuring adherence to consistent quality manufacturing, testing and labeling before providing reimbursement is the responsible way to protect patients. Why should some cannabis companies get a pass? By politicizing medicine and bypassing appropriate federal regulations, patients and payers are put at risk.
Graphic 1: FDA Approval Process for Rx Drugs4
1Insurance Information Institute, “Haze of Confusion - How employers and insurers are affected by a patchwork of state marijuana laws.” June 2019
2U.S. Food & Drug Administration. “FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity.” Issued March 9, 2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-advances-work-related-cannabidiol-products-focus-protecting-public-health-providing-market
3Drug Policy Alliance. “Can psilocybin mushrooms be used as medicine or therapy?” Available at: http://www.drugpolicy.org/drug-facts/psilocybin-mushrooms-medicine-therapy. Accessed on March 4, 2020.
4U.S. Food & Drug Administration, The drug development process, https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm, Accessed August 30, 2017.