For more than two decades, Dr. Wade Aubry has built a career as a clinician, medical director, administrator, health policy researcher, and health care consultant. He is currently a member of the faculty of the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco and former chief medical officer for Blue Shield of California.
Covering Cannabinoids spoke to Dr. Aubry about the current state of cannabis-based therapy coverage for medicinal use.
Q. Given the outcomes of the 2020 elections and with the majority of states now legalizing some form of marijuana (adult medical or recreational use), what is the biggest concern from a payer perspective about the use of cannabis-based products for medical purposes?
A. The current political climate is ripe for an expansion of non-FDA approved medical and recreational cannabis through state-legalized dispensary products. The biggest concern for payers is that states could potentially mandate insurance coverage for non-FDA approved products, which is inconsistent with accepted standards for coverage. Over the last 30 years, medical policy decision making by payers has become increasingly evidence-based and health plans generally will not provide coverage for products that are not FDA approved.
However, some states are trying to have legislatures pass mandates for medical marijuana coverage that would disrupt the current drug evaluation decision process. If these mandates pass, ultimately states would be forcing health plans to cover dispensary products of variable quality, safety, and effectiveness that don't meet the same clinical evidence standards required of FDA-approved products. This could seriously undermine medical necessity provisions of the contracts payers have with their subscribers.
The health insurance industry is not always seen in the best light, but it is important to understand that there need to be appropriate limits on benefits and coverage. If you cover just anything without sufficient evidence, you undermine the entire system as well as the bar of what is medically necessary, while increasing the cost of healthcare overall.
If you cover just anything without sufficient evidence, you undermine the entire system as well as the bar of what is medically necessary, while increasing the cost of healthcare overall.
Q. What risks do patients and health care providers face if states mandate coverage of medical marijuana?
A. Patients and health care providers face the real risk of not knowing fully the content, quality, consistency, benefits, and harms of the product they are using because CBD and medical marijuana products are not held to the same standards as FDA-approved drugs. Rigorous studies, such as those required by the FDA for drug approval, ensure the quality and consistency of products, as well as its outcomes in the treatment of whatever medical condition is being treated -- both beneficial and harmful. With knowledge derived from clinical trials, health care providers can make informed prescribing decisions for patients, including recommendations on utilization. Because medical marijuana products are not subject to the same level of scientific rigor, health care providers may be flying blind, thereby putting their patients at increased risk.
Q. What do payers need to understand about medical marijuana compared to FDA-approved medicines when making reimbursement decisions?
A. Payers should understand that state-specific medical marijuana quality controls are inconsistent. These inconsistencies frequently lead to variabilities in the concentration of THC and/or CBD within a given product as well as potential contamination, leading to uncertainty about the risks and benefits when ingested. However, FDA requirements are rigorous and address these issues before marketing and distribution is authorized. As a patient, doctor, medical director, or policymaker, it is critical to know the quality, risks, and benefits of a drug before widespread use.
Payers can educate their subscribers by making information available about medical marijuana or cannabis-based products and why they are not covered given lack of clinical evidence on efficacy and safety and bypassing the FDA approval process.
Q. The FDA recently noted the importance of real-world data (RWD) when considering the use and regulation of cannabis-based products, like CBD. But is evidence-based or real-world data alone enough to make coverage/reimbursement decisions?
A. Real-world data are important to study the long-term effects of a product. However, it is not as methodologically rigorous as a randomized controlled clinical trial, which is how drugs are studied before being approved by the FDA. Thus, the quality of the real-world evidence, which is often based on observational data, is not sufficient to truly understand the benefits and risks.
Q. In your opinion, what can be done in the near term to better educate payers about the difference between FDA-approved medicines and state legalized marijuana when it comes to the treatment of serious medical conditions?
A. In the near term, authoritative and independent health agencies and organizations can conduct systematic reviews to evaluate the quality of the evidence for the use of FDA-approved medications and state legalized marijuana for given conditions. Some of this has already been done by the National Academy of Medicine, and an updated review by the Agency for Healthcare Research and Quality (AHRQ) is also in process. In addition, some medical societies, including the American Psychiatric Association and the American Academy of Neurology, have reviewed and issued policy statements regarding the state of the evidence of cannabis-based products. These types of independent reviews and policy statements are particularly important when it comes to use of cannabis-based products for serious medical conditions.
Q. What is the long-term solution to securing coverage of cannabis-based products for serious medical conditions?
A. The long-term solution is to first have a standardized, consistent quality product and then subject that product to rigorous and methodologically sound clinical trials to determine its effect on health outcomes, both positive and negative, for a given condition. This type of careful manufacturing, quality control, and study, combined with FDA approval and evaluation by medical societies and independent reviewers, will provide the best products and help ensure their safety and effectiveness for patients, as well as provide the best information on their benefits, risk, and appropriate use.