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New treatment indications are under investigation for the use of cannabinoid-based drugs. Are you ready?
Chemical components of cannabis (also known as marijuana), called cannabinoids, activate specific receptors in the body to produce pharmacologic effects, particularly in the central nervous system and the immune system.
There are commercially available cannabinoids, and more could hit the market.
Here are four ways that managed care executives can prepare:
1. Be proactive
There is an opportunity to mitigate any potential undo financial impact of cannabinoid-based drugs by proactively evaluating management options before they hit the market, says Farrah Wong, PharmD, director, pipeline and drug surveillance at OptumRx. A variety of management strategies may be used, such as quantity limits or prior authorizations. Other potential management options are based on therapy guidelines and more advanced laboratory or diagnostic criteria.
“OptumRx closely watches the medication pipeline to prepare for new medications coming to market,” says Wong. “We are continually evaluating the potential impact of pipeline medications by using internal pharmacy and medical data and bringing many drugs before our Pharmacy & Therapeutics Committee for evaluation prior to FDA approval.”
2. Be informed
As with all medications, the FDA will review available clinical data surrounding the product to determine their approvability, explains Chris Peterson, PharmD, director in the emerging therapeutics department at Express Scripts. The approvability of these cannabinoid-based drugs includes their safety and efficacy for their studied indications.
Although the FDA has not approved any drug containing or derived from botanical marijuana, the FDA is aware that there is considerable interest in its use to treat a number of medical conditions. The approval process for cannabinoid-based drugs is similar to that of other drug products, in which an investigator must submit an investigational new drug (IND) application, including data from well-controlled clinical trials. According to the FDA, it will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality cannabinoid-based products to market.
As more data continues to be revealed regarding these products, it is crucial that managed care executives be prepared for the potential impact of these drugs in the marketplace.
3. Be patient
Perhaps foremost, with the exception of drugs to treat epilepsy, don’t expect these drugs to hit the marketplace anytime soon, cautions Constance Scharff, PhD, senior addiction research fellow and director of Addiction Research at Cliffside Malibu, a drug rehabilitation center in Malibu, California.
More than 80% of research is in the pre-clinical or discovery stages.
“That said, keep an eye on the clinical research as it develops,” she says. “Cannabinoid-based medications could potentially become useful drugs to treat several serious disorders and could become relatively inexpensive once generics become available.”
4. Be cautious
There should be significant attention and concern regarding the long-term impact of regular use of any cannabinoid-based drug. Kent Runyon, compliance officer and vice president of community relations for Novus Medical Detox Center in New Port Richey, Florida, says that the goal of drug companies will clearly be to expand use and application of these products to a broader audience and to increase use on a regular basis. “However, there are concerns within the mental health profession that these drugs may increase the risk of mental health problems and possibly even addiction to other substances,” Runyon says. “We are still struggling with a major opioid epidemic, which is a direct result of drug companies bringing to market medications promising to reduce discomfort. However, it clearly got prescribed far too broadly and without sufficient patient education.”
Runyon believes that this cycle may be repeating, and that far too many people discount the risk associated with cannabinoids and only focus on the potential benefits. “Parties that are pushing these drugs out of financial interests should move forward with great caution,” he says.
More information and research is necessary to determine exactly what place the cannabinoid-based medications will have in the marketplace; however, with several drugs coming up in the pipeline, it seems that these medications will indeed be future options in the treatment of several challenging conditions.