What does the future hold for MDMA? This is part 3 of a 4-part series on the future of MDMA. The series explores the Multidisciplinary Association for Psychedelic Studies’ (MAPS) ongoing FDA phase 3 clinical trials, rescheduling, health insurance, and the FDA program known as expanded access. 

If MDMA-assisted psychotherapy gets approved by the Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) treatment, the next big question will be whether or not it will be covered by health insurance.

Up until now, insurance companies have covered drugs, and insurance companies have covered therapy. But, MDMA-assisted psychotherapy involves therapy while on a drug.

“There are no mechanisms in place in mental health care to ensure the coverage of a drug-therapy combination,” said Ekaterina Malievskaia, the co-founder of Compass Pathways, a for-profit European psilocybin startup working to medicalize psilocybin-assisted psychotherapy. “We will have to be innovative in how we develop these [mechanisms], working with all stakeholders, including insurers.”

One glaring issue that psychedelic-assisted psychotherapy providers will have to address with insurance companies is the initial high costs and amount of labor involved with their treatment. The current protocols being developed for MDMA treatment involve a two-person co-therapy team and about 42 hours of therapy. This entails three day-long, eight-hour MDMA sessions and twelve 90-minute non-drug psychotherapy sessions for preparation and integration. While estimates for the MDMA itself are about $150 per session, estimates for full treatment are nearly $15,000.

Rick Doblin, the founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS), added that it is important to keep in mind that some PTSD patients will not need all three MDMA sessions, and others may need more than three sessions.

But, he says that MDMA treatment could save both patients and insurers a lot of money down the line. While the cost of medicine like an SSRI, without therapy, is much lower on a monthly basis, many find that traditional antidepressants don’t work well for them and need to be taken for months, years, or even decades — costs that will add up over a period of time. A worst-case-scenario PTSD sufferer could spend about $10,000 on treatment every four years according to the Congressional Budget Office. Couple that with lost productivity at work, higher rates of divorce (a process which can cost thousands), and the fact that many sufferers of PTSD also deal with depression, anxiety, and substance abuse (treatment which can also cost thousands).  

Moving forward, both Doblin and Malievskaia stressed the importance of following the well-being of patients from their studies. Getting approval from insurance companies, they say, will likely require post-approval studies and long-term follow-up.

“Our negotiations [with insurance companies] involve adding various measures of health care utilization and functionality to our Phase 3 designs including long-term follow-up,” Doblin said. “The purpose of these measures is to try to demonstrate in our research subjects that helping reduce PTSD symptoms also reduces other health care due to high levels of stress, emergency room visits, heart attacks, strokes, etc.”  

PTSD patients have higher than average health care utilization. But, the challenge is that reduced health care utilization shows up over many years, not just immediately or in a one-year follow-up. So, there is much more observation and documentation to be done among PTSD sufferers receiving MDMA-assisted psychotherapy.

Until this treatment is proven without a doubt to reduce long-term costs, many insurance companies do not have an incentive to cover MDMA-assisted psychotherapy. This brings us to one of the main reasons MAPS is working so closely with the United States Department of Veteran Affairs (VA) to bring this treatment to PTSD-suffering veterans. In a two-year period, from 2010 to 2012, the Department of Defense spent $789.1 million and the VA spent $8.5 billion on PTSD treatment.

“While successful treatment of PTSD can reduce the number of patients who become disabled from their PTSD, the insurance companies that cover disability payments are usually different than those that cover medical treatments,” Doblin said. “The one major exception is the VA which both pays for treatment and also pays for disability for a lifetime. That means that the VA has more incentive than any other insurance company to cover the costs of treatments that are initially more expensive, but can reduce disability payments in the long-run.”

Another consideration that Malievskaia said insurance companies will consider is the availability of trained and qualified therapists who can deliver the treatment. She said that these therapists will have to be credentialed in a way that is accepted by insurers. Compass Pathways currently requires therapists participating in their treatment-resistant depression trials to undergo a five-part training program, along with supporting at least six participants in a psilocybin research setting under the supervision of an experienced therapist.

In conversations about insurance, MAPS has also run into issues about therapist costs. Doblin told me that their two-person therapy team — which is very important to MAPS’ protocol — adds costs, but probably doesn’t make treatment twice as effective.

“For our research, we’ve focused on maximizing therapeutic benefit, not on providing the lowest-cost treatment for results that are just good enough to obtain FDA approval,” Doblin said.

In Europe, where there is national health care, cost is even more of an issue than in the US. One solution that MAPS has been grappling with is having only one licensed therapist and one student working for free or minimal costs. But, even this, he said, could cause an issue with insurers who may have trouble paying for an unlicensed therapist. So, MAPS is working to develop a new specialty for psychedelic psychotherapy which will provide people who are otherwise unlicensed with credentials.

“I am OK with making the overnight stays after each MDMA session — [a current part of MAPS’ protocol] — optional as a potential cost savings,” Doblin said. “But, I am much less comfortable going to a one-therapist model due to the safety and support provided by a two-therapist team.”

Nothing is completely set in stone. And, we won’t know if MDMA will be covered under insurance until we know if it is even approved for legal prescription use. Doblin said the priority for Phase 3 trials, regarding insurance, is to be able to present the insurance companies with significant results.

“Our challenge is to get such compelling results from MDMA and psychotherapy that insurance companies are willing to pay for both elements of our treatment,” Doblin said.