The Reimbursement Case for Psychedelic Therapies Must Incorporate the Patient’s Voice

Psychedelic Economics: Putting the Puzzle Together

For innovators, success in the psychedelic space demands economic innovation. While MDMA and other chemical compounds are not expensive to manufacture, the accompanying psychotherapy can be costly. This puzzle isn’t new. Prescriptions for other mental health treatments, including those targeting substance abuse, may be paired with therapy, thus increasing the cost and complexity of care. Failure to solve the reimbursement puzzle in these and other cases underscores the need to think beyond the pharmacy shelf.  

Historically, mental health treatments have been under-reimbursed. But, working with MAPS and Compass Pathways, the American Medical Association published its first-ever CPT III codes for psychedelic-assisted therapy, which went into effect on January 1, 2024. Enabling HCPs to get reimbursed, the codes reflect how much in-person labor is required for MDMA-AT.   

According to cost-effectiveness studies in 2020 and 2022, the therapy not only provides substantial clinical benefit at a time when many patients are not helped by conventional treatments like cognitive behavioral therapy (CBT), but has also proved cost-effective, enabling payers to begin saving money in as little as three years.  

Essential Launch Considerations

Among organizations vying for position in psychedelic psychotherapeutics, the Multidisciplinary Association for Psychedelic Studies (MAPS) plays a unique role. Neither a commercial company nor a patient advocacy organization, the nonprofit organization submitted the first new drug application (NDA) for MDMA-AT as a Breakthrough PTSD therapy in December 2023. MAPS says it is devoted to “changing the way people think of, talk about, and consume psychedelics through research, education, and advocacy.”  

Like other companies and organizations vying for leadership in this space, MAPS will need to consider questions on the minds of patient community stakeholders who participated in ICER’s early information-gathering efforts. Partnering with patients is the most efficient way for manufacturers answer questions on payers minds—for example:    

1. Given the current understanding that MDMA doesn’t work on its own, but only in concert with psychotherapy, can industry help ameliorate what seems to be a deepening shortage of therapists and trained facilitators, especially in rural areas?  
2. From the clinical data, how can payers and care providers tell which aspects of the treatment (the drug, the facilitator, the “set and setting”) make a difference, and how well will the therapy work in the real world?  
3. How can sponsors manage placebo and ‘nocebo’ effects when trial participants are, in fact, very likely to discern whether they are in the trial’s treatment or control arm?   
4. What broader conclusions can we draw about risks in taking MDMA for participants, and for others gaining access if the drug becomes widely available?  

We're Here to Help

Syneos Health works with sponsors and patient communities to capture patient insights and feedback throughout drug development. The methods we’ve evolved emphasize careful listening and empathy toward patients, investigators, clinicians and other engaged individuals. That includes members of relevant payer communities, as novel treatments only have an impact when they are accessible and affordable. We recognize the importance of surfacing data-driven patient insights that reflect how people living with mental health conditions think about and experience treatment value in their everyday lives.

To address the enormous mental health burden our society faces today, it’s time to pay attention to patient advocates urging health systems to think beyond standard health economic measures such as quality-adjusted life years. As a society, we must strive understand and measure how well a novel intervention might help someone in nuanced ways.

For example, measuring the number of family events attended or days spent at work is important, but drug developers may have no window onto how individuals think about the quality of time spent a work or with family. Post-therapy, is the individual gaining confidence when engaging in conversation? Is he or she more willing to approach a scenario that previously triggered symptoms? Learning the answers might afford a deeper sense of what it means when a treatment “works.” Evolving how we think about the value and metrics around mental health interventions from a first-person perspective will lead to more effective therapeutics and will go a long way toward reducing both individual and systemic costs.