MDMA Commercialization with Joy Sun Cooper and James Acer from MAPS
In the next few years, MDMA therapy is anticipated to go from being an experimental substance to being widely available as a FDA-approved medication. But what will this timeline look like? Joy Sun Cooper and James Acer from the MAPS Public Benefit Corporation (MAPS PBC) sat down with us to chat about access and when people will be able to get MDMA treatment.
Setting the stage: where MDMA therapy is now
We’ve seen amazing study results in patients with chronic PTSD, and MDMA has gained momentum as a potentially life-changing therapy for these individuals who haven’t been helped by conventional treatments.
In 2021, MAPS completed their phase III study on MDMA therapy for PTSD. Now, they’re in the process of a second phase III study. They plan to complete this second phase III study by the end of this year.
Once the phase III is complete, MAPS will apply for FDA approval for MDMA therapy. They anticipate FDA approval to come in late 2023. Once it is approved, the DEA will have three months to re-schedule or de-schedule MDMA from its current Schedule-1 status. MAPS anticipates that MDMA could be available in the medical setting as early as 2024.
“What a remarkable moment this is,” Cooper said at the start of the presentation. This is a critical period, as we pivot from scientific understanding to real-world applications. MAPS is leading the charge on MDMA therapy for PTSD, attempting to build a new ecosystem around this novel treatment.
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Getting MDMA therapy for PTSD
MAPS’ goal is healing for all. One of their foundational philosophies is that all patients with PTSD should be able to access MDMA therapy. They are attempting to establish MDMA as first-in-class treatment and standard of care for PTSD patients. In implementing MDMA in the clinical setting, MAPS aims to maintain a high quality of care while promoting widespread access.
MAPS’ goal is to help 1 million patients with PTSD by 2031. To do this, they’ll need to train a lot of clinicians in MDMA-assisted therapy. James Acer noted that they’ll need to train at least 30,000 therapists in the next two years. But not all training will be straight from MAPS; they plan to create a framework for training that can be distributed by third-party educators.
The Integrative Psychiatry Institute has developed a 200 hour training for Psychedelic-Assisted Therapy. The IPI training program is a full year long training program, offers an experiential component and features rich live content presented by thought leaders in the psychedelic therapy field. Recently IPI announced a collaboration with MAPS which allows IPI students access to MAPS asynchronous online materials. These MAPS eLearning materials represent a portion of the 100-hour certificate program in MDMA-assisted therapy for all eligible mental health professionals.
Successful completion of the MAPS online material enables IPI students to become eligible to complete the remainder of the MAPS certificate requirements. MAPS plans to offer the remaining training hours in a retreat format to IPI students at some point in the future. Learn more about the IPI Psychedelic-Assisted Therapy Program at the IPI website.
MDMA therapy is truly the first treatment of its kind, so it poses unique challenges. MAPS hopes that it will be the first truly integrated drug-therapy combo treatment. While other drugs run parallel to therapy, MAPS’ method has MDMA entwined with therapy for the best patient outcomes.
They predict the therapy piece will be included in the drug label (if approved). However, it doesn’t sound like a specific therapy modality will be mandatory and clinicians will be able to incorporate various therapeutic approaches with MDMA.
What will MDMA therapy look like for patients and clinicians?
Some processes will not become clear until close to FDA approval. While we have some answers, many are yet to come. MAPS will have recommendations for implementation, but many of these decisions will fall to the FDA, DEA, and insurers.
While the FDA regulates drugs, it doesn’t regulate therapy. Some standards for therapeutic practice may come from MAPS. Others will come from insurers and professional associations. As we learn more from applying MDMA there is sure to be new knowledge to implement as we go.
MAPS is strongly recommending that therapy be required in order for patients to access MDMA. They also believe that therapists should be present during MDMA sessions, and that this requirement should be included on the drug label for clinical practice.
MAPS also recommends preparation and integration therapy, but the specifics around number of sessions will likely not be on-label requirements for access. MAPS plans to advocate for clinical practice guidelines around non-drug therapy sessions.
MDMA therapy will be a very specific therapeutic approach. MAPS plans on training providers on this approach, but they don’t plan on mandating it’s use throughout therapy. Providers will be required to complete some training, but ultimately they will be free to use their own evidence-based therapies. Experimentation from practitioners may lead to innovation and improvements.
From their research, MAPS has shown significant benefit to most participants with 3 MDMA sessions, along with 12 non-drug sessions. But this number should be individualized depending on patient needs. This protocol is meant to be an acute treatment, not for chronic or intermittent use.
Each non-drug session could be around 90 minutes long. Most likely, the FDA will require 6-hour monitoring for active drug sessions.
The MDMA assisted therapy care team will likely be three separate people:
- Physician/prescriber: This person will conduct medical evaluations and prescribe MDMA. They will need to be on-call during active drug sessions, but likely will not need to be present during drug administration sessions.
- Licensed behavioral health provider: this person will develop a therapeutic relationship with the patient through non-drug and drug sessions. They will help the patient through introductory, MDMA-assisted sessions, and integration therapy.
- Paraprofessional: This person will be present during drug sessions, along with the therapist. They will be trained in MDMA-assisted therapy, but they will likely not be required to be a licensed health provider.
Cooper spoke about a “hub and spoke” model for implementation. These “hubs” would be specialized treatment settings, including multidisciplinary teams with MDMA training. Over time, “spokes” in the community could build connections for ongoing training, clinical development, case support, and referrals.
MAPS is also interested in group therapy for MDMA integration. They’re sponsoring a group therapy study in the next year, with more information to come.
How can we maximize access to PTSD therapy?
To drive equitable access, the speakers noted these factors:
- Flexible post-approval regulatory controls will help patients access this therapy safely while maintaining broad, equitable access.
- Generous patient assistance programs to ensure that price is not a barrier to treatment.
- Widespread payor coverage that isn’t burdened with utilization restrictions.
- A provider pool that is diverse in culture, geography, and life experiences.
- Effective patient advocacy, with evolving plans as we get closer to implementation.
Questions About MDMA Therapy for PTSD
Will insurance, Medicare, and Medicaid pay for MDMA-Assisted Therapy?
At the time of launch, MAPS hopes for “broad market access”. It is unknown if insurers will cover MDMA therapy when it becomes available. No drug is paid by all payers at the time of launch. Their goal is to get as much coverage as possible.
In their market research with payors, MAPS has received positive feedback. Patients with PTSD represent a huge unmet need in our society. Safety and efficacy data have shown that MDMA could improve so many lives in this population, and payers have responded well to this data.
In the US, a lot of mental health care happens outside of insurance networks. Limited access remains a persistent problem within the larger structure of US healthcare. This could limit MDMA’s ability to reach many of the people who could benefit from it.
MAPS remains “optimistic about treatment coverage, but not naive to the challenges”. MDMA therapy will need unique coverage under insurance, medicare, and medicaid. More information on coverage will come as we near FDA approval.
When will other countries authorize MDMA and on what terms?
MAPS is largely focused on US market commercialization.
MDMA is now accessible in Canada because of Canada’s recent special access expansion. Doctors in Canada can now request MDMA on behalf of patients who have life-threatening or treatment-resistant diagnoses. MAPS is assessing whether they can help play a role in this expansion, possibly as a distributor.
MAPS’ open-label MDMA study recently started in Europe. 7-8 separate sites will be treating a small number of patients to get familiar with protocols, and these sites are expected to move into phase III research later this year. The EMA (European Medicines Agency) approval process will probably start in the next several years.
Will there be off-label uses for MDMA therapy?
MAPS is not supporting off-label use for MDMA therapy right now. Currently, MDMA therapy is being promoted and tested as a treatment for PTSD only.
MAPS is in the process of studying other indications. They’re currently starting a phase II study for eating disorders, and other indications are being studied as well.
What regulations and policies will exist for therapists and distributors?
This is an area of uncertainty around MDMA therapy. We’ll need new regulations for training and qualifications to be sure this drug is delivered safely and effectively. Structures need to ensure that people who deliver MDMA therapy are properly trained. Treatment integrity and patient safety are vital.
How is MAPS promoting equitable access for MDMA therapy?
MAPS aims to train MDMA providers who are embedded in their communities. They want MDMA therapists to be a diverse, culturally competent group. MAPS has a scholarship program for BIPOC therapists in an effort to diversify the community of PTSD treatment providers.
In their first phase III trial, MAPS’ study group skewed overwhelmingly white. In their second phase III study, they reached out to more diverse communities. 50% of the people in the second study are POC.
How can the VA system get involved in MDMA therapy for PTSD?
A majority of people with PTSD are civilians, but many veterans are affected. Still, MAPS has been proud to see the first MDMA-assisted therapy delivered in the California VA this year. Another study in the Bronx VA is comparing frequency of MDMA sessions.
The VA is not a monolith system, so MAPS doesn’t expect nationwide availability when MDMA therapy becomes available. VA involvement in MDMA therapy will come from the local level.
What will the MDMA descheduling process look like?
Descheduling will likely come after clinical approval by the FDA.
It’s important to note that the DEA has to reschedule based on recommendations from FDA, but individual states have to deschedule as well. Half of states have an automatic trigger that will follow the DEA action. Other states will need legislation to deschedule MDMA.
MAPS is anticipating a potentially bifurcated new scheduling system. This would mean that MDMA and Ecstacy used in recreational settings would remain a schedule-1 substance, but the MDMA under MAPS would be de-scheduled. Patients would still be able to access MDMA therapy through their providers, but MDMA would remain illegal for the general population.
The next few months should see re-scheduling in states. MAPS is excited about state-level changes in MDMA scheduling, but this could affect their timelines for distribution post-approval.
What will MDMA be scheduled to?
The MAPS’ team believes that schedule 3 is appropriate for MDMA. But ultimately scheduling will be DEA decision that is informed by the FDA recommendations.
Could California make MDMA accessible outside of FDA approval?
MAPS has a broader goal for drug policy reform. The team supports bringing MDMA to the world as a legal substance in both clinical and non-clinical settings.
How will the delivery model compare to research studies?
Much of the delivery model is yet to be determined. MAPS hopes that the evidence-based practices held in research will carry through to the real world.
This could mean strategically regulating the way MDMA is delivered. It could also mean defining the standard of practice for MDMA therapy. Ultimately, we won’t know exactly how MDMA therapy will look in the real world until we see it. The good news is, that day is coming soon.
Joy Sun Cooper is Chief of Patient Access and Head of Commercialization for MAPS PBC. James Acer is Chief of Staff. We’d like to thank Joy and James for sharing their plans and insights into how patients will access MDMA therapy in our monthly speaker series. We look forward to more exciting updates from MAPS.
Interested in MDMA therapy? Check out our MDMA course which extensively covers MAPS therapy protocols and research findings. We also collaborated on a free e-course specifically on psychedelic therapy treatments for veterans.