Post Traumatic Stress Disorder (PTSD) is a mental health condition that can develop after an individual experiences or witnesses a traumatic event such as a physical assault, the unexpected death of a loved one, a natural disaster, or military combat. Approximately 13 million Americans are affected by PTSD each year. Women, marginalized groups, and military personnel have a greater prevalence of PTSD than the general population. However, the largest cause of PTSD is non-combat-related trauma.
PTSD symptoms can greatly impact one’s quality of life, and when severe, can impair a person's ability to function on the job, at home and in social interactions. Symptoms can include persistent, frightening thoughts and memories, sleep problems, feeling detached, and startling easily.
Because your workforce may include military veterans, crime victims, and employees with personal histories of traumatic experience like a serious car accident or injury to a child, it’s important to recognize prevalence and understand treatment options that may be available to your plan members.
Midomafetamine – an emerging new therapy
Indication: In combination with psychological intervention for post-traumatic stress disorder (PTSD)
Estimated FDA approval: August 2024
Therapeutic class: Psychedelic (entactogen)
Route of administration: Oral
FDA designations: Breakthrough Therapy
Manufacturer: Lykos Therapeutics
MDMA’s role in treatment
First-line treatment for PTSD is psychotherapy (talk therapy) which can be used alone or in combination with medication. Talk therapy involves learning skills to identify triggers, manage PTSD symptoms, and address work-related issues.
Two selective serotonin reuptake inhibitors (SSRIs), sertraline and paroxetine, have FDA-approved indications for PTSD. Other medications may be used off-label. If MDMA is FDA-approved, it would be the first psychedelic-assisted therapy and the first new drug approved for PTSD in over two decades.
MDMA (also known as “Ecstasy” or “Molly”) is an entactogen, which increases self-awareness, introspection, and personal reflection. Under the Controlled Substances Act, MDMA is currently a Schedule I drug; this prevents it from being used recreationally or medically. If FDA-approved, the Drug Enforcement Administration (DEA) would be required to reschedule MDMA so that it is available for prescription medical use.
Efficacy and safety
The New Drug Application submitted to the FDA was supported by data from two phase 3 clinical trials, which included adults with severe and moderate-to-severe PTSD. Experimental sessions consisted of three 8-hour dosing sessions of MDMA or placebo in conjunction with therapy conducted by trained personnel, followed by three 90-minute integration sessions to support processing the experience. MDMA demonstrated improvements in PTSD symptom severity and functional impairment compared to placebo over 18 weeks.
Adverse events that occurred most frequently with MDMA included muscle tightness, nausea, decreased appetite, and excessive sweating. There were no serious adverse events reported for MDMA in either phase 3 study.
Potential financial impact
The cost of MDMA upon approval has not yet been determined. One cost-effectiveness analysis found the cost of MDMA-assisted therapy as conducted in phase 3 trials is approximately $11,500 per individual, of which more than 90% is attributed to therapists’ compensation. MDMA is also being studied for use in other indications, which may further expand use.
What’s next – CarelonRx perspective
Although new treatment options for PTSD are greatly needed, questions remain about how MDMA may fit best in clinical practice, including which population may benefit most, along with long-term safety and response to treatment. MDMA will likely be used only by trained healthcare professionals and only after first-line treatment options have been unsuccessful.
MDMA is currently a Schedule I controlled substance and would require DEA rescheduling following approval. MDMA will likely be part of the medical benefit since it is administered during in-person sessions with a trained therapist. Looking to the future, we note that there are many other psychedelic therapies in development for diagnoses that include depression, anxiety, eating disorders, and substance use disorders.
CarelonRx closely monitors the drug and biologic pipeline and provides this spotlight information as part of our mission to improve health, reduce waste, lower total cost of care, and estimate future cost impact.
* Projections on future drug approvals and availability are based on information available at the time of publication and are not within the control of CarelonRx. Unless otherwise noted, information contained in this article was obtained from the Centers for Disease Control and Prevention (CDC) (cdc.gov), the Food and Drug Administration (FDA) (fda.gov), clinicaltrials.gov, releases from pharmaceutical manufacturers, National Institutes of Health (NIH) (nih.gov), and UpToDate.com (registration required). Information in this article is accurate as of May 6, 2024.
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