Tuesday, July 16, 2024

Post-Traumatic Stress Disorder Treatment Lacks Sufficient Evidence for MDMA-Assisted Psychotherapy

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The Institute for Clinical and Economic Review (ICER) has published a Final Evidence Report assessing the comparative clinical effectiveness and value of MDMA-assisted psychotherapy (MDMA-AP) for treating post-traumatic stress disorder (PTSD). The report, released on June 27, 2024, was the focus of the May 2024 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees.

ICER’s assessment of MDMA-AP included an evaluation of its clinical effectiveness and contextual considerations for adults with moderate-to-severe PTSD. The independent appraisal committee voted on the evidence, with a majority (14-1) concluding that the current evidence is not adequate to demonstrate a net health benefit for MDMA-AP compared to not treating with MDMA-AP. Additionally, all panelists (15-0) agreed that the evidence is not adequate to demonstrate a net health benefit for MDMA-AP when compared to short-term trauma-focused psychotherapies.

ICER Finds Insufficient Evidence for MDMA-Assisted Psychotherapy in Post-Traumatic Stress Disorder Treatment

David Rind, MD, ICER’s Chief Medical Officer, stated, “PTSD can be a severe condition affecting nearly all aspects of an individual’s life, and many current therapeutic options are insufficient for many people with post-traumatic stress disorder. Despite two randomized trials of MDMA-AP, functional unblinding in the trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms. It was encouraging to learn that the Food and Drug Administration (FDA) is investigating such issues, including those brought to light at our Public Meeting.”

During ICER’s Virtual Public Meeting, the voting highlighted several key considerations for payers and policymakers. These include the substantial unmet need despite currently available treatments and the significant relevance of this condition for people from racial and ethnic groups that have not been equitably served by the healthcare system. The panel did not take a vote on the long-term value for money of MDMA-AP due to the lack of a firm estimate of a potential launch price and the uncertainties surrounding the evidence.

Post-Traumatic Stress Disorder

ICER Report Calls for Policy Reforms on MDMA-Assisted Psychotherapy for Post-Traumatic Stress Disorder

ICER’s report includes a detailed set of policy recommendations aimed at informing critical decisions about pricing and coverage for stakeholders across the US health system. Recommendations from the policy roundtable of experts emphasize the need for improved identification and engagement with people living with post-traumatic stress disorder across diverse communities.

They also stress the importance of rigorous certification and oversight of providers, suggesting involvement from entities like the American Psychiatric Association to reduce conflicts of interest. Payers are encouraged to translate findings from pivotal trials of psychedelic treatments and recommendations from clinical guidelines into transparent, evidence-based coverage policies. These policies should provide clear clinical eligibility criteria and any step therapy approaches to ensure fair access to effective treatments.

ICER’s Final Evidence Report on MDMA-AP for post-traumatic stress disorder provides critical insights into the current evidence and highlights significant gaps and uncertainties. The recommendations aim to guide stakeholders in making informed decisions about the treatment’s pricing and coverage. While MDMA-AP shows potential, further investigation and robust evidence are necessary to ensure its efficacy and safety for post-traumatic stress disorder patients.

 

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Resource: Institute for Clinical and Economic Review, June 27, 2024

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