— Independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for MDMA-AP compared to short-term trauma-focused psychotherapies —

BOSTON, June 27, 2024  The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of MDMA-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).

ICER’s report on these therapies was the subject of the May 2024 public meeting of the of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. 

“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 PTSD,” said ICER’s Chief Medical Officer David Rind, MD. “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 FDA is investigating such issues, including those brought to light at our Public Meeting.”

ICER’s Virtual Public Meeting: Voting Results on Clinical Effectiveness and Contextual Considerations 

ICER assessed, and the independent appraisal committee voted on, the evidence of MDMA-AP for adults with a diagnosis of moderate-to-severe PTSD: 

  • A majority of panelists (14-1) found that current evidence is not adequate to demonstrate a net health benefit for MDMA-AP when compared to not treating with MDMA-AP.  
  • All panelists (15-0) found that current evidence is not adequate to demonstrate a net health benefit for MDMA-AP when compared to short-term traumas-focused psychotherapies. 

Panel members also weighed potential benefits and disadvantages beyond the direct health effects and special ethical priorities. Voting highlighted the following as particularly important for payers and other policymakers to note: 

  • There is substantial unmet need despite currently available treatments.
  • This condition is of substantial relevance for people from a racial/ethnic group that have not been equitably served by the healthcare system.

ICER’s Virtual Public Meeting: Voting Results on Long-Term Value for Money 

Consistent with ICER’s process, because there is no firm estimate yet of a potential launch price for the treatment, the panel did not take a vote on the treatment’s long-term value for money. 

MDMA-AP has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved.

Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. Given all these uncertainties, ICER did not calculate a health-benefit price benchmark for MDMA-AP.

Key Policy Recommendations: 

ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include: 

  • All stakeholders have a responsibility and an important role to play in improving the identification of people living with PTSD across diverse communities and in engaging with them in new ways to ensure that any effective new treatment option is introduced in a way that will help reduce health inequities.
  • Rigorous certification and oversight of providers is of the highest importance and should include entities other than the manufacturer, such as the American Psychiatric Association, to reduce potential conflicts of interest in maintaining the highest standards.  
  • Payers should translate the findings from pivotal trials of psychedelic treatments and the recommendations from available clinical guidelines into transparent, evidence-based coverage policies that provide a rationale for specific clinical eligibility criteria and any step therapy approaches. 

ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations  document. 

About ICER 

The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.