Yesterday, the Institute for Clinical and Economic Review (ICER) published its draft evidence report on MDMA-assisted psychotherapy (which it abbreviates to ‘MDMA-AP’) for the treatment of PTSD. ICER is a nonprofit organisation that, in its own words, collaborates “with stakeholders across the US healthcare system [to] assess how much better a health intervention is, and what a fair price could be.”
The organisation was keen to remind readers that the preliminary draft “marks the midpoint of ICER’s eight-month process of assessing these treatments.” As such, its findings are not final.
While ICER Chief Medical Officer David Runt noted that “PTSD can be a severe condition affecting nearly all aspects of an individual’s life” and that “current therapeutic options are insufficient for many people with PTSD”, he tempered expectations. “While MDMA-AP may be a promising therapy for PTSD,” he continued, “functional unblinding in the clinical trials and additional concerns around trial design and conduct leave many uncertainties about the balance of benefits and harms.”
“It will be incumbent on regulators with complete access to primary data”, he continued, “ to carefully assess whether MDMA-AP has been proven safe and effective.”
Our editor, Josh Hardman, reviewed the report overnight to pull out some key messages. If you have the time, however, you can take a look yourself (PDF).
In short: ICER is pessimistic regarding the level of clinical evidence provided by Lykos Therapeutics, highlighting various concerns that range from trial design and conduct issues through to potential ethical and safety problems. While the organisation is generally relaying concerns it has heard from parties with ‘firsthand’ and ‘secondhand’ experience or knowledge of the trials, it’s hard not to see certain sections as scathing.
ICER goes on to deem the clinical evidence to be of ‘low certainty’, which means it’s ‘insufficient’ in terms of feeding into a determination of comparative clinical effectiveness. That means that ICER’s cost effectiveness analyses are all exploratory. While that exploratory analysis does find MDMA-AP to be ‘less costly, more effective’ versus placebo, ICER is keen to remind readers that its analysis is somewhat hamstrung by its low certainty in the clinical evidence.
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