You are currently viewing In Brief: ICER Issues Final Evidence Report and Recommendations Re: MDMA-Assisted Therapy; Lykos Responds

In Brief: ICER Issues Final Evidence Report and Recommendations Re: MDMA-Assisted Therapy; Lykos Responds

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Today, the Institute for Clinical and Economic Review (ICER) published its Final Evidence Report on Lykos Therapeutics’ MDMA-assisted therapy for PTSD.

There’s no substantive change from its draft evidence report’s determination, or from the vote of its independent panel which resoundingly rejected the intervention.

That is, ICER finds the current evidence inadequate to demonstrate a net health benefit of MDMA-assisted therapy. Given the perceived inadequacy of the data, the organisation—which generally makes recommendations around the value for money of novel interventions—said that it was not possible to provide a health-benefit price benchmark for the drug at this time: a big blow to Lykos’ chances of achieving widespread reimbursement should they gain FDA’s approval in August.

For more on the report and panel’s findings, see our earlier coverage…

ICER’s Policy Recommendations

Aside from issuing its final report (which we don’t discuss in detail here owing to its similarity to that discussed in our earlier coverage, above), ICER has today shared three policy recommendations with respect to MDMA-assisted therapy, and psychedelic therapies more broadly.

The first states that any approval of a psychedelic therapy should be paired with “an expansive Risk Evaluation and Mitigation Strategies (REMS) program”, which would track adverse events and require “rigorous certification” of providers involved in the treatment.

That certification and oversight should not be carried out by Lykos alone, the recommendation continues, due to potential conflicts of interest. This echoed concerns voiced by some members of the FDA Advisory Committee meeting on MDMA, earlier this month. There, committee member Walter Dunn, for example, said that there are “serious questions” about whether Lykos is fit to oversee the training of therapists in a responsible manner, given the alleged misconduct seen in its studies.

Instead, ICER prescribes, groups like the American Psychiatric Association and American Psychological Association should be involved, and other stakeholders such as payors might have a role to play here, too. 

In practice, this could entail the manufacturer (Lykos, in this case) certifying providers before a separate entity (a speciality society, for example) provides a second sign-off. This certification and oversight should extend to both the prescriber and the therapists, ICER argues.

Payors might also consider identifying “a limited network of centers of excellence for the provision of psychedelic treatments”, it continues.

Its second recommendation suggests that, as soon as possible following any regulatory approval, both clinical specialty societies and large integrated provider systems like the VA should develop clinical practice guidelines.

“Payers look to see if guidelines exist when developing early coverage policies”, ICER wrote, “and therefore it will be important for all stakeholders to have rigorous guidelines to help align evidence, practice, and insurance coverage across the diverse payers in the US health system.”

Its final recommendation for psychedelic treatments is directed toward payors themselves. ICER urges them to “translate the findings from pivotal trials of psychedelic treatments and the recommendations from available clinical guidelines into transparent, evidence-based coverage policies”.

If MDMA-assisted therapy does receive approval in August, ICER says that it would “be reasonable for payers to draw relatively tight boundaries around coverage”, given what it characterises as “the context of the uncertainty at this time”.

For psychedelic-based treatments more broadly, ICER says it will “be reasonable for payers to consider step therapy”, given novel treatments “will lack the longer-term record of safety and effectiveness that has been demonstrated by several short-term trauma-focused psychotherapies”.

What’s more, if these new approaches are more resource-intensive (as psychedelic therapies such as MDMA-assisted therapy are), ICER says it is “also reasonable for payers to favor approaches requiring less clinician time to maximize access to an accepted form of therapy.”

Finally, ICER says that payors should keep a keen eye on studies of MDMA paired with evidence-based psychotherapy approaches, if Lykos’ approach is ultimately approved. Should those pairings of MDMA with existing approaches demonstrate equal or better outcomes, it notes, payors “should consider rapidly expanding coverage to include these options, which will likely help expand access and require fewer clinical resources.”

ICER also made more direct recommendations for future research, aside from suggesting that MDMA be tested in combination with evidence-based trauma-focused psychotherapies.

It suggests, for example, conducting head-to-head trials that compare MDMA-assisted therapy with first-line trauma-focused psychotherapies. Evaluating different models of delivering MDMA-assisted therapy, such as in a 1:1 therapist:patient context, or with fewer or more frequent therapy sessions.

Lykos Responds

Shortly after the final evidence report published, Lykos CEO Amy Emerson issued a statement.

There, Emerson accuses ICER of going beyond its “traditional scope” in that it explored trial design concerns as opposed to limiting its analysis to a value assessment.

The CEO also criticised ICER for drawing on “select anonymous reports, without adequate and proper documentation”, arguing that the organisation used those reports “to cast unfair doubt on the integrity of Lykos, dozens of dedicated clinicians and researchers, and data from hundreds of clinical trial participants.”

Regarding a “deeply unfortunate case of therapist sexual misconduct” in one of the company’s phase 2 studies, Emerson said that the incident was reported “in a timely manner to the appropriate authorities”, and that the company “banned the therapists from working with Lykos in any capacity.”

Despite her criticisms, the Lykos CEO said the company “has requested time to discuss its concerns with ICER and looks forward to a constructive dialogue.”

One can only wonder if it’s too little, too late?1

  1. Indeed, ICER's final report notes that Lykos reached out to ICER to request a call less than 24 hours prior to the report's publication.