Lykos calls ICER’s final report ‘subjective’

Psychedelic drug company Lykos Therapeutics wasn’t too happy with the Final Evidence Report issued by the Institute for Clinical and Economic Review (ICER) on its Midomafetamine (MDMA) Assisted Psychotherapy for Post-Traumatic Stress Disorder (PTSD). Lykos Therapeutics said it was disappointed in the contents and the overall findings of the report, while still asserting that it was encouraged that ICER found MDMA could be a cost-effective treatment for PTSD.

Lykos said in a statement, “However, like the interim report before it, the final report unfortunately goes beyond ICER’s traditional scope. It cites trial design concerns that, while important, have been and are being extensively discussed with FDA through the course of Lykos’ development program and New Drug Application (NDA) review. Further, it draws on select anonymous reports, without adequate and proper documentation, and uses these to cast unfair doubt on the integrity of Lykos, dozens of dedicated clinicians and researchers, and data from hundreds of clinical trial participants.”

ICER report

Green Market Report previously covered the ICER draft report that concluded that the current publicly available evidence is insufficient to assess the overall net benefit of MDMA-AP, which gave the company an “I” rating. ICER also stated that it would not provide Health Benefit Price Benchmarks for MDMA-AP based on that incomplete rating.

The final report came to the same conclusion and continued the I rating. It clearly stated that it had substantial concerns about the validity of the Lykos test results.

The report had three recommendations:

1. Improve the identification of people living with PTSD across diverse communities to reduce health inequities
2. For any approved therapy using a psychedelic agent, the FDA should establish an expansive Risk Evaluation and Mitigation Strategies (REMS) program with components including tracking of adverse outcomes, which requires rigorous certification of all healthcare providers involved in treatment.
3. Clinical researchers and life science companies in this space should attend to the research needed to help all stakeholders understand the appropriate place of psychedelic therapies in the care of people living with PTSD.

Lykos pushback

Lykos seemed to fall back on the ‘it’s not us, it’s you’ response. It accused ICER of not regarding the need for new PTSD treatments and that developing these treatments was complex.

The company also reiterated its study findings and complained that ICER diminished those findings. Lykos also believed that ICER focused too much on what it called a “deeply unfortunate case of therapist sexual misconduct stemming from a 2015 Phase 2 clinical trial.” Lykos said it reported the incident promptly to the appropriate authorities and banned the therapists from working with Lykos in any capacity.

Ultimately, this final report relies on subjective analysis in a manner that seems misaligned to the data-driven approach ICER is meant to provide, and in doing so creates a concerning precedent that could negatively impact innovative treatments. The company has requested time to discuss its concerns with ICER and looks forward to a constructive dialogue.

Public Comments

While Lykos seemed to suggest that there was only one incident of sexual boundaries being crossed in its study, a read through of the public comments attached to the ICER report told another story. There was more than one person publicly speaking about the study and how therapists crossed the line in the physical treatment of patients.

There was one response that favored the Lykos treatment and suggested that current study methods, specifically the blinding nature of studies, weren’t appropriate for psychedelic drugs. The comment also noted that the MDMA had helped many suffering patients.

Lykos is still hoping for FDA approval, but the negative vote with the Advisory Council is beginning to make that approval look less likely. However, if it did get the approval in August, the negative ICER report would make the battle for patients to get reimbursed for treatments more difficult.

 

The post Lykos calls ICER’s final report ‘subjective’ appeared first on Green Market Report.

via http://www.KahliBuds.com