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By Rachael Green, Benzinga

The American Medical Association’s (AMA) Panel recently released the full details of a new code for psychological support during the administration of psychedelic treatments. Slated to take effect starting in 2024, the new temporary CPT III code marks an important step toward broader access to the novel treatments as it gives healthcare providers a way to code and seek reimbursement for psychological support during the administration of any FDA-approved psychedelic therapies given to patients.

The addition of the psychedelics code was made possible by Compass Pathways Plc. (NASDAQ: CMPS), a company conducting clinical trials of psilocybin treatment using COMP360, COMPASS’s proprietary formulation of synthetic psilocybin, and MAPS Public Benefit Corporation (PBC), two companies developing psychedelics-based treatments for mental health conditions. The two companies submitted a joint application to the AMA to add a new CPT III code for psychedelic therapies.

CPT Codes Lend Legitimacy To Emerging Psychedelics Market

While no psychedelic has yet been approved by the Food and Drug Administration (FDA) for the market, a growing body of research from the last decade or so has yielded positive data on the therapeutic potential of substances like psilocybin, MDMA or LSD for a range of some of the most common and most difficult to treat mental health conditions.

“Psychedelic-assisted therapies represent a potential new frontier in the treatment of mental health conditions and our top priority is ensuring there is a path forward to integrate them into the healthcare system, if FDA approved,” said MAPS CEO Amy Emerson.

The new CPT code paves the way for psychedelics – subject to FDA approval – to become a widely adopted set of new therapeutics. “This is a major step forward to enabling broad and equitable access to psychedelic therapies,” said Compass CEO Kabir Nath.

CPT coding is a standardized set of codes used nationwide for reporting of medical services and procedures, claims processing and developing guidelines for medical care review. Essentially, if psychedelic therapies are approved, this new code is the basis for what will be used to document treatment in patient medical records and submit claims to payers for reimbursement.

COMPASS And MAPS Are Also Edging Closer To FDA Approval With Late Stage Clinical Trials

The AMA’s acceptance of COMPASS and MAPS PBC’s new code application puts the mechanisms for adoption in place if either company is granted FDA approval for their psychedelic therapies. With that code in place, both companies are working to move their current late-stage clinical trials through the approval process.

A phase 3 trial is already underway for COMP360, the synthetic psilocybin treatment developed for treatment-resistant depression (TRD). The trial is building on the company’s phase 2b trial, in which 30% of TRD patients achieved remission by the third week after taking just one 25-milligram dose at the start of the trial. At the 12-week follow-up, over 20% of patients were still in remission.

These results are promising given the challenging TRD patient population. Less than a third of people diagnosed with depression achieve full remission with the first antidepressant they try – and even when they do, it takes an average of about seven weeks of daily medication for remission to happen.

For treatment-resistant depression – where a patient has been failed by at least two different antidepressants – the numbers are even worse. Remission rates for patients trying a third antidepressant range from just 8% to 12%, depending on the specific antidepressant tried. From the fourth treatment attempt onward, remission rates remain low.

The COMP360 trial outcomes suggest it could be a meaningful alternative for these patients who struggle to find any relief with the current standards of care. The phase 3 program currently underway will be conducted across approximately 150 sites worldwide. Two other phase 2 trials are also being conducted, one for post-traumatic stress disorder (PTSD) and another for anorexia nervosa.

Meanwhile, MAPS already has two phase 3 trials under its belt, both for an MDMA-assisted therapy it developed for PTSD. In the first of those trials, 88% of participants saw meaningful improvement in their symptoms with the treatment while 67% responded so well that they no longer met the diagnostic criteria for PTSD after 18 weeks. Based on that data and its previous trials, the company is preparing to submit a new drug application to the FDA in the third quarter of this year.

Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing.

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Contact Details

Stephen Schultz

stephen.schultz@compasspathways.com

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