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By Rachael Green, Benzinga
The American MedicalAssociation’s (AMA) Panel recently released the full details of anew code for psychological support during the administration ofpsychedelic treatments. Slated to take effect starting in 2024, thenew temporary CPT III code marks an important step toward broaderaccess to the novel treatments as it gives healthcare providers a wayto code and seek reimbursement for psychological support during theadministration of any FDA-approved psychedelic therapies given topatients.
Theaddition of the psychedelics code was made possible by CompassPathways Plc. (NASDAQ: CMPS), a company conducting clinical trialsof psilocybin treatment using COMP360, COMPASS’s proprietaryformulation of synthetic psilocybin, and MAPS Public BenefitCorporation (PBC), two companies developing psychedelics-basedtreatments for mental health conditions. The two companies submitteda joint application to the AMA to add a new CPT III code forpsychedelic therapies.
CPT CodesLend Legitimacy To Emerging Psychedelics Market
While no psychedelic hasyet been approved by the Food and Drug Administration (FDA) for themarket, a growing body of research from the last decade or so hasyielded positive data on the therapeutic potential of substances likepsilocybin, MDMA or LSD for a range of some of the most common andmost difficult to treat mental health conditions.
“Psychedelic-assistedtherapies represent a potential new frontier in the treatment ofmental health conditions and our top priority is ensuring there is apath forward to integrate them into the healthcare system, if FDAapproved,” said MAPS CEO Amy Emerson.
The new CPT code paves the way forpsychedelics – subject to FDA approval – to become a widelyadopted set of new therapeutics. “This is a major step forward toenabling broad and equitable access to psychedelic therapies,” saidCompass CEO Kabir Nath.
CPT coding is a standardized set of codes used nationwide forreporting of medical services and procedures, claims processing anddeveloping guidelines for medical care review. Essentially, ifpsychedelic therapies are approved, this new code is the basis forwhat will be used to document treatment in patient medical records andsubmit claims to payers for reimbursement.
COMPASS And MAPS Are Also Edging Closer To FDA Approval WithLate Stage Clinical Trials
The AMA’s acceptance of COMPASS and MAPS PBC’snew code application puts the mechanisms for adoption in place ifeither company is granted FDA approval for their psychedelictherapies. With that code in place, both companies are working to movetheir current late-stage clinical trials through the approvalprocess.
A phase 3trial is alreadyunderway for COMP360, the synthetic psilocybin treatmentdeveloped for treatment-resistant depression (TRD). The trial isbuilding on the company’s phase 2b trial, in which 30%of TRD patients achieved remission by the third week aftertaking just one 25-milligram dose at the start of the trial. At the12-week follow-up, over 20% of patients were still in remission.
These results arepromising given the challenging TRD patient population. Lessthan a third of people diagnosed with depression achieve fullremission with the first antidepressant they try – and even whenthey do, it takes an average of about seven weeks of daily medicationfor remission to happen.
For treatment-resistant depression – where a patient has beenfailed by at least two different antidepressants – the numbers areeven worse. Remission rates for patients trying a third antidepressantrange from just 8% to 12%, depending on the specific antidepressanttried. From the fourth treatment attempt onward, remission ratesremain low.
TheCOMP360 trial outcomes suggest it could be a meaningful alternativefor these patients who struggle to find any relief with the currentstandards of care. The phase 3 program currently underway will beconducted across approximately 150 sites worldwide. Two other phase 2trials are also being conducted, one for post-traumaticstress disorder (PTSD) and another for anorexianervosa .
Meanwhile, MAPS already has two phase 3 trials under its belt,both for an MDMA-assisted therapy it developed for PTSD. In the firstof those trials, 88% of participants saw meaningful improvement in their symptoms with thetreatment while 67% responded so well that they no longer met thediagnostic criteria for PTSD after 18 weeks. Based on that data andits previous trials, the company is preparing to submit a new drugapplication to the FDA in the thirdquarter of this year.
Company BioCOMPASS Pathwaysplc (Nasdaq: CMPS) is a mental health care company dedicated toaccelerating patient access to evidence-based innovation in mentalhealth. Our focus is on improving the lives of those who are sufferingwith mental health challenges and who are not helped by currenttreatments. We are pioneering the development of a new model ofpsilocybin therapy, in which our proprietary formulation of syntheticpsilocybin, COMP360, is administered in conjunction with psychologicalsupport. COMP360 has been designated a Breakthrough Therapy by theU.S. Food and Drug Administration (FDA) and has received InnovativeLicensing and Access Pathway (ILAP) designation in the UK fortreatment-resistant depression (TRD). We have commenced a phase 3clinical program of COMP 360 psilocybin therapy in TRD, the largestrandomised, controlled, double-blind psilocybin therapy clinicalprogram ever conducted. Previously, we completed a phase 2b study withtop line data showing a statistically significant (p<0.001) andclinically relevant improvement in depressive symptom severity afterthree weeks for patients who received a single high dose of COMP360psilocybin with psychological support. We are also conducting phase 2clinical studies of COMP360 psilocybin therapy for post-traumaticstress disorder (PTSD) and anorexia nervosa. COMPASS is headquarteredin London, UK, with offices in New York and San Francisco in theUnited States. Our vision is a world of mental wellbeing.
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Contact Details
StephenSchultz
stephen.schultz@compasspathways.com
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