Expanded Prescriber Framework Opens Non-Hospital Psilocybin, MDMA Therapy with 750+ Clinicians and Public Coverage
OPTH•Australia’s TGA expanded Optimi Health’s Authorized Prescriber framework for psilocybin and MDMA, broadening eligible therapists to include registered psychotherapists, counsellors, Aboriginal and Torres Strait Islander health workers and opening non-hospital sites under defined safety protocols. Public and private insurers now cover therapy, while over 750 clinicians are CPAT-trained and no serious adverse events have been reported, supporting scale-up.
1. Regulatory Framework Update
The Therapeutic Goods Administration published final recommendations on May 29, expanding the Authorized Prescriber scheme to allow psychiatrists to prescribe Optimi’s MDMA for PTSD and psilocybin for treatment-resistant depression. This makes Australia the first country to regulate both substances as medicines under a GMP-compliant production framework, following stakeholder consultation that closed on May 19.
2. Workforce and Treatment Settings Expansion
Under the updated framework, therapy teams must include an on-site AP psychiatrist and at least one CPAT-trained professional, drawn from a wider pool of psychotherapists, counsellors, social workers or Aboriginal and Torres Strait Islander health workers. Treatment can now occur in any medically supervised environment with secure Schedule 8 storage, trained staff, resuscitation equipment and proximity to an emergency department.
3. Safety Profile and Reimbursement Coverage
No serious adverse events have been reported under the scheme since December 2025, with structured reporting to Human Research Ethics Committees and a national registry. Coverage now spans the Department of Veterans’ Affairs, National Disability Insurance Scheme, WorkCover schemes and private insurer Medibank, establishing a broad payer base for commercial expansion.
