Access Pathways to Medical Cannabis: Special Access Scheme A (SAS-A)

At the time of publishing, there are currently two approved medical cannabis treatments on the ARTG:

• Nabiximols (Sativex) – Approved to improve symptoms related to spasticity in people with MS, reporting lack of efficacy from other anti-sacity treatments²
• Cannabidiol (Epidyolex) – Approved as an adjunct treatment severe and rare forms of epilepsy in children aged 2+4

Yet, for those who are seriously ill, medical cannabis may offer subjective relief for a wide range of symptoms such as; chronic pain, nausea and vomiting; sleep and appetite disturbances, depressed mood  & stress where other treatments have been unable to provide effective relief.³⁴

Registered medical practitioners may apply for access to unapproved therapeutic goods via the TGA through the following pathways:¹

• Special access scheme (SAS) – provide access for an individual patient on a case-by-case basis
• Authorised prescriber scheme (AP) – provide access for multiple patients with the same condition

In cases where approved medications are unsuitable or ineffective, Australian healthcare practitioners can access unapproved therapeutic goods, such as medical cannabis, through the Special Access Scheme A (SAS-A) or the Authorised Prescriber (AP) pathways. This module explores these pathways, outlines approved and unapproved medical cannabis treatments, and provides insight into their potential role in managing symptoms for seriously ill patients.

Preview this module by watching the video above.

Estimated Duration: 1.25 hours

Access Duration: 12 months from date of purchase

Upon completion of this module, you’ll be able to:

• Clarify the purpose of the Australian Register of Therapeutic Goods (ARTG)
• Outline the categories of unregistered therapeutic goods
• Identify and explain the regulated access pathways for unapproved goods
• Summarise the purpose and eligibility criteria for each category of the Special Access Scheme (SAS), including SAS-A, SAS-B, and SAS-C
• Define the term seriously ill as it pertains to SAS-A
• Complete the online SAS form to notify the Therapeutic Goods Administration (TGA) and the relevant state or territory authorities regarding the medical cannabis prescription
• Discuss prescribing practitioner considerations and obligations for providing medical cannabis treatment

References

¹ Therapeutic Goods Administration. “Prescribe an Unapproved Therapeutic Good (Health Practitioners).” Therapeutic Goods Administration (TGA), 14 Dec. 2022, www.tga.gov.au/products/unapproved-therapeutic-goods/prescribe-unapproved-therapeutic-good-health-practitioners.

² Therapeutic Goods Administration. Sativex Oromucosal Spray, Nabiximols 80 mg/mL Pump Actuated Metered Dose Aerosol (181978). Therapeutic Goods Administration (TGA). Published May 26, 2022. Accessed October 2, 2024. https://www.tga.gov.au/resources/artg/181978

³ Herbert A, Hardy J. Medicinal Cannabis Use in Palliative Care. Australian Journal of General Practice. 2021;50(6):363-368. doi:https://doi.org/10.31128/ajgp-02-21-5831

⁴ Therapeutic Goods Administration. Guidance for the Use of Medicinal Cannabis in the Treatment of Palliative Care Patients in Australia. Therapeutic Goods Administration (TGA). Published June 23, 2023. Accessed October 2, 2024. https://www.tga.gov.au/resources/resource/reference-material/guidance-use-medicinal-cannabis-treatment-palliative-care-patients-australia