A SAS drug refers to a therapeutic good that is made available under the Special Access Scheme (SAS), primarily in Australia. These are typically "unapproved" therapeutic goods, meaning they have not been evaluated by the Therapeutic Goods Administration (TGA) for general marketing in Australia, but are accessible for specific patient needs.
Understanding the Special Access Scheme (SAS)
The Special Access Scheme (SAS) provides a pathway for Australian registered health practitioners to access therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG). This access is granted on a case-by-case basis for individual patients who have a clinical need for these unapproved treatments.
Essentially, a "SAS drug" isn't a classification of the drug itself, but rather a description of how it is accessed by a patient. The drug might be approved in other countries, or it might be a novel therapy still undergoing trials, but the key point is its "unapproved" status within the Australian regulatory framework for general supply.
Key Characteristics of a SAS Drug
To be considered a "SAS drug" and supplied under this scheme, several conditions apply:
- Unapproved Status: The therapeutic good (which includes medicines, medical devices, and other health products) is not currently approved for supply in Australia by the TGA and is therefore not listed on the ARTG.
- Individual Patient Basis: Access is granted for a specific, individual patient, not for widespread use or general distribution. Each patient's case is assessed independently.
- Health Practitioner Initiated: An Australian registered health practitioner (such as a medical doctor, dentist, or nurse practitioner) must apply for and take responsibility for the use of the unapproved good for their patient.
- Clinical Need: The health practitioner must determine that the patient has a genuine clinical need for the unapproved therapeutic good, often because:
- There is no suitable approved alternative available.
- The patient has a rare condition.
- The patient has exhausted all approved treatment options.
- Case-by-Case Assessment: Each application for a SAS drug is assessed individually, considering the specific patient's condition and the proposed treatment.
Pathways for Unapproved Therapeutic Goods
While the Special Access Scheme is a primary pathway for accessing unapproved therapeutic goods for individual patients, other mechanisms also exist to facilitate access in specific circumstances. These alternative pathways might include clinical trials, authorised prescriber schemes, or compassionate access programs, each with its own criteria and regulatory oversight.
The SAS exists to bridge the gap between patient need and the rigorous, often lengthy, process of therapeutic good approval, ensuring that patients with critical or unmet medical needs can still access potentially life-saving or life-improving treatments under appropriate medical supervision.
