An introduction to SAS and Authorised Prescriber pathways

If you’re researching prescription medicines in Australia, you'll probably come across terms like SAS, SAS-B and Authorised Prescriber (AP). They sound like different types of treatment or medicines, but they're actually regulatory pathways that allow appropriately qualified health practitioners to prescribe medicines that haven't been approved for general supply in Australia(1).

Some medicinal products available in Australia are classed as unapproved therapeutic goods. This means they're not included in the Australian Register of Therapeutic Goods(ARTG)(2) and are not evaluated by the TGA for safety, quality and effectiveness in the same way as medicines included in the ARTG.

This doesn't mean these products are banned from prescription or supply. Australian law provides several pathways allowing eligible health practitioners to prescribe unapproved medicines if they are clinically appropriate. Two of the most common pathways are the Special Access Scheme (SAS)(3) and the Authorised Prescriber (AP) Scheme(4).

What does the Special Access Scheme mean?

The Special Access Scheme allows an eligible registered health practitioner to access an unapproved therapeutic good for an individual patient.

There are three SAS categories in Australia, known as Category A, Category B and Category C. The pathways available to practitioners depend on factors including the patient's circumstances, the medicine involved, and the type of health practitioner.

Most patients arelikely to hear about SAS Category B, usually shortened to SAS-B.

Under SAS-B, health practitioners apply to the TGA to access an unapproved product for a particular patient. The application needs to include a clinical reason for the proposed use. This includes treatments that have been tried or considered previously, why medicines included in the ARTG may not be appropriate, and the expected benefits compared against the possible risks.

The TGA assesses Category B applications individually. Approval must be received before the unapproved product can be supplied.

This means that a SAS-B application is not just administrative paperwork attached to an otherwise automatic prescription. The decision to prescribe remains a clinical one. The practitioner needs to consider the patient's circumstances and the available evidence supporting use of the proposed medicine.

What are SAS-A and SAS-C?

You may also see theother two SAS categories mentioned.

SAS Category A applies to patients who meet the TGA definition of being seriously ill. This can mean a condition where death may occur within a short timeframe, or where premature death may occur without early treatment. A medical practitioner can access eligibleunapproved therapeutic goods immediately, but must notify the TGA within 28days.

SAS Category C applies to specific unapproved therapeutic goods that have an established history of use. The medicine, its intended use and the type of health practitioner must meet the conditions set out by the TGA. Prior approval is not required, but the TGA must generally be notified within 28 days.

Many medicines are notavailable through SAS Category C.

What does Authorised Prescriber mean?

The AuthorisedPrescriber pathway works differently.

Instead of having to seek TGA approval for individual patients each time, eligible medical practitioners can apply to become an Authorised Prescriber of an unapproved therapeutic good for a specified class of patients with the same condition.

Once authorised, the practitioner does not need to make a separate SAS application to the TGA for each patient whose condition comes under the terms of the authorisation.

That doesn't mean every patient who consults an Authorised Prescriber will be given a prescription. Authorisation gives practitioners the regulatory pathway to prescribe an unapproved medicine, but whether a prescription is appropriate for individual patients is still a clinical decision.

Authorised Prescribers also have ongoing responsibilities. These include reporting suspected adverse events or product defects and reporting the number of patients treated every six months(5).

Depending on the medicine, becoming an Authorised Prescriber may require approval or endorsement from a Human Research Ethics Committee (HREC) or a relevant specialist college(6), although some medicines with an established history of use have different pathways that don't require this endorsement.

SAS-B versus Authorised Prescriber

The most common distinction is how many patients are covered by the regulatory authority.

Under SAS-B, access is considered for individual patients. Practitioners must submit an application, and receive TGA approval, before the unapproved medicine can be supplied.

Under the Authorised Prescriber Scheme, medical practitioners receive authority covering a defined class of patients, and the specific condition. Additional TGA approval is not required for individual patients treated within that authorisation.

For the patient, however, the clinical consultation is central to either pathway.

Does TGA approvalmean the medicine itself is TGA approved?

No, a SAS approval or an Authorised Prescriber authority does not mean the TGA has approved the medicine itself for general use.

An unapproved therapeutic good remains outside the ARTG. The TGA states that these products have not been assessed by it for safety, quality and effectiveness.

What the SAS and Authorised Prescriber schemes do is provide legal mechanisms allowing unapproved therapeutic goods to be accessed under certain circumstances.

What does this mean during a consultation?

Medical practitioners are responsible for working within the appropriate regulatory pathway, and patients generally don't need to decide whether a SAS or Authorised Prescriber pathway is used.

For patients, the most relevant part of the process is the clinical assessment. Practitioners considering the use of unapproved medicines must consider your health circumstances, available treatment options, the evidence supporting its proposed use, and the possible risks involved.

So, if you hear SAS-B or Authorised Prescriber mentioned by a clinic or pharmacy, or come across these terms in information about a medicine, you should think of them as regulatory access pathways and not different types of treatment or medicine.

They explain how an unapproved medicine may be lawfully accessed, but not whether the medicine is suitable for you. That decision must always depend on an individual clinical assessment by an appropriately qualified AHPRA-registered health practitioner.