FAQ

Everything you need to know about prescribing
and accessing unapproved therapeutic goods in Australia.

Process

Any doctor, including General Practitioners and Specialists, can prescribe unapproved therapeutic goods by submitting a formal application to the Therapeutic Goods Administration (TGA) on their patient’s behalf.

Doctors can prescribe unapproved therapeutic goods to patients if they have not responded to conventional medical treatments, or if their current medication has unwanted side effects and is deemed unsuitable to continue usage.

The application, called a SAS-B or Special Access Scheme Category B application, is submitted to the TGA online by the prescribing doctor. The doctor assesses which medication and dosage form is most suitable for the individual patient’s needs and clinically justifies the reasons for prescribing unapproved therapeutic goods over conventional treatments. The doctor will also detail the suggested dosage and frequency, length of treatment time, and intended monitoring.

SAS-B applications have a relatively quick turnaround time of about 2-3 business days. Your prescribing doctor will contact you as soon as approval is granted and provide you with your prescription, or send it to your preferred pharmacy for dispensing.

Experienced unapproved therapeutic goods prescribers may choose to become Authorised Prescribers for unapproved therapeutic goods categories and dosage forms through the TGA’s Authorised Prescriber Scheme (APS). Authorised Prescribers can prescribe unapproved therapeutic goods products without needing to gain prior approval through the TGA’s Special Access Scheme. This means doctors can provide their patients with a unapproved therapeutic goods prescription immediately during the consult, rather than having to wait for their SAS-B application to be approved before providing the prescription.

A Telehealth appointment provides an online consultation service with a certified medical practitioner over telephone. Here the practitioner will discuss your lifestyle and medical history, as well as addressing any questions you have about unapproved therapeutic goods. Once eligibility has been determined, the doctor can formally apply through the Special Access Scheme for approval to write a prescription for unapproved therapeutic goods, or if the doctor is an Authorised Prescriber, they may write a prescription and provide it to the patient or dispensing pharmacy immediately.

You can expect regular check ins with your doctor to be included in your treatment plan. Here you’ll review your dosage and routine, and discuss your experience. This is so the doctor can make changes to dosing, titration schedules, or product strength according to your individual response to the therapy.

As every patient is different, finding the right dosage and treatment plan is a process of trial and adjustment. Within our industry the common mantra regarding dosage is: “start low, go slow.” As a general rule, doctors will prescribe a lower dosage to begin your plan, so that your body can adjust to unapproved therapeutic goods. Increasing your dose too quickly may result in unwanted side effects or tolerance without improving efficacy. It’s important to communicate with your doctor about your experience throughout your treatment.

The Therapeutic Goods Administration has outlined specific criteria for prescribing unapproved therapeutic goods over conventional medications.

If you are a patient exhibiting some, or all of the following, you may be eligible for a unapproved therapeutic goods prescription.

  • A medical condition diagnosed by a practicing doctor.
  • Having previously sought traditional treatment methods with unbearable/adverse side effects and/or no efficacy in treating the prescribed condition.

If applying through the Special Access Scheme, the TGA will require clinical justification from your prescribing doctor. This will include your individual condition and circumstances, supported by sufficient evidence to support the use of unapproved therapeutic goods over conventional treatments.

An unapproved therapeutic goods prescription and plan may be suitable for your situation if your medical condition;

  • Has lasted for three months or longer;
  • Has not responded to conventional medical treatments or treatment has resulted in unbearable/adverse side effects; and

Pricing

General consultation costs can vary depending on the type of doctor or clinic you’re visiting.
As a general guide, preliminary consultations which determine your eligibility for unapproved therapeutic goods usually costing anywhere between $59-$200. If you are simply after a script renewal, you will likely be looking at a cost between $50-$100 AUD.

Note: Concessions are available through some clinics, where doctors may offer a discount off the initial consult price.

Unapproved therapeutic goods products are not listed on the Australian Register of Therapeutic Goods (ARTG) and are therefore not able to be subsidised via the Pharmaceutical Benefits Scheme (PBS).

Unapproved therapeutic goods products have varying price points due to numerous factors, including dosage form, total active ingredient content, ratio of active ingredients, where the product is grown and how it is manufactured. Doctors prescribe unapproved therapeutic goods products depending on their patients individual therapeutic needs.

As an example: one week’s worth of pain management therapy may total anywhere between $30-$90, which represents a monthly payment between $120-$360 AUD. A doctor may prescribe 6 months’ of treatment in order to explore the full potential of unapproved therapeutic goods.

Some private health insurance companies offer financial aid for unapproved therapeutic goods under their non-PBS pharmaceuticals cover. Contact your private health insurance company to find out if this is included in your cover.

If you are a Veteran, the Department of Veterans Affairs offer funding for unapproved therapeutic goods treatment on a case-by-case basis. This includes Gold or Orange Card holders, or White Card holders with an accepted condition, or non-liability healthcare. More information can be found here.

If you are experiencing financial difficulties, we suggest speaking to your doctor to determine a product that is both affordable and suitable for your condition.

(Disclaimer) Always consult with a healthcare professional about whether unapproved therapeutic goods are appropriate for your needs.

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