Treatment access
What it takes for a treatment to reach you in Australia, in plain English. What being listed on the PBS means, how a doctor can arrange a treatment that is not approved for general supply, and what a medicine shortage report does and does not tell you. Not medical advice.
A treatment being approved somewhere, or even approved in Australia, is not the same as you being able to get it affordably here. Several separate decisions sit in between, made by different bodies under different rules. This page lays them out.
It is a general explainer, written in our own words. It is not a lookup tool, and it cannot tell you whether any particular treatment is available or subsidised for your situation. That is a question for your doctor and your pharmacist.
Being approved and being affordable are two different decisions
The first decision is whether a treatment may be supplied in Australia at all. The Therapeutic Goods Administration assesses quality, safety and how well it works, and decides whether it may be supplied here and for which uses. That decision says nothing about price.
The second decision is whether the government will pay most of the cost. That is the Pharmaceutical Benefits Scheme, and it is assessed separately, on separate grounds, including whether the health benefit justifies the cost to taxpayers. A treatment can be perfectly legal to buy in Australia and still cost a great deal, because it is not subsidised.
A listing can also be restricted, which means the subsidy applies only where specific clinical criteria are met. This is the part that surprises people most often: a treatment can be on the PBS and still not be subsidised for you, because your circumstances sit outside the terms the listing was granted under.
Voxsanity publishes no PBS data. We do not show subsidy status, prices, restriction wording or listing dates for any medicine, and nothing on this site can tell you what you will pay. pbs.gov.au is the authoritative source, and your pharmacist can tell you on the spot. Our own plain English explainer of how the scheme works is the PBS in plain English.
Treatments that are not approved for general supply
Sometimes the treatment a doctor wants is not approved for general supply in Australia. There are arrangements for that, and all of them are actioned by a registered health practitioner, never by the patient.
The Special Access Scheme, usually called the SAS, has three pathways. Which one applies depends on how urgent the situation is and whether the treatment is already on a published government list.
Category A
For people who are seriously ill. A doctor can arrange the treatment straight away and tells the TGA afterwards. It is meant for urgent situations where waiting for approval would put the person at serious risk. Only a medical practitioner can use this pathway.
Category B
An application. The practitioner sends a request to the TGA and waits for a decision before the treatment can be supplied. It is used when the situation does not fit Category A and the treatment is not on the Category C list. The TGA looks at each request on its own facts.
Category C
Built around a published list of treatments with a well understood history of use for certain purposes. Where a treatment and its use are on that list, an approved type of health practitioner can supply it and then notify the TGA, without waiting for approval first. It covers only the exact treatments and uses named on the list.
Authorised Prescriber
Separate from the three SAS pathways, the TGA can authorise a specific doctor to prescribe a specific unapproved medicine to patients in their care with a particular condition. This is called being an Authorised Prescriber. Once it is granted, that doctor can prescribe the medicine to eligible patients without a separate application each time. Whether this arrangement applies is a decision for the doctor and the TGA.
A patient cannot apply for SAS access themselves. It has to be done by a health practitioner registered with AHPRA. For Category A, and to become an Authorised Prescriber, that practitioner must be a medical practitioner. For Categories B and C the TGA also allows certain other registered health practitioners to be the named prescriber, within their own scope of practice and subject to conditions it sets for each category. The TGA publishes a searchable table of exactly who is eligible for which pathway: see its Special Access Scheme guidance for health practitioners. Always speak to your own doctor about your own situation. For a fuller walk through, see our Special Access Scheme explainer.
Compassionate access, which is a different thing again
Compassionate access is not part of the Special Access Scheme. The pathways above are TGA arrangements; compassionate access is something a manufacturer offers, and the TGA does not run it.
Some manufacturers run compassionate access or early access programs that provide a medicine at reduced or no cost to patients who meet criteria the manufacturer sets, sometimes before or around the time of approval. These programs are run by the manufacturer rather than the government, and a doctor arranges them. What is available changes over time, so this is a question for your doctor.
What a medicine shortage report means, and what it does not
A shortage report means the Therapeutic Goods Administration has been told that the supply of a medicine is, or will be, lower than the expected demand for a period.
It does not mean the medicine is gone, and it does not always affect everyone. Shortages often affect some brands or strengths and not others. If a medicine you take is in short supply, speak to your pharmacist, who can advise on availability and alternatives. Do not change how you take a medicine without speaking to your doctor or pharmacist.
Two limits are worth knowing. These reports are national and describe registered products, so they cannot tell you what your own pharmacy has in stock. And a local supply problem that was never reported to the TGA does not appear at all, so the absence of a shortage notice is not evidence that a medicine is available.
You can read the reports the TGA is currently publishing on our medicine shortages pages, or check one medicine directly in the TGA's own Medicine Shortage Reports Database. Our plain English explainer of what one of these reports contains is what a shortage report means.
Questions you could ask your doctor
If treatment access is on your mind, these are questions you could raise at an appointment. They are suggestions to help start a conversation, not instructions, and the answers depend on your own situation.
- Is there a treatment for my condition that is subsidised, and would it suit my situation?
- If a treatment is not subsidised, is there a Special Access Scheme or Authorised Prescriber pathway that could be relevant?
- If something I take is in short supply, is there a suitable alternative brand or strength?
- What would a private prescription involve, and roughly what would it cost?
- Are there any clinical trials recruiting in Australia that might be worth me looking into?
Where to go next
Not medical advice. Information on this site does not constitute medical advice. This page is a general explainer written in our own words, and it displays no data about any medicine. Always consult your doctor or pharmacist before making any decision about your health, and confirm current subsidy, availability and cost with your pharmacist or at pbs.gov.au.