The Special Access Scheme (SAS) is a mechanism within the drug approval system that allows people with serious or terminal illnesses to use experimental or unlicensed treatments or drugs. The SAS allows people in particular circumstances to access drugs which are in an investigational stage (still undergoing clinical trials); which have been withdrawn from the Australian market; which are available overseas but are not marketed in Australia; or which have been through clinical trials and are still moving through the government regulatory process.
The SAS in its current form was developed out of recognition, in the early 1990s, that it was taking substantially longer for potentially lifesaving treatments (such as HIV antivirals) to become available in Australia than was the case overseas. In particular, people with HIV and their doctors argued that, for ethical reasons, seriously ill or terminally ill patients needed to have the right to access treatments which they or their doctor believed could extend their life, particularly when no other options were available.
Most HIV antivirals have been available through SAS before being approved by the Federal Government and listed on the a class=“glossary-term” href=”/glossary/term/121”>Pharmaceutical Benefits Scheme (PBS).
Who pays for drugs on the SAS?
SAS drugs are provided free of charge by agreement with the company who makes them. A patient can’t be asked to pay the company for the drug because it is not yet licensed for sale in Australia.
How are SAS agreements negotiated?
In recent years, NAPWA has worked closely with pharmaceutical companies and prescribing doctors to enable early access to promising new drugs through the SAS. These negotiations take into account the available clinical research, the importance of the drug to improving HIV treatments, the capacity for the company to provide adequate stocks and any particular groups of patients who might need priority access.
How can I get an SAS drug?
If you have HIV or another serious illness and your doctor requests the treatment, you may be eligible to access a drug through the SAS. The regulatory agency responsible for approval of medicines and medical devices in Australia, the Therapeutic Goods Administration (TGA), must be notified by your doctor, but they do not always have to approve access for extremely ill patients: the responsibility rests with your prescribing doctor.
In HIV treatment, there are usually two ways of accessing an unapproved drug through SAS:
1. Usually, drug companies making new HIV antivirals will develop a special a class=“glossary-term” href=”/glossary/term/511”>protocol (a set of agreed criteria and procedures) to supply the drug to patients meeting specific clinical criteria, under a general SAS program for HIV. The intent is usually to make the drug available to people who are unable to construct an effective treatment regimen using currently licensed HIV treatments, perhaps because they have developed resistance to licensed treatments or can’t take them for other reasons. The drug company may specify other criteria which must be fulfilled (e.g. patients may have to have a particular T-cell range, viral load, or resistance profile). Since some drugs may have particular risks or benefits, there may also be tests to make sure that it would be generally safe for you to take that drug. HIV/AIDS community organisations, doctors and patient advocates are continually working with the pharmaceutical industry to ensure SAS mechanisms are in place promptly when new drugs are coming through the pipeline, and to ensure treatment is made available on an equitable but clinically appropriate basis.
2. Sometimes, you may need access to a particular medicine not available in Australia. This could include, for example, a treatment for an opportunistic infection, or to manage a side effect from your routine HIV treatment. In this case, your doctor may need to enter into a one-off or individual arrangement with the manufacturer to get access to that treatment.
Is the drug company legally obliged to provide a treatment or drug requested through SAS?
No, a company is free to reject an SAS application. However, in the past, manufacturers of HIV antivirals have accepted that it is morally appropriate to offer some access to new drugs for people at great risk of becoming ill from HIV or running out of treatment options, especially since it can take some time for drugs already approved overseas to gain approval and listing on the PBS in Australia.
Another issue to be weighed up is the potential benefit of the drug versus any risk associated with taking it. In general, SAS drugs are drugs which are either still experimental (the clinical research into the drug is not complete), or about which we have only a limited or short-term understanding of potential effects on people. As data about some of the side effects of long-term HIV treatment continues to emerge, this underscores the importance of understanding that there may be unknown risks associated with any drug, and cautions against accessing experimental drugs unless there is a real and urgent medical need.
How do you qualify for an SAS medication?
The TGA recognises two categories of patients for the purposes of accessing drugs through SAS.
Category A patients are defined clearly in the regulation as “persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.” Most HIV SAS programs work with this category.
This means that you don’t need to have special approval from the TGA to access the drug: your doctor is considered the authority for the prescription.
As in a clinical trial, the patient or the patient’s guardian needs to give a class=“glossary-term” href=”/glossary/term/496”>informed consent — they must understand the potential risks as well as benefits of any treatment. After informed consent has been given, the doctor needs to fill out an authority to supply the drug.
There is an additional category of access to unapproved treatments, Category B. This is more complicated, and requires that the TGA directly approve access to that drug. Category B applications require a justification be provided as to why you are seeking to access the drug, which your doctor will need to supply. There is likely to be a careful weighing up of any evidence for or against use of the drug.
Are there categories of drugs which you can’t get under the SAS?
Yes. A request to supply any medicine is dependent on the fact that the importation complies with any Customs controls and legislation around importation. Medicines subject to customs control can’t be supplied without an import permit or permission. This list obviously includes controlled drugs like amphetamines or narcotics, but also includes other categories of drugs like anabolic steroids, growth hormones, and certain antibiotics.
Injections (apart from insulin) which contain materials of human or animal origin can’t be brought in through personal importation. A full list of controlled drugs and information about these categories is available through the TGA website.
How long can you get the drug for?
Most HIV antiviral treatment is ongoing. So HIV advocates and activists have insisted that agreeing to supply a drug to HIV-positive people through SAS means that the company is ethically obliged to continue to supply the drug until it is approved for marketing and listed on the PBS. Sometimes, this may be a short process (perhaps 12 months); in other cases, a drug may take two years or more to gain approval and PBS listing.
The informed consent form should indicate that the company agrees to supply this treatment until such a time as it is available and accessible on the PBS.
Are there other ways of accessing new drugs?
New treatments may also be available in Australia through clinical trials. Clinical trials may offer certain additional benefits in terms of monitoring, availability of support, and the sense of having contributed to the research process, but trials are not for everyone. You may not wish to make the commitment, particularly to a long-term trial, or one which requires frequent monitoring or hospital or doctor visits. You should weigh up all these issues carefully with your doctor.
