Section 100 highly specialised drugs
What the PBS Section 100 HSD program covers, which medicines it includes, approved supply channels, the Home Medicines Service, and specialist prescriber requirements.
What is Section 100?
Section 100 of the National Health Act 1953 gives the Minister for Health the power to approve the supply of certain PBS medicines through channels other than community pharmacies. The Highly Specialised Drugs (HSD) program is the principal Section 100 arrangement in use.
HSD medicines are indicated for chronic, serious, and sometimes life-threatening conditions that require specialist prescribing, complex patient management, or ongoing monitoring. They are distinguished from general PBS items by their:
- High clinical complexity — often require specialist initiation and ongoing monitoring
- Narrow patient populations — rare or serious conditions with limited prevalence
- Specialist supply chain — hospital outpatient pharmacies or HSD-approved community pharmacies
- Often high cost per patient — though the government bears most of this through PBS subsidy
Key Section 100 HSD drug classes
| Drug class | Examples | Supply channel |
|---|---|---|
| HIV antiretrovirals | tenofovir, emtricitabine, dolutegravir, bictegravir (combination products) | Approved prescribers; specific HIV clinics or GPs with experience; home delivery via HSD |
| Immunosuppressants (transplant) | ciclosporin, tacrolimus, mycophenolate, azathioprine, sirolimus | Transplant centres; outpatient hospital pharmacy or approved community pharmacy with HSD |
| Growth hormone | somatropin (Genotropin, Norditropin, Saizen) | Paediatric endocrinologist; community pharmacy or HSD program |
| α1-antitrypsin | alpha1-proteinase inhibitor (Prolastin-C) | Respiratory physician; hospital outpatient pharmacy |
| Enzyme replacement therapy | imiglucerase (Gaucher disease), alglucosidase alfa (Pompe disease) | Specialist metabolic physician; specific approved sites |
Full list: PBS HSD drug list ↗. Individual items vary in prescriber requirements — check the Schedule for each item.
Supply channels
Public hospital outpatient pharmacy
The most common supply channel for inpatient-initiated HSD items. Public patients often receive medicines free of charge under state hospital funding. Requires an outpatient appointment or dispensing visit at the hospital pharmacy.
Approved community pharmacy
Certain community pharmacies are accredited to dispense HSD items. These pharmacies must meet specific storage, counselling, and monitoring requirements. PBS co-payments apply. Standard Safety Net recording (where applicable).
Home Medicines Service (HSD)
An HSD home delivery option enabling eligible patients to receive medicines delivered directly to home. Reduces the burden of regular hospital visits for chronic therapies (HIV, immunosuppressants, enzyme replacement). Ask your specialist team to enrol you.