Highly Specialised Drugs Program
Highly specialised drugs (HSDs) are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, are restricted to supply through public or private hospitals having access to appropriate specialist facilities. HSDs are subsidised through the Pharmaceutical Benefits Scheme (PBS) under Section 100 (s100) of the National Health Act 1953. Commonwealth funding of HSDs for public hospital patients is conditional upon prescriber and patient eligibility criteria.
Drugs included in the program:
- PBS HSD program and authority criteria
- Complex Authority Required (CAR) HSD program and authority criteria
- Community Access Arrangements
Community Access Arrangements
Changes to some s100 programs, including the introduction of community access arrangements for Highly Specialised Drugs, have been recommended by the Pharmaceutical Benefits Advisory Committee. Frequently Asked Questions (FAQs) have been prepared that outline changes to certain Section 100 programs under the PBS.
- Changes to certain s100 programs including clozapine for maintenance therapy, HIV antiretroviral therapy (ART) and hepatitis B medicines.
Patient & prescriber eligibility
See Department of Human Services for more information on patient and prescriber eligibility.
Eligible patients (PDF 51KB) are those receiving medical treatment by a medical practitioner at, or from, an approved public hospital as a:
- non-admitted patient
- day admitted patient
- patient on discharge
Inpatients are not funded under this program – refer to your hospital pharmacy department for further information.
Patients must be under appropriate specialist medical care and be eligible for a Medicare card as:
- an Australian resident
- a person covered under the Reciprocal Health Care Agreement
- an eligible overseas representative
It is a condition of funding that public hospitals, and registered community pharmacies, acting as agents of a public hospital, confirm patient eligibility by sighting and recording valid Medicare card details.
To prescribe these HSD medicines under the PBS a medical practitioner must be:
- a specialist medical practitioner who is affiliated with the hospital the patient is receiving treatment from, and is either
- a staff hospital specialist or
- a visiting or consulting specialist of the hospital
- an accredited prescriber of medication for the treatment of hepatitis C who is approved by a state or territory to prescribe medication for the treatment of hepatitis C under this Special Arrangement for maintenance therapy only.
- an accredited prescriber of medication for the treatment of HIV or AIDS who is approved by a state or territory to prescribe medication for the treatment of HIV or AIDS under this Special Arrangement, and
- a medical practitioner approved by the federal and state or territory government to prescribe maintenance therapy when it is impractical to get a prescription from the treating affiliated specialist medical practitioner. The treating staff hospital specialist must also agree to the prescription.
Prescribing, dispensing & claiming requirements
HSDs are subsidised under the PBS for the stated approved indication. The prescriber verifies this by recording the Authority code on the prescription.
HSDs prescribed for eligible public hospital patients are STREAMLINED authority prescriptions except for Complex Authority Required (CAR) HSD medicines and where increased quantities or repeats are required.
Where the prescriber wishes to prescribe a HSD above the determined maximum quantity/repeats, or if they wish to prescribe a CAR HSD, they must apply to the Department of Human Services (Medicare) for approval. Approval for increased quantities or repeats may be obtained by telephoning 1800 888 333 or posting the authority prescription form to Medicare. Approval for CAR HSDs must be applied for in writing. The prescriber will be required to quote the Hospital Provider Number when applying.
PBS HSD prescribed in public hospitals can only be claimed by an approved public hospital using PBS Online. Community pharmacies cannot claim public hospital HSD.
HIV ART and hepatitis B medicines
For valid PBS prescriptions written on and from 1 July 2015, all approved pharmacies will be able to dispense HIV ART and hepatitis B medicines provided through the HSD program regardless of whether the medicine is prescribed in a hospital or community setting.
Clozapine for maintenance therapy
Community pharmacies are able to dispense clozapine for maintenance therapy regardless of where the medicine was prescribed.
CAR HSDs prescribed in public hospitals can be dispensed and claimed by either the public hospital pharmacy or a community pharmacy
All HSDs prescribed in private hospitals must be dispensed and claimed by a private hospital pharmacy or by a community pharmacy
From 1 July 2015, public hospital pharmacies may dispense and claim prescriptions for HIV ART, clozapine and hepatitis B medicines that have been written in the community setting.