Section 100 – Highly Specialised Drugs Program

Page last updated: 17 April 2024

• Highly Specialised Drugs Program - (Public Hospital)
• Highly Specialised Drugs Program - (Private Hospital)
• Highly Specialised Drugs Program - (Community Access)

The Highly Specialised Drugs (HSD) Program provides access to specialised Pharmaceutical Benefits Scheme (PBS) medicines for the treatment of chronic conditions which, because of their clinical use and other special features, have restrictions on where they can be prescribed and supplied. In most cases, medical practitioners are required to undertake specific training or be affiliated with a specialised hospital unit to prescribe these medicines.

The National Health (Highly Specialised Drugs Program) Special Arrangement 2021 provides the legislative framework for the HSD Program.

To gain access to HSDs, a patient must:

• be an Australian resident and eligible for a Medicare card
• attend a participating hospital and be a day admitted patient, a non-admitted patient or a patient on discharge
• be under appropriate specialist medical care and meet specific medical criteria. 

An eligible medical practitioner in a public or private hospital may prescribe HSDs. In addition, Clozapine for the treatment of schizophrenia (maintenance therapy only), HIV antiretroviral medicines, opioid dependence treatment, hepatitis B medicines, lanreotide and octreotide may be prescribed by authorised community based practitioners.

Not more than two months’ supply (one month’s supply in the case of clozapine and opioid dependence treatment medicines), with provision for up to 5 repeats or one month and 11 repeats – up to 12 months’ supply, will be authorised.

PBS patient co-payments apply.  Benefits are available for the listed clinical indications only and there is no facility for individual patient approval for indications outside those listed. Commonwealth subsidy is not available for hospital in-patients.

Where a patient is entitled to be treated as an eligible person as a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply will be limited to the original prescription only.  Repeat prescriptions for subsidised HSDs for these patients are not permitted.

Private Hospitals

For HSDs prescribed through private hospitals, claiming and approval of authority prescriptions is administered by Services Australia. Prescribers must quote the provider number of the hospital when applying where required. Maximum quantities and repeats for HSDs are listed in the PBS Schedule. 

Private hospital prescriptions for HSDs can be dispensed by s94 approved private hospital authorities or by s90 approved pharmacists.

The remuneration rates for HSDs through private hospitals comprise the normal PBS ready-prepared dispensing fee plus a mark-up ascertained as follows:

• 10% for drugs with an ex-manufacturer price of less than $40
• $4 for drugs with an ex-manufacturer price of between $40 and $100
• 4% for drugs with an ex-manufacturer price of between $100.01 and $1000
• $40 for drugs with an ex-manufacturer price of greater than $1000.

 

Public Hospitals

For HSDs prescribed through public hospitals, claiming and approval of authority prescriptions is administered by Services Australia. HSDs prescribed through public hospitals may require prior approval from Services Australia. Prior approval from Services Australia is required for all prescriptions where the dose is above the determined maximum quantity and/or number of repeats.

The dispensed price for the supply of HSDs by a hospital authority for a public hospital is the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity.

Complex Authority Required (CAR) medicines

CAR medicines require prior approval from Services Australia when initiating treatment. Subsequent treatment phases may have different authority requirements (telephone/electronic or Authority Required (STREAMLINED)) however the medicine remains CAR. Application for authorisation can be made by either:

• posting an Authority Prescription form and other application form(s), where applicable to Services Australia
• using the form upload facility in Health Professional Online Services (HPOS)
• using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS)
• using the Services Australia free-call service for PBS Complex Drugs Programs enquiries (1800 700 270) or
• using the appropriate Streamlined code.

Prescribers must quote the provider number of the hospital when applying. Maximum quantities and repeats for HSDs are listed in the PBS Schedule. 

Public hospital prescriptions for CAR medicines can be dispensed by approved s94 public hospital authorities or by s90 approved pharmacists.

Community Access

The HSD Community Access arrangements introduced 1 July 2015 better align existing HSD Program arrangements with current clinical practice. These arrangements allow authorised community based practitioners to prescribe clozapine for the treatment of schizophrenia (maintenance therapy only), HIV antiretroviral, opioid dependence treatment, hepatitis B medicines, lanreotide and octreotide without the need to be affiliated with a hospital. Patients also have greater choice about where they access their medicines, through either a community pharmacy, or a private or public hospital pharmacy. Community pharmacists are able to dispense these medicines regardless of where the medicine is prescribed.

The remuneration rates for HSDs dispensed through community pharmacies comprise the normal PBS ready-prepared dispensing fee plus a mark-up ascertained as follows:

• 10% for drugs with an ex-manufacturer price of less than $40
• $4 for drugs with an ex-manufacturer price of between $40 and $100
• 4% for drugs with an ex-manufacturer price of between $100.01 and $1000
• $40 for drugs with an ex-manufacturer price of greater than $1000.