Highly Specialised Drugs (HSD) Program 012-63040000

The Australian Government provides funding for certain specialised medications under the HSD Program.

The HSD Program provides Pharmaceutical Benefits Scheme (PBS) subsidised medicines for the treatment of complex medical conditions that require ongoing specialised medical supervision. These include (but are not limited to):

• human immunodeficiency virus (HIV)
• schizophrenia, and
• rheumatoid arthritis

Some of these subsidised medicines have restrictions on where they can be supplied because of their clinical use, or other special features.

HSD are medicines:

• recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS), and are for the treatment of a small identifiable patient target group needing ongoing specialised medical supervision. For example:
• human immunodeficiency virus (HIV)/ Acquired immune deficiency syndrome (AIDS), or
• the treatment of schizophrenia
• for the treatment of complex medical conditions which, because of their clinical use or other special features, are restricted to public, public participating and private hospitals with access to appropriate specialist facilities. An exception is items supplied under the HSD Community Access program. The Resources page contains a diagram showing the program
• administered and funded under Section 100 of the National Health Act 1953

Note: benefits are available for listed clinical indications only. Usual PBS patient co-payments apply.

Persons eligible for Commonwealth subsidy through this program must be:

• patients in the community or attending day services (that is, not hospital in-patient), and
• is, or is to be treated as an 'eligible person' satisfying the following criteria from the Health Insurance Act 1973

To be prescribed HSD as Pharmaceutical Benefits Scheme (PBS) items, a patient must receive appropriate specialist medical treatment by an approved prescriber or hospital as a:

• day admitted patient
• non-admitted patient, or
• patient on discharge

and

• be under appropriate specialist medical care
• meet specific medical criteria
• be an Australian resident in Australia (or another eligible person)

Note: an exception is items supplied under the HSD Community Access program. The Resources page contains a diagram showing the program.

HSDs are prescribed to a patient on discharge and are dispensed within the hospital setting to take home. These are not medicines administered in the hospital.

Inpatients should not have medicines funded by the PBS administered to them in the hospital. This is even when those medicines were administered on the same day that the patient was discharged.

To prescribe HSD as Pharmaceutical Benefits Scheme (PBS) items, prescribers are required to be affiliated with specialist hospital units. A general practitioner (GP) or non-specialist hospital doctor can only prescribe HSDs to provide maintenance therapy under the guidance of a treating specialist.

A person eligible to prescribe HSD will be either:

• a staff hospital specialist
• a visiting or consulting hospital specialist
• an accredited prescriber of human immunodeficiency virus (HIV)/ Acquired immune deficiency syndrome (AIDS)
• an accredited prescriber of Hepatitis maintenance medication
• an accredited prescriber of Clozapine
• a hospital doctor or GP to provide maintenance therapy
• an authorised nurse practitioner (for opioid dependence treatment medicines and HIV/AIDS, hepatitis B only)

Acceptable situations

For the purposes of maintenance therapy, hospital based doctors and medical practitioners can prescribe HSD:

• where it is impractical for a patient to get a prescription from their treating specialist
• with the agreement of the patient

Prescribing outside hospital location

The HSD Program was developed for out-patient clinics, however private hospitals do not usually have out-patient clinics. It is therefore acceptable for the specialist to be located away from the private hospital but, they must have admitting rights to the hospital.

An approved hospital must provide the hospital provider number to the specialist doctor who is prescribing HSD. The specialist doctor then provides the hospital provider number to Services Australia to gain approval for the HSD, ensuring compliance with the program requirements.

This link to the hospital is essential, as supply of HSDs are restricted to public and private hospitals with access to appropriate specialist facilities.

Note: an exception is items supplied under the HSD Community Access program. The Resources page contains a diagram showing the program.

The HSD community access program allows authorised community based practitioners, without the need to be affiliated with a hospital, to prescribe:

• antiretroviral HIV and hepatitis B medicines
• clozapine for the treatment of schizophrenia (maintenance therapy only)
• opioid dependence treatment medicines.

Patients can access these HSD medicines from the pharmacy of their choice, regardless of where these medicines are prescribed.

The approval process to prescribe these medicines is the same for all prescribers, with Streamlined Authority requirements applying for community, private and public hospital based prescribers. Authority approval is still required for increased quantities and/or increased repeats.

The Resources page contains a diagram showing the program.

Transitional arrangements for opioid dependence treatment (ODT) medicine prescriptions

A transition period for prescriptions written before 1 July 2023 can be used to support PBS supplies after 1 July 2023. For the purposes of submitting claims for payment to Services Australia, prescriptions written before 1 July 2023 will be treated as if written on 1 July 2023.

The Resources page contains a for link to Opioid Dependence Treatment Program on the PBS website.