Prescribing, dispensing and claiming Highly Specialised Drugs

Highly Specialised Drugs (HSDs) are subsidised through the Pharmaceutical Benefit Scheme (PBS).

They’re administered under section 100 of the National Health Act 1953.

The HSD program provides access to specialised PBS medicines for the treatment of chronic conditions. These drugs have special arrangements on how they can be prescribed and supplied. This is due to their clinical use and special features.

The National Health (Highly specialised drugs program) Special Arrangement 2010 provides the legislative framework for the HSD program.

Prescribing requirements

In most cases, medical practitioners need to complete specific training to prescribe HSDs. For more information on HSD prescriber requirements go to, Prescriber eligibility for highly specialised drugs on the Services Australia website.

An eligible medical practitioner in a public or private hospital may prescribe HSDs.

There’s also provision for medical practitioners prescribing maintenance therapy for patients in some special circumstances.

Examples include:

  • when it’s impractical to get a prescription from the treating affiliated specialist medical practitioner and the specialist has agreed to the prescription
  • when the Commonwealth and the state or territory government has agreed they may prescribe medication for maintenance therapy.

Medical practitioners must seek approval to prescribe authority required items as a pharmaceutical benefit. They must be approved before they prescribe maintenance therapy under the PBS.

Approval of authority prescriptions can be obtained by:

  • calling the Services Australia authority free-call service on 1800 888 333
  • posting an authority prescription form to Services Australia
  • uploading the relevant authority prescription form and any supporting documents through HPOS.

Note: Requests for approval of HSD authority prescriptions are not widely available in the Online PBS Authorities system in HPOS at this stage. This is due to the information we collect for HSDs.

Patient requirements

To gain access to HSD pharmaceutical benefits, a patient must be:

  • an Australian resident
  • a person covered by a Reciprocal Health Care Agreement (RHCA)
  • an eligible overseas representative.

A patient must be receiving appropriate specialist medical treatment. It can be by an approved prescriber or from a hospital.

The patient needs to be:

  • a non-admitted patient
  • a day admitted patient
  • a patient on discharge.

A PBS co-payment apply will apply for patients. Benefits are available for the listed clinical indications only. There’s no facility for individual patient approval for indications outside those listed. A Commonwealth subsidy isn’t available for hospital in-patients in most cases. There are some exceptions. Please see the drugs table in section 9A of the National Health (Highly specialised drugs program,) Special Arrangement 2010 to view these exceptions.

Where a patient is entitled to treatment under a RHCA, the supply will be limited to the original prescription. Repeat prescriptions for subsidised HSDs for these patients are not permitted.

Private hospitals

Prescribing in private hospitals

For HSDs prescribed through private hospitals, Services Australia administers the claiming and approval of authority prescriptions. Different levels of authority may be required for the same drug depending on the type of hospital. Prescribers must quote the provider number of the hospital when applying for Authority to prescribe.

Supplying in private hospitals

Private hospital prescriptions for HSDs can be dispensed by section 94 approved private hospital pharmacists or by section 90 approved pharmacists. No more than 2 months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats or one month and 11 repeats - up to 12 months’ supply, will be authorised. For Opioid Dependence Treatment medicines, you can authorise no more than 28 days’ supply with provision for up to 2 repeats.

Public hospitals

Prescribing in public hospitals

For HSDs prescribed through public hospitals, Services Australia administers the claiming and approval of authority prescriptions. Many HSDs prescribed through public hospitals are Authority required (Streamlined) items. The Schedule highlights which items require a written application for Authority.

Authority approvals are required for prescriptions where the dose or repeats are above the determined maximum quantity in the PBS Schedule.

Supplying in public hospitals

Public hospital prescriptions for HSDs can be dispensed by section 94 approved public hospital authorities (or section 90 approved pharmacists through agency arrangements). No more than 2 months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats or one month and 11 repeats - up to 12 month’s supply, will be authorised. For Opioid Dependence Treatment medicines, you can authorise no more than 28 days’ supply with provision for up to 2 repeats.

The dispensed price for the supply of HSDs by a hospital authority for a public hospital is either:

  • the sum of the approved ex‑manufacturer price
  • the proportional ex‑manufacturer price for each pack quantity.

Complex Authority Required (CAR) medicines

CAR medicines are listed in the National Health (Highly specialised drugs program) Special Arrangement 2010. Prescribers must quote the provider number of the hospital when applying. Maximum quantities and repeats for HSDs are listed in the Schedule.

Public hospital prescriptions for CAR medicines can be dispensed by approved section 94 public hospital authorities or by section 90 approved pharmacists.

Community access (including opioid dependence treatment medicines)

The HSD community access arrangements allow 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 also have greater choice about where they access their medicines. It can be 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 was prescribed.

No more than 2 months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats or one month and 11 repeats - up to 12 months’ supply, will be authorised. For opioid dependence treatment medicines, you can authorise no more than 28 days’ supply with provision for up to 2 repeats.

From 1 July 2023, opioid dependence treatment (ODT) medicines will become part of the Section 100 HSD Program (Community Access) arrangements. Services Australia will administer the claiming of these ODT prescriptions.

Read more about the Opioid Dependence Treatment Program including factsheets on the PBS website.

Supplier eligibility and restrictions

Certain pharmacies can dispense and claim HSDs. The following table lists eligibility criteria and restrictions:

HSD ItemDispense from a
s. 94 public hospital		Dispense from a
s. 94 private hospital		Dispense from a
s. 90 community pharmacy		Dispense from a
s. 92 dispensing doctor
HSD public - non‑CAR itemYesNoNoNo
HSD public - CAR itemYesNoYesNo
HSD private - non‑CAR itemNoYesYesNo
HSD Private - CAR itemNoYesYesNo
HSD - community access arrangement itemYesYesYesYes

Hospitals not approved under section 94 can apply for approval to prescribe and supply HSDs under the National Health (Highly specialised drugs program) Special Arrangements Instrument 2010.

Pharmacies must only dispense and claim HSDs appropriate for their pharmacy type. The patient’s eligibility determines the item code approved and the type of pharmacy that can dispense and claim the prescription. Pharmacies are not eligible for payment if the prescription is dispensed by the incorrect type of pharmacy. For example, a public or private hospital

Requirements for HSD public hospital items - excludes HSD CAR items

Listing in the ScheduleAuthority required (STREAMLINED)
Prescribing

Prescribe using either:

  • a PBS public hospital prescription
  • a PBS Authority prescription
  • an approved hospital medication chart if supplied within a public hospital.
A PBS Authority or public hospital prescription must be used when you prescribe a quantity or number of repeats greater than the maximum listed in the Schedule.
You don’t need to contact us if the prescription is for the listed quantity and repeats.

Authority approval is required from us if the prescription is for an increased quantity or increased repeats or both.

You can seek authority approval to prescribe an increased quantity and/or increased repeats for an Authority required (STREAMLINED) item online via Health Professional Online Services (HPOS).

To seek authority approval to prescribe an increased quantity and/or increased repeats for an Authority required (STREAMLINED) item, call the PBS Authority Approvals Telephone Line on 1800 888 333.

Write the authority approval number on the prescription using the format PUB M 1234RX.

SupplyingYou may dispense from a public hospital pharmacy only.

Requirements for HSD private hospital items - excludes HSD CAR items

Listing in the ScheduleAuthority required
Prescribing

Prescribe using:

  • a PBS authority prescription.

Authority approval is required from us.

You can seek authority approval to prescribe online via Health Professional Online Services (HPOS).

For approval to prescribe Authority required items, call the PBS Authority Approvals Telephone Line on 1800 888 333.

Write the authority approval number on the prescription using the format PTE M 1234 RX.

Supplying

You may dispense from:

  • a private hospital pharmacy
  • a community pharmacy.

Requirements for HSD community access arrangement items

Listing in the ScheduleAuthority required (STREAMLINED)
Prescribing

Prescribe using either:

  • a PBS public hospital prescription
  • a PBS authority prescription
  • an approved hospital medication chart if supply will occur within the public hospital.

A PBS Authority or public hospital prescription must be used when the quantity or number of repeats is greater than the maximum listed in the Schedule.

You don’t need to contact us if the prescription is for the listed quantity and repeats.

Authority approval is required from us if the prescription is for an increased quantity or increased repeats.

You can also seek authority approval to prescribe an increased quantity and/or increased repeats for an Authority required (STREAMLINED) item online via Health Professional Online Services (HPOS).

To seek Authority approval to prescribe an increased quantity and/or increased repeats for an Authority required (STREAMLINED) item, call the PBS Authority Approvals Telephone Line on 1800 888 333.

Write the authority approval number on the prescription using the format HSD M XXXXRX.

Supplying

Dispense from:

  • a public hospital pharmacy
  • a private hospital pharmacy
  • a community pharmacy
  • a dispensing doctor.

Requirements for HSD Complex Authority Required (CAR) items

Listing in the ScheduleAuthority required
Prescribing

For public hospital HSD CAR items you can prescribe using:

  • a PBS authority prescription
  • a PBS public hospital prescription.

For private hospital HSD CAR items you can prescribe using:

  • a PBS authority prescription.

Authority approval is required from us to prescribe HSD CAR items.

For approval to prescribe authority required (phone) items, call the PBS Authority Approvals Telephone Line on 1800 700 270 and select the IVR option applicable. More information on item details is available on the PBS website

For approval to prescribe authority required (written) items, submit a written application and prescription to:

Services Australia
Complex Drugs Programs
Reply Paid 9826
Hobart TAS 7001

The completed prescription and supporting documentation, including patient clinical details, must be included with the application.

Requirements for applications are outlined in the PBS Schedule.

For phone approval:

  • write the authority approval number on the prescription using the format CAR M 1234RX
  • write the approved item code on the prescription, as provided by our delegate.

For written application prescriptions, we’ll endorse by:

  • stamping it ‘Approved by PBS-DHS’, marking the quantity and number of repeats authorised
  • stamping it ‘Public hospital PBS item code’ or ‘private hospital PBS item code’
  • stamping it ‘Section 100 CAR approved’
  • including the appropriate approved item code from the PBS Schedule written in the ‘delegate approval’ section of the prescription.
Supplying

For public hospital HSD CAR items you can dispense from:

  • a community pharmacy
  • a public hospital pharmacy.

For private hospital HSD CAR items you can dispense from:

  • a community pharmacy
  • a private hospital pharmacy.

Prescription requirements

The following information must be included on all HSD private hospital prescriptions:

  1. Prescriber’s name, practice address and prescriber number.
  2. Authority prescription number - we require this number to grant an authority approval. This number is also used by the pharmacy as a reference when dispensing. The authority prescription number is generated by the prescribing software for computer generated prescriptions.
    Note: The exact location of this number on the prescription may vary.
  3. Patient’s name, address and card details.
  4. Authority required item name, form and strength.
  5. Dose and instructions for use.
  6. Quantity and number of repeats.
  7. Signature of the prescriber and the date the prescription was written.
  8. Authority approval number.
  9. An indication whether the prescription is to be supplied under the PBS or Repatriation Pharmaceutical Benefits Scheme (RPBS).

Prescribers need to quote the hospital provider number when applying for an authority approval online or over the phone. The hospital provider number must be written on the prescription for written applications. The hospital provider number isn’t required for HSD Community Access items.

HSD Private prescription

An example HSD PTE prescription with the doctor, patient, and perscription filled in

The following information must be included on all HSD public hospital prescriptions:

  1. Hospital name, address, phone number, hospital provider number and the prescriber number and provider number.
  2. Authority prescription number.
  3. Patient’s name, address and card details.
  4. Authority required item name, form and strength.
  5. Dose and instruction for use.
  6. Quantity and number of repeats.
  7. Prescriber’s name, signature and the date the prescription was written.
  8. Authority approval number.
  9. An indication whether the prescription is to be supplied under the PBS or RPBS.

HSD Public Prescription

Hospital prescriptions must include the hospital name and hospital provider number. Medication charts used in public hospitals must meet the same requirements as a hospital prescription.

The hospital name, address, phone number and provider number will be printed on every prescription on the top left corner or is generated by the prescribing software for computer generated prescriptions. Hospital computer generated prescriptions may vary depending on the state or territory government.

Additional information for pharmacists

You should determine if the HSD prescription can be dispensed by your type of pharmacy. The authority approval on the prescription will help you to identify which pharmacy type can dispense the prescription. For example, a PTE prefix approval means the prescription was written in a private hospital. PUB prefix approval means it was written in a public hospital.

Authority approval cannot be obtained retrospectively.

After you complete the required information in the Pharmacy Dispensing Software, you’ll need to respond to warning or rejection messages. A warning or rejection message will be displayed if your pharmacy type cannot supply the prescription. You can contact us if you need clarification.

If you receive an unapproved PBS/RPBS authority prescription, contact the prescriber to confirm the prescription’s status.

Claiming requirements

Public hospital pharmacies

Prescriptions must be filed in the corresponding claim for:

  • Authority required (streamlined) items
  • Authority required items, including increased quantities and or repeats of authority required (streamlined) items
  • HSD CAR items.

If the supply has been dispensed using an approved medication chart, pharmacists must certify all paperless claims when using PBS Online. This must be done for the length of the claim period.

Public hospital pharmacies who claim for HSDs must keep paperwork for a minimum of 2 years from the date of dispensing.

Private hospital pharmacies

Prescriptions must be filed in the corresponding claim for:

  • HSD Community Access Authority required (STREAMLINED) items
  • Authority required items, including increased quantities and or repeats of HSD Community Access Authority required (streamlined) items
  • HSD CAR items.

Private hospital pharmacies who make a claim for HSDs must keep paperwork for a minimum of 2 years from the date of dispensing.

Community pharmacies

Prescriptions should be kept for:

  • HSD Community Access Authority required (streamlined) items
  • Authority required items, including increased quantities and or repeats of HSD Community Access Authority required (streamlined) items
  • HSD CAR items.

Community pharmacies who claim for HSDs must keep paperwork for a minimum of 2 years from the date of dispensing.

Pricing

There are different mark ups for HSDs compared to other PBS items.

Payment to approved suppliers is based on the ex-manufacturer price and doesn’t allow for a wholesale mark-up.

The Department of Health and Aged Care recommends that approved suppliers order HSDs directly from manufacturers.

For more information about the remuneration rates for HSDs, go to the Section 100 - Highly Specialised Drugs Program on the Department of Health and Aged Care website.

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Page last updated: 21 November 2023.
QC 32081