Highly specialised drugs

Highly specialised drugs (HSDs) are subsidised through the Pharmaceutical Benefits Scheme (PBS) and administered under section 100 of the National Health Act 1953.

HSDs are for the treatment of complex medical conditions that require ongoing specialised medical supervision. The HSD Program is part of the PBS. Read more about prescribing, dispensing and claiming HSDs.

The process for prescribing and dispensing HIV antiretroviral therapy (ART), clozapine for maintenance therapy, and hepatitis B items has been simplified under HSD Community Access (CA) arrangements. Read more about changes to certain s100 programs.

About

Dispensing requirements

Dispensing requirements for PBS highly specialised drugs. Restrictions apply to certain pharmacies that can dispense and claim HSDs.

Under the National Health Act 1953, approved suppliers include:

  • community pharmacies approved under section 90
  • public and private hospitals approved under section 94, and
  • medical practitioners approved under section 92 (applicable to HSD CA items only)

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

HSD items are approved as either:

  • a HSD public hospital item (HSD PUB)
  • a HSD private hospital item (HSD PTE), or
  • a HSD community access item (HSD CA)

Complex Authority required (CAR) HSD items are also listed with separate public and private hospital item codes.

Pharmacies must only dispense and claim HSDs appropriate for their pharmacy type. The patient's eligibility determines the item code approved and then the type of pharmacy that can dispense and claim the prescription. We will not pay for prescriptions dispensed by the incorrect type of pharmacy.

HSD item Dispense from a Public hospital Dispense from a Private hospital Dispense from a Community pharmacy Dispense from a Medical practitioner

HSD PUB
(non-CAR item)

yes no no no

HSD PUB
(CAR item)

yes no yes no

HSD PTE
(non-CAR item)

no yes yes no

HSD PTE
(CAR item)

no yes yes no
HSD CA yes yes yes yes

Online claiming for HSDs

Information about online claiming for HSDs.

Public hospitals

Public hospitals wanting to claim HSDs require section 94 approval, or section 100 approval for non-dispensing public hospitals to supply and claim PBS HSDs.

The public hospital needs to apply to us to use online claiming for PBS HSDs.

Public hospitals participating in the Pharmaceutical Reform Arrangements that are already using online claiming for PBS can claim HSDs through their existing online claiming system.

Public hospitals that do not use online claiming for PBS HSDs need to change or upgrade their software to allow them to do so.

Private hospitals

Private hospitals must continue using existing online claiming channels for HSDs.

Related information

Offline claiming

Offline claiming that allowed state and territory health departments to submit HSD claims on behalf of a public hospital ended on 31 December 2012.

Community pharmacies and friendly societies

Community pharmacies and friendly societies may not have access to public hospital HSD item codes and be able to claim for these items. However, they can dispense and claim public hospital CAR HSD and PBS trastuzumab prescriptions.

Where a community pharmacy or a friendly society acts as an agent for a non-dispensing public hospital, the claim for the HSD must be lodged by the public hospital. The community pharmacy or friendly society will have private arrangements with the hospital for administration and remuneration. If a community pharmacy or friendly society attempts to claim public hospital HSDs item codes through online claiming for PBS, the claim will be rejected.

Applicable items

Applicable medicines for highly specialised drugs (HSD).

HSDs

An authority approval is required from us for most HSD private listings and increased quantities and repeats.

Complex Authority Required HSDs and PBS trastuzumab

Funded HSDs include Complex Authority Required Highly Specialised Drugs (CAR HSDs) and PBS trastuzumab for early-stage breast cancer.

CAR HSDs are Authority required medicines.

An approved prescriber does not need prior approval from us when prescribing an authority required (STREAMLINED) public hospital or HSD CA item. An approved prescriber must include the 4-digit streamlined authority code on the prescription.

Read more about the PBS, on the PBS website.

Patient contribution

Patient contribution to the HSD.

All eligible patients need to pay a contribution fee for each supply of PBS or Repatriation Pharmaceutical Benefits Scheme (RPBS) HSDs. The fee may be general, concessional or an entitlement.

Receipting HSD prescriptions

For receipting HSD prescriptions, the patient, or an agent of the patient, must sign and date the HSD prescription, when supplied, to certify they have received the medicine. Agents acting on behalf of the patient must sign, date and write their own address on the receipt. The approved pharmacist must certify the benefit was supplied where it is impractical to get a receipt or acknowledgement from the patient or their agent.

A certification must include:

  • the reason why a receipt could not be received from the patient or agent
  • the date of supply, and
  • the pharmacist’s name and signature

Other pharmacy staff must not act as an agent or certify supply in the ordinary course of pharmacy business.

PBS Safety Net for HSDs

All PBS HSDs dispensed under this initiative will count towards an eligible person's PBS Safety Net threshold.

Under the PBS Safety Net, patients receive additional PBS benefits when their annual
out-of-pocket cost for prescription items exceeds a specified threshold. The PBS Safety Net threshold can be reached using prescriptions filled at community pharmacies, friendly societies and public hospitals.

Audits of HSDs

Hospital pharmacies must have adequate and auditable systems in place, and the prescription and supply of highly specialised drugs is monitored and audited.

We require hospital pharmacies to have adequate and auditable systems in place to ensure:

  • supply is to eligible patients, and
  • prescribing is in accordance with PBS restriction criteria

The prescribing and supply of HSDs will be monitored, and patients’ records may be audited with the agreement of the hospital pharmacy.

Prescriptions and internal medication paperwork must be kept for a minimum of 2 years from the date of dispensing, for audit purposes.

Prescriber eligibility

To prescribe HSDs under the PBS, a prescriber must be:

  • affiliated with the hospital the patient is receiving treatment from and be 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 and act under a 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 a special arrangement
  • a medical practitioner prescribing maintenance therapy when it is impractical to get a prescription from the treating affiliated specialist medical practitioner and the specialist has agreed to the prescription, or
  • a medical practitioner whom the Commonwealth and the state or territory government has agreed may prescribe medication for maintenance therapy

Patient eligibility

Patient eligibility for highly specialised drugs.

An eligible patient:

  • is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973 (the Act), and
  • receiving appropriate specialist medical treatment by an approved prescriber, or from a hospital as:
    • a non-admitted patient
    • a day admitted patient, or
    • a patient on discharge

An eligible person is defined by the Act as one of the following:

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

An Australian resident is a person who resides permanently in Australia and is one of the following:

  • an Australian citizen
  • a person who holds a permanent visa
  • a New Zealand citizen, or
  • an applicant for permanent residence in certain circumstances - not a parent applicant who has a valid visa with permission to work or has a parent, spouse or child who is an Australian citizen or holds permanent resident status with an interim Medicare card

Eligible overseas representative means:

  • the head of a diplomatic mission or consular post, established in Australia, of those countries with which Australia has an Reciprocal Health Care Agreement except for New Zealand and Norway
  • staff of those diplomatic missions or consular posts, or
  • family members of heads or staff of those diplomatic missions or consular posts

Eligible overseas persons will have a Medicare card.

An eligible person who has enrolled in Medicare and has not yet received their card can use their Medicare card receipt with their Medicare number printed on it as evidence of eligibility.

Reciprocal Health Care Agreement

If 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 these patients are not permitted.

Read more about Reciprocal Health Care Agreements.

Community access

Community Access arrangements

Under the HSD CA arrangements, we have simplified the dispensing and prescribing requirements of certain HSDs.

Dispensing requirements

If you are an approved supplier and receive a valid PBS prescription for HSD CA items, you can supply and claim the prescription. This is regardless of whether the prescription was written in a hospital or community setting.

Approved suppliers are:

  • section 90 approved pharmacists
  • section 94 approved hospital authorities, or
  • section 92 approved medical practitioners

For section 94 hospitals, patients now have greater choice over accessing their items, through either a community pharmacy, or a private or public hospital pharmacy.

You must only supply an authority required (STREAMLINED) item when the approved prescriber has written the streamlined authority code on the PBS/RPBS prescription. You will need our approval if the authority prescription is for increased quantities, increased repeats, or both.

Prescribing requirements

You can prescribe under these arrangements if you are:

  • a hospital-based prescriber or general practitioner, and
  • an accredited prescriber of that medication

You do not have to be affiliated with a public or private hospital. The medications you can prescribe under the arrangements are:

  • HIV ART for initial and maintenance therapy
  • hepatitis B items for initial and maintenance therapy, and
  • clozapine for maintenance therapy only

Initial therapy with clozapine is under the HSD program and not part of HSD CA arrangements. Initial therapy must be started by an appropriate specialist who has an affiliation with a public or private hospital.

If you are writing prescriptions for the PBS listed quantity and repeats, you do not need to contact us for authority approval. You can use the authority required (STREAMLINED) number listed in the PBS Schedule as long as the use of the item meets the requirement of the listing.

If you are prescribing increased quantities, repeats or both, you need to get prior authority approval:

  • through the Online PBS Authorities system
  • by submitting a written application, or
  • by telephone

Same day prescribing is not allowed for these medications.

Patient requirements

Information about requirements for patients to be eligible under the HSD CA arrangements.

Patients must be under appropriate medical care from an approved prescriber to be eligible under the HSD CA arrangements.

Patients will be able to access medicines under the HSD CA program from the approved supplier of their choice. It does not matter whether these items are prescribed in a hospital or community setting.

Receipting HSD prescriptions

The patient, or an agent of the patient, must sign and date the HSD prescription after it has been supplied to certify they have received the item. Agents acting on behalf of the patient must sign, date and write their own address on the receipt. The approved supplier must certify the benefit was supplied where it is impractical to get a receipt or acknowledgement from the patient or their agent.

A certification must include:

  • the reason why a receipt could not be received from the patient or agent
  • the date of supply, and
  • the pharmacist’s name and signature

Other pharmacy staff must not act as an agent or certify supply in the ordinary course of pharmacy business.

PBS Safety Net for HSDs

All PBS HSDs dispensed under this initiative will count towards an eligible person's PBS Safety Net threshold.

Under the PBS Safety Net, patients receive additional PBS benefits when their annual out-of-pocket cost for prescription items exceeds a specified threshold. The PBS Safety Net threshold can be reached using prescriptions filled at community pharmacies and friendly societies at public hospitals.

HSD-approved hospitals must be registered as Safety Net hospitals. This includes non-participating public hospitals supplying HSDs.

Resources

Streamlined authority process

Approved prescribers need to follow certain procedures to claim items identified as authority required (STREAMLINED) by the Schedule of Pharmaceutical Benefits.

Read more about streamlined authority process

Education guide - Medical practitioners in private practice - writing PBS and RPBS prescriptions

Information about writing PBS and RPBS prescriptions for medical practitioners in private practice.

Read more about Medical practitioners in private practice - writing PBS and RPBS

Education guide - Dispensing checklist for participating public hospitals

Information to help you dispense and claim Pharmaceutical Benefits Scheme (PBS) medicines in participating public hospitals.

Read more about dispensing PBS medicines in participating public hospitals

Page last updated: 27 August 2017