Program Information

Maximum quantities and repeats for HSD are listed in the Schedule.

HSD prescribed through public hospitals, except Complex Authority Required Highly Specialised Drugs (CAR-HSD), are Authority required (STREAMLINED) PBS Prescriptions.

CAR-HSD require written authority applications.

Public hospital prescriptions for HSD can only be dispensed by public hospital pharmacies the exceptions being prescriptions for CAR-HSD which can be dispensed in community pharmacies.

Commonwealth subsidy is not available for hospital in-patients.

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Pharmaceutical Benefits Advisory Committee

Overview
The Pharmaceutical Benefits Advisory Committee is established under the National Health Act 1953 to make recommendations to the Federal Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits, and to advise the Minister about any other matters relating to the Pharmaceutical Benefits Scheme. The Committee is also required by the Act to consider the effectiveness and cost of a proposed benefit relative to other therapies.

Role of the Pharmaceutical Benefits Advisory Committee

The Committee considers the effectiveness, cost effectiveness and clinical place of a product relative to other products already listed in the Pharmaceutical Benefits Scheme (PBS) for the same or similar indications. Where there is no listed alternative, the Committee considers the benefits that the new product will provide for patients compared with the cost of achieving those benefits.

The PBAC considers submissions from interested parties, such as the Highly Specialised Drugs Working Party or the drug's manufacturer, for inclusion of a pharmaceutical under the special funding arrangements under section 100 of the National Health Act. When PBAC recommends a drug for inclusion in the Highly Specialised Drugs Program it also defines the clinical indications which the Commonwealth will subsidise. The PBAC is obliged to make recommendations about a product consistent with the uses of the drug that have been approved for marketing by the Therapeutic Goods Administration.
In recommending listings, the PBAC also advises the Pharmaceutical Benefits Pricing Authority about the cost effectiveness of new products in relation to those products already listed.

Principles

Patient Eligibility

• The patient must be entitled to hold a Medicare Card in accordance with the National Health Insurance Act 1953 or be an eligible overseas representative. Appendix 4 provides the extract on patient eligibility as set out in the Commonwealth/State Administrative Arrangements.
• Prescribing of the drug must be in accordance with the criteria recommended by the Pharmaceutical Benefits Advisory Committee which are set out in Appendix 2.

Prescriber Eligibility Guidelines

A person eligible to prescribe HSDs can be a staff hospital specialist, a visiting or consulting hospital specialist, or a hospital doctor or general practitioner who has gained accreditation through a recognised State program.
Hospital based doctors and general practitioners may prescribe HSDs in the following situations:

• Where they are accredited prescribers of HIV/AIDS and/or Hepatitis C medication;
• To provide maintenance therapy in situations where it is impractical to obtain a prescription from the treating specialist and with their agreement; or
• Where the State/Territory and Commonwealth agree on a specific arrangement.

A general practitioner or non-specialist hospital doctor can be accredited to prescribe HIV/AIDS and/or Hepatitis C medication following State or Territory approval.

Agreed Price Lists

The Pharmaceutical Benefits Pricing Authority is responsible for negotiating a national price list with the drug's supplier. The Commonwealth Department of Health and Ageing provides information on agreed price based on the Pharmaceutical Benefits Pricing Authority's negotiated position. This price list, referred to as the agreed price, is used as the basis for reimbursement and is set out at Appendix 3. This Appendix will be updated as required by hospital circular which will be dated with effective dates. Hospitals may purchase the drugs at a higher price, however, if a higher purchase price is paid, reimbursement will only be at the agreed price.

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PRIVATE HOSPITALS

As of 1 November 2000, the Commonwealth, via Medicare Australia, will administer Highly Specialised Drugs (HSDs) supplied through private hospitals.

Prescribers in private hospitals will need to obtain prior authority approval from Medicare Australia on PBS/RPBS prescription pads before these drugs can be dispensed. When telephoning for approval specify it is an HSD authority immediately. Not more than 2 months supply (one for Clozapine) and 5 repeats will be authorised.

Authority approval:

PBS - FREE CALL 1800 888 333
RPBS - FREE CALL 1800 552 580

Prescriptions for Highly Specialised Drugs originating from a private hospital can be dispensed by a community pharmacy or the prescribing private hospital’s pharmacy. Private hospital pharmacies should submit their claims for HSD directly to Medicare Australia, as with other PBS/RPBS scripts. Private hospitals seeking approval to participate in the HSD Program after 1 November 2000 should contact the Commonwealth Government Adviser on 02-6289 2331.

Further information is available from the Medicare Australia on 132 290 or in the Schedule of Pharmaceutical Benefits.

Funding and Reporting Arrangements

Hospital Obligations
To receive funding under the HSD Program the hospital must abide by the following conditions.

Patient Certification

Prescribing doctors must certify that the patient meets the Pharmaceutical Benefits Advisory Committee criteria by writing the streamlined Authority required four digit code on the prescription form if applicable.

Authority approvals are required for prescriptions where the prescription is above the determined maximum quantity and/or number of repeats.

Approval of authority prescriptions by Department of Human Services (Australia) may be obtained either by posting an Authority Prescription Form to Department of Human Services, or by using Department of Human Services' Authority Freecall service (1800 888 333). Prescribers must quote the provider number of the hospital when applying.

Co-payment

Where applicable, charge patients the appropriate fee according to their status; either general patient rate or concessional rate.
A patient is required to pay a contribution for each supply of a HSD item.

Payment

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