Clozapine Highly Specialised Drug Program
Clozapine is available under the PBS Highly Specialised Drugs Program for the treatment of schizophrenia in patients who are non-responsive to, or are intolerant of, other neuroleptic agents.
Initiation of treatment with clozapine
Consumers must be under the care of a psychiatrist for a minimum of 18 weeks and dispensing and claiming occurs at a public hospital pharmacy. Distribution for pick-up from a community pharmacy may be negotiated.
The approval process for prescribing clozapine for initial therapy is:
- Public hospital prescribers:
- STREAMLINED Authority code 5015
- Private hospital prescribers:
- Authority required – prescribers must phone or write to the Department of Human Services (Medicare) (1800 888 333) for authority to prescribe.
Maintenance therapy with clozapine – Community access
From 1 July 2015 the Department of Human Services (Australian Government) introduced changes to the way clozapine can be prescribed and dispensed for maintenance therapy.
Under the new arrangements clozapine may be prescribed by accredited general practitioners or other community prescribers and be dispensed in community pharmacies.
The following clinical criteria will apply for maintenance therapy:
- previous initial treatment under a psychiatrist for a period of no less than 18 weeks, AND
- the treating psychiatrist agrees the patient is suitable for community-based management and prescribing, AND
- the patient's clozapine dosage is considered stable by the treating psychiatrist, AND
- treatment is under the supervision and direction of the psychiatrist reviewing the patient at regular intervals.
Eligible community based prescribers (maintenance therapy only) can prescribe clozapine without the need to demonstrate an affiliation with a hospital. All other prescriber eligibility criteria remain the same, including registration with a clozapine centre.
The approval process to prescribe clozapine for maintenance therapy will be the same for all prescribers. The STREAMLINED Authority code for maintenance therapy is 4998. Prescribers will be required to contact Medicare (1800 888 333) for an authority for increased quantities or repeats.
Community pharmacist information
Registered community pharmacists are able to dispense clozapine for maintenance therapy regardless of where the medicine was prescribed. With respect to the safe supply of clozapine, they will be required to meet all relevant PBS, state and clozapine monitoring system requirements in order to participate.
Additional resources for clinicians are available on the SA Health clozapine page.
Therapeutic Goods Administration (TGA) requirements
The two pharmaceutical companies who supply clozapine are required by the TGA to maintain patient monitoring databases because of the risk of agranulocytosis associated with the use of clozapine.
Pharmacists must log into the relevant clozapine patient monitoring system and check the patient's blood results each time they dispense clozapine. If the blood results have not already been entered into the monitoring system by the clozapine coordinator, the pharmacist must enter the blood results prior to dispensing.
Patients accessing clozapine
Regardless of where the clozapine (maintenance therapy) is prescribed, consumers can access their clozapine from either a hospital or community pharmacy.
In alignment with other PBS medicines, consumers will be charged a co-payment for each prescription of clozapine. The co-payment will count towards their Safety Net entitlements.