The PBS subsidises eltrombopag and romiplostim for patients with severe chronic immune idiopathic thrombocytopenic purpura.
For patients with severe chronic immune idiopathic thrombocytopenic purpura, treatment with etrombopag (Revolade®) or romiplostim (Nplate®) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953.
Section 100 arrangements
These items are only available to a patient who is attending either:
- an approved private hospital
- a public participating hospital or
- a public hospital
- day admitted patient
- non-admitted patient or
- patient on discharge
These items aren't available as PBS medicines for in-patients of the hospital. The hospital provider number must be included on the application form.
Patients must meet one of 3 restrictions. These restrictions are:
- initial treatment
- continuing treatment—first period of continuing treatment, or re-initiation of interrupted treatment, or
- continuing treatment— second and subsequent applications for continuing treatment
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing etrombopag or romiplostim.
Schedule item details
Dose - Eltrombopag is available as 25 mg or 50 mg tablets in a pack of 28 tablets.
The recommended starting dose is 50 mg once a day. After starting eltrombopag, adjust the dose to achieve and maintain a platelet count greater than or equal to 50,000 as necessary to reduce the risk for bleeding. Do not exceed 75 mg per day.
Dose - Romiplostim is available in single use vials of:
- 250 micrograms or
- 500 micrograms
For the initial romiplostim application, prescribers must ask for the appropriate quantity of vials of appropriate strength to provide sufficient medicine for a single treatment at a dose of 1 microgram per kg. 1 repeat may be requested with the initial written application.
During the initial period of dose titration, authority applications for a single dose and 1 repeat can be made by contacting us on the Complex Drugs enquiry line. The dose (micrograms per kg per week) must be provided at the time of application.
Once a patient's dose has been stable for 4 weeks, authority approval can be given for enough vials of appropriate strength for up to 4 weeks of treatment and up to 4 repeats, based on the patient's weight and dose (micrograms per kg per week). Authority approval is given on the condition that the total period of treatment is no longer than 24 weeks.
Authority approval will not be given for doses of higher than 10 micrograms per kg per week.
Information relevant to all patients
Patients can trial eltrombopag and/or romiplostim in the initial 24 weeks treatment period. Patients who don't demonstrate a response to treatment with eltrombopag and/or romiplostim under the initial restriction won't be eligible for further PBS subsidised treatment with either medicine.
Patients who meet the criteria for the first period of continuing treatment, or for re-initiation of interrupted treatment must be made in writing. Send all written applications to the Complex drugs address on the contact us page.
Subsequent applications can be made by contacting us on the Complex Drugs enquiry line.
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.
Reciprocal Health Care Agreement
Where an eligible patient is a visitor from a country Australia has a Reciprocal Health Care Agreement with, the supply of eltrombopag and romiplostim will be limited to the original prescription only. Repeat prescriptions for eltrombopag and romiplostim are not permitted.
Lodging an application
All applications must be submitted in writing. Send all written applications to the Complex drugs address on the contact us page.
- lodge Idiopathic thrombocytopenic purpura Initial PBS authority application and Supporting information form for an adult patient starting initial PBS subsidised treatment of idiopathic thrombocytopenic purpura. The patient and prescriber acknowledgements must be completed
- lodge Idiopathic thrombocytopenic purpura Continuing PBS authority application Supporting information form for an adult patient's 1st continuing application or for re-initation of interrupted treatment of idiopathic thrombocytopenic purpura
For more information contact us on the Complex Drugs enquiry line.