Idiopathic thrombocytopenic purpura
Etrombopag (Revolade®) or romiplostim (Nplate®) for the treatment of severe chronic immune idiopathic thrombocytopenic purpura can be supplied through the Pharmaceutical Benefits Scheme (PBS) as authorised under Section 100 arrangements 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
as a
- 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.
Restriction details
Patients must meet one of three 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.
View a full transcript of the Schedule of Pharmaceutical Benefits (the Schedule) restriction details.
Item details
Eltrombopag is available as 25mg or 50mg tablets in a pack of 28 tablets.
The recommended starting dose is 50 mg once daily. After starting eltrombopag, adjust the dose to achieve and maintain a platelet count ≥ 50,000 as necessary to reduce the risk for bleeding. Don’t exceed 75 mg per day.
Romiplostim is available in single use vials of:
- 250 mcg, or
- 500 mcg.
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 1mcg/kg. One repeat may be requested with the initial written application.
During the initial period of dose titration, authority applications for a single dose and one repeat can be made by calling 1800 700 270* option 4 Monday to Friday 8.00am to 5.00pm EST. The dose (mcg/kg/week) must be provided at the time of application.
Once a patient’s dose has been stable for four weeks, authority approval can be given for enough vials of appropriate strength, for up to four weeks of treatment and up to four repeats, based on the patient’s weight and dose (mcg/kg/week). Authority approval is given on the condition the total period of treatment is no longer than 24 weeks.
Note: authority approval will not be given for doses of higher than 10mcg/kg/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.
Continuing treatment
First continuing treatment application:
- patients who meet the criteria for the first period of continuing treatment, or for re-initiation of interrupted treatment must be made in writing.
Subsequent applications can be made by calling 1800 700 270* option 4 Monday to Friday 8.00am to 5.00pm EST.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for PBS medicines.
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.
Lodgement
All applications must be submitted in writing. Send all written applications to:
Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
For more information call 1800 700 270* (option 4) Monday and Friday 8.00am to 5.00pm EST.
Application forms
Use this form for an adult patient starting initial PBS subsidised treatment of idiopathic thrombocytopenic purpura. The patient and prescriber acknowledgements must be completed.
Use this form for an adult patient’s first continuing application or for re-initation of interrupted treatment of idiopathic thrombocytopenic purpura
* Call charges apply from mobile and pay phones only.
Important: the information on this website is correct at the time of publishing and is subject to change.
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Last updated: 29 June, 2012