Idiopathic thrombocytopenic purpura
Through the Pharmaceutical Benefits Scheme (PBS), under Section 100 arrangements of the National Health Act 1953, authority to prescribe etrombopag (Revolade®) or romiplostim (Nplate®) is required for the treatment of severe chronic immune idiopathic thrombocytopenic purpura.
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
and is either a
- day admitted patient
- non-admitted patient or
- patient on discharge.
These items are not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form.
Restriction details
There are three restrictions, one of which a patient must satisfy before approval will be granted to prescribe romiplostim. These restrictions are:
- initial treatment
- continuing treatment— first period of continuing treatment, or re-initiation of interrupted treatment
- 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 size of 28 tablets.
The recommended starting dose is 50 mg once daily. After initiating eltrombopag, adjust the dose to achieve and maintain a platelet count ≥ 50,000 as necessary to reduce the risk for bleeding. Do not exceed 75 mg per daily.
Romiplostim is available as single use vials of:
- 250mcg, or
- 500mcg
At the time of the initial romiplostim application, prescribers must request the appropriate quantity of vials of appropriate strength to provide sufficient medicine for a single treatment at a dose of 1mcg/kg. Up to one repeat may be requested with the initial written application.
Subsequently during the initial period of dose titration, authority applications for a single dose and up to one repeat may be made by calling Medicare Australia on 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 a period of four weeks, authority approvals for sufficient vials of appropriate strength based on the patient’s weight and dose (mcg/kg/week) for up to four weeks of treatment and up to four repeats may be granted. Authority approval is provided on the condition that the total period of treatment authorised under this restriction 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 will be able to trial either eltrombopag and/or romiplostim within the initial 24 weeks treatment period. Patients who fail to demonstrate a response to treatment with either eltrombopag and/or romiplostim under the initial restirction will not be eligible to receive further PBS subsidised treatment with either of these drugs.
Continuing treatment
First continuing treatment application:
- Applications for 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 may be made by calling Medicare Australia 1800 700 270* (option 4) available Monday and Friday 8.00am to 5pm EST.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for subsidised medicines.
Reciprocal Health Care Agreement
Where an eligible patient is a visitor from a country Australia has entered into 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:
Medicare Australia
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
Lodge this form for an adult patient starting initial PBS subsidised treatment of idiopathic thrombocytopenic purpura. The patient and prescriber acknowledgements must be completed.
Lodge 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: 31 October, 2011