Idiopathic thrombocytopenic purpura

The PBS subsidises eltrombopag and romiplostim for patients with severe chronic immune idiopathic thrombocytopenic purpura (ITP).

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with eltrombopag and romiplostim under the National Health Act 1953, section 100 for patients aged 18 years or older with ITP.

Patients must be eligible for the PBS and meet the relevant restriction criteria.

The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing eltrombopag and romiplostim.

Section 100 arrangements

Eltrombopag and romiplostim

These items are only PBS subsidised for day admitted patients, non-admitted patients, or patients on discharge who are attending either:

  • an approved private hospital
  • a public participating hospital
  • a public hospital.

These items aren't PBS subsidised for hospital in-patients. You must include the hospital name and provider number on the authority application form.

Treatment specifics

Patients can trial either eltrombopag or romiplostim within the initial 24 week treatment period. A patient is only allowed a single 24 week treatment period. They may not start this period again after a treatment break.

A patient may be authorised under the balance of supply or change of therapy restriction to complete up to 24 weeks of the initial treatment if they:

  • started initial treatment with one of the two agents
  • are required to change to the other agent.

No further changes to an alternative agent will be authorised after the initial 24 week treatment period. A patient who has demonstrated a response to both agents within the initial treatment period will only be eligible for PBS subsidy on the most recent one. Patients who fail to demonstrate a response to treatment with eltrombopag or romiplostim after completing 24 weeks initial therapy won’t be eligible for further PBS subsidised treatment with either drug.

Authority applications

Applying for initial treatment

Apply for initial authority approval to prescribe PBS subsidised eltrombopag or romiplostim to treat ITP in writing and either:

All written applications must include the completed:

Applying for balance of supply or change of therapy

Apply for balance of supply or change of therapy authority approval to prescribe PBS subsidised eltrombopag or romiplostim to treat ITP within the initial 24 weeks. This application can be made either:

Applying for first continuing or re-initiation of interrupted continuing treatment

Apply for first continuing or re-initiation of interrupted continuing treatment authority approval to prescribe PBS subsidised eltrombopag or romiplostim to treat ITP in writing and either:

All written applications must include the completed:

Applying for subsequent continuing treatment

Applications for subsequent continuing authority approval to prescribe PBS subsidised eltrombopag or romiplostim to treat ITP can be made either:

Patients must meet one of 3 restrictions:

  1. initial treatment (applications in writing)
  2. continuing treatment—first period of continuing treatment or re-initiation of interrupted treatment (applications in writing)
  3. continuing treatment— second and subsequent applications for continuing treatment (Applications via phone or OPA).

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 either:

  • 250 micrograms
  • 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 either eltrombopag or romiplostim within the initial 24 weeks treatment period. If a patient has started initial treatment with one of the two agents, change of therapy to the alternative agent may be authorised. This authorisation would allow them to complete a total of 24 weeks initial treatment. No further changes to the alternative agent will be authorised after the initial 24 week period. A patient who has demonstrated a response to both agents within the initial treatment period will only be eligible for PBS subsidy on the most recent agent. Patients who fail to demonstrate a response to treatment with eltrombopag or romiplostim after a total combined 24 weeks initial therapy won’t be eligible to receive further PBS subsidised treatment with either of these drugs. To be approved for first continuing treatment, the application must be for the most recent medication that the patient has shown response to in the initial 24 weeks of treatment.

Further information

Call the PBS Complex Drugs Programs enquiry line for further information.

Page last updated: 4 February 2021