Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe thrombocytopenia

Initial treatment - New patient

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND

Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;

(a) a platelet count of less than or equal to 20,000 million per L; OR

(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.

The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.

Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.

Authority approval will not be given for doses higher than 10 micrograms/kg/week

The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:

(a) details of a platelet count supporting the diagnosis of ITP.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe thrombocytopenia

First Continuing treatment or Re-initiation of interrupted continuing treatment

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or

Patient must have changed treatment from either eltrombopag or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; or

Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.

The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.

Authority approval will not be given for doses higher than 10 micrograms/kg/week

The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe thrombocytopenia

Second or Subsequent Continuing treatment

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND

Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.

The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.

Authority approval will not be given for doses higher than 10 micrograms/kg/week

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe thrombocytopenia

Balance of supply or change of therapy

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND

Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or

Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or

Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or

Patient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; AND

The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.

Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction.