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

Atypical haemolytic uraemic syndrome (aHUS)

Initial treatment - Balance of Supply

Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND

Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND

Patient must not receive more than 20 weeks supply under this restriction; AND

Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND

Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.

ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion, and must have been submitted to Services Australia within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.

Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.

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

Atypical haemolytic uraemic syndrome (aHUS)

Recommencement - Balance of Supply

Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; AND

Patient must not receive more than 20 weeks supply under this restriction; AND

Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND

Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.

Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.