Written Authority Required Drugs

Granulomatosis - severe active granulomatosis with polyangiitis or severe active microscopic polyangiitis

The PBS subsidises rituximab for patients with severe active granulomatosis with polyangiitis or severe active microscopic polyangiitis.

Patients with severe active granulomatosis with polyangiitis, or severe active microscopic polyangiitis, can be subsidised for treatment with rituximab (MabThera®). This is subsidised through the PBS under Section 100 of the National Health Act 1953.

Section 100 arrangements

Rituximab (MabThera®) is only available to a patient who is attending:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital

and is a

  • day admitted patient
  • non-admitted patient, or
  • patient on discharge

The hospital provider number must be included on the application form. This item is not available as a PBS benefit for in-patients of the hospital.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing rituximab (MabThera®) to patients.

Schedule item details

Rituximab (MabThera®) is available as:

  • 500 mg/50 mL injection, 1 x 50 mL vial
  • 100 mg/10 mL injection, 2 x 10 mL vial

At the time of application, you must:

  • clearly indicate the strength of rituximab (MabThera®) required, and
  • request the appropriate number of vials to provide sufficient medication for 4 weeks of treatment

This drug is PBS subsidised for the:

  • induction of remission, which includes patients who have received treatment with rituximab for this condition before 1 January 2016, or
  • re-induction of remission for patients who have previously received and responded to the PBS subsidised treatment with rituximab (MabThera®) for this condition
This drug is not PBS subsidised for maintenance of remission.

Lodging an application

For a patient starting initial PBS subsidised treatment with rituximab (MabThera®), all applications must:

Send all written applications to the Complex Drugs Programs address on the contact us page.

Further information

For more information contact us on the Complex Drugs Programs enquiry line.

This information was printed Monday 20 May 2019 from https://www.humanservices.gov.au/organisations/health-professionals/services/medicare/written-authority-required-drugs/drug-program-or-condition/granulomatosis-severe-active-granulomatosis-polyangiitis-or-severe-active-microscopic-polyangiitis It may not include all of the relevant information on this topic. Please consider any relevant site notices at https://www.humanservices.gov.au/individuals/site-notices when using this material.

Page last updated: 13 March 2019