Atypical haemolytic uraemic syndrome

The PBS subsidises eculizumab for patients with atypical haemolytic uraemic syndrome (aHUS).

Treatment with eculizumab can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953 for patients with atypical haemolytic uraemic syndrome (aHUS).

Section 100 arrangements

This item is available to a patient attending:

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

and is either a

  • non-admitted patient, or
  • patient on discharge

You must include the hospital provider number on the application form.

Patient eligibility

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

You must also provide serial hematological results every 3 months while the patient is receiving treatment.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing eculizumab.

Meningococcal infections

Meningococcal infections can quickly become life-threatening for patients being treated with eculizumab.

The Advisory Committee on Immunization Practices (ACIP) recommends meningococcal vaccinations for patients with complement deficiencies. If your patient is starting treatment with eculizumab, they must comply with the recommendation and be immunised against meningococcal.

You must provide a:

  • vaccination certificate with each application, or
  • written statement that vaccination has or will be administered and appropriate antibiotic prophylaxis has been prescribed

You must monitor your patients for early signs of meningococcal infections and evaluate immediately if you suspect infection.

Refer to the product information for eculizumab for more information about managing the risk of meningococcal infection.

Applications

Initial treatment

Make all initial applications for authority approval to prescribe eculizumab for the treatment of aHUS in writing and fax to the aHUS program on 1800 785 672. You don’t need to mail the completed application to the PBS Complex Drugs Programs address.

All applications must include a completed:

Patients will be approved for a maximum of 24 weeks treatment. They must have their response to treatment assessed at completion. If eligible, patients can get 28 weeks of 'extended initial 1' treatment.

Extended initial treatment

Make all extended initial 1 and 2 applications for authority approval to prescribe eculizumab for the treatment of aHUS in writing and fax to the aHUS program on 1800 785 672. You don’t need to mail the completed application to the PBS Complex Drugs Programs address.

All applications must include a completed:

Patients must have their response to treatment assessed at the completion of 'extended initial 1' treatment. If eligible, patients can get 28 weeks of 'extended initial 2' treatment.

Continuing treatment

Make all continuing applications for authority approval to prescribe eculizumab for the treatment of aHUS in writing and fax to the aHUS program on 1800 785 672. You don’t need to mail the completed application to the PBS Complex Drugs Programs address.

All applications must include a completed:

Patients who respond to a total of 80 weeks of initial treatments may be eligible for a maximum of 24 weeks of continuing treatment.

Recommencement of treatment

Make all recommencement applications for authority approval to prescribe eculizumab for the treatment of aHUS in writing and fax to the aHUS program on 1800 785 672. You don’t need to mail the completed application to the PBS Complex Drugs Programs address.

All applications must include a completed:

Patients who show an adequate response before a break in treatment can restart if they have a disease flare.

Further information

For more information call the PBS Complex Drugs Programs enquiry line.

Page last updated: 27 August 2017