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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
- a public hospital.
You must include the hospital name and 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:
- authority prescription form
- cover letter detailing the prescriber’s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence
- all relevant supporting documentation
- Atypical Haemolytic Uraemic Syndrome (aHUS) - eculizumab Initial PBS authority application form.
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:
- authority prescription form
- cover letter detailing the prescriber’s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence
- all relevant supporting documentation
- Atypical Haemolytic Uraemic Syndrome (aHUS) - eculizumab Extended initial PBS authority application form.
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:
- authority prescription form
- cover letter detailing the prescriber’s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence
- all relevant supporting documentation
- Atypical Haemolytic Uraemic Syndrome (aHUS) - eculizumab Continuing PBS authority application form.
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:
- authority prescription form
- cover letter detailing the prescriber’s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence
- all relevant supporting documentation
- the Atypical Haemolytic Uraemic Syndrome (aHUS) - eculizumab Recommencement PBS authority application form.
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.