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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with ravulizumab and zilucoplan under the National Health Act 1953, section 100 for patients with gMG.
Patients must be eligible for the PBS and meet the relevant restriction criteria.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing ravulizumab and zilucoplan.
Section 100 arrangements
Ravulizumab and zilucoplan
These items are only PBS-subsidised for non-admitted patients, day admitted patients or patients on discharge who are attending either:
- an approved private hospital
- a public hospital.
These items aren’t PBS-subsidised for public hospital in-patients.
You must include the hospital name and provider number on the authority application form.
Treatment specifics
To be eligible for PBS-subsidised treatment with ravulizumab or zilucoplan, patients must be treated by a prescriber who is either a:
- neurologist
- clinical immunologist with expertise in the treatment of myasthenia gravis
- medical practitioner in consultation with one of the above specialist types.
PBS-subsidised gMG treatment settings and time limits
Where the term ‘gMG biological agent’ is referenced, it refers to ravulizumab and zilucoplan.
The following are settings and time limits where a gMG biological agent is PBS-subsidised:
- 3 months of acute treatment - ‘acute severe gMG’
- 6 months of bridging therapy - ‘bridging therapy for gMG’
- Continuous therapy - ‘treatment refractory gMG’.
A patient may transition sequentially from one phase to another where all criteria are met e.g. (1) to (2) to (3) but cannot return to an earlier treatment setting.
Switching between PBS-subsidised gMG biological agents
Switching between gMG biological agents is permitted. Treatment switching should be limited to when a patient moves between different treatment settings such as moving from (1) to (2) or (2) to (3).
In the acute severe (1) or bridging therapy (2) settings, a patient may switch to an alternate gMG biological agent if they’re experiencing an intolerance or toxicity necessitating treatment withdrawal.
Patients can switch by requalifying through the relevant restrictions. We can only approve a balance of the time limits specified within the relevant treatment setting. This means the remainder of the 3 months (acute severe gMG); or 6 months (bridging therapy for gMG) after accounting for the treatment of the previous gMG biologic.
In the treatment refractory (3) setting, a patient may switch to an alternate gMG biological agent through either:
- the initial restriction if they’ve trialled a different gMG biologic, but didn’t respond to treatment
- the continuing restriction if they’ve trialled a different gMG biological agent and have responded to treatment.
Non-steroidal immunosuppressant (NS-IST)
A NS-IST is one of the following:
- azathioprine
- ciclosporin
- cyclophosphamide
- methotrexate
- mycophenolate
- tacrolimus.
Authority applications
Please note: You’ll get an immediate assessment when you request PBS authorities online.
Acute severe gMG
Applying for treatment of acute severe gMG
Applications for authority approval to prescribe PBS-subsidised ravulizumab or zilucoplan to treat acute severe gMG can be made in:
- real time using the Online PBS Authorities system
- writing and using HPOS Form upload
- writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed generalised myasthenia gravis - acute severe treatment authority application form
- relevant attachments.
Bridging therapy for gMG
Applying for bridging therapy
Applications for bridging therapy authority approval to prescribe PBS-subsidised ravulizumab or zilucoplan to treat gMG can be made in:
- real time using the Online PBS Authorities system
- writing and using HPOS Form upload
- writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed generalised myasthenia gravis - bridging therapy authority application form
- relevant attachments.
Treatment refractory gMG
Applying for initial treatment
Applications for initial authority approval to prescribe PBS-subsidised ravulizumab or zilucoplan for treatment refractory gMG can be made in:
- real time using the Online PBS Authorities system
- writing and using HPOS Form upload
- writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed generalised myasthenia gravis - treatment refractory initial authority application form
- relevant attachments.
Applying for initial grandfather treatment
Applications for initial grandfather authority approval to prescribe PBS-subsidised ravulizumab or zilucoplan for treatment refractory gMG can be made in:
- real time using the Online PBS Authorities system
- writing and using HPOS Form upload
- writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed generalised myasthenia gravis - treatment refractory initial grandfather authority application form
- relevant attachments.
Applying for continuing treatment
Applications for continuing authority approval to prescribe PBS-subsidised ravulizumab or zilucoplan for treatment refractory gMG can be made in:
- real time using the Online PBS Authorities system
- writing and using HPOS Form upload
- writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed generalised myasthenia gravis - treatment refractory continuing authority application form
- relevant attachments.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.