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Item |
Description |
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1 |
Is there an age restriction for PBS-subsidised ravulizumab or zilucoplan to treat gMG?
No. Patients of any age can apply for ravulizumab or zilucoplan. However, as dosing must align with the Therapeutic Goods Administration (TGA)-approved product information, patients must be at least 40kg for ravulizumab.
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2 |
What are the treatment settings for PBS‑subsidised gMG?
There are 3 defined treatment settings for PBS-subsidised gMG biological agents ravulizumab and zilucoplan:
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Acute severe gMG - up to 3 months of short-term stabilisation
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Bridging therapy for gMG - up to 6 months of temporary control while background therapy is optimised, and
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Treatment‑refractory gMG - continuous long-term therapy for established treatment refractory disease
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3 |
Can a patient move between treatment phases?
Yes. A patient may transition through the phases forward from acute treatment to bridging therapy to treatment refractory, provided they meet the criteria for each phase.
In addition, bridging therapy can be skipped and patients can transition from acute to treatment refractory, providing all criteria are met. However, they cannot return to an earlier phase once progressed.
For example, a patient who has entered bridging therapy cannot go back to acute severe treatment. By the same logic, once a patient enters the treatment refractory setting, they are not allowed to move back to acute severe or bridging therapy.
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4 |
Why are patients not allowed to move backwards once they are in the treatment refractory phase?
The reason is because each setting reflects a different treatment intent. Acute severe and bridging therapies are time-limited interventions (maximum 3 and 6 months treatment respectively), whereas treatment refractory status confirms ongoing, established disease requiring long-term biological therapy.
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5 |
Can a gMG patient switch between ravulizumab and zilucoplan?
Yes. Switching between gMG biological agents is permitted under the restriction, subject to the following conditions:
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Switching should generally be limited to movement between treatment settings
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'acute severe gMG' to 'bridging therapy'
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'bridging therapy' to 'treatment refractory gMG'
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'acute severe gMG' to 'treatment-refractory gMG'
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Acute severe gMG and bridging therapy
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Switching is permitted where intolerance or toxicity necessitates treatment withdrawal
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The patient must re-qualify under the relevant restriction
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Approval is limited to the remaining balance of the applicable treatment period (3 months for acute severe gMG or 6 months for bridging therapy), accounting for time already treated with the previous gMG biologic
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In Treatment refractory gMG setting, switching is permitted:
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under the initial restriction, if the patient did not respond to a prior gMG biologic, or
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under the continuing restriction, if the patient responded to a prior gMG biologic
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6 |
When will the grandfather restriction expire?
The grandfather restriction will stay in place for 1 year after being listed.
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7 |
Can replacement or top-up prescriptions be approved using Balance of Supply (BoS) item codes?
No. There are no BoS item codes. Replacement and top-up prescriptions will need to be entered under previously approved item code and restriction.
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8 |
Where are the dosing schedules for gMG located?
Dosing tables can be found on the:
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Master code sheet
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gMG individual code sheet, and
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Tables 1, 2 and 3 on this page
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9 |
Is a loading dose required before applying for maintenance treatment with ravulizumab?
No. Loading is optional. Patients may commence on non-loading/maintenance doses.
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10 |
Is a loading dose required for zilucoplan?
No, the dosing of zilucoplan is 1 syringe per day and a loading dose is not required.
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11 |
Can a prescriber request a loading dose and maintenance doses together with the initial application for ravulizumab?
Yes. The initial application for ravulizumab can include script/s for the loading dose and maintenance doses. Alternatively, maintenance treatment can be requested separately before the dose is due (two weeks after loading dose is given).
If maintenance treatment is requested separately in writing, a copy of the original application form can be submitted.
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12 |
What other PBS-subsidised conditions is ravulizumab listed to treat?
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Atypical haemolytic uraemic syndrome (aHUS). Refer all aHUS requests to a pharmaceutical adviser
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Paroxysmal nocturnal haemoglobinuria (PNH), and
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Neuromyelitis optica spectrum disorder (NMOSD)
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Expand all
PBS gMG restriction and item codes