Neuromyelitis optica spectrum disorder (NMOSD) in Pharmaceutical Benefits Scheme (PBS) 012-25030536

NMOSD restriction and item codes

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$\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.png$ PBS NMOSD restriction and item codes

Ravulizumab NMOSD loading dose and vial calculator (patients ≥ 40kg)

Table 1

Body weight	Loading dose	Number of 300mg vials	Number of 1100mg vials
40kg to less than 60kg	2400mg	8	0
60kg to less than 100kg	2700mg	9	0
100kg and over	3000mg	10	0

Ravulizumab NMOSD maintenance dose and vial calculator (patients ≥ 40kg)

Table 2

Body weight	Loading dose	Number of 300mg vials	Number of 1100mg vials
40kg to less than 60kg	3000mg	10	0
60kg to less than 100kg	3300mg	0	3
100kg and over	3600mg	1	3

Contact details

PBS Complex Drugs Programs

Forms

Neuromyelitis optica spectrum disorder - ravulizumab - initial authority application form (PB382)

Neuromyelitis optica spectrum disorder - ravulizumab - initial grandfather authority application form (PB383)

Services Australia website

Neuromyelitis optica spectrum disorder

External websites

PBS schedule for neuromyelitis optics spectrum disorder

FAQs from Service Officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item	Description
1	Is there an age restriction for PBS-subsidised ravulizumab to treat NMOSD? No. Patients of any age can apply for ravulizumab. However, as dosing must align with the TGA-approved product information, patients must be at least 40kg.
2	When will the grandfather restriction of ravulizumab expire? The grandfather restriction will stay in place for 1 year after being listed. Ravulizumab was listed on 1/04/2025 and the grandfather restriction is expected to cease around 1/04/2026.
3	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.
4	Where are the dosing schedules for NMOSD located? On the code sheet and OB. Dosing tables can be found on the Master code sheet, the NMOSD individual code sheet, as well as under the Resources tab on the OB page.
5	Can a prescriber request a loading dose and continuing treatment with the initial application? No. The initial application should only include script/s for the loading dose. Continuing treatment can then be requested via telephone or using the Online PBS Authorities system before the dose is due (two weeks after loading dose is given).
6	What other PBS-subsidised conditions is ravulizumab listed to treat? Atypical haemolytic uraemic syndrome (aHUS) and paroxysmal nocturnal haemoglobinuria (PNH). Refer all aHUS requests to a pharmaceutical adviser.

Operational Information