Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Neuromyelitis optica spectrum disorder (NMOSD)

Initial treatment - loading dose

Patient must have a confirmed diagnosis of NMOSD with aquaporin-4 immunoglobulin G auto-antibody (AQP4-IgG); AND

Patient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; AND

Patient must have experienced at least one relapse in the last 12 months while receiving treatment with rituximab; or

Patient must have a documented intolerance to rituximab of a severity necessitating permanent treatment withdrawal; or

Patient must have a documented contraindication to rituximab therapy; AND

Patient must not receive more than 2 weeks of treatment under this restriction; AND

Must be treated by a neurologist; or

Must be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for a single loading dose for induction therapy, according to the specified dosage in the approved Product Information (PI). Refer to the approved PI for patient weight ranges for the 100 mg/mL doses (consisting of 300 mg in 3 mL and 1.1 g in 11 mL vials).

An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.

Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.

The authority application must be in writing and must include all of the following:

(1) details of the proposed authority prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the patient's Expanded Disability Status Scale (EDSS) score; and

(ii) details of prior rituximab treatment (dosage, date of commencement and duration of therapy), or details of contraindications or developed intolerances necessitating treatment withdrawal.

This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.