1.  The whole of this instrument

1 April 2025

1 April 2025

Hyrimoz

C12120 C14061 C14063 C14064 C14107 C14136

See Schedule 2

See Schedule 2

Lenalidomide‑Teva

C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362

See Schedule 2

See Schedule 2

Lenalidomide‑Teva

C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362

See Schedule 2

See Schedule 2

Lenalidomide‑Teva

C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362

See Schedule 2

See Schedule 2

Mycophenolate APOTEX

C5554 C5795 C9691 C9693

300

5

Tenofovir/Emtricitabine 300/200 APOTEX

C6985 C6986

60

5

C16368

Neuromyelitis optica spectrum disorder (NMOSD)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

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

Patient must not have experienced a relapse while receiving treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.

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 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment.

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

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.

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

Compliance with Authority Required procedures

C16398

Neuromyelitis optica spectrum disorder (NMOSD)

Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2025; AND

Patient must have a confirmed diagnosis of NMOSD with AQP4-IgG prior to commencing treatment with this drug; AND

Patient must have a recorded baseline Expanded Disability Status Scale (EDSS) score of no higher than 7 prior to commencing treatment with this drug; AND

Patient must have had at least one relapse in the 12 months prior to commencing treatment with this drug for this condition; AND

Patient must have received treatment with rituximab immediately prior to the most recent relapse prior to initiation of ravulizumab; 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 have a current Expanded Disability Status Scale (EDSS) score of no higher than 7; AND

Patient must not have experienced a relapse while receiving treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

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 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment.

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

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.

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 baseline Expanded Disability Status Scale (EDSS) score before commencement with this drug for this condition; and

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

(iii) 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.

Compliance with Written Authority Required procedures

C16400

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 had at least one relapse in the last 12 months; AND

Patient must have experienced the most recent relapse 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.

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.

Compliance with Written Authority Required procedures