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

Bridging therapy for generalised myasthenia gravis (gMG)

Patient must have a diagnosis of MGFA Disease Class II to IV; AND

Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND

Patient must not be experiencing a myasthenic crisis; AND

Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or

Patient must have had a thymectomy; AND

Patient must be receiving concomitant treatment with an oral corticosteroid; AND

Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND

Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND

Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication; AND

Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

The authority application must be via the Online PBS Authorities System or in writing and must include:

(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);

(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].

If the application is submitted through HPOS form upload or mail, it must include the following:

(1) details of the proposed 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).

A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.

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

Treatment refractory generalised myasthenia gravis (gMG)

Initial treatment - Treatment refractory gMG patients

Patient must have a diagnosis of MGFA Disease Class II to IV; AND

Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND

Patient must not be experiencing a myasthenic crisis; AND

Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or

Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND

Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND

Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or

Patient must have had a thymectomy; AND

Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND

The treatment must provide no more than 6 months of therapy per initial authority application; AND

Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).

The authority application must be via the Online PBS Authorities System, or in writing and must include:

(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];

(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).

If the application is submitted through HPOS form upload or mail, it must include:

(1) details of the proposed 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).

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

Treatment refractory generalised myasthenia gravis (gMG)

Continuing treatment - Treatment refractory gMG patients

Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND

Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND

Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND

Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND

Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or

Patient must have had a thymectomy; AND

The treatment must provide no more than 6 months of therapy per continuing authority application; AND

Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.

If the application is submitted through HPOS form upload or mail, it must include:

(1) details of the proposed 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).

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

Treatment refractory generalised myasthenia gravis (gMG)

Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2026; AND

Patient must have a diagnosis of MGFA Disease Class II to IV; AND

Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND

Patient must not be experiencing a myasthenic crisis; AND

Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND

Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or

Patient must have had a thymectomy; AND

Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND

Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND

Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND

The treatment must provide no more than 6 months of therapy under this restriction; AND

Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

The authority application must be via the Online PBS Authorities System, or in writing and must include:

(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];

(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);

(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).

If the application is submitted through HPOS form upload or mail, it must include:

(1) details of the proposed 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).

A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.