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

Acute severe generalised myasthenia gravis (gMG)

Loading dose

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 considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment 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 be commencing treatment with an NS-IST within 2 weeks; or

Patient must have had a thymectomy; AND

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

Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication ('acute severe gMG'); AND

Patient must not have accessed a prior PBS-subsidised gMG biological agent; or

Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; 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.

Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.

At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).

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 TGA PI will not be approved.

The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.

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).

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

Bridging therapy for generalised myasthenia gravis (gMG)

Loading dose

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 ('bridging therapy for gMG'); 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.

Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.

At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).

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 TGA PI will not be approved.

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 (Loading dose)

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

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).

Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.

At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).

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 TGA PI will not be approved.

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 (Loading dose)

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

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.

Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.

At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient's weight, according to the specified dosage in the TGA approved Product Information (PI).

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 TGA PI will not be approved.

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).