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

Acute severe generalised myasthenia gravis (gMG)

Non-loading/maintenance doses

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 received a loading dose of this drug for this indication; 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.

At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, 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).