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Acute severe generalised myasthenia gravis (gMG) Clinical criteria: 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. Treatment criteria: 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 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).
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Zilucoplan inhibits the effects of C5 through a dual mechanism of action. It specifically binds to complement protein C5, thereby inhibiting its cleavage by the C5 convertase to C5a and C5b, which results in a downregulation of the assembly and cytolytic activity of the MAC. Additionally, by binding to the C5b moiety of C5, zilucoplan sterically hinders binding of C5b to C6, which prevents the subsequent assembly and activity of the MAC, should any C5b be formed.”
“The mean plasma terminal elimination half-life was approximately 172 hours (7-8 days).”
Working under the parallel aged-care framework? Aged-care equivalent →
Bridging therapy for generalised myasthenia gravis (gMG) Clinical criteria: 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. Treatment criteria: 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.
Treatment refractory generalised myasthenia gravis (gMG) Clinical criteria: Treatment Phase: 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. Treatment criteria: 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).
“Zilucoplan is not a substrate of major CYP enzymes or transporters (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 3A4, or P-gp, BCRP, OATP1B1 or OATP1B3). Based on the results, zilucoplan will not inhibit or induce these major drug metabolising enzymes (CYPs and UGTs) and transporters in a clinically relevant manner.”