Loading
If this is the first time anyone has visited this substance, we may be fetching live data from TGA Product Information, PBS, and state framework sources — that can take up to a minute. Cached substances load in a second or two.
Ravulizumab, sold under the brand name Ultomiris, is a humanized monoclonal antibody complement inhibitor medication designed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). It is designed to bind to and prevent the activation of complement component 5 (C5).
Read the full article on WikipediaParoxysmal nocturnal haemoglobinuria (PNH) Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (new patient) induction dose Patient must not have received prior treatment with this drug for this condition, AND Patient must have a diagnosis of PNH established by flow cytometry, AND Patient must have a PNH granulocyte clone size equal to or greater than 10%, AND Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal, AND Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded, AND The treatment must be the sole PBS-subsidised therapy for this condition. Treatment criteria: Must be treated by a haematologist; OR Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: (1) details of the proposed prescription(s); 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). At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided: (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5
Atypical haemolytic uraemic syndrome (aHUS) Clinical criteria: Treatment Phase: Balance of Supply - maintenance doses Patient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase, AND Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample, AND Patient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase, AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase. Treatment criteria: Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion, AND Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia. Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
Neuromyelitis optica spectrum disorder (NMOSD) Clinical criteria: Treatment Phase: 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 experienced at least one relapse in the last 12 months 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. Treatment criteria: 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.
Bridging therapy for generalised myasthenia gravis (gMG) Clinical criteria: Treatment Phase: 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 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. 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 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 (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 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). 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 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).
Acute severe generalised myasthenia gravis (gMG) Clinical criteria: Treatment Phase: 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. 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. 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).
Working under the parallel aged-care framework? Aged-care equivalent →