Tocilizumab =========== Concentrate for injection 80 mg in 4 mL SavePrivate hospital PBS item code15475LMaximum quantity2 units Repeats5 More detailsProgramHS AdministrationINJECTION Benefit typeS Brands - Avtozma[TGA record](https://www.tga.gov.au/resources/artg/444940 "TGA ARTG record 444940")[PI (PDF)](https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2025-PI-01692-1 "Product Information (PDF)") Dispensed price for maximum quantity (DPMQ)2 pricesAvtozma · s90-cp-s100$184.90 Avtozma · s94-private-s100$177.66 Restrictions & indications ------------------------------ Streamline authority code18941 Juvenile Idiopathic Arthritis (Active, Severe) - Subsequent continuing treatment Show full PBS criteriaHide full PBS criteriaSevere active juvenile idiopathic arthritis Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must be at least 18 years of age. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) an active joint count of fewer than 10 active (swollen and tender) joints; or (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (c) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. Notes (3)TREATMENT OF ADULT PATIENTS WITH A HISTORY OF JUVENILE IDIOPATHIC ARTHRITIS The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and tocilizumab for a patient over 18 years who has a history of juvenile idiopathic arthritis with onset prior to the age of 18 years. Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, etanercept and tocilizumab only. A patient is eligible for PBS-subsidised treatment with only 1 of the 3 biological medicines at any one time. From 1 April 2014, a patient receiving PBS-subsidised biological medicine therapy is considered to be in a treatment cycle where they may swap to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements, within a single treatment cycle, a patient may: (i) continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy; and (ii) fail to respond or to sustain a response to each PBS-subsidised biological medicine once only. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure. Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 5 year break in PBS-subsidised biological medicine therapy before they are eligible to receive further PBS-subsidised biological medicine therapy. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine was approved to the date of the first application for initial treatment with a biological medicine under the new treatment cycle. A patient who received PBS-subsidised biological medicine treatment immediately prior to 1 April 2014 is considered to be in their first cycle as of 1 April 2014. A patient who has had a break in biological medicine treatment of at least 24 months immediately prior to making a new application, on or after 1 April 2014, will commence a new treatment cycle under the Initial 3 treatment restriction A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 24 months may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction. A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 24 months must commence a new treatment cycle under the Initial 3 treatment restriction. There is no limit to the number of treatment cycles a patient may undertake in their lifetime. How to prescribe PBS-subsidised biological medicine therapy after 1 April 2014. (1) Initial treatment. Applications for initial treatment should be made where: (i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or (ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine of less than 24 months) \[further details are under 'Swapping therapy' below\]; or (iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 24 months with the same medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine therapy of less than 24 months); or (iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 24 months (Initial 3 - recommencement of treatment after a break in biological medicine of more than 24 months). Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy. A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment. (2) Continuing treatment. Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Adalimumab and infliximab only: Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response. It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. (3) Swapping therapy. Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (joint count and ESR/CRP) or the prior non-biological medicine therapy requirements, except if the patient has had a break in therapy of more than 24 months who would then need to requalify under the Initial 3 restrictions with respect to the indices of disease severity. A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle. To ensure a patient receives the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction. (4) Baseline measurements to determine response. A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the joint count submitted with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements. (5) Recommencement of treatment after 24 months break in PBS-subsidised therapy. A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological medicine therapy of at least 24 months, must qualify under the Initial 3 restriction and meet the relevant criteria and index of disease severity. No increase in the maximum quantity or number of units may be authorised. No increase in the maximum number of repeats may be authorised. Prescribing notes (3)No increase in the maximum quantity or number of units may be authorised. No increase in the maximum number of repeats may be authorised. TREATMENT OF ADULT PATIENTS WITH A HISTORY OF JUVENILE IDIOPATHIC ARTHRITIS The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and tocilizumab for a patient over 18 years who has a history of juvenile idiopathic arthritis with onset prior to the age of 18 years. Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, etanercept and tocilizumab only. A patient is eligible for PBS-subsidised treatment with only 1 of the 3 biological medicines at any one time. From 1 April 2014, a patient receiving PBS-subsidised biological medicine therapy is considered to be in a treatment cycle where they may swap to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements, within a single treatment cycle, a patient may: (i) continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy; and (ii) fail to respond or to sustain a response to each PBS-subsidised biological medicine once only. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure. Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 5 year break in PBS-subsidised biological medicine therapy before they are eligible to receive further PBS-subsidised biological medicine therapy. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine was approved to the date of the first application for initial treatment with a biological medicine under the new treatment cycle. A patient who received PBS-subsidised biological medicine treatment immediately prior to 1 April 2014 is considered to be in their first cycle as of 1 April 2014. A patient who has had a break in biological medicine treatment of at least 24 months immediately prior to making a new application, on or after 1 April 2014, will commence a new treatment cycle under the Initial 3 treatment restriction A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 24 months may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction. A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 24 months must commence a new treatment cycle under the Initial 3 treatment restriction. There is no limit to the number of treatment cycles a patient may undertake in their lifetime. How to prescribe PBS-subsidised biological medicine therapy after 1 April 2014. (1) Initial treatment. Applications for initial treatment should be made where: (i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or (ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine of less than 24 months) [further details are under 'Swapping therapy' below]; or (iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 24 months with the same medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine therapy of less than 24 months); or (iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 24 months (Initial 3 - recommencement of treatment after a break in biological medicine of more than 24 months). Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy. A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment. (2) Continuing treatment. Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Adalimumab and infliximab only: Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response. It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. (3) Swapping therapy. Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (joint count and ESR/CRP) or the prior non-biological medicine therapy requirements, except if the patient has had a break in therapy of more than 24 months who would then need to requalify under the Initial 3 restrictions with respect to the indices of disease severity. A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle. To ensure a patient receives the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction. (4) Baseline measurements to determine response. A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the joint count submitted with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements. (5) Recommencement of treatment after 24 months break in PBS-subsidised therapy. A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological medicine therapy of at least 24 months, must qualify under the Initial 3 restriction and meet the relevant criteria and index of disease severity. Other listings for Tocilizumab Concentrate for injection 80 mg in 4 mL ---------------------------------------------------------------------- [Public10077JMaximum 1 units · 0 repeats - Juvenile Idiopathic Arthritis (Active, Severe) - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 1 (new patient) - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)](/p/10077J)[Public10081NMaximum 1 units · 0 repeats - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 1 (new patient) - Juvenile Idiopathic Arthritis (Active, Severe) - Balance of supply - Continuing treatment - Juvenile Idiopathic Arthritis (Active, Severe) - Subsequent continuing treatment - Juvenile Idiopathic Arthritis (Active, Severe) - First continuing treatment - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply](/p/10081N)[Public12775JMaximum 1 units · 0 repeats - Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)](/p/12775J)[Public12794JMaximum 1 units · 0 repeats - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab) - Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilzumab after resolution of the critical shortage of tocilizumab)](/p/12794J)[Public1476QMaximum 1 units · 0 repeats - Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 1 (new patient) - Systemic Juvenile Idiopathic Arthritis - Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months) - Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)](/p/1476Q)[Public15429CMaximum 1 units · 0 repeats - Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 1 (new patient) - Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)](/p/15429C)[Public13304FMaximum 4 units · 5 repeats - Systemic Juvenile Idiopathic Arthritis - Continuing treatment](/p/13304F)[Public13324GMaximum 2 units · 5 repeats - Juvenile Idiopathic Arthritis (Active, Severe) - Continuing treatment](/p/13324G)[Public13690MMaximum 2 units · 5 repeats - Rheumatoid Arthritis (Severe Active) - Subsequent continuing treatment](/p/13690M)[Public15440PMaximum 2 units · 5 repeats - Rheumatoid Arthritis (Severe Active) - First continuing treatment - balance of supply - Rheumatoid Arthritis (Severe Active) - First continuing treatment](/p/15440P) Data source: [Australian Government PBS Schedule](https://www.pbs.gov.au/info/browse/download) · Record updated 30 September 2026. Verify current listing and prescribing requirements on the [official PBS website](https://www.pbs.gov.au/).