Tocilizumab =========== Concentrate for injection 400 mg in 20 mL SavePublic hospital PBS item code15439NMaximum quantity1 units Repeats0 More detailsProgramHB AdministrationINJECTION Benefit typeA Brands - Avtozma[TGA record](https://www.tga.gov.au/resources/artg/444943 "TGA ARTG record 444943")[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$442.46 Avtozma · s94-public-s100$399.39 Restrictions & indications ------------------------------ AUTHORITY REQUIRED Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 1 (new patient) Show full PBS criteriaHide full PBS criteriaSevere active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND Patient must not receive more than 16 weeks of treatment 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. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder 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). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must 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 determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records: (a) the active joint count, ESR and/or CRP result and date of results; (b) details of prior treatment, including dose and date/duration of treatment. (c) If applicable, details of any contraindications/intolerances. (d) If applicable, the maximum tolerated dose of methotrexate. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. AUTHORITY REQUIRED Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Show full PBS criteriaHide full PBS criteriaSevere active rheumatoid arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment 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. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder 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). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must 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 determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records: (a) the active joint count, ESR and/or CRP result and date of result; (b) the most recent biological agent and the date of the last continuing prescription. (c) If applicable, the new baseline scores. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. AUTHORITY REQUIRED Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) Show full PBS criteriaHide full PBS criteriaSevere active rheumatoid arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 weeks of treatment 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. Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores. Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below. 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) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) 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 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). The assessment of response to treatment must be documented in the patient's medical records. An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must 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 determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. At the time of the authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. Notes (4)Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday). Encouraging biosimilar prescribing for treatment naive patients is Government policy. A viable biosimilar market is expected to result in reduced costs for biological medicines, allowing the Government to reinvest in new treatments. Further information can be found on the Medicines webpage (www.health.gov.au/health-topics/medicines). **PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS** The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy of the biological medicines for adults with severe active rheumatoid arthritis. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid arthritis'. Some benefits are not biological medicines, but are small molecules. However, for practical purposes, these benefits are included within the term 'biological medicine'. Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid arthritis. Upon 5 inadequate responses to biological medicines with the specific PBS indication of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular biological medicine has provided an inadequate response, it must not be subsidised again. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered a treatment failure. (1) Selecting the correct 'Treatment phase' listing to apply under Initiating subsidy: (i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised biological medicine treatment; or (ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised treatment has at least been initiated through any Initial 1 listing, but the prescribed biological medicine is changing, (b) there has been a break in biological medicine of less than 24 months, but resumption of treatment is with the same biological medicine last prescribed, (c) there has been a break in biological medicine of less than 24 months and resumption of treatment is with a different biological medicine to that last prescribed, (d) treatment with rituximab has occurred within the past 24 months and is the most recent therapy prescribed leading up to this authority application, irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered before and after rituximab. Initial 2 does not require markers of inflammation/joint count to be re-established - those recorded in the first Initial 1 application can remain as baseline measures. Prerequisite DMARD treatments need not be re-proven to be inadequate. The prescribed biological medicine may be changed at any time, regardless of whether the current prescribed biological medicine has been obtained through Initial treatment or Continuing treatment. However, the change in biological medicine cannot be back to the same biological medicine where that medicine has provided an inadequate response. (iii) Apply through 'Initial 3 treatment' where treatment is recommencing following a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can include rituximab where prescribed as the most recent treatment - the 24 month break in therapy is from the second dose of the prior rituximab course. Response assessment to any course of PBS-subsidised biological therapy must follow a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment and Continuing treatment clearly do reflect this requirement. Where a response assessment is not conducted with a 'Continuing treatment' application, the biological medicine will be assumed to have failed, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Authority applications for patients who experienced adverse reaction necessitating permanent treatment withdrawal should be submitted through 'Initial 2 treatment' or 'Initial 3 treatment'. Indicate where the adverse reaction has occurred in the authority application. Continuing subsidy: Apply under a 'Continuing treatment' phase listing only where treatment has initiated through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint count) demonstrate response following at least 12 weeks of treatment. Continuing treatment should never precede Initial treatment where the same biological medicine is being prescribed. The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid arthritis with the same biological medicine'. Where treatment of severe rheumatoid arthritis is continuing with a different biological medicine, 'Continuing treatment' is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis with a different biological medicine' - see 'Initial 2 treatment' where continuing treatment is with a different biological medicine. 'Continuing treatment' is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment. Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing', the next authority application following immediately after any 'Initial treatment' authority application is to be through 'First continuing'. Following this, the next authority application is to occur under the 'Subsequent continuing' treatment phase. Assuming the drug continues to provide an adequate response, 'Subsequent continuing' is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment. Balance of Supply listings: Maximum quantities and the number of repeats stated in a PBS-listing are values that prescribers may seek up to, but are not obligated to prescribe. From time to time, there may be particular reasons why a prescriber may elect not to request the full maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs, the intent of Balance of Supply treatment phase listings is to circumvent the need for another written-only authority application to be completed, as a written-only authority application may not be practical in terms of providing timely access to continued treatment. Apply under a 'Balance of Supply' treatment phase (where available) when either the full maximum quantity or repeat prescriptions available under a particular treatment phase, was not requested and where the biological medicine has had insufficient time to demonstrate an adequate response. Where the preceding supply has been adequate to provide at least 12 weeks of treatment and has resulted in an adequate response, it may be more practical to access further treatment under 'Continuing treatment'. (2) Baseline measurements to determine response. Determination of response to treatment must be based on baseline measurements of the joint count, ESR and/or CRP provided with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements demonstrating elevation of both joint count and markers of inflammation any time that an initial treatment authority application is provided and the eligibility for continuing treatment must be assessed according to these revised baseline measurements. To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must 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 determined on the total number of major joints. Applications under the Initial 1 treatment restriction for a new patient must include a joint count and ESR and/or CRP measured at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than 4 weeks old at the time of application. Applications under the Initial 3 treatment restriction for recommencement of treatment after a break in biological medicine of more than 24 months must include a joint count and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application. **Biosimilar prescribing policy** Prescribing of a biosimilar brand where available is encouraged for treatment naive patients. Prescribing notes (4)Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday). Encouraging biosimilar prescribing for treatment naive patients is Government policy. A viable biosimilar market is expected to result in reduced costs for biological medicines, allowing the Government to reinvest in new treatments. Further information can be found on the Medicines webpage (www.health.gov.au/health-topics/medicines). PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy of the biological medicines for adults with severe active rheumatoid arthritis. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid arthritis'. Some benefits are not biological medicines, but are small molecules. However, for practical purposes, these benefits are included within the term 'biological medicine'. Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid arthritis. Upon 5 inadequate responses to biological medicines with the specific PBS indication of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular biological medicine has provided an inadequate response, it must not be subsidised again. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered a treatment failure. (1) Selecting the correct 'Treatment phase' listing to apply under Initiating subsidy: (i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised biological medicine treatment; or (ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised treatment has at least been initiated through any Initial 1 listing, but the prescribed biological medicine is changing, (b) there has been a break in biological medicine of less than 24 months, but resumption of treatment is with the same biological medicine last prescribed, (c) there has been a break in biological medicine of less than 24 months and resumption of treatment is with a different biological medicine to that last prescribed, (d) treatment with rituximab has occurred within the past 24 months and is the most recent therapy prescribed leading up to this authority application, irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered before and after rituximab. Initial 2 does not require markers of inflammation/joint count to be re-established - those recorded in the first Initial 1 application can remain as baseline measures. Prerequisite DMARD treatments need not be re-proven to be inadequate. The prescribed biological medicine may be changed at any time, regardless of whether the current prescribed biological medicine has been obtained through Initial treatment or Continuing treatment. However, the change in biological medicine cannot be back to the same biological medicine where that medicine has provided an inadequate response. (iii) Apply through 'Initial 3 treatment' where treatment is recommencing following a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can include rituximab where prescribed as the most recent treatment - the 24 month break in therapy is from the second dose of the prior rituximab course. Response assessment to any course of PBS-subsidised biological therapy must follow a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment and Continuing treatment clearly do reflect this requirement. Where a response assessment is not conducted with a 'Continuing treatment' application, the biological medicine will be assumed to have failed, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Authority applications for patients who experienced adverse reaction necessitating permanent treatment withdrawal should be submitted through 'Initial 2 treatment' or 'Initial 3 treatment'. Indicate where the adverse reaction has occurred in the authority application. Continuing subsidy: Apply under a 'Continuing treatment' phase listing only where treatment has initiated through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint count) demonstrate response following at least 12 weeks of treatment. Continuing treatment should never precede Initial treatment where the same biological medicine is being prescribed. The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid arthritis with the same biological medicine'. Where treatment of severe rheumatoid arthritis is continuing with a different biological medicine, 'Continuing treatment' is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis with a different biological medicine' - see 'Initial 2 treatment' where continuing treatment is with a different biological medicine. 'Continuing treatment' is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment. Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing', the next authority application following immediately after any 'Initial treatment' authority application is to be through 'First continuing'. Following this, the next authority application is to occur under the 'Subsequent continuing' treatment phase. Assuming the drug continues to provide an adequate response, 'Subsequent continuing' is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment. Balance of Supply listings: Maximum quantities and the number of repeats stated in a PBS-listing are values that prescribers may seek up to, but are not obligated to prescribe. From time to time, there may be particular reasons why a prescriber may elect not to request the full maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs, the intent of Balance of Supply treatment phase listings is to circumvent the need for another written-only authority application to be completed, as a written-only authority application may not be practical in terms of providing timely access to continued treatment. Apply under a 'Balance of Supply' treatment phase (where available) when either the full maximum quantity or repeat prescriptions available under a particular treatment phase, was not requested and where the biological medicine has had insufficient time to demonstrate an adequate response. Where the preceding supply has been adequate to provide at least 12 weeks of treatment and has resulted in an adequate response, it may be more practical to access further treatment under 'Continuing treatment'. (2) Baseline measurements to determine response. Determination of response to treatment must be based on baseline measurements of the joint count, ESR and/or CRP provided with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements demonstrating elevation of both joint count and markers of inflammation any time that an initial treatment authority application is provided and the eligibility for continuing treatment must be assessed according to these revised baseline measurements. To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must 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 determined on the total number of major joints. Applications under the Initial 1 treatment restriction for a new patient must include a joint count and ESR and/or CRP measured at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than 4 weeks old at the time of application. Applications under the Initial 3 treatment restriction for recommencement of treatment after a break in biological medicine of more than 24 months must include a joint count and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application. Biosimilar prescribing policy Prescribing of a biosimilar brand where available is encouraged for treatment naive patients. Other listings for Tocilizumab Concentrate for injection 400 mg in 20 mL ------------------------------------------------------------------------ [Public10064QMaximum 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/10064Q)[Public10072DMaximum 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/10072D)[Public12763RMaximum 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/12763R)[Public12802TMaximum 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/12802T)[Public1482BMaximum 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/1482B)[Public15442RMaximum 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)](/p/15442R)[Public13299YMaximum 2 units · 5 repeats - Systemic Juvenile Idiopathic Arthritis - Continuing treatment](/p/13299Y)[Public13339CMaximum 1 units · 5 repeats - Juvenile Idiopathic Arthritis (Active, Severe) - Continuing treatment](/p/13339C)[Public13715WMaximum 1 units · 5 repeats - Rheumatoid Arthritis (Severe Active) - Subsequent continuing treatment](/p/13715W)[Public15430DMaximum 1 units · 5 repeats - Rheumatoid Arthritis (Severe Active) - First continuing treatment - balance of supply - Rheumatoid Arthritis (Severe Active) - First continuing treatment](/p/15430D) 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/).