Tocilizumab
===========

Concentrate for injection 400 mg in 20 mL

SavePublic hospital

PBS item code15442RMaximum 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 &amp; indications
------------------------------

AUTHORITY REQUIRED

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)

Show full PBS criteriaHide full PBS criteriaSevere active juvenile idiopathic arthritis

Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)

Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND

Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND

Patient must not receive more than 16 weeks of treatment under this restriction; AND

Must be treated by a paediatric rheumatologist; or

Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND

Patient must be under 18 years of age.

If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.

If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.

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.

An adequate response to treatment is defined as:

(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, 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).

At the time of 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 one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.

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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months 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.

Notes (2)The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients who have severe active juvenile idiopathic arthritis.

This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.

Alternative biological medicine refers to adalimumab and etanercept.

Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant 'First continuing - Temporary listing' PBS listing.

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).

Prescribing notes (2)The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients who have severe active juvenile idiopathic arthritis. This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage. Alternative biological medicine refers to adalimumab and etanercept. Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant 'First continuing - Temporary listing' PBS listing.

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).

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)[Public15439NMaximum 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/15439N)[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/).
