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

Concentrate for injection 200 mg in 10 mL

SavePrivate hospital

PBS item code15476MMaximum quantity1 units

Repeats0

More detailsProgramHS

AdministrationINJECTION

Benefit typeA

Brands

- Avtozma[TGA record](https://www.tga.gov.au/resources/artg/444939 "TGA ARTG record 444939")[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$226.95

Avtozma · s94-private-s100$217.98

Restrictions &amp; indications
------------------------------

AUTHORITY REQUIRED

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)

Show full PBS criteriaHide full PBS criteriaSevere active rheumatoid 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 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 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.

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.

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).

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.

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.

Notes (2)The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for adults with severe active rheumatoid arthritis. This listing is a temporary listing and is only to be used to transfer patients back to tocilizumab from another biological medicine, where treatment was changed due to unavailability of tocilizumab due to the critical medicines shortage.

The term biological medicine refers to the tumour necrosis factor (TNF) alfa antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), the chimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab), the T-cell co-stimulation modulator (abatacept) and the Janus kinase (JAK) inhibitors (baricitinib, tofacitinib, upadacitinib).

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 the biological medicines for adults with severe active rheumatoid arthritis. This listing is a temporary listing and is only to be used to transfer patients back to tocilizumab from another biological medicine, where treatment was changed due to unavailability of tocilizumab due to the critical medicines shortage. The term biological medicine refers to the tumour necrosis factor (TNF) alfa antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), the chimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab), the T-cell co-stimulation modulator (abatacept) and the Janus kinase (JAK) inhibitors (baricitinib, tofacitinib, upadacitinib).

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 200 mg in 10 mL
------------------------------------------------------------------------

[Public10056GMaximum 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/10056G)[Public10058JMaximum 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/10058J)[Public12791FMaximum 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/12791F)[Public12796LMaximum 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/12796L)[Public1481YMaximum 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/1481Y)[Public13305GMaximum 1 units · 5 repeats

- Juvenile Idiopathic Arthritis (Active, Severe) - Continuing treatment](/p/13305G)[Public13330NMaximum 2 units · 5 repeats

- Systemic Juvenile Idiopathic Arthritis - Continuing treatment](/p/13330N)[Public13684FMaximum 1 units · 5 repeats

- Rheumatoid Arthritis (Severe Active) - Subsequent continuing treatment](/p/13684F)

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/).
