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

Injection 162 mg in 0.9 mL single use pre-filled syringe

SaveGeneral schedule

PBS item code15446YMaximum quantity4 units

Repeats3

More detailsProgramGE

AdministrationINJECTION

Benefit typeA

Brands

- Avtozma

Dispensed price for maximum quantity (DPMQ)3 pricesAvtozma · Community pharmacy$760.99

Avtozma · Private hospital$735.10

Avtozma · Public hospital$715.84

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).

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.

Notes (4)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).

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 (4)No increase in the maximum quantity or number of units may be authorised.

No increase in the maximum number of repeats may be authorised.

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 Injection 162 mg in 0.9 mL single use pre-filled syringe
---------------------------------------------------------------------------------------

[General12102YMaximum 4 units · 0 repeats

- 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) - in a patient of any weight being administered a subcutaneous form of this biological medicine](/p/12102Y)[General11748HMaximum 4 units · 1 repeats

- Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - 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 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
- Juvenile Idiopathic Arthritis (Active, Severe) - Initial treatment - Initial 1 (new patient)
- 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)](/p/11748H)[General12105DMaximum 4 units · 1 repeats

- Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)
- Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 1 (new patient weighing less than 30 kg)
- Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)](/p/12105D)[General12768BMaximum 4 units · 1 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/12768B)[General11720WMaximum 4 units · 2 repeats

- Juvenile Idiopathic Arthritis (Active, Severe) - Continuing treatment](/p/11720W)[General12086DMaximum 4 units · 2 repeats

- Systemic Juvenile Idiopathic Arthritis - Continuing treatment in a patient weighing less than 30 kg](/p/12086D)[General13301CMaximum 4 units · 2 repeats

- Juvenile Idiopathic Arthritis (Active, Severe) - Continuing treatment](/p/13301C)[General10951JMaximum 4 units · 3 repeats

- Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
- Rheumatoid Arthritis (Severe Active) - Balance of supply - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
- 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)](/p/10951J)[General11741YMaximum 4 units · 3 repeats

- 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 24 months)
- 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) - Balance of supply - 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)](/p/11741Y)[General12095NMaximum 4 units · 3 repeats

- Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg)
- Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 1 (new patient weighing at least 30 kg)
- Systemic Juvenile Idiopathic Arthritis - Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)](/p/12095N)[General12762QMaximum 4 units · 3 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/12762Q)[General12806BMaximum 4 units · 3 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/12806B)[General15445XMaximum 4 units · 3 repeats

- Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 1 (new patient)
- Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
- Rheumatoid Arthritis (Severe Active) - Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)](/p/15445X)[General10954MMaximum 4 units · 5 repeats

- Rheumatoid Arthritis (Severe Active) - First continuing treatment - balance of supply
- Rheumatoid Arthritis (Severe Active) - First continuing treatment](/p/10954M)[General11730JMaximum 4 units · 5 repeats

- Juvenile Idiopathic Arthritis (Active, Severe) - First continuing treatment
- Juvenile Idiopathic Arthritis (Active, Severe) - Balance of supply - Continuing treatment
- Juvenile Idiopathic Arthritis (Active, Severe) - Subsequent continuing treatment](/p/11730J)[General11743CMaximum 4 units · 5 repeats

- Giant Cell Arteritis (Active) - Initial treatment](/p/11743C)[General12099TMaximum 4 units · 5 repeats

- Systemic Juvenile Idiopathic Arthritis - Continuing treatment in a patient weighing at least 30 kg](/p/12099T)[General13685GMaximum 4 units · 5 repeats

- Rheumatoid Arthritis (Severe Active) - Subsequent continuing treatment](/p/13685G)[General15432FMaximum 4 units · 5 repeats

- Juvenile Idiopathic Arthritis (Active, Severe) - Subsequent continuing treatment](/p/15432F)[General11721XMaximum 4 units · 6 repeats

- Giant Cell Arteritis (Active) - Continuing treatment](/p/11721X)[General15421PMaximum 4 units · 6 repeats

- Giant Cell Arteritis (Active) - Continuing treatment](/p/15421P)

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/).
