PBS Arrangements for tocilizumab shortage – 1 November 2021
Page last updated: 29 October 2021
In response to the shortages of multiple presentations of tocilizumab (Actemra®) products, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended temporary changes to the Pharmaceutical Benefits Scheme (PBS) listings for biological medicines in order to facilitate timely access to appropriate alternative therapies. These changes will avoid inaccurate categorisation and recording of the switch from tocilizumab to an alternative, as a treatment failure with Services Australia. To minimise the impact of this shortage to patients, the PBAC recommended these listings should provide prescribers and patients with increased time (up to 24 weeks) to demonstrate response to the new therapy.
Further information regarding the shortage is available at Shortages of tocilizumab (Actemra) medicines | Therapeutic Goods Administration (TGA)
Information for Prescribers
New, temporary listings have been applied to medicines currently PBS listed for the treatment of severe active rheumatoid arthritis (abatacept, adalimumab, baricitinib, certolizumab, etanercept, golimumab, infliximab, rituximab, tofacitinib, and upadacitinib) and for the treatment of severe active juvenile idiopathic arthritis (adalimumab and etanercept).
These listings include:
- Initial treatment – Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
Prescribers can request initial treatment in writing via mail or through the form upload facility in Health Professional Online Services (HPOS). Further, prescribers may request up to 24 weeks treatment under this listing, at which time the patient must demonstrate a response to treatment in order to access continuing treatment.
- Initial treatment – Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab) – Balance of Supply.
Prescribers can request the balance of treatment for certain biological medicines (abatacept, certolizumab and infliximab) through a Balance of Supply (BOS) restriction in real time using the Online PBS Authorities System or by telephone.
- First continuing treatment – Temporary listing
Prescribers can request continuing treatment through the written/upload. Prescribers may request up to 24 weeks treatment under this listing. Requests may be made in writing via mail or through the form upload facility in HPOS.
These arrangements will be in place from 1 November 2021 until the shortage of tocilizumab has been resolved.
Once the shortage has resolved, prescribers will be able to transfer their patients back to therapy with tocilizumab should they choose to do so. Temporary listings are planned that will enable patients to transfer back to tocilizumab, that avoid inaccurate categorisation and recording of the switch back to tocilizumab from alternative treatment, as a treatment failure with Services Australia.
Existing patients – Systemic juvenile idiopathic arthritis
There are no alternative bDMARD listed on the PBS for the treatment of systemic juvenile idiopathic arthritis. Prescribers should check the Therapeutic Goods Administration (TGA) website for advice on conservation of stock of tocilizumab for this patient population.
Existing patients – Active Giant Cell Arteritis
There are no alternative bDMARD listed on the PBS for the treatment of active giant cell arteritis. Prescribers should check the Therapeutic Goods Administration (TGA) website for advice on conservation of stock of tocilizumab for this patient population.
Information for Pharmacists
A list of the item codes for the new temporary listings, and corresponding medicine, is available at Summary of PBS Item Codes for switching from tocilizumab due to shortage (PDF 133KB) - (Word 21KB). Please take care when selecting the appropriate item code.
To assist with timely access for patients prescribed subcutaneous formulations of tocilizumab the TGA has made a Serious Scarcity Substitution Instrument (SSSI). For details of the SSSI please refer to Tocilizumab (Actemra) Serious Scarcity Substitution Instrument | Therapeutic Goods Administration.
Information about PBS subsidy arrangements for PBS listed medicines subject to a SSSI may be accessed on the PBS website Pharmaceutical Benefits Scheme (PBS) | Serious Shortage Medicine Substitution
Information for consumers
If you (or someone you provide care for) uses tocilizumab (Actemra®), you should contact your prescriber as soon as possible for further guidance on managing treatment during the shortage.
If you are prescribed either the Actemra® pre-filled syringe or the ACTPen autoinjector, you may need to switch between these two Actemra® products during the shortage. Ask your specialist to show you how to use both medicines products in case you need to swap temporarily.
