PBS Arrangements for tocilizumab shortage
Page last updated: 20 August 2021
The sponsor of tocilizumab (Actemra), Roche Products Pty Limited, has notified the Therapeutic Goods Administration (TGA) of shortages of multiple presentations of tocilizumab (Actemra) products due to global demand in response to the COVID-19 pandemic. A joint advice statement for prescribers, prepared by the TGA in consultation with the Australia Rheumatology Association and Arthritis Australia is available at Shortages of tocilizumab (Actemra) medicines | Therapeutic Goods Administration (TGA)
In response to this shortage, the Department has been working with Services Australia to facilitate patient access to appropriate continuing treatment options via the Pharmaceutical Benefits Scheme (PBS).
Information for Prescribers
The following PBS arrangements have been put in place to facilitate access to appropriate continuing treatment for patients currently prescribed tocilizumab who are unable to access their medicine due to the shortage. These arrangements will be in place from 15 August 2021 until further notice, or the shortage of tocilizumab has been resolved.
Existing patients – Severe active rheumatoid arthritis or severe active juvenile idiopathic arthritis
Switching from subcutaneous tocilizumab to intravenous tociluzumab
If a prescriber considers it appropriate to switch from tocilizumab subcutaneous to intravenous form, they can request the balance of treatment through the relevant Balance of Supply (BOS) restriction in real time using the Online PBS Authorities System.
Switching from tocilizumab to an alternative biological disease modifying drug (bDMARD)
If a prescriber considers it appropriate to switch to an alternative bDMARD, an exemption applies to the PBS requirement of demonstrating response if it’s not possible due to the shortage. Prescribers must note on the change / recommencement authority application form that the change in therapy and inability to demonstrate response is due to the tocilizumab shortage.
Switching back to tocilizumab from an alternative bDMARD
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, an exemption applies to the PBS requirement of demonstrating response to the alternative bDMARD, if the patient hasn’t competed 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.
Patients continuing on alternative therapy
If a prescriber changes therapy to an alternative bDMARD and treatment continues beyond 16 weeks, evidence of a response must be submitted to Services Australia according to PBS listing requirements. Where a response assessment is not conducted within the specified timeframe and submitted to Services Australia, the patient will be deemed to have failed to respond to treatment with the drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. However, a change back to treatment with tocilizumab will not be impeded providing the patient hasn’t previously failed to respond to tocilizumab.
When requesting authority approval for tocilizumab, prescribers must note on the authority application that the patient was affected by the tocilizumab shortage and wishes to resume Tocilizumab treatment.
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 consider the advice provided in the joint statement from the TGA, Australian Rheumatology Association and Arthritis Australia.
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 consider the advice provided in the joint statement from the TGA, Australian Rheumatology Association and Arthritis Australia.
Information for Pharmacists
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 an 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.