Information about the Tocilizumab (Actemra®) Shortage

Update 4 May 2022: The shortage of subcutaneous tocilizumab preparations has been resolved.

This information has been published on the TGA’s medicine shortage reports database.

The Serious Scarcity Substitution Instrument (SSSI) for the SC preparations of tocilizumab has now lapsed due to this improvement in supply. 

The TGA webpage Serious Scarcity Substitution Instruments (SSSIs) is in the process of being updated to reflect the lapsing of the SSSI.

Please note that the supply of IV tocilizumab remains constrained and the current shortage notifications for these preparations are still in place.

As per the update in early March 2022 the supply of IV preparations will be limited to 50% of pre-pandemic levels until mid 2022. Therefore the recommendations for the use of IV tocilizumab remain the same as communicated in March. 

Systemic juvenile idiopathic arthritis (sJIA) patients and polyarticular juvenile idiopathic arthritis (pJIA) patients 

  • Patients undergoing IV tocilizumab treatment for sJIA and pJIA may resume their normal dosing regimen.
  • Patients with sJIA and pJIA can be initiated on IV tocilizumab if required.

Adult rheumatoid arthritis patients

  • Adult patients who have been continued on IV tocilizumab treatment for rheumatoid arthritis during the shortage may resume their normal dosing regimen if dosing intervals have been increased during the shortage.
  • For those adult patients who were previously on IV tocilizumab and were switched to alternative biologic or targeted synthetic agent due to the tocilizumab shortage but are now experiencing flare may resume IV tocilizumab.
  • Adult patients who were switched from IV tocilizumab to abatacept can be switched back to IV tocilizumab.
  • Consider initiation of IV tocilizumab in adult RA patients if clinically indicated.

 

 

Update March 2022:

There is currently a global shortage of tocilizumab (Actemra®).  As a result tocilizumab products are currently in limited supply in Australia. If you are currently taking tocilizumab (Actemra®), these shortages may affect your treatment.

Arthritis Australia continues to work with the Therapeutic Goods Administration (TGA), Roche Australia, and the Australian Rheumatology Association (ARA) to manage the shortage and communicate to consumers.


IV tocilizumab consumers

Supply is improving and hospitals are receiving increased allocations of IV tocilizumab, however these will still be less than pre-pandemic levels.

Due to the improved outlook, some further changes have been made to the recommendations for use for those consumers who are currently or previously on IV tocilizumab.

The new ARA recommendations are as follows:

Systemic juvenile idiopathic arthritis (sJIA) consumers and polyarticular juvenile idiopathic arthritis (pJIA) consumers

  • Consumers undergoing IV tocilizumab treatment for sJIA and pJIA may resume their normal dosing regimen.
  • Consumers with sJIA and pJIA can be initiated on IV tocilizumab if required.

Adult rheumatoid arthritis consumers

  • Adult consumers who have been continued on IV tocilizumab treatment for rheumatoid arthritis during the shortage may resume their normal dosing regimen if dosing intervals have been increased during the shortage.
  • For those adult consumers who were previously on IV tocilizumab and were switched to alternative biologic or targeted synthetic agent due to the tocilizumab shortage but are now experiencing flare may resume IV tocilizumab.
  • Adult consumers who were switched from IV tocilizumab to abatacept can be switched back to IV tocilizumab.
  • Consider initiation of IV tocilizumab in adult RA consumers if clinically indicated.

Consumers should contact their rheumatologists for further advice.

Any changes to the availability of IV tocilizumab products will be communicated to consumers and rheumatologists.

 

Subcutaneous (SC) tocilizumab consumers

Supply of subcutaneous tocilizumab is improving.  Due to the improved supply, the ARA now recommend that:

  • Adult consumers who were switched from SC tocilizumab to abatacept can be switched back to SC tocilizumab

Consumers should contact their rheumatologists for further advice. To assist consumers, the tocilizumab Serious Scarcity Substitution Instrument (SSSI) has been extended until 30 April 2022. The SSSI makes sure that pharmacists can offer adult consumers whichever subcutaneous presentation is available at the pharmacy without the need for a new script.

Frequently asked questions 

Am I eligible for IV tocilizumab?

At this time, IV tocilizumab is available to consumers with:

  • Systemic Juvenile Idiopathic Arthritis
  • Polyarticular Juvenile Idiopathic Arthritis
  • Rheumatoid arthritis who have stayed on tocilizumab with extended dosing intervals
  • Rheumatoid arthritis who were previously on IV tocilizumab and were switched to alternative biologic or targeted synthetic agent due to the shortage, but are now experiencing flare requiring prednisolone
  • Cytokine release syndrome

My doses of tocilizumab have been spaced out but I am having flares – how can I access more tocilizumab?

If your doses were spaced out due to the shortage it is now recommended that you go back to your normal dosing regimen.

As per the ARA recommendations above:

  • Adult consumers who have been continued on IV tocilizumab treatment for rheumatoid arthritis during the shortage may resume their normal dosing regimen if dosing intervals have been increased during the shortage. Contact your rheumatologist to discuss your treatment.

I have been switched to another medicine but it’s not working well for me – can I go back to using tocilizumab?

Paediatric consumers may resume their normal dosing regimen of tocilizumab.

As per the ARA recommendations above:

  • Adult consumers who have been continued on IV tocilizumab treatment for rheumatoid arthritis during the shortage may resume their normal dosing regimen if dosing intervals have been increased during the shortage. Contact your rheumatologist to discuss your treatment.

My hospital doesn’t have enough tocilizumab for my treatment. What can I do?

Supply is improving so hospitals should be able to obtain stock for you if you fit the criteria above. Your rheumatologist can contact Roche Australia if you continue to have problems accessing tocilizumab

Why is there a shortage?

The shortage is due to increased global demand for tocilizumab for use in people who are severely ill with COVID-19.

Who is affected?

In Australia, tocilizumab is used to treat children and adults with the following conditions:

  • rheumatoid arthritis (RA)
  • systemic juvenile idiopathic arthritis (sJIA)
  • polyarticular juvenile idiopathic arthritis (pJIA)
  • giant cell arteritis (GCA)
  • cytokine release syndrome (CRS).

How long is the shortage expected to last?

The supply of all tocilizumab products is expected to remain limited until at least the first half of 2022.

Which products are affected by the shortage?

All tocilizumab products are affected:

  • There is limited stock of the intravenous (IV) presentations used for infusions
  • Supply of the pre-filled syringes and ACTPen Autoinjector is improving but is still less than pre-pandemic levels. However existing consumers should be able to access one or the other and the pharmacist can switch these for you at the pharmacy without you needing to get a new prescription from your rheumatologist.

What steps are being taken to manage the shortage?

The Therapeutic Goods Administration (TGA) is working with Roche and other stakeholders to manage supply to reduce the impact of the current shortage on those taking tocilizumab.

What will happen with my treatment?

As supply of tocilizumab is improving, you may be able to start or recommence back on tocilizumab therapy. It is important to talk to your rheumatologist to discuss managing your treatment during this shortage.

If you have sJIA, pJIA or GCA, you should be able to resume your normal dosing regimen and new consumers can start using tocilizumab if needed.If you are an adult RA consumer who has continued on IV tocilizumab treatment during the shortage, you may now resume your normal dosing regimen.

If you were switched to a different medicine due to the tocilizumab shortage but are now experiencing flares you may resume IV tocilizumab.

If you were switched from IV tocilizumab to abatacept (which is now in shortage) you can be switched back to IV tocilizumab.

New adult RA consumers can also be commenced on IV tocilizumab if your rheumatologist recommends it.

What alternative treatments are available?

Alternative biologic treatments are available for people with RA.  If you need to switch medicines, your rheumatologist can advise the best alternative treatment for you.

What if I have already tried 3 or 4 biologics that have not worked for me?

As supply of tocilizumab is improving, you may be eligible to recommence therapy with tocilizumab. New treatment options have also become available in recent times which may be effective.  You should discuss these options with your rheumatologist.

What if my pharmacist doesn’t have stock?

If you have a script for the prefilled syringe or the ACTPen, you should contact your pharmacist well before your supply runs out, to order your medication.

Your pharmacist should be able to order either the prefilled syringe or the ACTPen. If your pharmacist says they have no stock, ask them to continue to check with their wholesaler directly (rather than through a portal), or to try a different wholesaler.

If you are an adult and use the prefilled syringe or ACTPen autoinjector you might need to swap between these two products.  Ask your rheumatologist, GP or rheumatology nurse to show you how to use both types in case you need to swap.  Alternatively, contact Roche Medical Information on 1800 233 950 or [email protected]  for information on how to use these products.

If I need to change treatment, what will happen if I don’t do as well on the new treatment?

Talk to your rheumatologist as soon as possible to review your treatment if you are not doing well on the new treatment. You may be able to switch back to tocilizumab as supply is improving.

It may help to talk to your rheumatology team in advance to develop a flare action plan.

For arthritis information and access to local support services, call the Arthritis Infoline on 1800 011 041 or contact the organisations listed below.

If I don’t do well on the new treatment, will that affect my future eligibility for biologics?

If you do not respond to the new treatment, this will not count as a ‘fail’ unless the alternative treatment continues for longer than 16 weeks.

Will I be able to go back to tocilizumab when supply returns to normal?

You will be able to resume tocilizumab treatment when supply returns to normal.

Will I be able to stay on the new treatment if that works for me?

You will be able continue on the new treatment if it works for you.

 

Further information and support

Useful links for Pharmacists

  • Information for pharmacies can be found on the TGA website here and as a downloadable pdf here
  • Please note that pharmacists will need to call wholesalers to order tocilizumab. Wholesaler portals will likely show zero stock quantity for both subcutaneous medicines, even if they are available.


Additional useful links

  • Further information can be found on the TGA website here
  • PBS Arrangements for tocilizumab shortage can be found here

 

Tocilizumab Consumer Webinar

A Consumer Webinar was held and recorded on 8 September 2021 to share more about this issue and  have questions answered by:

      • Professor Catherine Hill, President, Australian Rheumatology Association
      • Elspeth Kay, Assistant Secretary, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration
      • Dr Ben Whitehead, Paediatric Rheumatologist
      • Stuart Knight, General Manager, Roche Products Pty Limited
      • Jonathan Smithers, CEO Arthritis Australia
      • Franca Marine, Policy and Government Relations Manager, Arthritis Australia

Watch the Webinar

 

 

Updated: March 2022