Joint statement: Supply allocations of intravenous tocilizumab (Actemra) during serious shortage

Roche Products Pty Limited (Roche), the sponsor of tocilizumab (Actemra), notified the TGA of shortages of multiple presentations of tocilizumab products due to a significant increase in global demand for tocilizumab arising from its use in treating critically ill COVID-19 patients. Global supply is now extremely limited and patient-level shortages are expected until early 2022.

This statement has been co-developed by the Therapeutic Goods Administration (TGA) and:

• The Australian Rheumatology Association.
• The Medicine Availability Working Group comprising representatives from state and territory health departments
• National Pharmaceutical Services Association and other pharmaceutical wholesalers
• Roche Products Pty Limited

Allocations of IV tocilizumab

Due to extremely limited stock of intravenous (IV) tocilizumab until early 2022, supply must be tightly constrained to conserve stock for patients who have no alternative therapies (refer to priority indications below). TGA's assessment of supply indicates stock will run out unless use of current stocks of IV tocilizumab is urgently reduced to 25% of previous (May 2020-May 2021) usage.

Effective immediately, supply of IV tocilizumab (Actemra) from wholesalers will unfortunately be reduced to:

• 25% of usual supply for public hospitals
• 10% of usual supply for private hospitals and community pharmacy.

Wholesalers will allocate stock to individual hospitals and pharmacies based on an average of 12 months of sales prior to when the shortage began. Customers will be limited to purchasing a proportion of their average monthly purchases. Roche will no longer supply Actemra IV directly to hospitals and pharmacies.

These allocations have been developed to support access to patients in greatest need of tocilizumab. We will continue to monitor stock and will review constraints monthly. Hospitals and pharmacies must urgently implement conservation methods to manage stock they have available.

We understand this is a very difficult situation for patients and health professionals. The TGA will continue to work with stakeholders to communicate with and assist patients and health professionals manage treatment during the shortage.

Priority indications

All patients who are able to, should be moved from intravenous tocilizumab to another treatment during the shortage. Clinicians should prioritise use of their existing and new stock for the priority conditions listed below.

Stakeholders have agreed on priority registered indications for each presentation based on severity of the condition and lack of alternative treatments.

Priority indications for IV tocilizumab

• Cytokine Release Syndrome (CRS)
• Systemic juvenile idiopathic arthritis (sJIA)
• Polyarticular juvenile idiopathic arthritis (pJIA)

Off-label use for COVID-19

Although treatment of patients with COVID-19 is not a registered indication, patients in ICU who are mechanically ventilated or unable to take alternative treatments (pdf,145kb) (such as baricitinib) are also considered high-priority to receive IV tocilizumab.

Patients with the above indications have no or very few alternative treatments. Therefore, hospitals and clinics should ensure stock of IV tocilizumab is reserved for these patients.

Patients who are prescribed IV tocilizumab for rheumatoid arthritis should be switched to alternate treatments immediately wherever possible.

Priority indications for subcutaneous tocilizumab

Stakeholders agreed that priority conditions for subcutaneous presentations are:

• Systemic juvenile idiopathic arthritis (sJIA)
• Giant cell arteritis (GCA)
• Polyarticular juvenile idiopathic arthritis (pJIA)

Patients with the above indications for subcutaneous tocilizumab have no or very few alternative treatments. Therefore, supply of subcutaneous tocilizumab should be prioritised for patients with these indications.

Subcutaneous presentations of tocilizumab are available in limited quantities. New patients should not be started on subcutaneous tocilizumab unless there are no suitable alternative treatments.

Wholesalers have been advised to constrain supply of subcutaneous tocilizumab to usual purchasing history.

Background

To extend the supply of tocilizumab, the TGA have been working with a range of stakeholders to reduce usage and conserve stock for patients with no alternatives. Further information is available on the TGA website: Shortages of tocilizumab (Actemra) medicines.

In late August 2021, Roche advised that the global demand for tocilizumab had increased dramatically due to COVID-19 and supply of IV tocilizumab will be extremely limited until early 2022.

The TGA worked with Roche, pharmaceutical wholesalers, state and territory health department representatives on the Medicine Availability Working Group, the Australian Rheumatology Association, Medicines Australia and Arthritis Australia to establish a protocol for allocation of remaining IV tocilizumab stock.

Based on information from Roche, wholesalers and states and territories, the Medicine Availability Working Group have been regularly modelling tocilizumab availability. The most recent modelling shows that supply of IV tocilizumab would be exhausted by mid-October 2021 if usage continued at usual rates.

Supply constraints have been implemented to preserve stock for priority indications. Supply has been allocated to reflect the fact that patients with these conditions are primarily treated in the public hospital setting.

Quick Reference Information

Information for consumers/patients

• Tocilizumab (Actemra) is commonly used to treat rheumatoid arthritis.
• If you are being treated with tocilizumab (Actemra) contact your prescriber as soon as possible.
• If you have been receiving Actemra by an infusion, your specialist may prescribe a different medicine to treat your condition.
• If you use the prefilled syringe or ACTPen autoinjector, you might need to swap between these two medicines. Ask your prescriber, GP or rheumatology nurse to teach you how to use both types in case you need to swap.

Information for rheumatologists, private hospitals and clinicians treating existing tocilizumab patients in the community setting

• Reserve IV tocilizumab stock for priority conditions (Cytokine Release Syndrome and Juvenile Idiopathic Arthritis) and patients who are unable to switch medicines
• Contact patients treated with IV tocilizumab and switch to alternative treatments wherever possible
• Do not switch to subcutaneous presentations of tocilizumab, where possible
• Order through your usual wholesalers
• Additional stock may not be available beyond allocations. If stock is available, it will only be provided for priority conditions.
• Do not initiate new patients on IV or subcutaneous tocilizumab unless alternative treatments are contraindicated or not clinically appropriate.

Information for public hospitals

• Reserve IV tocilizumab stock for priority conditions (Cytokine Release Syndrome and Juvenile Idiopathic Arthritis) and patients who are unable to switch medicines
• Switch patients to alternative treatments wherever possible
• Do not switch to subcutaneous presentations of tocilizumab
• Order through your usual wholesalers
• Stock will be managed within jurisdictions. If you need additional supplies for priority patients, contact your jurisdictional health department representative. Note that additional supplies may be limited or not available.

Information for private hospital and community pharmacists

• Contact the prescriber to discuss alternative treatment options
• Do not order IV tocilizumab unless a patient presents a prescription
• Order stock through your usual wholesalers
• Subcutaneous presentations of tocilizumab are available in limited quantities
• The prefilled syringe and ACTPen autoinjector are interchangeable under the Serious Scarcity Substitution Instrument, if the conditions in the instrument are met.