Orencia (abatacept) medicines 2024 shortage

The information that follows on this page is no longer current. 

In April 2024, the pharmaceutical company Bristol-Myers Squibb Australia (BMS) notified us of shortages of both Orencia (abatacept) 125 mg/mL products for subcutaneous administration. Although the ClickJect (autoinjector) presentation is now available to order, the pre-filled syringe presentation is expected to remain in short supply until the end of September 2024: 

These shortages occurred due to manufacturing delays and consequently an increase in consumer demand. 

Serious Scarcity Substitution Instrument

To facilitate availability, we have made a Serious Scarcity Substitution Instrument (SSSI) that allows a pharmacist to dispense a ClickJect (autoinjector) to someone with a script for the prefilled syringe, and the other way around. 

The SSSI for Orencia (abatacept) started on 15 May 2024 and will finish on 31 October 2024.

Medicine Shortages Action Group

As Orencia is an important medicine used to treat certain types of arthritis, including rheumatoid arthritis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis, we created a Medicine Shortages Action Group (MSAG) and are worked with the Australian Rheumatology Association (ARA), Arthritis Australia (AA), BMS and pharmacy groups to minimise the impact of the shortage as much as possible.

Information for patients and their carers

The pharmaceutical company Bristol-Myers Squibb Australia (BMS) has notified us that Orencia ClickJect (autoinjector) is now available. However, Orencia Prefilled syringe remains in shortage until end September 2024.

While the supply situation has improved, please seek advice from your specialist before modifying your treatment regimen.

As supply stabilises, you may need to switch between the Orencia prefilled syringe and the ClickJect (autoinjector), when only one of these products is available. 

• Both products contain the same medicine (abatacept), at the same strength (125 mg/mL), and are given by subcutaneous injection, but the injection device is different.
• At your next appointment with your specialist, ask them to show you how to use both products in case you need to switch temporarily.
• If your pharmacist offers you a substitute medicine, they should explain the differences between the prefilled syringe and the ClickJect (autoinjector) and how to give the product you have been switched to.
• Talk to your specialist or pharmacist if you have any questions about this substitution.
• For more information, go to the Arthritis Australia website.

Information for prescribers

As notified by Bristol-Myers Squibb Australia (BMS), the shortage of Orencia ClickJect (autoinjector) has resolved and supply of subcutaneous presentations has improved. 

As a result, BMS have ceased the Orencia Stock Hypercare Plan (OSHP) ordering mechanism. Therefore, the eligibility form is no longer required for patients, effective 1 August 2024. 

Orencia Prefilled syringe remains in shortage until end September 2024.

The Australian Rheumatology Association (ARA) published guidance when the shortage commenced, which included recommendations that:

• no new patients should be started on subcutaneous or intravenous abatacept
• patients should be switched to an alternative biological or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) where possible
• stock should be conserved for patients who have previously used two other b/tsDMARDs, or who have a relative or absolute contraindication to other b/tsDMARDs.

During the shortage, if a pharmacist has only one of the Orencia subcutaneous products in stock, they can dispense either the ClickJect (autoinjector) or the prefilled syringe to a patient, regardless of which is prescribed (see Serious Scarcity Substitution Instrument- external site (SSSI), above). 

To assist with supply, we approved the importation and supply of two overseas-registered abatacept subcutaneous products under section 19A of the Therapeutic Goods Act 1989. The syringe form (BMS China) is subsidised on the Pharmaceutical Benefits Scheme (PBS). Detailed information about these products is available on the Section 19A approvals database.  

In cases where a patient is unfamiliar with the product they are getting, the pharmacist may give them information about how to administer the substitute product, or they may ask them to contact you or another suitably qualified health practitioner for guidance.

Pharmacists will advise patients to contact you if neither Orencia subcutaneous medicine is available. 

Information for pharmacists

As advised by BMS, the shortage of Orenica Clickjet (autoinjector) has resolved. 

BMS has discontinued the Orencia Stock Hypercare Plan (OSHP) ordering mechanism and you are no longer required to submit the completed OSHP eligibility form to order Orencia stock. Normal ordering processes have now resumed for available subcutaneous presentations.

For any concerns regarding the OHSP ordering process, please contact BMS directly on 1800 067 567.

To assist with supply, we have approved the importation and supply of two overseas-registered abatacept subcutaneous products under section 19A of the Therapeutic Goods Act 1989. The syringe form (BMS China) is subsidised on the Pharmaceutical Benefits Scheme (PBS). Pharmacists can search for ‘Orencia’ on the Section 19A approvals database for details about the companies supplying these products and their contact details. It is important to note that there can be a slight delay in stock being readily available for ordering after a section 19A approval is granted.

The Serious Scarcity Substitution Instrument (SSSI, see above) allows you to substitute a ClickJect (autoinjector) to someone with a script for the prefilled syringe, and the other way around. You can do this without prior approval from the prescriber if you follow the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2) of the SSSI. The following also applies when using this SSSI to substitute one Orencia subcutaneous product with the other:

• Use your professional judgement to assess the patient’s capacity to understand the substitution, and to determine if substituting the medicine is appropriate for the patient. You will also need to get their consent to accept the substitution. 
• You will need to instruct the patient on how to administer the substitute product, or you can refer them to their prescriber, GP or nurse to do this. 
• When explaining the substitution to patients and to get their consent, you can use Consumer Medicine Information (CMI) leaflets or an abatacept medication leaflet, as well as instructional leaflets and videos from BMS, to aid their understanding. You can also use translation services, the help of a carer or assistance from organisations such as a local Aboriginal Community Controlled Health Organisation (ACCHO) to ensure the patient fully understands the situation. 

Substituting one Orencia subcutaneous product for the other may not be appropriate for some patients. This may be due to a patient’s limited dexterity, for example, or because of other medical conditions. If you have assessed that a substitution is not appropriate, refer the patient back to their prescriber for review of their treatment.

We will publish Medicine Shortage Alerts and update this page as we get new information. You can also find up-to-date information on our Medicine shortage reports database.