In January 2022, Bristol-Myers Squibb Australia Pty Ltd (BMS), the sponsor of abatacept (Orencia), notified the Therapeutic Goods Administration (TGA) of shortages of multiple presentations of abatacept products. The shortages occurred because of manufacturing capacity constraints, supplier component challenges and shipment delays. There is no impact to the quality of abatacept.
Abatacept is used to treat certain types of arthritis including rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. Abatacept is listed on the Pharmaceutical Benefits Scheme (PBS) for severe active rheumatoid arthritis.
The shortages are across both subcutaneous (SC) presentations of abatacept and are expected to continue throughout the first half of 2022.
Supply of abatacept differs between the intravenous (IV) and subcutaneous presentations:
- Supply of both subcutaneous presentations (ClickJect prefilled autoinjector and prefilled syringe) is expected to be limited throughout the first half of 2022, and the availability of these presentations will be variable.
- There is sufficient stock of IV abatacept to support current IV patients only.
Because of this shortage, the usage of subcutaneous abatacept presentations must be significantly reduced. Patients requiring continued access to subcutaneous abatacept will be given a form from their prescriber to take to their pharmacy. Pharmacists will be able to offer whichever abatacept subcutaneous product is available to patients during the shortage under the Serious Scarcity Substitution Instrument for abatacept, without the need for a new prescription.
BMS are monitoring the situation closely and are actively working to minimise the impact of the shortages. Any updates will be published on the Medicine Shortage Reports Database.
Because there is very limited availability of subcutaneous abatacept presentations, the TGA has been working closely with the Australian Rheumatology Association (ARA), Arthritis Australia and BMS to manage these shortages and minimise their impact on patients in Australia. The availability of abatacept subcutaneous presentations will slowly increase throughout 2022.
Information for consumers
Because there will be limited amounts of abatacept prefilled syringe and ClickJect prefilled autoinjector throughout the first half of 2022, specialists will work to greatly reduce the usage of abatacept. Your specialist may need to change your treatment.
You should contact your specialist to discuss treatment options as soon as possible.
If you are staying on abatacept, your specialist will give you a form to take to your pharmacy. When you go to the pharmacy to get your abatacept, give the form to your pharmacist with your script. They need the form to order your medicine.
You may need to switch between the abatacept prefilled syringe or the ClickJect prefilled autoinjector during the shortage. Your pharmacist can offer you whichever subcutaneous product is available while the Serious Scarcity Substitution Instrument for abatacept, is in force during the shortage. At your next appointment, ask your specialist to show you how to use both products in case you need to swap temporarily. If you are offered a substitute medicine, your pharmacist will explain to you the differences between the prefilled syringe and the ClickJect autoinjector and how to administer it.
