This information was kindly shared with us by Arthritis Australia. It is current as of 24 April 2024.
Bristol Myers Squibb (BMS), the manufacturer of abatacept (Orencia®), has recently announced an expected shortage of both the ClickJect (autoinjector) and pre-filled syringe subcutaneous formulations of the medication.
According to BMS, a disruption in the supply chain is anticipated from June 2024, leading to the unavailability of abatacept for a period expected to be several months. BMS have advised that this is due to global supply chain issues and that Australia is not the only country affected.
In response to the shortage, BMS has worked with the Australian Rheumatology Association (ARA) and the Therapeutic Goods Administration (TGA) to manage supply, prioritising access for those most in need of uninterrupted treatment with abatacept. This means that the majority of patients currently using subcutaneous abatacept will need to switch to an alternative biological or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) to conserve stock for patients whose rheumatologist considers to have no or limited alternative treatment options.
Recommendations for Rheumatologists
The Australian Rheumatology Association (ARA) has issued recommendations to rheumatologists to manage the shortage effectively:
- Patients should be switched to an alternative b/tsDMARD where possible.
- New patients should not be started on abatacept. This includes both the subcutaneous (SC) and intravenous (IV) formulations.
- Stock should be reserved for patients who have previously used two other b/tsDMARDs or have a relative or absolute contraindication to other b/tsDMARDs.
- For eligible patients requiring continued abatacept treatment, consideration should be given to increasing the dosing interval if clinically appropriate.
- Patients should remain on single-dose syringe or ClickJect prefilled autoinjector formulations and not transition to the IV presentation except in exceptional circumstances.
Recommendations for People Who Currently Use Abatacept
BMS have put in place an Orencia® Stock Hypercare Plan (OSHP) to manage orders of abatacept (Orencia®) and dispensing from pharmacies over the period of the shortage.
Consumers will need to:
- Have their treating specialist (rheumatologist or clinical immunologist) confirm if they are eligible to continue on abatacept.
- Receive a completed OSHP Eligibility Form from their specialist and present it to their pharmacy (the form can also be emailed directly to the pharmacy by the specialist).
Individuals affected by the shortage are encouraged to contact their treating rheumatologist or clinical immunologist promptly for further guidance.
As details unfold, Arthritis Australia will be actively working with Bristol Myers Squibb (BMS), the Therapeutic Goods Administration (TGA), the Australian Rheumatology Association (ARA) and pharmacists to minimise any disruptions to consumers. CreakyJoints Australia will share new information as it comes to hand.
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