As of the 30 August 2024, the abatacept (Orencia) subcutaneous shortage will be resolved. From this date:

• The TGA medicine shortage notification for abatacept 125 mg single dose syringe will no longer be in place.
• Abatacept 125 mg single dose syringe, BMS, China Stock approved under Section 19A will no longer be available.
• Normal ordering processes for both abatacept pre-filled syringe and ClickJect autoinjector can resume via DHL online portal.
• Patients may switch back to, and new patients may be initiated on, any of the abatacept presentations as deemed appropriate by their treating physician.

BMS Dear Doctor Letter - 28 August 2024

BMS Dear Pharmacist Letter - 28 August 2024

Bristol Myers Squibb (BMS), manufacturers of Orencia (abatacept) have announced that the Orencia Stock Hypercare Plan (OSHP) has now ceased as there is sufficient supply to meet normal demand.   

BMS has received approximately 16 weeks' (at pre-shortage levels) of abatacept ClickJect autoinjector ahead of schedule. The serious scarcity substitution instrument (SSSI) will remain in effect until 31 October 2024. The SSSI allows pharmacists to substitute the abatacept ClickJect autoinjector for the pre-filled syringe without a new prescription from the prescriber. This is important as the next shipment of abatacept pre-filled syringe is not expected until late September. 

What does this mean for you?

1. From 1 August, you will no longer be required to complete an OSHP form for patients you wish to prescribe abatacept.
2. Patients may be switched back to abatacept if clinically appropriate.
3. Patients whose dosing interval was increased during the shortage may be returned to their previous dose if clinically appropriate. 
4. New patients can be commenced on abatacept SC and IV. 

This information has also been communicated to pharmacists, through the Pharmaceutical Society of Australia and the Pharmacy Guild.  

Thank you for the extra work and effort in managing patients on abatacept during this shortage.

If you have any questions or concerns, please contact Jing Ye, ARA Clinical Project Officer at project@rheumatology.org.au.

BMS has reported that the supply rate of abatacept remains unchanged. Although usage has decreased by approximately 30%, this reduction is still significantly below the necessary 67% that had been estimated as necessary to prevent a complete stock outage.

As a result with current supply rates and Australian stock levels:

1. Orencia ClickJect has no stock remaining.
2. Orencia prefilled syringe (PFS) supplies are expected to be exhausted by mid-July.

However, BMS has secured a small amount of abatacept prefilled syringes from overseas. The TGA has approved the application for this overseas-registered product. We were informed this morning that this stock has arrived and is currently being redressed to meet Australian requirements. It is expected that this additional, albeit limited, stock will be available in pharmacies by July 8. Please inform your patients that the packaging may look different to prevent any confusion regarding the medication.

Despite obtaining this additional overseas stock, we remain in a shortage situation. Therefore, to ensure the availability of abatacept for patients with no alternative options and to avoid a complete out of stock situation, it is crucial not to transition patients who have been moved off abatacept back onto it or to alter dosing intervals if they are stable on extended dosing.

As per our previous communication, we recommend that:

1. No new patients be started on abatacept SC or IV.
2. Patients be transitioned off abatacept where possible.
3. Stock be conserved for patients who have:
   1. Prior use of two other b/tsDMARDs.
   2. Relative or absolute contraindications to other b/tsDMARDs.

For patients meeting these criteria and needing to stay on abatacept, consider increasing the dosing interval if clinically appropriate.

Previously, we advised against moving patients from the single-dose syringe or ClickJect prefilled autoinjector to the IV presentation except in exceptional circumstances. However, we were informed this morning that the IV abatacept stock is relatively stable, and therefore prescribers may consider a switch to the IV formulation in patients for whom treatment with an alternative DMARD or a reduced dose of abatacept is not feasible or has been poorly tolerated.

Please note that the Serious Scarcity Substitution Instrument (SSSI) is currently in effect, allowing pharmacists to substitute the abatacept PFS for the ClickJect autoinjector without a new prescription from the prescriber.

As both Orencia 125 mg/mL subcutaneous injection products are in short supply, the Therapeutic Goods Administration (TGA) have implemented the 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) starts on 15 May 2024 and will finish on 31 October 2024.

The supply of overseas-registered abatacept products is currently also being explored to help reduce the impact on patients. 

For more information, please see the TGA web alert and the updated TGA Abatacept shortage webpage. 

We regret to inform you that as of 10:00 AM AEST 11 April 2024, we received notification from Bristol Myers Squibb (BMS), the manufacturers of abatacept (Orencia), regarding an anticipated shortage of both subcutaneous formulations of abatacept. Following this notification, we immediately convened with BMS representatives.  

We are actively exploring every possible solution with the Therapeutic Goods Administration (TGA), the Pharmaceutical Benefits Advisory Committee (PBAC), and Services Australia to minimise any obstacles, enabling you to continue managing your patients currently prescribed abatacept effectively. 

BMS has indicated that this shortage stems from global supply challenges, with Australia not being the only country affected. Rest assured, we are fully committed to navigating through these challenges and will keep you updated on any progress and solutions to manage this situation effectively.

The shortages are across the subcutaneous (SC) presentations only and are outlined below:

• Orencia Clickjet (autoinjector) 125mg/mL will be out of stock from 3 June 24 until 30 August 24
• Orencia Prefilled Syringe 125mg/mL will be out of stock from 17 June 24 until 30 September 24

There is only sufficient stock of the intravenous (IV) abatacept (Orencia) presentation to support current patients.

Due to limited stock of abatacept (Orencia) single dose syringe and ClickJect prefilled autoinjector until the end of September 2024, supply must be tightly constrained to conserve stock for patients with no alternatives.

As per previous shortages of abatacept we recommend that:

• no new patients be started on abatacept SC or IV 
• patients be moved off abatacept where possible 
• stock be conserved for patients who have
  • prior use of 2 other b/tsDMARDs
  • relative or absolute contraindication to other b/tsDMARDs
• for people who meet the above criteria and need to stay on abatacept consider increasing the dosing interval if clinically appropriate
• patients not be moved from single dose syringe or ClickJect prefilled autoinjector to the IV  presentation except in exceptional circumstances

We are committed to keeping our members promptly informed as additional details emerge. For immediate updates and resources, please visit the dedicated section on the ARA website, accessible through this link.

Please be assured, we are actively collaborating with BMS and engaging with the necessary authorities to effectively address the shortages. Our top priority is to mitigate the impact on both you and your patients, ensuring the continuity and quality of care.

11 April 2024 - Letter received by ARA from BMS regarding abatacept shortage