Shortage of abatacept (Orencia) medicines

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 (ClickJect prefilled autoinjector and prefilled syringe) presentations of abatacept. Supply of both subcutaneous presentations 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 intravenous (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 specialist 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.

In this section: Information for consumers | Information for prescribers | Information for pharmacists

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 your specialist decides you need to stay on abatacept, they 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. Because of the shortage, your pharmacist will not have your medicine in stock when you first give them the form, so it may take longer than usual to get 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.

For more information and support, visit the Arthritis Australia website.

Information for prescribers

Consider the current shortage of abatacept subcutaneous presentations when prescribing. Any changes to treatment should be carefully discussed with your patients, including any possible adverse effects.

Due to limited stock of abatacept prefilled syringe and ClickJect prefilled autoinjector throughout the first half of 2022, usage must be significantly reduced, and supply must be tightly constrained, to conserve stock for patients with limited alternatives.

The TGA met with the Australian Rheumatology Association (ARA) and Arthritis Australia to discuss potential clinical management options during the shortage. The ARA has provided clinical guidelines to help manage this shortage.

Australian Rheumatology Association clinical guidelines

The ARA recommend that during the shortage:

• no new patient be initiated on abatacept
• patients be moved off abatacept, where possible
• patients are not moved from the prefilled syringe or ClickJect prefilled autoinjector to the IV presentation except in exceptional circumstances
• stock be conserved for patients who have:
  • prior use of 2 other biologic or targeted-synthetic disease-modifying antirheumatic drugs (b/tsDMARDs),
    OR
  • relative or absolute contraindication to other b/tsDMARD.

BMS have developed a process to facilitate ordering for patients who meet the ARA's guidelines. For each individual patient who is to remain on abatacept, prescribers must complete a patient eligibility form to enable pharmacists to order stock.

Specialists are advised to contact BMS on 1800 067 567 for more information about the prioritisation process or to access the form.

Supply of each subcutaneous presentation will vary throughout the shortage. To assist patients with timely access to abatacept, we made the Serious Scarcity Substitution Instrument for abatacept. Under the instrument, pharmacists may offer patients a different subcutaneous presentation to the one originally prescribed. You should show your patients how to use both presentations in case they need to swap temporarily.

Information for pharmacists

Supply of the abatacept subcutaneous prefilled syringe and ClickJect prefilled autoinjector will fluctuate during the shortage.

The TGA made a Serious Scarcity Substitution Instrument (SSSI) for abatacept to allow pharmacists to dispense whichever subcutaneous formulation of abatacept is available to patients who meet the specific permitted circumstances. The TGA abatacept SSSI webpage has information for pharmacists on the substitution instrument and process for substitution.

Many patients who usually use abatacept will need to change their treatment during the shortage. Rheumatologists will give a completed eligibility form to patients who are continuing treatment on abatacept. You will need this form to access stock.

As supply is limited, many patients will be moved to alternative treatments. If a patient presents to you without an eligibility form, refer them to their specialist to discuss their treatment options.

BMS have instructions for pharmacists to explain the ordering process for abatacept subcutaneous presentations during the shortage.

• Abatacept shortage - instructions for pharmacists (pdf,219kb)

To order abatacept subcutaneous prefilled syringe or ClickJect prefilled autoinjector:

1. Collect your patient's eligibility form and confirm if patient is happy to receive substitute if preferred presentation is unavailable.
2. Confirm availability of preferred abatacept subcutaneous presentation through DHL.
3. If patient's preferred presentation is not available, discuss availability of the alternative presentation.
4. Once you confirm the presentation with the patient, submit the eligibility form and order through DHL.

Pharmacists should contact BMS on 1800 067 567 for more information about the ordering process.