May 2022 update

Please note that the TGA has extended the Serious Scarcity Substitution Instrument (SSSI) described in the main text below from 30 April to end 30 June 2022. 

In addition, supply of abatacept is improving with more IV product now available. The Australian Rheumatology Association (ARA) have provided updated clinical guidelines. They now recommend the following to prescribers:
• no patients should be initiated on subcutaneous abatacept; however
• new patients can be initiated on IV abatacept.

Learn more on the TGA decision here and from the ARA here.

 

What is abatacept?

Abatacept (Orencia) is a biological prescription medicine. It reduces cytokine production and inflammation by modulating a key costimulatory signal required for full activation of T lymphocytes that are found in the joint synovium of people with rheumatoid arthritis (RA) and other autoimmune diseases.1-3

It is approved by the Therapeutic Goods Administration (TGA) in combination with methotrexate for people with RA (moderate to severe, and severe, active and progressive), or with or without methotrexate for psoriatic arthritis (PsA) and polyarticular and systemic juvenile idiopathic arthritis (JIA).3

Abatacept is subsidised under the Pharmaceutical Benefits Scheme (PBS) in combination with methotrexate for adults with severe active RA.4

 

What are the shortages?

In January 2022 the sponsor of abatacept notified the TGA of shortages of the two abatacept subcutaneous products registered in Australia:5,6

  • 125 mg single-dose prefilled syringe injection7
  • 125 mg single-dose prefilled autoinjector (ClickJect)7

Supply of these products is expected to be limited throughout the first half of 2022, leading to variable availability.5,7

The shortages have been caused by a combination of manufacturing capacity constraints, supplier component challenges and shipment delays. This has not had an impact on the quality of abatacept.5,6 Bristol-Myers Squibb (BMS) Australia Pty Ltd, the sponsor, is regularly reviewing the shortages and supply of the subcutaneous products.6

The TGA has approved the import of overseas-registered abatacept subcutaneous products to assist with supply. See Database of section 19A approvals to import and supply medicines to address medicine shortages for more information about the supply of these products.

There is sufficient stock of intravenous (IV) abatacept to support current IV patients only.5

Current shortages and updates are published on the TGA website:

See Shortages of abatacept (Orencia) medicines for full information.

See Medicine shortage reports database for specific notifications.

 

Serious Scarcity Substitution Instrument

The TGA has issued a Serious Scarcity Substitution Instrument (SSSI) until 30 April 2022 to ensure timely access for adults who need subcutaneous abatacept. Further extensions to this date may be provided. The SSSI makes the abatacept subcutaneous products interchangeable at the pharmacy level:8

This allows a pharmacist to dispense either product to a patient when one is available, without needing to obtain prior approval from the prescriber. The pharmacist will notify the prescriber of the substitution soon after.8

Both products affected by the shortage are the same strength of abatacept and administered by subcutaneous injection. However, their delivery devices are different. Patients should be provided with information and instructions to ensure they understand these differences and how to use the devices.8

The products can only be substituted for adults (≥ 18 years).8

See full details about the SSSI for abatacept.

 

PBS arrangements

PBS arrangements are in place that address the shortages of abatacept under the SSSI. These arrangements help support continuation of treatment when a patient’s usual product is not available.9

Under these arrangements, pharmacists can substitute the abatacept subcutaneous products with each other without prior approval from the prescriber.9

See PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument for more information, including the item codes and frequently asked questions.

 

Guidance

The TGA has worked closely with the Australian Rheumatology Association (ARA), Arthritis Australia (AA) and BMS to develop guidance for prescribers, pharmacists and consumers, to help:5

  • manage the shortage by reducing the usage of abatacept subcutaneous products, and
  • minimise the impact on patients, many of whom will need to change product during the shortage.

See the full TGA guidance here.

 

Guidance for prescribers

The ARA guidance for prescribers recommends that during the shortage:5

  • new patients are not to be initiated on abatacept
  • existing patients be moved off abatacept, where possible
  • existing patients are not to be moved from subcutaneous abatacept to IV abatacept, except in exceptional circumstances, because there is only sufficient stock of IV abatacept to support current IV patients
  • stock of abatacept subcutaneous products is to be conserved for patients who have:
    • prior use of two other biologic or targeted-synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) eg, had an insufficient response to them, or
    • a relative or absolute contraindication to other b/tsDMARDs.

Prescribers must complete a patient eligibility form developed by BMS for patients who meet the ARA guidance and need to continue taking subcutaneous abatacept, to enable pharmacists to order stock.5

Prescribers are advised to contact BMS on 1800 067 567 for more information about the prioritisation process or to access the eligibility form.5

Patients who are continuing to take subcutaneous abatacept should be provided with information and instructions on the product devices to ensure they understand how to use them.8

 

Guidance for pharmacists

The abatacept SSSI allows pharmacists to dispense whichever abatacept subcutaneous product is available: the pre-filled syringe or the autoinjector (ClickJect). This can be done without prior approval from the prescriber, so long as the permitted circumstances provided within the SSSI are met:8,10

  • patient is aged ≥ 18 years
  • pharmacist has advised the patient or person acting on behalf of the patient:
    • on suitable instructions for administering the substitute product, or to obtain instructions from the prescriber or suitably qualified health practitioner for administering the substitute product, and
    • on the dose to be taken.

Pharmacists should use their professional and clinical judgement to determine whether a patient is suitable for substitution and ensure the patient is fully informed and consents to the change.8

See Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2022 for more information on the permitted circumstances.

Ordering stock5

A patient’s treating specialist will give them a completed eligibility form if they are continuing treatment on abatacept. If a patient presents with an abatacept script but does not have a patient eligibility form, pharmacists should refer them to their specialist to discuss their treatment. 

To order an abatacept subcutaneous product, pharmacists will need to:

  • collect the patient's completed eligibility form
  • confirm if the patient is happy to receive a substitute if their preferred product is unavailable
  • confirm availability of the patient’s preferred product through DHL (transport logistics company)
  • if the preferred product is available, submit the completed eligibility form and order it through DHL
  • if the preferred product isn’t available, advise the patient or person acting on behalf of the patient that there may be a substitute abatacept subcutaneous product (see details of the required advice above and in the SSSI)
  • confirm the patient or person acting on behalf of the patient agrees to use the substitute product
  • submit the completed eligibility form and order the substitute product through DHL.

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

BMS has instructions for ordering stock of abatacept subcutaneous products during this shortage.

 

For patients and consumers

Abatacept is the active ingredient in a medicine called Orencia. The active ingredient is what makes the medicine work. Some people use abatacept to treat health problems like rheumatoid arthritis.5

In Australia at the moment there are limited amounts of two abatacept (Orencia) medicines:5

  1. abatacept syringe
  2. abatacept autoinjector pen (ClickJect)

Production, supply and shipping problems have caused the limited amounts. They will continue during the first half of 2022.5

If you use abatacept, talk with your doctor about what to do while there are limited amounts. Some people will keep taking abatacept. Others might change to a different medicine.5

If you stay on abatacept, you might need to switch between the syringe and pen.5

Your doctor should:5

  • explain that the syringe and pen are the same strength of abatacept
  • explain that each one uses a different device to inject abatacept
  • show you how to use both the syringe and pen
  • talk about how your pharmacist can get you the syringe or pen.

Your doctor will fill out a form if you are going to keep taking abatacept. You give this form and your prescription to your pharmacist. They will check if they can order the syringe or pen you usually use.5

If your pharmacist can't get it, they will talk with you about getting the other one. If you agree to use it your pharmacist can order it without needing to first check with your doctor.5

Your pharmacist can also show you how to use both the syringe and pen.5

For more information:

Arthritis Australia Information about the abatacept (Orencia) shortage

NPS MedicineWise Biological medicines and COVID-19 FAQs

 

References

  1. Australian Medicines Handbook. Abatacept. Adelaide: AMH Pty Ltd, 2022 (accessed 15 February 2022).
  2. Australian Medicines Handbook. Rheumatoid arthritis. Adelaide: AMH Pty Ltd, 2022 (accessed 15 February 2022).
  3. Bristol-Myers Squibb Australia Pty Ltd. Abatacept (Orencia) product information. Mulgrave, Victoria: Bristol-Myers Squibb Australia Pty Ltd, 2021 (accessed 15 February 2022).
  4. Pharmaceutical Benefits Scheme. PBS General Schedule (February 2022). Canberra: Australian Government Department of Health, 2022 (accessed 16 February 2022).
  5. Therapeutic Goods Administration. Shortage of abatacept (Orencia) medicines. Canberra: Australian Government Department of Health, 2022 (accessed 2 March 2022).
  6. Bristol-Myers Squibb Australia Pty Ltd. Our Medicines. Mulgrave, Victoria: Bristol-Myers Squibb Australia Pty Ltd, 2022 (accessed 15 February 2022).
  7. Therapeutic Goods Administration. Abatacept - medicine shortage information. Canberra: Australian Government Department of Health, 2022 (accessed 15 February 2022).
  8. Therapeutic Goods Administration. Substitution instrument to address shortage of abatacept (Orencia). Canberra: Australian Government Department of Health, 2022 (accessed 15 February 2022).
  9. Pharmaceutical Benenfits Scheme. PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument. Canberra: Australian Government Department of Health, 2022 (accessed 15 February 2022).
  10. Australian Government Department of Health. Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2022. Canberra: Australian Government Department of Health, 2022 (accessed 16 February 2022).