For many Australians, adalimumab has been a life-changing treatment for their chronic inflammatory condition. Yet subsidised access is fragmented and sometimes based on outdated criteria. A new proposal seeks to update the criteria and unite all conditions under a common access framework. You can help make this happen.
About Adalimumab
Adalimumab is an advanced treatment (or biologic DMARD) used to treat:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Juvenile idiopathic arthritis
- Crohn’s disease
- Ulcerative colitis
- Chronic plaque psoriasis
- Hidradenitis suppurativa
- Non-infectious uveitis
In Australia, adalimumab has been subsidised through the Pharmaceutical Benefits Scheme (PBS) for the treatment of inflammatory conditions for more than 20 years. It is sold under various brand names, including Humira®, Amgevita®, Hadlima®, Hyrimoz®, Icacio®, Yuflyma® and Abrilada®.
Proposed Changes to Adalimumab Access
The current restrictions were developed at different times and use different clinical criteria. In some conditions, access still depends on fixed joint counts, blood test results, severity scores or specified treatment steps that do not fully reflect current clinical guidelines.
This proposal calls for the Pharmaceutical Benefits Advisory Committee (PBAC) to replace these separate clinical eligibility rules with one common framework for starting and continuing adalimumab.
A patient would still need to have one of the nine conditions, active disease that substantially affects quality of life and an inadequate response, intolerance or contraindication to appropriate conventional treatment. Treatment would remain the responsibility of an experienced specialist and could continue only if a clinically meaningful response is documented.
Some patients have active disease that substantially affects daily life but do not meet a historical PBS threshold, even where current guidelines support treatment with a biologic medicine. The proposed changes would allow the treating specialist to assess the whole clinical picture using current guideline measures suited to the patient’s condition, rather than relying on a single test, count or score.
How Access May Change Across the Nine Conditions
The practical effect would differ by condition. The summary below describes how access may change for each condition. The specialist would still need to confirm that adalimumab is appropriate and that the patient meets the common criteria in the proposed framework.
- Rheumatoid arthritis: Access would no longer depend only on fixed joint counts and blood-test results. The specialist could use a current guideline measure of overall disease activity.
- Psoriatic arthritis: Assessment could take account of the full pattern of disease, including joints, tendons, spine and skin, rather than joint counts and blood tests alone.
- Ankylosing spondylitis: A current guideline disease-activity score could be used instead of several separate imaging, symptom and blood-test thresholds.
- Juvenile idiopathic arthritis: Children could be assessed using age and disease-type-appropriate measures rather than fixed minimum joint counts or other older thresholds.
- Crohn’s disease: Access could cover the moderate-to-severe population, including fistulising disease, after appropriate conventional treatment, rather than being mainly limited to severe disease.
- Ulcerative colitis: Current access is already broadly aligned. The proposal would allow the specialist to use current guideline measures rather than fixed scores and treatment steps.
- Chronic plaque psoriasis: Assessment could include overall disease extent, high-impact areas and effects on quality of life, with prior treatment guided by current recommendations.
- Hidradenitis suppurativa: Current severity tools could replace older staging and a fixed lesion count. The need for prior conventional treatment would be assessed using current guidelines.
- Non-infectious uveitis: Access could be considered for active disease that has a substantial impact after appropriate conventional treatment, rather than only once the disease is vision-threatening.
How the Proposed Listing Would Work
- Specialist confirms the diagnosis and need for treatment: The patient has one of the nine approved conditions, and adalimumab is considered clinically appropriate under the relevant guideline.
- Disease activity and prior treatment are documented: Active disease substantially affects quality of life and appropriate conventional treatment has been unsuccessful, not tolerated, or contraindicated.
- Initial treatment is prescribed using a streamlined authority: The specialist does not need to submit a written authority application but must confirm and document that the PBS criteria are met.
- Benefit is reassessed: PBS-subsidised treatment continues only when the patient has a clinically meaningful response, assessed using the relevant guideline.
What does “streamlined authority” mean? Initial treatment would not require the specialist to submit a written application and wait for individual approval. The specialist would use the relevant authority code, confirm that the patient meets the restriction and keep the supporting clinical information in the medical record.
What We Invite You to Do
Consumer information helps the PBAC understand the benefits, harms and practical effects of the proposed change, including impacts that may not be captured in clinical studies. Patients, carers, clinicians, consumer organisations and members of the public may provide comments.
GHLF Australia/CreakyJoints Australia would like to collate your comments into a single submission and send it to the PBAC on your behalf. You can respond as someone who has used or is using adalimumab. You can also respond on behalf of someone you care for. Your comments can relate to any or all of the following points:
- Whether current PBS eligibility rules have delayed or prevented access to appropriate treatment.
- Which outcomes matter most, including daily function, pain, fatigue, vision, skin symptoms, work or school, mental health and carer burden.
- Whether fixed measures such as joint counts, blood tests or severity scores reflect the full impact of the condition.
- Experience with conventional treatments, specialist care, treatment response and the authority process.
How to submit your comments to us
Please send your responses to us by:
- Typing your comments into a Word document and attaching it to your email OR
- Typing your comments directly into your email.
Your comments can be as simple as a few bullet points or as long as two or three pages. Please specify if you are happy for us to use your first name and the initial of your last name, or if you prefer to remain anonymous.
Email your comments to Rosemary Ainley at rainley@ghlf.org.au no later than 5 pm on Thursday 10 September 2026. We will collate your replies into a single submission and send it to the PBAC on your behalf.
PLEASE NOTE THE SHORT DEADLINE FOR COMMENTS.
If you wish to make your own submission directly to the PBAC, you can do so at https://ohta-consultations.health.gov.au/ohta/pbac-november-2026. The due date for individual submissions is Wednesday 16 September. You are welcome to contact us for tips on writing your own effective submission.
Thank you.
The information in this article came from a PBAC submission summary document provided to clinicians, consumers and consumer organisations by Amgen Australia. The proposal includes all adalimumab brands. The content of all our submissions is independent and not influenced by any external organisation.
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You are welcome to share this request with anyone you think might like to have their voice heard in this inquiry.
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