Accessing biologic treatments in Australia

When a child has Crohn’s disease or ulcerative colitis, standard treatments don’t always provide enough relief. If inflammation remains active despite other medicines, a paediatric gastroenterologist may discuss biologic therapy as another treatment option.

Biologics are medicines that target specific parts of the immune system involved in inflammation. For some children, they can help control symptoms, reduce inflammation and support longer periods of remission.

In Australia, eligible children may be able to access certain biologic treatments through the Pharmaceutical Benefits Scheme (PBS). Understanding how specialist approval works and where treatment is given can help families know what to expect.

💙 What are biologic treatments?

Biologics are advanced medicines made using biological processes. They target particular proteins or pathways involved in the inflammation associated with IBD.

For children with Crohn’s disease or ulcerative colitis, treatment options may include:

• Infliximab: Usually given through an intravenous infusion at a hospital or specialist infusion service.

• Adalimumab: Usually given as an injection under the skin. Some families may be able to administer it at home after training.

These medicines are not suitable for every child. The treating specialist considers the type of IBD, how active the disease is, previous treatments, test results and the child’s overall health.

🩺 When might a child need biologic treatment?

A paediatric gastroenterologist may consider biologic therapy when a child has moderate to severe disease, ongoing inflammation or a poor response to other treatments.

It may also be considered when a child cannot tolerate certain medicines or has complications that require more targeted treatment.

Before recommending a biologic, the specialist will review your child’s medical history, symptoms, blood tests, stool tests and, where appropriate, endoscopy or imaging results.

The aim is to choose a treatment that offers the best balance of potential benefits, risks and practical considerations for your child.

How can children access biologics through the PBS?

The Pharmaceutical Benefits Scheme (PBS) subsidises certain biologic medicines for eligible children with Crohn’s disease or ulcerative colitis.

Access is subject to specific requirements, which may include the child’s age, disease severity, previous treatments and evidence of active inflammation.

For example, the PBS has specific eligibility criteria for infliximab and adalimumab in children with Crohn’s disease and ulcerative colitis. These requirements differ according to the condition and treatment.

The process generally involves the following steps:

1. Assessment by a specialist

Your child’s paediatric gastroenterologist assesses whether a biologic is appropriate and which medicine may be suitable.

2. Checking PBS eligibility

The specialist checks whether your child meets the current PBS criteria for the proposed treatment. These may include particular disease activity scores, previous treatment trials and relevant test results.

3. Applying for approval

Where required, the specialist submits a PBS authority application with the relevant clinical information. Some medicines have specific approval processes, and the treating team can explain what applies to your child.

4. Arranging treatment

Once the necessary approvals and arrangements are in place, the hospital or specialist team explains where treatment will be given, how often it is needed and what preparation is required.

5. Monitoring the response

The team reviews your child’s symptoms, blood and stool tests, and other assessments as needed. Continued PBS-subsidised treatment may require evidence that the medicine is working and that eligibility criteria remain satisfied.

You can check the current requirements through Services Australia’s information about PBS treatments for paediatric Crohn’s disease and ulcerative colitis.

🏥 What happens during a hospital infusion?

Some biologics, including intravenous infliximab, are administered through a drip into a vein. This is commonly arranged through a hospital day unit or specialist infusion service.

The exact process varies between hospitals, but a typical appointment may include:

• Checking your child’s symptoms and general health before treatment.

• Recording observations such as temperature, pulse and blood pressure.

• Inserting an intravenous cannula.

• Administering the medicine over a period of time.

• Monitoring your child during and after the infusion for possible reactions.

Initial treatment often involves a series of doses followed by maintenance infusions at planned intervals. The schedule depends on the medicine, your child’s response and the specialist’s treatment plan.

You may be able to stay with your child during the appointment. Ask the hospital what to bring, whether food and drinks are permitted, how long the visit is expected to take and what arrangements are available for school-aged children.

🏡 Can biologic treatment be given at home?

Some biologics, such as adalimumab, are administered by injection under the skin rather than through an infusion.

Depending on the medicine, your child’s age, PBS eligibility and the arrangements offered by the treating service, injections may be given at home after appropriate training.

Your healthcare team can explain how to store the medicine, prepare the injection, dispose of sharps safely and manage missed doses.

Not every biologic can be administered at home, and some treatments require hospital or specialist supervision.

💰 How much does biologic treatment cost?

The cost depends on the medicine, PBS eligibility, where it is supplied and whether treatment is provided through a public or private service.

For eligible patients, PBS subsidies can substantially reduce the cost of certain biologics.

However, the arrangements for hospital-administered medicines can differ from those for prescriptions collected at a community pharmacy.

Before treatment starts, ask your specialist or hospital team:

• Is this medicine subsidised through the PBS for my child’s condition?

• Does the hospital supply the medicine?

• Will there be any out-of-pocket costs?

• Are there costs associated with infusions, appointments or private hospital care?

• What happens if my child does not meet the PBS criteria?

If you are concerned about costs, ask the hospital’s social worker or financial counselling service whether support or alternative arrangements may be available.

🩸 What monitoring is needed during treatment?

Biologic treatment requires ongoing medical supervision. Before starting, your child’s team may arrange screening for certain infections, review vaccinations and assess other health risks.

During treatment, monitoring may include:

• Blood tests to check for inflammation and possible side effects.

• Stool tests, including faecal calprotectin, to assess bowel inflammation.

• Reviews of symptoms, growth and general wellbeing.

• Further investigations if the treatment is not controlling the disease as expected.

The specific tests and frequency depend on the medicine and your child’s circumstances.

Contact the treating team if your child develops a fever, signs of a significant infection or other concerning symptoms. Follow the team’s instructions about whether treatment should be delayed when your child is unwell.

💙 What if the first biologic doesn’t work?

Children respond differently to biologic medicines. Some improve significantly, while others may have an incomplete response or lose response over time.

If treatment isn’t working as expected, the gastroenterologist may review the diagnosis, assess ongoing inflammation and consider whether further tests or a change in treatment are needed.

Depending on the circumstances, options may include adjusting the treatment plan or considering another medicine. PBS eligibility requirements apply when changing or recommencing subsidised treatment.

It is important not to stop or change your child’s medication without discussing it with their treating team.

📋 Questions to ask your child’s gastroenterologist

If biologic treatment has been suggested, consider asking:

• Why is this medicine being recommended for my child?

• What benefits and risks should we understand?

• Does my child meet the current PBS eligibility criteria?

• How will the medicine be given, and how often?

• Where will infusions take place?

• What tests are needed before and during treatment?

• What should we do if our child becomes unwell?

• How will we know whether the treatment is working?

• What are the next steps if it doesn’t work?

Writing down your questions before the appointment can help you feel more prepared and ensure you understand the treatment plan.

🌱 Supporting your child through treatment

Starting a biologic can feel like a big step for both children and parents. Understanding the process, knowing what to expect at appointments and having a clear plan for monitoring can make the experience less overwhelming.

Your child’s IBD team can guide you through treatment options, PBS requirements, infusion arrangements and follow-up care. Don’t hesitate to ask for information in language your child can understand, so they can feel involved in their care as they grow.

🔗 Where to find more information

• Services Australia: PBS treatment for paediatric Crohn’s disease

• Services Australia: PBS treatment for ulcerative colitis

• Pharmaceutical Benefits Scheme (PBS)

This article provides general information for Australian families. Treatment options, PBS eligibility and costs can change. Your child’s paediatric gastroenterologist can explain which treatments are suitable and how to access them.