Dr Ray Boyapati.

Children with IBD are missing out on effective treatments because of PBS prescribing restrictions that are jeopardising their health and potentially leading to poorer outcomes, the Gastroenterological Society of Australia says.

It is calling for a top-down approach where biologics are available first-line to be included as a prescribing option alongside stepwise escalation, allowing gastroenterologists to choose the most appropriate therapy for their patients.

Melbourne gastroenterologist Dr Ray Boyapati, chair of GESA’s IBD faculty, said while the current blanket step-up approach to IBD prescribing once made sense when biologic medications were “extremely expensive” and there was not a lot of evidence around their first-line use, the treatment landscape had changed.

It was now clear there were certain patients who benefited from aggressive therapies delivered earlier, which could change the course of their disease, he said.

“As clinicians, we want to do the right thing by our patients, and we know that earlier treatment of severe IBD affects outcomes, affects their quality of life and their long-term outcomes, including surgery, hospitalisation and in kids, their growth and development. It is very difficult as clinicians to know that and still have to go through that [step-up] process that means delays,” he told the limbic.

“For children and for young people in particular, waiting for the disease to worsen before then accessing effective therapy obviously means ongoing inflammation, it means exposure to steroids, potential growth problems and then bowel damage.”

Dr Boyapati referred to the TISKids randomised controlled trial, which showed first-line infliximab treatment achieved better remission outcomes than conventional treatment (exclusive enteral nutrition or corticosteroid and immunomodulator therapies) in children with moderate-to-severe Crohn’s disease.

The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) had also released joint guidelines with ECCO recommending consideration of anti-TNF therapy early in children with high-risk disease, he said.

In the last three months, discussions in Senate estimates have brought the issue to political and media attention.

“We currently have a case here in Canberra where we have two young boys, brothers, with Crohn’s disease. Their mother has watched one of her sons’ health be destroyed by the older medicines and then vastly improved by biologics. She’s now watching her other son go on the same journey, and I think she’s very sensibly asking why,” Senator David Pocock said in an exchange in February.

Dr Boyapati said he had noticed increased engagement on the issue from health bureaucrats, with both the federal government and the Pharmaceutical Benefits Advisory Committee reaching out to GESA and Crohn’s & Colitis Australia after the issue had been raised multiple times in Senate estimates.

In response, GESA has put together a letter signed by Dr Boyapati, alongwith the president, the CEO and paediatric gastroenterologists, calling for increased access to biologics for paediatric patients and pointing out the evidence.

The change in approach from Canberra has made Dr Boyapati optimistic.

“That’s a notable shift for us, and I don’t want to put it lightly, I think this is a big change that hopefully could result in changes to policy,” he said.

Teenagers transitioning to adult care forced to ‘requalify’ for biologics

However, another pressing issue for GESA has been the tightening of Services Australia regulations that has had “unintended but shocking” consequences for patients treated with biologics outside of the PBS as children, effectively forcing them to requalify for the drugs as adults, Dr Boyapati said.

Previously, adolescent patients with moderate-to-severe ulcerative colitis or severe Crohn’s disease who initiated biologics during childhood outside of the PBS could transition to PBS-funded treatment as adults without having to meet disease-severity entry criteria, if they had a clinician’s letter explaining their circumstances.

But midway through last year, a Services Australia legislative change enforcing tighter adherence to PBS criteria and preventing exemptions put an end to that pathway, instead requiring this group of patients to qualify for biologics.

“Practically speaking, what that means is patients who are potentially in remission and doing well on a medication would have to come off that medication in order to flare, in order to qualify for these drugs, which is obviously a completely untenable and ridiculous situation, and quite shocking in our view,” Dr Boyapati said.

“It could potentially lead to hospitalisations — and it’s during a critical life stage as well, which is when people are transitioning to adulthood and going to university.”

The main groups affected are patients who initiated biologics through non-PBS pathways such as hospital programs or drug company compassionate access schemes as children after not responding to PBS-listed drugs for paediatric use, and patients who initiated biologics while overseas and are now living in Australia.

The numbers aren’t likely to be large, “but for those people affected, it’s quite catastrophic”, Dr Boyapati said.

In response, GESA, Crohn’s & Colitis Australia and Australia’s paediatric gastroenterologists have joined forces to make the consequences of the change clear to the federal government and have also met with the PBAC Deputy Chair.

Dr Boyapati said to their credit, the PBAC acted.

In a December 2025 meeting, the committee recommended changing the PBS criteria of golimumab, ozanimod, tofacitinib, upadacitinib, ustekinumab and vedolizumab to allow this group of patients continued access to the therapies.

Under the amended listings, prescribers would need to show that:

• The treatment started before age 18 through a non-PBS pathway;
• The patient met the paediatric PBS criteria for initial therapy at the time treatment started;
• The patient has demonstrated or maintained an adequate clinical response.

But now in March, GESA is still waiting on the follow-through.

“It is frustrating from our point of view,” Dr Boyapati said.

“Even last week, we had reports of this problem still persisting.

“We are having a meeting with PBAC shortly, and we’ll be raising this issue.”

A Department of Health, Disability and Ageing spokesperson said regarding the positive PBAC recommendation in December, “additional steps must still be completed before any changes can take effect”.

“The Department is working to finalise these arrangements and proceed with the listing update as quickly as possible.”

The spokesperson added that at its meeting in March 2026 meeting, the PBAC considered a proposal seeking advice on matters relating to the broader administration of PBS listings for IBD. Outcomes of this will be available on the PBS website on 24 April 2026.