Crohn's disease - Paediatric patient

The Pharmaceutical Benefits Scheme (PBS) subsidises TNF alfa antagonists for paediatric patients with Crohn's disease.

Information to apply for PBS subsidised with tumour necrosis factor alpha (TNFα) antagonist agents for paediatric patients with severe refractory Crohn's disease.

Authority to provide PBS subsidised tumour necrosis factor alpha (TNFα) antagonist agents for paediatric patients with moderate to severe refractory Crohn's disease is available under Section 85 and Section 100 of the National Health Act 1953.

Where the term TNFα appears it refers to adalimumab and infliximab only.

All applications must be made and completed by a:

  • gastroenterologist (code 87), or
  • consultant physician in internal medicine specialising in gastroenterology (code 81), or
  • consultant physician in general medicine specialising in gastroenterology (code 82), or
  • paediatrician, or
  • specialist paediatric gastroenterologist

Patients must meet the relevant criteria as indicated in the PBS restrictions and be eligible for the PBS.

Section 100 arrangements only for infliximab

Infliximab is available to a patient who is attending either:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital
The hospital provider number must be included on the application form.

The patient must either be:

  • a day admitted patient
  • a non-admitted patient, or
  • on discharge
Infliximab is not PBS subsidised for in-patients of the hospital.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing adalimumab and infliximab to patients.

For continuing PBS subsidised treatment, the patient must demonstrate or sustain an adequate response to treatment with a TNF alfa antagonist agent as defined in each restriction.

Treatment

Initial treatments

Applications for initial treatment should be made where patients have received no prior PBS subsidised treatment with a TNF alpha antagonist agent.

All applications for initial treatment will be limited to a maximum of:

  • 16 weeks of adalimumab
  • 14 weeks of infliximab

Patients must be assessed for a response to any course of PBS subsidised initial TNF alpha antagonist agent treatment:

  • after 12 weeks of adalimumab treatment
  • up to 12 weeks after the first dose for infliximab treatment
This assessment must be submitted to us no later than 4 weeks from the date that the course is completed. Where a response assessment is not submitted to us within this timeframe, patients will be found to have failed to respond to treatment with that bDMD agent.

Continuing treatment

After an initial treatment course with a TNF alpha antagonist agent, patients may qualify to receive up to 24 weeks of continuing treatment providing they have demonstrated an adequate response to treatment.

Patients are eligible to receive further continuing treatment in courses of up to 24 weeks providing they continue to sustain a response.

Patients must be assessed for a response to each course of continued treatment. The assessment must be submitted to us no later than 4 weeks from the date that the course is completed. Where a response assessment is not submitted to us within this timeframe, patients will be found to have failed to respond to treatment with that bDMD agent.

Recommence treatment

Once an authority for initial treatment with a TNF alpha antagonist agent is approved, patients may recommence treatment with the same TNF alpha antagonist agent. A response to treatment must be provided within the relevant timeframes set out in the restrictions, listed on the PBS website

All applications to recommence will be limited to a maximum of:

  • 16 weeks of adalimumab
  • 14 weeks of infliximab

The prescriber may submit new baseline measurements for patients who have had a break in PBS subsidised treatment with a TNF alpha antagonist agent and who wish to recommence treatment.

Changing treatments

To avoid confusion, applications for patients who wish to change to an alternative TNF alpha antagonist agent should be accompanied by the approved authority prescription or remaining repeats for the TNF alpha antagonist agent the patient is ceasing.

Adalimumab to infliximab

Patients may change from adalimumab to infliximab, providing they are eligible, without having to requalify with respect to either the:

  • indices of disease severity, or
  • previous therapy requirements

Applications will be limited for a maximum of 14 weeks of infliximab treatment.

Infliximab to adalimumab

Adalimumab is PBS subsidised for patients with severe refractory Crohn's disease.

Patients can only change from infliximab to adalimumab if they have a current Paediatric Crohn’s Disease Activity Index (PCDAI) score of 40 or greater. They do not have to requalify with respect to the previous therapy requirements.

All applications to change treatments to adalimumab will be limited to a maximum of 16 weeks.

Schedule item details

Adalimumab (Humira®) is presented as:

  • a prefilled syringe containing 40 mg of adalimumab in 0.8 mL
  • a prefilled pen containing 40 mg adalimumab in 0.8 mL
  • a prefilled syringe containing 20 mg of adalimumab in 0.4 mL

Patients weighing 40 kg or more:

The dose for patients is 4 injections at week zero, 2 injections at week 2 and thereafter 1 injection every 2 weeks.

The form of adalimumab required must be specified on the prescription as either a prefilled syringe or a prefilled pen.

You will be required to make 2 authority prescriptions. The first authority prescription will be for the induction pack of 6 doses of 40 mg and no repeats. The second prescription should be written for 2 doses of 40 mg and 2 repeats.

Patients weighing less than 40 kg:

The dose for patients is 2 injections of 40 mg at week zero, 2 injections of 20 mg at week 2 and thereafter 1 injection of 20 mg every 2 weeks.

You will be required to make 2 authority prescriptions. The first authority prescription will be for the first 2 doses of 40 mg and no repeats. The second prescription should be written for 2 doses of 20 mg and 3 repeats.

The form of adalimumab required must be specified on the prescription as either a prefilled syringe or a prefilled pen.

Infliximab (Remicade®) is presented as a vial containing 100 mg of lyophilised powder.

The dose for patients is 5 mg/kg given intravenously.

Initially, patients are to be treated at week zero, week 2 and week 6. Subsequent infusions are at 8 weekly intervals.

Authority prescriptions should be written for the actual number of vials to provide a dose of 5mg/kg and 2 repeats.

Toxicity criteria and severity descriptors

Use our list of Crohn's disease toxicity criteria and severity descriptors to ensure patient eligibility can be fully assessed.  This list of descriptors should be used in conjunction with the application when demonstrating a patient’s inability to tolerate prior systemic therapy.

Lodging an application

All applications for authority to provide initial or continued PBS subsidised treatment for paediatric patients with moderate to severe refractory Crohn's disease must be provided in writing.

Initial treatment

Complete and return the Crohn's disease Initial paediatric PBS authority application Supporting information form (PB085)

We will not consider an application for initial treatment unless the patient acknowledgement is completed.

Continuing or changing treatment

Complete and return the Crohn's disease Continuing PBS authority application and Supporting information form (PB161)

This form can also be used to advise when your patient is demonstrating a response to the current PBS subsidised treatment but not continuing treatment at this time.

Further information

For more information contact the Complex Drugs Program enquiry line.

Page last updated: 8 November 2016

This information was printed Saturday 10 December 2016 from humanservices.gov.au/health-professionals/enablers/crohns-disease-paediatric-patient It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.