Severe allergic asthma - paediatric patient

The PBS subsidises omalizumab for paediatric patients with uncontrolled severe allergic asthma.

Treatment with omalizumab can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953 for paediatric patients with uncontrolled severe allergic asthma.

Section 100 arrangements

This item is available to a patient attending:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital

and is either a

  • day admitted patient
  • non-admitted patient, or
  • patient on discharge

You must include the hospital provider number on the application form.

This item isn’t available as a PBS benefit for hospital in-patients.

Patient eligibility

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

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing omalizumab.

Toxicity and severity descriptors

To ensure patient eligibility can be fully assessed, details of toxicity experienced from the required prior therapies must be provided in the application, in accordance with the toxicity and severity descriptors for severe allergic asthma.

Applications

All applications must be completed by the treating paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

Initial treatment

Make all initial applications for authority approval to prescribe omalizumab for the treatment of paediatric patients with uncontrolled severe allergic asthma in writing and:

All applications must include a completed:

A completed Asthma Control Questionnaire (ACQ-5 or ACQ-IA) calculation sheet must be submitted with the application. This sheet is available from Novartis Medical Information.

Medical practitioners should request the appropriate maximum quantity and number of repeats to provide an initial course of omalizumab of up to 28 weeks, including the recommended number of doses for the patient’s baseline IgE level and body weight.

Grandfather treatment

For patients starting initial PBS subsidised treatment with omalizumab, and who started non-PBS subsidised treatment before 1 December 2016, lodge a Paediatric severe allergic asthma Initial grandfather PBS authority application form (PB190).

Medical practitioners should request the appropriate maximum quantity and number of repeats to provide an initial course of omalizumab of up to 24 weeks, including the recommended number of doses for the patient’s baseline IgE level and body weight.

Continuing treatment

Make all applications for continuing authority approval to prescribe omalizumab for the treatment of paediatric patients with uncontrolled severe allergic asthma in writing and:

All applications must include a completed:

For patients who meet the continuation criterion for PBS subsidised omalizumab treatment, submit the application for continuity of treatment at the 22 to 26 week assessment. Subsequent continuing applications can be submitted at 18 to 22 weeks.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 24 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient.

Recommencement of treatment

Patients who want to start a second or subsequent treatment cycle after a break in PBS subsidised omalizumab of at least 6 months must requalify for initial treatment and meet the relevant criteria at that time.

Further information

For more information call the PBS Complex Drugs Programs enquiry line.

Page last updated: 7 December 2016

This information was printed Saturday 10 December 2016 from humanservices.gov.au/health-professionals/enablers/severe-allergic-asthma-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.