Severe allergic asthma - adult patient

The Pharmaceutical Benefits Scheme subsidises omalizumab for patients with uncontrolled severe allergic asthma.

For patients aged 12 years or older with uncontrolled severe allergic asthma, treatment with omalizumab (Xolair®) may be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953.

Section 100 arrangements

This item is only available to a patient who is attending either:

  • 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

This item is not available as a PBS benefit for in-patients of a hospital. The hospital provider number must be included on the application form.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing omalizumab (Xolair®).

Initial treatment

All patients starting treatment with omalizumab (Xolair®) must have had a formal assessment and correction of inhaler technique in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique available on the National Asthma Council Australia website.

A completed Asthma Control Questionnaire 5-item (ACQ-5) calculation sheet, including the date of assessment of the patient’s symptoms, must be submitted. This sheet is available from Novartis Medical Information.

An immunoglobulin E (IgE) pathology report must be provided with each initial and recommencement application. A re-assessment of free IgE can only be made at least 12 months after the last dose of omalizumab (Xolair®). For patients recommencing omalizumab (Xolair®) within 12 months of the last dose, the previous pre-omalizumab (Xolair®) IgE level should be used.

Continuing treatment

All applications for continuing treatment must include a measurement of response to the prior course of therapy.

Applications for the first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab (Xolair®). If the same physician cannot assess the patient contact us on the Complex Drugs Programs enquiry line.

Patients who fail to respond to a course of PBS subsidised omalizumab (Xolair®) for the treatment of uncontrolled severe allergic asthma, will not be eligible to receive further PBS-subsidised treatment with omalizumab (Xolair®) for this condition within 6 months of the date when the treatment finished.

Recommencing treatment

A patient who wants to trial a second or subsequent treatment cycle following a break in PBS-subsidised omalizumab (Xolair®) therapy of at least 6 months, must requalify for initial treatment with respect to the:

  • indices of disease severity
  • oral corticosteroid dose
  • ACQ-5 score, and
  • relevant exacerbation history

Patients must have received optimised standard therapy, at adequate doses and for the minimum period specified, immediately prior to the time the new baseline assessments are performed.

Toxicity and severity descriptors

To ensure patients' 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.

Schedule item details

Dose - omalizumab (Xolair®) is available as a 75 mg pre-filled syringe or 150 mg pre-filled syringe.

Omalizumab (Xolair®) is administered subcutaneously every 2 or 4 weeks.

Doses and dosing frequency are determined by:

  • baseline serum total IgE level (IU/mL), measured before the start of treatment, and
  • body weight (kg)

Dosing must be in accordance with the Therapeutic Goods Administration (TGA) approved product information.

Initial application

Prescriptions should be written for the most cost-effective syringe combination for a sufficient quantity to supply the patient with 4 weeks of treatment and up to 6 repeats. A separate authority prescription must be written for each strength of syringe.

Continuing application

Prescriptions should be written for the most cost-effective syringe combination for a sufficient quantity to supply the patient with 4 weeks of treatment and up to 6 repeats. A separate authority prescription must be written for each strength of pre-filled syringe.

Test requirements

Initial applications must include:

  • IgE result, and
  • ACQ-5 calculation sheet

Continuing applications must include an ACQ-5 calculation sheet.

Lodging an application

All initial applications must be in writing and submitted to the Complex Drugs Programs address on the contact us page.

Lodge Severe allergic asthma Initial PBS authority application Supporting information form (PB075) for a patient starting or recommencing PBS-subsidised treatment with omalizumab (Xolair®).

The patient and prescriber acknowledgements must be completed.

Lodge Severe allergic asthma Continuing PBS authority application and Supporting information form (PB076) for a patient continuing PBS-subsidised treatment with omalizumab (Xolair®).

Further information

For more information contact the Complex Drugs Programs enquiry line.

Page last updated: 1 December 2016

This information was printed Saturday 10 December 2016 from It may not include all of the relevant information on this topic. Please consider any relevant site notices at when using this material.