Severe allergic asthma - adolescent and adult patient

The PBS subsidises omalizumab for patients aged 12 years or older 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 patients aged 12 years or older 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 a:

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

You must include the hospital provider number on the application form

This item is not available as a PBS subsidised 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.

All patients starting treatment with omalizumab must have had a formal assessment and correction of inhaler technique in accordance with the National Asthma Council (NAC) Information Paper - Inhaler Technique for People with Asthma or COPD. This is available from the National Asthma Council Australia.

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.

Applications

Initial treatment

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

All applications must include a completed:

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 12 months or more after the last dose of omalizumab.

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

Continuing treatment

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

All applications must include a completed:

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

The same physician who initiated treatment with omalizumab should also complete the application for the first assessment. If the same physician cannot assess the patient, call the Complex Drugs Programs enquiry line.

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

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

Continuing applications must include an ACQ-5 calculation sheet. For patients transitioning from paediatric treatment to adolescent and adult treatment, an exacerbation calculation sheet must be included instead.

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.

The previous pre-omalizumab IgE level should be used for patients recommencing omalizumab within 12 months of the last dose.

Patients must have received optimised standard therapy, at adequate doses and for the minimum period specified, immediately before the new baseline assessments.

Further information

For more information call the Complex Drugs Programs enquiry line.

Page last updated: 3 January 2017

This information was printed Tuesday 21 February 2017 from humanservices.gov.au/health-professionals/enablers/severe-allergic-asthma-adolescent-and-adult-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.