Severe allergic asthma
Through the Pharmaceutical Benefits Scheme (PBS), under Section 100 arrangements of the National Health Act 1953, authority to supply omalizumab (Xolair®) is required for the treatment of patients with uncontrolled severe allergic asthma aged 12 years or older.
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 outlines restrictions for prescribing omalizumab.
Initial treatment
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 for Health Professionals on Inhaler Technique available at www.nationalasthma.org.au
.
A completed Asthma Control Questionnaire five 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 on 1800 671 203 or medinfo.phauno@novartis.com
.
An 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. For patients recommencing omalizumab within 12 months of the last dose the previous pre-omalizumab IgE level should be used.
Recommencement of treatment
A patient who wants to trial a second or subsequent treatment cycle following a break in PBS subsidised omalizumab therapy of at least six months, must requalify for initial treatment with respect to the indices of disease severity (oral corticosteroid dose, Asthma Control Questionnaire (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.
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. If the same physician cannot assess the patient call Medicare on 1800 700 270* (option 1) available Monday to Friday 8.00am to 5.00pm EST.
Patients who fail to respond to a course of PBS subsidised omalizumab for the treatment of uncontrolled severe allergic asthma, will not be eligible to receive further PBS subsidised treatment with omalizumab for this condition within six months of the date when the treatment finished.
Item details
Dose
Omalizumab is available as 150mg vial.
Xolair® is administered subcutaneously every two or four 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).
- Doses ≤ 300 mg per four week interval are administered once every four weeks.
- Doses > 300 mg per four week interval are split into two equal doses administered every two weeks.
Initial application
Prescriptions should be written for a sufficient quantity of vials to supply the patient with four weeks of treatment and up to six repeats.
Continuing application
Prescriptions should be written for a sufficient quantity of vials to supply the patient with four weeks of treatment and up to five repeats.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Test requirements
All initial applications must include:
- IgE result
- ACQ5 calculation sheet
All continuing applications must include:
- ACQ5 calculation sheet
Lodgement
All initial applications must be submitted in writing.
Send all written applications to:
Medicare
Prior written approval of specialised drugs
Reply Paid 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information
Call 1800 700 270* (option 1) Monday to Friday 8.00am to 5.00pm EST
Toxicity and severity descriptors
To ensure that the eligibility of patients can be fully assessed, a comprehensive list of toxicity and severity descriptors which should be used in conjunction with the application when demonstrating a patient’s inability to tolerate optimised asthma therapy is attached.
- Severe allergic asthma inhaled corticosteroids [PDF, 99Kb]
, long acting beta-2 agonist and oral corticosteroid toxicity and severity descriptors
Application Forms
- Initial PBS subsidised treatment (Form 4767) [PDF, 237Kb] - Lodge this form for a patient starting initial PBS subsidised treatment, or recommencing PBS subsidised treatment with omalizumab. The patient and prescriber acknowledgements must be completed.
- Continuing PBS subsidised treatment (Form 4768) [PDF, 209Kb] - Lodge this form for a patient continuing PBS subsidised treatment with omalizumab
*Call charges apply from mobile or pay phones only.
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Last updated: 1 July, 2011