Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Uncontrolled severe asthma

Continuing treatment

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND

Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND

Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND

The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Patient must be aged 12 years or older.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).

All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.

The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this drug.

Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.

A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy.

The following information must be provided at the time of application and must be documented in the patient's medical records:

(a) Asthma Control Questionnaire (ACQ-5) score; and

(b) If applicable, maintenance oral corticosteroid dose; and

(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.

The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.