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

Uncontrolled severe allergic asthma

Continuing treatment

Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND

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

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

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

An adequate response to this biological medicine is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) 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 Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.

A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.

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 biological medicine for this condition.

A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.

At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab 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 24 weeks therapy.

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

(a) If applicable, the baseline and maintenance oral corticosteroid dose; and

(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or

(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and

(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.

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