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

Uncontrolled severe 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; AND

Patient must be aged 6 to less than 12 years.

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.

All applications for continuing treatment with this biological medicine must include a measurement of response to the prior course of therapy. 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 must be made at around 20 weeks after the first PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

The first assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, 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 dupilumab, sufficient for 24 weeks therapy.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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

(a) maintenance oral corticosteroid dose; and

(b) Asthma Control Questionnaire (ACQ-5) score; or

(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

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.

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

Uncontrolled severe asthma

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2025; AND

Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by 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, defined by at least one of the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility, (ii) airway hyperresponsiveness, (iii) peak expiratory flow (PEF) variability; AND

Patient must have had a duration of asthma of at least 1 year prior to commencement of non-PBS-subsidised treatment with this drug; AND

Patient must have had a documented total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition, with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or

Patient must have had a blood eosinophil count of at least 150 cells per microlitre in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or

Patient must have had a fractional exhaled nitric oxide of at least 20 ppb in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND

Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated or sustained an adequate response to treatment with this drug if the patient has received at least 28 weeks of 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; AND

Patient must have been aged 6 to less than 12 years prior to starting non-PBS-subsidised treatment with this drug.

Optimised asthma therapy includes:

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

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.

The following initiation criteria indicate failure to achieve adequate control with optimised asthma therapy and must be demonstrated in all patients at the time of the application:
(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed prior to non-PBS-subsidised treatment with this drug for this condition (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),
AND
(b) while receiving optimised asthma therapy in the prior to non-PBS-subsidised treatment with this drug for this condition 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate to determine whether the patient has achieved or sustained an adequate response to non-PBS subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been at least 28 weeks

All applications for continuing treatment with this biological medicine must include a measurement of response to the prior course of therapy. 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 must be made at around 20 weeks after the first dose of PBS-subsidised treatment with this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

The first assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug for this condition.

A patient who fails to demonstrate a response to 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.

A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.

The length of the break in therapy is measured from the date of the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new 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 dupilumab, sufficient for 24 weeks of therapy.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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

(a) prior optimised asthma drug therapy (date of commencement and duration of therapy); and

(b) IgE, blood eosinophils or fractional exhaled nitric oxide results and date from prior to initiating non-PBS-subsidised treatment with this drug; and

(c) date of commencing non-PBS-subsidised treatment with this drug for this condition.

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

(e) If applicable, the Asthma Control Questionnaire (ACQ-5) scores, including the date of assessment of the patient's symptoms; or

(f) If applicable, the Asthma Control Questionnaire interviewer administered version (ACQ-IA) scores, including the date of assessment of the patient's symptoms.