TABLE 1

Inclusion, continuation and exclusion criteria for Australian Mepolizumab Registry participation

Inclusion criteria
 Able to provide informed written consent
 Age ≥12 years#
 Asthma diagnosis confirmed by doctor or hospital and documented for ≥1 year#
 Confirmed variable airflow obstruction (one or more of the following)#:

  • FEV1 reversibility ≥12% and ≥200 mL at baseline within 30 min after administration of salbutamol (200–400 µg), OR

  • Airway hyper-responsiveness defined as >20% decline in FEV1 during a direct bronchial provocation test or >15% decline during an indirect test, OR

  • Peak expiratory flow variability of >15% between the two highest and two lowest peak expiratory flow rates during 14 days

 Optimised asthma management skills (formal assessment of and adherence to correct inhaler technique, documented in medical records)
 FEV1 ≤ 80% predicted documented on one or more occasions in the previous 12 months#
 Optimised asthma therapy (unless contraindicated or not tolerated)#:

  • ≥12 months maximal inhaled therapy with adherence and correct technique documented, including:

    • o High-dose inhaled corticosteroid

    • o Long-acting β2 agonist therapy

      AND

  • Treatment with oral corticosteroids (OCS) (daily OCS for at least 6 weeks OR a cumulative dose of ≥500 mg prednisolone equivalent in the previous 12 months)

Uncontrolled asthma, as defined by#:

  • Asthma Control Questionnaire (ACQ-5) score ≥2 in the previous month AND

  • One of the following experienced in the previous year:

    • o ≥1 admission to hospital for a severe asthma exacerbation, OR

    • o ≥1 severe asthma exacerbation requiring documented use of systemic corticosteroids (OCS initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

 Eosinophilic asthma as determined from peripheral blood eosinophil count ≥300 cells·µL−1 in the previous 12 months#
Continuation criteria for government-subsidised treatment with mepolizumab
 Demonstrated or sustained an adequate response to mepolizumab treatment as evidenced by:

  • A reduction in the Asthma Control Questionnaire (ACQ)-5 score of at least 0.5 from baseline

    OR

  • A reduction in the maintenance oral dose of corticosteroid by at least 25% from baseline

    AND

    No deterioration in the ACQ-5 from baseline

Exclusion criteria
 Not receiving mepolizumab treatment in combination with or within 6 months of PBS subsidised omalizumab treatment#,¶
 People highly dependent on medical care
 Cognitive impairment preventing completion of data collection forms

Australian Commonwealth Government Pharmaceutical Benefits Scheme (PBS) criteria for #initiation of a subsidised mepolizumab cycle and continuation of PBS-subsidised mepolizumab after 26–30 weeks of treatment (1st continuation assessment), 18–22 weeks (subsequent continuation assessments).