PBAC's latest decision on Tiotropium bromide: Recommended with restriction (2015). Considered for Add-on maintenance bronchodilator treatment in adult patients with severe persistent asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 µg budesonide/day or equivalent) and long-acting beta-2 agonists and who experienced one or more severe exacerbations in the previous year.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adult patients with severe persistent asthma receiving optimised therapy with inhaled corticosteroids (≥800 µg budesonide/day or equivalent) and long-acting beta-2 agonists who have experienced at least one severe exacerbation in the previous year.
Therapy area
Respiratory
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Time to first severe exacerbation
Pivotal trial size
912 patients
Key trials
205.416, 205.417, 205.341
Comparator
placebo plus ICS and LABA
ICER note
Document text ends mid-sentence at section 6.13; economic data redacted or incomplete in the extracted text.