Tiotropium BromideBraltus
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.
Decisions on record
The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.
- Meeting Jul 2015 Recommended Chronic obstructive pulmonary disease
- Meeting Jul 2015 Not recommended Asthma
- Meeting Jul 2009 Recommended Chronic obstructive pulmonary disease no PSD
Access path
- TGA registered · Braltus
TGA label narrower than the PBS population
- Jul 2015Not recommended
vs placebo plus ICS and LABA
From the public summary
7.1 The PBAC did not recommend the listing of tiotropium as add-on therapy for the treatment of severe uncontrolled asthma. In making its recommendation, the PBAC 16PSD · Jul 2015
7.2 The PBAC accepted the clinical place for tiotropium as an add-on therapy to an ICS and a LABA for adult patients with severe persistent asthma who have experienced at least one serious exacerbation in the previous year. The PBAC noted the comments from The Lung Foundation and The Centre of Research Excellence in Severe Asthma and agreed that there is a need for additional treatments for severe uncontrolled asthma.PSD · Jul 2015
4 Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2014. 10PSD · Jul 2015
Methods used to generate results Extrapolated trial data and Markov model Seven health states: 1) optimal asthma control; 2) acceptable asthma control; 3) uncontrolled asthma; 4) non-severe exacerbation; 5) severe exacerbation without hospitalisation; 6) severe exacerbation with hospitalisation; and 7) death (all-cause) Health State Utility Values Source Optimal control '''''''''' Health states Trial 205.416/205.417, Acceptable control ''''''''''' …PSD · Jul 2015
6.18 The submission described tiotropium 5 µg as superior in terms of comparative effectiveness and non-inferior in terms of comparative safety over placebo.PSD · Jul 2015
6.19 The evaluation considered this claim was adequately supported in terms of statistical measures and tiotropium provided superior efficacy to placebo in terms of trough FEV , time to first exacerbation, time to first severe exacerbation and ACQ-7 score.PSD · Jul 2015
6.3 The PBAC noted The Centre of Research Excellence in Severe Asthma supported the clinical need for additional treatment options for severe asthma.PSD · Jul 2015
6.51 In the PSCR, the sponsor acknowledged the areas of uncertainty with the financial estimates and was willing to accept a risk sharing arrangement around the financial estimates specific to the severe asthma indication.PSD · Jul 2015
Cost-effectiveness
Document text ends mid-sentence at section 6.13; economic data redacted or incomplete in the extracted text.
Decision context
PopulationAdult 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Not recommended | placebo plus ICS and LABA | — | RCT · Time to first severe exacerbation |
Consumer voice
Two consumer organisations supported the addition of tiotropium as a treatment option for severe asthma, citing evidence of improved lung function and increased time to first severe flare-up. The Centre of Research Excellence in Severe Asthma also supported the clinical need for additional treatment options.
the addition of regular tiotropium increased the time to the first severe flare-up and improved lung function, compared with placebo Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to 'severe persistent asthma' while TGA label applies to all asthma patients meeting ICS/LABA and exacerbation criteria.