Tiotropium Bromide Plus Olodaterol HydrochlorideSpiolto Respimat (with dose indicator)
Recommended RespiratoryRestrictedNot applicable line
Treatment of chronic obstructive pulmonary disease (COPD) in patients stabilised on a combination of a long-acting muscarinic antagonist and long-acting beta-2 agonist.
1
Submissions
2015–15
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2017 Recommended Asthma and chronic obstructive pulmonary disease (COPD)
Access path
- TGA registered · Spiolto Respimat (with dose indicator)
TGA label narrower than the PBS population
- Jul 2015Recommended · restricted
vs glycopyrronium/indacaterol FDC, umeclidinium/vilanterol…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of tiotropium/olodaterol FDC as an Authority required (STREAMLINED) benefit for the treatment of chronic obstructive pulmonary disease for patients already stabilised on concomitant LAMA and LABA therapy.PSD · Jul 2015
7.2 The PBAC recommended the listing on a cost-minimisation basis to the existing LAMA/LABA fixed dose combinations, umeclidinium/vilanterol and glycopyrronium/indacaterol. The equi-effective doses are considered to be tiotropium 5 microgram with olodaterol 5 microgram (two inhalations daily), umeclidiniumPSD · Jul 2015
Economic analysis
6.17 The submission presented a cost-minimisation analysis. The equi-effective doses were estimated as: tiotropium/olodaterol FDC 5 µg / 5 µg; glycopyrronium/indacaterol FDC 50 µg / 110 μg; and umeclidinium/vilanterol FDC 62.5 µg / 25 µg.PSD · Jul 2015
The equi-effective doses were based on the currently PBS listed doses, which were included in the clinical trials. This was considered reasonable.PSD · Jul 2015
Clinical claim
6.14 The PSCR emphasised that the results of the indirect comparisons for the outcome of trough FEV were the basis of the submission’s clinical claim. 1PSD · Jul 2015
6.15 Comparison 1: versus glycopyrronium/indacaterol FDC Comparison 2: versus umeclidinium/vilanterol FDC Comparison 4: versus tiotropium plus olodaterol concurrently The submission described tiotropium/olodaterol FDC as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over glycopyrronium/indacaterol FDC or umeclidinium/vilanterol FDC or tiotropium plus olodaterol concurrently.PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The basis of listing is a cost-minimisation to two main comparators; glycopyrronium/indacaterol FDC and umeclidinium/vilanterol FDC. PSD · 2015
Decision context
PopulationAdults with moderate to severe COPD (FEV₁ <80%) who have been stabilised on a combination of a long-acting muscarinic antagonist and long-acting beta-2 agonist
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended · restricted | glycopyrronium/indacaterol FDC, umeclidinium/vilanterol FDC, tiotropium monotherapy, olodaterol monotherapy, and tiotrop | — | RCT · PFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to patients stabilised on LAMA+LABA combination and FEV₁ <80%; TGA label covers all COPD patients.