Olodaterol
Not recommended RespiratoryRestrictedSecond-line line
Maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD) in patients with a history of significant symptoms despite currently receiving regular long-acting muscarinic antagonist therapy.
1
Submissions
2014–14
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Jul 2014 Not recommended Striverdi® Respimat® Boehringer Ingelheim Pty Ltd New listing (Major submission) Chronic obstructive pulmonary disease (COPD) Restricted benefit for the treatment of chronic obstructive pulmonary disease (COPD). Sponsor Comment: The sponsor had no comment.
From the public summary
PBAC outcome
7.1 The PBAC rejected the submission requesting PBS-listing for olodaterol for the treatment of COPD. The PBAC did not accept that tiotropium, as presented in the submission, was the appropriate comparator. The clinical evidence available does not support the claim that olodaterol is non-inferior to indacaterol in terms of clinical efficacy.PSD · Jul 2014
7.2 The PBAC noted that indacaterol was recommended on the basis of cost minimisation compared with fluticasone with salmeterol and tiotropium, but considered with the listing of indacaterol, tiotropium was no longer the appropriate comparator. The PBAC agreed with the ESC that indacaterol was the appropriate comparator, as it is in the same pharmacological class as olodaterol and that a LABA is most likely to be replaced by a LABA.PSD · Jul 2014
Economic analysis
6.21 The submission considers, based on doses included in the clinical trials, olodaterol 5 microgram is equivalent to: tiotropium 18 microgram indacaterol (150 microgram or 300 microgram) fluticasone 500 microgram + salmeterol 50 microgram (with concomitant tiotropium 18 microgram therapy) indacaterol 150 microgram (with concomitant tiotropium 18 microgram therapy)PSD · Jul 2014
6.22 The ESC noted that on the basis of evidence provided in the indirect comparison, olodaterol 5 microgram may not be equivalent to indacaterol 150 microgram or 300 microgram.PSD · Jul 2014
Clinical claim
6.17 The submission claimed: Olodaterol is non-inferior to tiotropium; The comparison of olodaterol versus indacaterol as monotherapy was inconclusive; Olodaterol plus tiotropium is non-inferior to fluticasone/salmeterol plus tiotropium; and Olodaterol plus tiotropium is non-inferior to indacaterol plus tiotropium.PSD · Jul 2014
6.18 The commentary found that: Olodaterol does not show significant clinical superiority to placebo in respect of change in trough FEV at 12 weeks. 1 Olodaterol is non-inferior to tiotropium for trough FEV at 6 weeks; no 1 evidence was available for the clinical outcome of change in trough FEV at 12 1 weeks. As monotherapy, olodaterol is inferior to indacaterol for efficacy outcomes using indirect comparisons.PSD · Jul 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdult patients with chronic obstructive pulmonary disease with a history of significant symptoms despite currently receiving regular long-acting muscarinic antagonist therapy.
Why it was knocked back
- claim of non-inferior comparative effectiveness compared to indacaterol not adequately supported by data, inferior to indacaterol as monotherapy based on indirect comparison, change in trough FEV1 approximately lower with olodaterol compared to indacaterol
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Not recommended | indacaterol | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT00792805 | Ph 3 | 563 | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with significant symptoms despite prior long-acting muscarinic antagonist therapy; TGA label includes all COPD patients regardless of prior treatment.