Indacaterol With Glycopyrronium
Once daily maintenance bronchodilation in patients with chronic obstructive pulmonary disease (COPD) who have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist.
Access path
- Jul 2014Recommended · restricted
vs indacaterol 150 µg and glycopyrronium 50 µg given…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of indacaterol/glycopyrronium as an Authority required (STREAMLINED) listing for the treatment of chronic obstructive pulmonary disease for patients already stabilised on concomitant LAMA and LABA therapy.PSD · Jul 2014
7.2 The PBAC considered, amongst other matters, that the cost-effectiveness of indacaterol/glycopyrronium would be acceptable if it were cost-minimised against the umeclidinium/vilanterol FDC when used for COPD. The equi-effective doses are considered to be indacaterol 110 microgram with glycopyrronium 50 microgram to umeclidinium (as bromide) 62.5 microgram with vilanterol (as trifenatate) 25 microgram.PSD · Jul 2014
6.10 Switching from ICS/LABA to indacaterol/glycopyrronium is now appropriately included in the pricing and estimates used in the current submission, however, the switching rates applied for these patients are still uncertain.PSD · Jul 2014
6.11 The sponsor originally proposed a DPMQ of '''''''''''''''''''', which is equivalent to the sum of the component products. This was modified to extend the population to include patients currently on ICS/LABA alone (rather than only in combination with LAMA as for the previous submission), and by recalculating the price based on the weighted average of the medications currently used to treat COPD based on BEACH data.PSD · Jul 2014
6.5 As for the March 2014 submission, this submission claimed that indacaterol/glycopyrronium is superior in terms of comparative effectiveness and equivalent in terms of safety over either of the components given as monotherapy.PSD · Jul 2014
6.6 The PBAC considered that the claim of superiority for the FDC, in terms of additional change in FEV was supported by the data, but that the change was not clinically 1 significant based on the previous definition of minimum clinically important difference used by the Committee.PSD · Jul 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission was on a cost-minimisation basis compared to the components given concomitantly.
The PBAC considered, amongst other matters, that the cost-effectiveness of indacaterol/glycopyrronium would be acceptable if it were cost-minimised against the umeclidinium/vilanterol FDC when used for COPD. PBAC · 2014
Decision context
PopulationAdults with COPD who have been stabilised on a combination of a long acting muscarinic antagonist (LAMA) and long acting beta-2 agonist (LABA).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended · restricted | indacaterol 150 µg and glycopyrronium 50 µg given concurrently; indacaterol + tiotropium; LABA/ICS plus tiotropium; umec | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SHINE | Ph 3 | 2,144 | Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment | completed |
Consumer voice
One healthcare professional expressed that combining LABA/LAMA in a single device would improve the management of COPD patients requiring two classes of bronchodilator.
LABA/LAMA in one device would improve the management of COPD patients requiring two classes of bronchodilator. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients stabilised on prior LAMA+LABA combination; TGA label allows any COPD patient.