Indacaterol + Glycopyrronium
Not recommended RespiratoryRestrictedSecond-line line
Once-daily maintenance dual bronchodilator treatment to relieve symptoms in patients with COPD currently on LABA or LAMA monotherapy who require additional relief from symptoms.
1
Submissions
2014–14
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC rejected the submission requesting PBS-listing for indacaterol/glycopyrronium FDC for the treatment of COPD. The PBAC considered that the cost-minimisation approach used, where the price of the FDC was cost- minimised to the sum of the prices of the component products (dose adjusted) was not justified by the evidence presented in the submission.PSD · Mar 2014
7.2 The PBAC considered the nominated comparators were generally appropriate. The PBAC noted that the position of ICS/LABA in the treatment algorithm for COPD is changing, and ICS/LABA is currently recommended in patients with very severe disease. The PBAC therefore considered that the comparisons with LAMA/LABA presented in the submission were the most relevant.PSD · Mar 2014
Economic analysis
6.23 The submission presented a cost-minimisation analysis based on the non-inferiority claims. A summary of the cost-minimisation is presented in the table below.PSD · Mar 2014
Summary of cost minimisation Molecule Ex-man '''''''''''''''''''' '''''''''''''' '''''' Price per µg Requested ''''''''''''''' price Indacaterol 150 μg ''''''''''''''''' '''''''''''''''''' '''''''''''''' '''''''''''''''' Glycopyrronium 50 μg ''''''''''''''''' ''''''''''''' '''''''''''' '''''''''''''''' Ex-manufacturer '''''''''''''''' Price to pharmacist ''''''''''''''''''''' DPMQ '''''''''''''''' Source: Table 158 & Table 159, p279 of the submission; …PSD · Mar 2014
Clinical claim
6.20 The submission claimed that indacaterol/glycopyrronium FDC is superior in terms of comparative effectiveness and equivalent in terms of safety over either of the components given as monotherapy. The PBAC considered this claim was reasonable.PSD · Mar 2014
6.21 The submission claimed that indacaterol/glycopyrronium FDC is non-inferior in terms of comparative effectiveness and equivalent in terms of safety compared to the component products given concurrently.PSD · Mar 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationPatients with moderate to severe COPD currently on LABA or LAMA monotherapy requiring additional relief from symptoms.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Not recommended | indacaterol and glycopyrronium given concurrently; indacaterol plus tiotropium; LABA/ICS plus tiotropium | — | 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 |
| INTRUST1 | Ph 3 | 1,134 | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) … | completed |
| INTRUST2 | Ph 3 | 1,142 | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) … | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients already on LABA or LAMA monotherapy requiring additional symptom relief; TGA label covers all COPD patients regardless of prior therapy.