Umeclidinium Bromide And Vilanterol TrifenatateAnoro Ellipta
Treatment of chronic obstructive pulmonary disease (COPD) in adults where symptoms persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA) and/or long acting beta2 agonist (LABA), or in patients stabilised on a combination of LAMA and LABA in separate devices.
Access path
- TGA registered · Anoro Ellipta
TGA label narrower than the PBS population
- Mar 2014Not recommended
Absence of individual components (umeclidinium and vilanterol) on PBS is problematic for stepwise treatment; risks of…
From the public summary
7.1 The PBAC rejected the submission requesting PBS-listing for UMEC/VI 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 indacaterol plus tiotropium was not justified by the evidence presented in the submission.PSD · Mar 2014
7.2 The PBAC also considered that having a combination product available without having the individual components available was problematic. Patients with COPD cannot be treated in the stepwise manner recommended without changing the LABA and LAMA medications.PSD · Mar 2014
6.26 The submission presented a cost-minimisation analysis based on the non-inferiority claim versus tiotropium plus indacaterol. The equi-effective doses were estimated as UMEC/VI 62.5/25 micrograms and tiotropium 18 micrograms plus indacaterol 150 micrograms. A summary of the cost-minimisation analysis is presented in the table below. 8PSD · Mar 2014
6.22 The submission claimed that UMEC/VI combination therapy has comparable effectiveness to indacaterol (150 µg) plus tiotropium (18 µg) at 12 weeks. The submission also claimed that UMEC/VI combination therapy is non-inferior in terms of efficacy to indacaterol/glycopyrronium (110/50 micrograms).PSD · Mar 2014
6.23 The submission claimed that UMEC/VI combination therapy has a mostly benign and similar safety profile to indacaterol plus tiotropium, and is non-inferior in terms of safety to indacaterol/glycopyrronium.PSD · Mar 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The PBAC agreed with the ESC that having a combination product available without having the individual components available was problematic. PBAC · 2014
Decision context
PopulationAdult patients with COPD where symptoms persist despite regular bronchodilator treatment with LAMA and/or LABA, or patients stabilised on combination LAMA and LABA in separate devices
Why it was knocked back
- Absence of individual components (umeclidinium and vilanterol) on PBS is problematic for stepwise treatment; risks of inappropriate early combination therapy transition and potential double-dosing of LABAs; no superiority demonstrated over comparator on clinically relevant outcomes; concerns regarding safety profile with higher adverse event and serious adverse event rates in some trials; safety risks from potential prescribing errors and incorrect dosing of FDC products
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Not recommended | tiotropium plus indacaterol | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DB2113361 | Ph 3 | 1,493 | Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 1… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to patients with persistent symptoms despite LAMA and/or LABA treatment; TGA label has no prior treatment requirement.