Umeclidinium + Vilanterol
Long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) who have symptoms persisting despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA) and/or long acting beta-2 agonist (LABA), or who are stabilised on a combination of a LAMA and LABA.
Access path
- Jul 2014Recommended · restricted
vs tiotropium with indacaterol
- Nov 2014Not recommended
proposed restriction does not address PBAC concerns about patients initiating FDC before clinically appropriate, no new…
From the public summary
6.1 The PBAC rejected the submission to extend the current listing for umeclidinium with vilanterol (UMEC/VI) to include patients with chronic obstructive pulmonary disease (COPD) who have symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA) and/or a long acting beta-2 agonist (LABA).PSD · Nov 2014
6.2 The PBAC considered that the proposed restriction does not address the concerns previously raised by the PBAC when initially recommending UMEC/VI for listing, in that patients may initiate a FDC before clinically appropriate. No new data were presented in the submission to justify amending the current listing. The PBAC noted that the magnitude of the potential synergistic effects of using the combination of a LAMA and LABA are still unclear.PSD · Nov 2014
6.4 As in March 2014, the submission claimed the UMEC/VI combination therapy has comparable effectiveness to indacaterol 150 microgram plus tiotropium 18 microgram at 12 weeks. The submission claimed that UMEC/VI combination therapy has a mostly benign and similar safety profile to indacaterol plus tiotropium. 2PSD · Jul 2014
6.5 The PBAC considered that the claim of non-inferior comparative effectiveness to indacaterol plus tiotropium was reasonable.PSD · Jul 2014
Cost-effectiveness
This is a minor submission for restriction amendment; no new economic evaluation was conducted.
Decision context
PopulationAdult patients with COPD who have symptoms persisting despite regular bronchodilator treatment with a LAMA and/or LABA, or who are stabilised on a combination of a LAMA and LABA in separate devices.
Why it was knocked back
- proposed restriction does not address PBAC concerns about patients initiating FDC before clinically appropriate, no new data presented to justify amending listing, magnitude of synergistic effects of LAMA and LABA combination remains unclear, restriction inconsistent with indacaterol/glycopyrronium listing, quality use of medicine concerns regarding proliferation of FDC treatments and use of FDC prior to patient trialling combination therapy via separate inhalers
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Not recommended | — | — | Other |
| Jul 2014 | Recommended · restricted | tiotropium with indacaterol | — | Cost-minimisation · Surrogate |
Consumer voice
The Thoracic Society of Australia and New Zealand (TSANZ) provided advice clarifying the likely use of combination LAMA/LABAs in clinical practice and noted that requiring patients to be stabilised on separate devices before initiating the fixed-dose combination (FDC) may lead to patient confusion regarding correct inhaler use, while also highlighting the benefits of fewer inhaler devices to limit
the use of umeclidinium/vilanterol as proposed (i.e. requiring that patients be stabilised on a combination of a LAMA and LABA in separate devices before initiating the FDC) may lead to patient confusion regarding correct inhaler use if patients have to use multiple inhaler types Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with persistent symptoms despite LAMA and/or LABA treatment, or stabilised on LAMA+LABA combination.