Umeclidinium BromideIncruse Ellipta
Not recommended RespiratoryRestrictedFirst-line line
Treatment of chronic obstructive pulmonary disease (COPD) as monotherapy, in combination with a long-acting beta agonist (LABA), and in combination with a LABA and an inhaled corticosteroid (ICS).
1
Submissions
1 resub
2014–14
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2014 Not recommended umeclidinium bromide 62.5 microgram/actuation + vilanterol trifenatate 25 microgram/actuation inhalation: powder for Anoro® Ellipta® GlaxoSmithKline Australia Pty Ltd Change to recommended listing (Minor submission) Chronic obstructive pulmonary disease Amend recommended restriction to also include no PSD
- Meeting Jul 2014 Recommended powder for inhalation, 62.5 microgram/actuation, 30 actuations Incruse® Ellipta® GlaxoSmithKline Australia Pty Ltd New listing (Major submission) Chronic obstructive pulmonary disease (COPD) Restricted Benefit listing for the treatment of adult patients with COPD. Based on an indirect comparison usi
- Meeting Jul 2014 Recommended powder for inhalation, umeclidinium bromide 62.5 microgram/actuation + vilanterol trifenatate 25 microgram/actuation Anoro ® Ellipta® GlaxoSmithKline Australia Pty Ltd New listing (Minor submission) Chronic obstructive pulmonary disease (COPD) Authority Required (Streamlined) listing for the treatm
Access path
- TGA registered · Incruse Ellipta
TGA label narrower than the PBS population
- Jul 2014Recommended · restricted
vs tiotropium
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended listing of umeclidinium as a restricted benefit for the treatment of chronic obstructive pulmonary disease with a maximum quantity of one pack with five repeats on the basis of non-inferiority to tiotropium.PSD · Jul 2014
7.2 The PBAC accepted that tiotropium is the appropriate comparator but also considered that glycopyrronium bromide (recommended at the November 2013 PBAC meeting) and aclidinium (recommended at the March 2014 PBAC meeting) may also be relevant comparators.PSD · Jul 2014
Economic analysis
6.15 The submission presents a cost-minimisation analysis using a comparison of drug costs only.PSD · Jul 2014
6.16 Umeclidinium 62.5 mcg once daily and tiotropium 18 mcg once daily are claimed to be equi-effective. The claim is based on an indirect comparison of data from 18 key randomised trials, two for umeclidinium and 16 for tiotropium.PSD · Jul 2014
Clinical claim
6.12 The submission described umeclidinium 62.5 mcg is non-inferior in terms of effectiveness and non-inferior in terms of safety when compared to tiotropium 18 mcg.PSD · Jul 2014
6.13 The following concerns were raised by the ESC: The submission provides only evidence for the use of umeclidinium as monotherapy; and There is heterogeneity within the trials included in the meta-analysis for the main comparator, tiotropium, which is likely to be related to differences in patient characteristics among the trials.PSD · Jul 2014
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated as the drug is claimed to be equi-effective with tiotropium.
The submission presents a cost-minimisation analysis using a comparison of drug costs only. PSD · 2014
Decision context
PopulationAdult patients with chronic obstructive pulmonary disease (COPD) of mild to severe severity.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended · restricted | tiotropium | — | Meta-analysis · FEV1 |
Similar precedents
Umeclidinium + Vilanterol81%Umeclidinium Bromide And Vilanterol Trifenatate77%Fluticasone Furoate / Umeclidinium / Vilanterol74%Indacaterol With Glycopyrronium71%Aclidinium Bromide Plus Eformoterol Fumarate Dihydrate71%Aclidinium Bromide70%Tiotropium Bromide With Olodaterol Hydrochloride69%Tiotropium69%
Regulatory · TGA
Label narrower than PBS population — PBAC specifies disease severity (mild to severe), treatment combinations, and first-line positioning; TGA label is unrestricted by severity or treatment line.