Tiotropium Bromide With Olodaterol HydrochlorideSpiolto Respimat (with dose indicator)
Chronic obstructive pulmonary disease (COPD) in patients with persistent symptoms despite regular monotherapy with a long-acting muscarinic antagonist (LAMA) or long-acting beta-2 agonist (LABA), or in patients stabilised on combination LAMA and LABA therapy.
Decision on record
- Meeting Nov 2017 Recommended Asthma and chronic obstructive pulmonary disease (COPD)
Access path
- TGA registered · Spiolto Respimat (with dose indicator)
TGA label narrower than the PBS population
- Nov 2017Recommended · restricted
vs other LAMA/LABA fixed-dose combinations (umeclidinium with…
- PBS listing · Restricted
From the public summary
6.1 The PBAC decided to defer the requested change to the Authority Required (STREAMLINED) listing for tiotropium with olodaterol FDC to allow patients taking either a LAMA or LABA to move straight to the FDC until after the PBAC has considered the Post-market Review of COPD Medicines.PSD · Nov 2017
6.2 The PBAC acknowledged the consumer comments received from health care professionals and organisations that indicated support for the proposed change to the restriction. The PBAC noted that the proposed changes would align the restrictions with the treatment algorithm in the COPD-X Plan.PSD · Nov 2017
5.2 The PBAC noted and welcomed the input from health care professionals (3) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the potential benefits from a convenience and quality use of medicines perspective of allowing treatment with tiotropium with olodaterol FDC if stabilisation is not achieved with LAMA or LABA monotherapy.PSD · Nov 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Minor submission with budget impact analysis showing net saving.
Decision context
PopulationAdults with COPD who have persistent symptoms despite regular bronchodilator treatment with a LAMA or LABA monotherapy, or who are stabilised on concomitant LAMA and LABA therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended · restricted | other LAMA/LABA fixed-dose combinations (umeclidinium with vilanterol, aclidinium with eformoterol, indacaterol with gly | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Health care professionals and organisations provided input supporting the proposed change to allow patients with persistent symptoms on LAMA or LABA monotherapy to move directly to tiotropium with olodaterol FDC. They noted that the current process of trialling patients on two separate devices was cumbersome and posed quality use of medicines issues.
Both organisations were of the view that it is clinically appropriate to allow patients who have symptoms that persist despite regular bronchodilator treatment with either a LAMA or LABA to move straight to a LAMA/LABA FDC. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with persistent symptoms despite monotherapy or on combination therapy; TGA label permits any COPD patient.