← The record

Tiotropium With Olodaterol

Recommended RespiratoryAuthority Required 💬 consumer voice

Treatment of chronic obstructive pulmonary disease (COPD) in patients with persistent symptoms despite regular bronchodilator treatment with a long-acting muscarinic antagonist (LAMA) or long-acting beta 2 agonist (LABA), or in patients stabilised on a combination of LAMA and LABA.

2
Submissions
1 resub
2020–24
On the record
ICER range
Cost-min
Cost basis

Decisions on record

2 decisions
  • Meeting Nov 2024 Recommended Chronic obstructive pulmonary disease
  • Meeting Jul 2020 Recommended Chronic obstructive pulmonary disease

Access path

2 submissions · public record
  1. Jul 2020
    Recommended

    vs tiotropium with olodaterol disposable inhaler (currently…

  2. Nov 2024
    Recommended

    Comparator changed: tiotropium with olodaterol disposable inhaler (currently listed…

  3. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
5.1 The PBAC recommended the General Schedule Authority Required (STREAMLINED) listing of a new pack size of tiotropium with olodaterol (Spiolto Respimat®) with 2 cartridges x 60 actuations for the treatment of chronic obstructive pulmonary disease (COPD) under the same circumstances as the currently listed Spiolto Respimat with corresponding 60-day maximum dispensed quantities (MDQ).PSD · Nov 2024
5.2 The PBAC noted that the submission requested that the double pack be the only listed pack size for the 60-day MDQ listing, with the single pack remaining listed against only the 30-day prescription listings. The PBAC recalled that at its December 2022 meeting, Spiolto Respimat was recommended as suitable for listing on the PBS with increased MDQs.PSD · Nov 2024
Consumer comments
4.2 The PBAC noted and welcomed the input from one organisation via the Consumer Comments facility on the PBS website. The Lung Foundation Australia described a number of benefits of 60-day prescribing for people with COPD including reduced costs associated with prescriptions and travel, particularly for those in rural and remote regions.PSD · Nov 2024

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated as 1 x double pack provides no incremental efficacy or toxicity benefit over 2 x single packs.

Cost-effectiveness accepted ×2

Decision context

PopulationAdults with chronic obstructive pulmonary disease and persistent symptoms despite regular bronchodilator treatment with a LAMA or LABA, or stabilised on combination LAMA/LABA therapy.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Nov 2024 Recommended 2 x single packs of tiotropium with olodaterol Cost-minimisation · Cost-minimisation
Jul 2020 Recommended tiotropium with olodaterol disposable inhaler (currently listed presentation) Cost-minimisation · Cost-minimisation

Consumer voice

Nov 2024

The Lung Foundation Australia provided consumer input supporting the expansion of 60-day prescribing for COPD, highlighting benefits including reduced prescription costs, lower travel expenses particularly for rural and remote patients, and decreased inequities in medication access.

The Lung Foundation Australia described a number of benefits of 60-day prescribing for people with COPD including reduced costs associated with prescriptions and travel, particularly for those in rural and remote regions. Consumer comments · PSD
out-of-pocket costaccess barriersrural and remote access

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients with persistent symptoms despite LAMA/LABA monotherapy or on LAMA/LABA combination; TGA label has no such treatment-history requirement.