TiotropiumSpiriva
Long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD) and treatment of severe asthma in adults and children aged 6–17 years.
Decisions on record
- Meeting Nov 2024 Recommended Severe asthma; bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease
- Meeting Mar 2024 Recommended Chronic obstructive pulmonary disease (COPD)
- Meeting Jul 2020 Recommended Chronic obstructive pulmonary disease Severe asthma
- Meeting Mar 2019 Recommended Chronic obstructive pulmonary disease (COPD)
- Meeting Mar 2019 Not recommended Chronic obstructive pulmonary disease (COPD)
- Meeting Nov 2018 Recommended Asthma
- Meeting Mar 2018 Not recommended Severe asthma
- Meeting Nov 2017 Not recommended Severe asthma
5 earlier decisions
- Aug 2017 Recommended Chronic Obstructive Pulmonary Disease (COPD) no PSD
- Jul 2017 Not recommended Severe asthma
- Nov 2016 Deferred Chronic obstructive pulmonary disease (COPD) no PSD
- Mar 2016 Recommended Asthma
- Mar 2002 Recommended Chronic obstructive pulmonary disease no PSD
Access path
- TGA registered · Spiriva
TGA label narrower than the PBS population
- Mar 2016Recommended · restricted
vs placebo plus ICS and LABA
- Jul 2017Not recommended
Change of restriction level not an appropriate mechanism to address sponsor's concerns; would cause consumer and…
- Nov 2017Not recommended
Use of different restriction levels for same drug solely for purpose of managing RSA considered inappropriate and may…
- Mar 2018Not recommended
Listing: Restricted → Authority Required
- ↻ resubmittedNov 2018Recommended · restricted
Comparator changed: placebo plus optimised asthma therapy → placebo
- Mar 2019Recommended · restricted
Comparator changed: placebo → tiotropium (as bromide monohydrate) 18 microgram powder for…
- Mar 2019Not recommended
The PBAC rejected the sponsor's request not to mark Braltus® and Spiriva® as equivalent. This is a reversal of the…
- ↻ resubmittedJul 2020Recommended
Evidence: Other → Cost-minimisation
- Mar 2024Recommended · restricted
Comparator changed: Spiriva Respimat disposable inhaler → Spiriva (tiotropium with…
- Nov 2024Recommended
Comparator changed: Spiriva (tiotropium with HandiHaler device) → 2 x single packs of…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the General Schedule Authority Required (STREAMLINED) listing of a new pack size of tiotropium (Spiriva® Respimat®) with 2 cartridges x 60 actuations for the treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD) and for the treatment of severe asthma under the same circumstances as the currently listed Spiriva 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, Spiriva Respimat was recommended as suitable for listing on the PBS with increased 7PSD · Nov 2024
6.49 The resubmission presented a trial-based cost-effectiveness analysis based on the direct randomised trials, 205.446 (6-11 years) and 205.456 (12-17 years). The economic evaluation was in the form of a cost per symptomatic exacerbation avoided, as the resubmission considered that there was insufficient data to develop a full cost utility model. The primary outcome of FEV peak (0–3h) was not used in the model.PSD · Nov 2018
6.50 Overall, the base case economic evaluation remained unchanged. The resubmission updated the drug, hospitalisation and ED visits costs from the previous March 2018 submission.PSD · Nov 2018
6.41 The resubmission described tiotropium plus optimised asthma therapy as superior in terms of effectiveness and non-inferior in terms of safety compared to placebo plus optimised asthma therapy. This was unchanged from the previous submission.PSD · Nov 2018
6.42 In March 2018 the PBAC assessed the evidence from the trials in children and adolescents aged 6-17 years with severe asthma (205.446 and 205.456) and found the “clinical claim of superior effectiveness in comparison to placebo plus optimised asthma therapy to be questionable as there were several issues with the methodology and conclusions based on the clinical trials presented in the submission” (Paragraph 7.1 Tiotropium PSD, March 2018 PBAC).PSD · Nov 2018
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
6.80 The PSCR stated there is currently a RSA for tiotropium in adults with severe asthma.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. The submission demonstrated nil net financial impact to PBS/RPBS, with no cost difference between 1 x double pack and 2 x single packs.
The minor submission estimated there to be no financial implications to the PBS or changes in PBS usage as the submission expected Spiriva Respimat re-usable inhaler to only substitute for Spiriva Respimat disposable inhaler and both forms of tiotropium have the same price. PSD · 2020
Decision context
PopulationAdults with COPD or severe asthma requiring long-term maintenance treatment, and children aged 6–17 years with severe asthma meeting specific clinical criteria.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | 2 x single packs of tiotropium (Spiriva Respimat) | — | Cost-minimisation · Cost-minimisation |
| Mar 2024 | Recommended · restricted | Spiriva (tiotropium with HandiHaler device) | — | Cost-minimisation · Cost-minimisation |
| Jul 2020 | Recommended | Spiriva Respimat disposable inhaler | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Recommended · restricted | tiotropium (as bromide monohydrate) 18 microgram powder for inhalation capsule (Spiriva®) | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Not recommended | — | — | Other |
| Nov 2018 | Recommended · restricted | placebo | — | RCT · FEV1 |
| Mar 2018 | Not recommended | placebo plus optimised asthma therapy | — | RCT · FEV1 peak (0–3h) |
| Nov 2017 | Not recommended | — | — | — |
| Jul 2017 | Not recommended | — | — | Other |
| Mar 2016 | Recommended · restricted | placebo plus ICS and LABA | $15k–45k | RCT · Exacerbation |
Consumer voice
The Lung Foundation Australia provided consumer input supporting the expansion of the 60-day Prescription Program, highlighting reduced costs and travel burden for people with COPD, particularly those in rural and remote regions.
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
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to long-term maintenance treatment and specified age range (children 6–17 years) versus broad TGA label covering all treatment indications.