SalbutamolAsmol CFC-Free
Relief of acute bronchospasm in patients with asthma and other obstructive airways diseases. Specifically, a pressurised inhalation formulation with integrated dose counter to assist patients in determining remaining doses and reducing medication wastage.
Decisions on record
- Meeting Nov 2019 Recommended Asthma and chronic obstructive pulmonary disease (COPD)
- Meeting Nov 2016 Recommended Asthma
- Meeting Nov 2014 Recommended 200 microgram inhalation: powder for, 128 capsules, Ventolin® Rotacaps®, GlaxoSmithKline Australia Pty Ltd Change to listing (Out-of-session) Asthma Amend maximum quantity and number of repeats to align with a new pack size.
Access path
- TGA registered · Asmol CFC-Free
TGA label equal than the PBS population
- Nov 2014Recommended
vs currently listed pack of 100 capsules
- Nov 2016Recommended
Listing: Unrestricted → Restricted
- Nov 2019Recommended
Evidence: Cost-minimisation → Single-arm
- Mar 2020Recommended · restricted
Comparator changed: salbutamol MDI without dose counter → salbutamol pressurised…
- PBS listing · Restricted
From the public summary
5.1 The PBAC noted the sponsor’s correspondence of 20 January 2020 that it was unable to list Ventolin DC on the PBS with only a '''''''''% increase compared to the Ventolin MDI, as in the sponsor’s view it did not reflect the added safety value for this product.PSD · Mar 2020
5.2 The PBAC recalled that when making its November 2019 recommendation for listing Ventolin DC with a small premium ('''''''''%) over the current Ventolin MDI price was based on, among other matters, the potential health benefits related to the likely risk 5PSD · Mar 2020
6.4 As a minor submission, an economic comparison was not relevant.PSD · Nov 2016
5.2 The PBAC noted and welcomed the input from individuals (7) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with salbutamol including improved quality of life.PSD · Nov 2019
Cost-effectiveness
No formal ICER calculated. This is a cost-minimisation submission for a device modification (addition of dose counter) to an existing PBS-listed medication. The PBAC assessed cost-effectiveness pragmatically via acceptable price premium rather than formal cost-utility analysis.
The PBAC considered that it remained difficult to ascertain a cost-effectiveness premium for Ventolin DC, in particular when taken outside the disaster relief context, and therefore advised that a '''''''''% premium over the current Ventolin MDI price would be appropriate. PBAC · 2020
Decision context
PopulationAdult and paediatric patients with asthma and obstructive airways diseases requiring salbutamol pressurised metered-dose inhalers for acute bronchospasm relief.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2020 | Recommended · restricted | salbutamol pressurised inhalation without dose counter (Ventolin MDI, Asmol MDI) | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Recommended | salbutamol MDI without dose counter | — | Single-arm · Patient satisfaction |
| Nov 2016 | Recommended | — | — | Cost-minimisation |
| Nov 2014 | Recommended | currently listed pack of 100 capsules | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Seven individuals and two organisations (Asthma Australia and The Lung Foundation) submitted comments highlighting improved quality of life from salbutamol treatment and emphasising the importance of accurate metered doses, with suggestions that a dose counter could help patients monitor medication use and know when to replace it.
The comments described a range of benefits of treatment with salbutamol including improved quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both cover salbutamol pressurised inhalation for acute bronchospasm relief in asthma and obstructive airways diseases across adult and paediatric populations.