Fluticasone Propionate With SalmeterolEvocair MDI
Treatment of asthma in patients aged 4 years or older; treatment of chronic obstructive pulmonary disease (COPD) in patients with severe COPD and a history of repeated exacerbations.
Decision on record
- Meeting Nov 2023 Recommended Asthma, chronic obstructive pulmonary disease
Access path
- TGA registered · Evocair MDI
TGA label equal than the PBS population
- Nov 2023Recommended
vs Seretide Accuhaler 250/50 and 500/50, Fluticasone…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of the following new forms of fluticasone propionate with salmeterol, under the same circumstances as the current PBS listings for Seretide Accuhaler 250/50 and 500/50:PSD · Nov 2023
• powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses (Salflumix Easyhaler 250/50), for the treatment of asthma. 11PSD · Nov 2023
5.14 The submission presented a cost-minimisation analysis of Salflumix Easyhaler 250/50 and 500/50 compared with current PBS-listed brands of fluticasone with salmeterol 250/50 and 500/50 (Table 3). 9PSD · Nov 2023
5.15 As a Category 4 submission, the economic analysis has not been independently evaluated.PSD · Nov 2023
5.12 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Salflumix Easyhaler 250/50 and 500/50 compared with Seretide Accuhaler 250/50 and 500/50.PSD · Nov 2023
5.13 The PBAC considered that the claims of non-inferior comparative effectiveness and non-inferior comparative safety were reasonable.PSD · Nov 2023
5.2 The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. The comments noted the high burden of disease and costs to the healthcare system due to asthma and COPD. Comments also noted that correct inhaler technique was essential and poor technique can lead to worsening of symptoms. Asthma Australia noted that there is a high proportion of patients who use their inhaler devices incorrectly.PSD · Nov 2023
5.3 The PBAC noted the consumer comments stated that there are multiple inhaler devices available, and the availability of a new device has the potential to cause confusion in practice. Both Asthma Australia and Lung Foundation Australia considered it was important to have adequate education, and education materials, available for both health care professionals and patients on how to appropriately use the Easyhaler device.PSD · Nov 2023
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated as drugs are bioequivalent with identical costs.
Decision context
PopulationAdults and children aged 4 years or older with asthma, and adults with severe COPD (FEV1 <50% predicted normal) with a history of repeated exacerbations and significant symptoms despite regular beta-2 agonist therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | Seretide Accuhaler 250/50 and 500/50, Fluticasone Salmeterol Ciphaler, Pavtide Accuhaler | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Two consumer organisations noted the high disease burden of asthma and COPD, emphasised the importance of correct inhaler technique and adequate education for both healthcare professionals and patients, and highlighted that a new device option could benefit patients with difficulty using other inhalers. Environmental concerns regarding carbon emissions were also raised.
Asthma Australia noted that there is a high proportion of patients who use their inhaler devices incorrectly. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC indication matches TGA label requirements for asthma and COPD populations, including age specification and clinical criteria.