Budesonide With FormoterolBUFOMIX EASYHALER
Treatment of asthma (mild asthma, asthma in patients with frequent episodes or requiring maintenance and reliever therapy, and asthma in patients who have failed fluticasone propionate and salmeterol) and chronic obstructive pulmonary disease (COPD) in adults and adolescents 12 years and older.
Decisions on record
- Meeting Nov 2023 Recommended Asthma, chronic obstructive pulmonary disease
- Meeting Jul 2019 Not recommended Asthma
Access path
- TGA registered · BUFOMIX EASYHALER
TGA label narrower than the PBS population
- Jul 2019Not recommended
vs ICS daily maintenance plus SABA as needed (ICS+SABA)
- ↻ resubmittedNov 2019Recommended · restricted
Comparator changed: ICS daily maintenance plus SABA as needed (ICS+SABA) → inhaled…
- Nov 2023Recommended
Comparator changed: inhaled corticosteroid (ICS) plus short-acting beta2-agonist (SABA) →…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of the following new forms of budesonide with formoterol under the same circumstances as the currently PBS-listed Symbicort Turbuhaler 200/6 and 400/12:PSD · Nov 2023
• powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 11PSD · Nov 2023
5.14 The submission presented a cost-minimisation analysis of Bufomix Easyhaler compared with Symbicort Turbuhaler (Table 1). 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 Bufomix Easyhaler 200/6 and 400/12 compared with Symbicort Turbuhaler 200/6 and 400/12.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 for asthma and COPD management and poor technique can lead to worsening of symptoms. Asthma Australia noted that 7PSD · Nov 2023
Comments considered that the PBS listings of a new device could provide an option for patients who have difficulty using other inhaler devices.PSD · Nov 2023
Cost-effectiveness
This is a Category 4 minor submission for a new brand/formulation of an already PBS-listed drug (budesonide with formoterol). No economic evaluation or ICER was conducted as the product is bioequivalent to existing listed brands.
Decision context
PopulationAdults and adolescents aged 12 years and older with asthma (mild asthma, asthma with frequent episodes despite treatment with oral or inhaled corticosteroids, or asthma in patients who have failed fluticasone propionate and salmeterol) or moderate to severe COPD (FEV1 ≤50% predicted normal) with symptoms despite long-acting bronchodilator use and/or history of recurrent exacerbations.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | Symbicort Turbuhaler 200/6 and 400/12; also BiResp Spiromax, DuoResp Spiromax, and Rilast Turbuhaler | — | Single-arm · Other |
| Nov 2019 | Recommended · restricted | inhaled corticosteroid (ICS) plus short-acting beta2-agonist (SABA) | — | RCT · Asthma exacerbations / symptom control |
| Jul 2019 | Not recommended | ICS daily maintenance plus SABA as needed (ICS+SABA) | — | RCT · Severe asthma exacerbations |
Consumer voice
Consumer organisations highlighted the high disease burden and healthcare costs associated with asthma and COPD, emphasizing that correct inhaler technique is essential for effective management and that poor technique can lead to symptom worsening.
The comments noted the high burden of disease and costs to the healthcare system due to asthma and COPD. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts asthma to mild, frequent-episode, or prior-therapy-failure subsets; TGA label covers all asthma indications without these stratifications.