Budesonide + FormoterolBUFOMIX EASYHALER
Recommended RespiratoryAuthority RequiredSecond-line line
Asthma in children aged <12 years who have failed PBS-subsidised fluticasone propionate and salmeterol as a fixed dose combination.
1
Submissions
1 resub
2019–19
On the record
—
ICER range
Not modelled
Cost basis
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
- Dec 2019Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
4.1 In order to maintain a level of guidance for clinicians around the appropriate use of FDCs in children, the PBAC recommended that the existing PBS restrictions for ICS+LABA FDC products should be retained. The PBAC noted that the existing restrictions align with the Therapeutic Goods Administration (TGA) indications and product information (PI) for these products.PSD · Dec 2019
4.2 The PBAC recalled the clinician concerns raised in July 2019 regarding paediatric patients who experience fluticasone propionate + salmeterol failure, and reiterated its advice that there was a clinical need in this group that was not covered by the existing PBS restrictions.PSD · Dec 2019
Cost-effectiveness
This is not a new drug submission; it is a PBS restriction advisory item. No economic evaluation was performed.
Decision context
PopulationChildren aged ≥6 years with asthma who have failed PBS-subsidised fluticasone propionate and salmeterol fixed dose combination therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2019 | Recommended · restricted | — | — | Registry |
Similar precedents
Budesonide With Formoterol88%Budesonide With Eformoterol Fumarate Dihydrate82%Fluticasone Propionate With Formoterol Fumarate Dihydrate71%Fluticasone Propionate With Eformoterol Fumarate69%Fluticasone Propionate With Salmeterol69%Fluticasone Furoate / Vilanterol Trifenatate69%Budesonide / Glycopyrronium / Formoterol68%Beclometasone With Formoterol68%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to children who failed fluticasone propionate/salmeterol; TGA label does not require prior treatment failure.