PBAC's latest decision on Budesonide with formoterol: Recommended with restriction (2023). Considered for 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.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2019
Submissions
3
2019 → 2023
Eligible population
Adults 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.
Therapy area
Respiratory
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Other
Pivotal trial size
1,043 patients
Key trials
Tamasi et al 2018 (1,043 patients), Lavorini et al 2021, Chrystyn & Lavorini 2020
Comparator
Symbicort Turbuhaler 200/6 and 400/12; also BiResp Spiromax, DuoResp Spiromax, and Rilast Turbuhaler
Economic model
Not modelled
ICER note
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.
Submission history
Jul 2019: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required