Budesonide With Glycopyrronium And Formoterol
Long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) in patients not adequately treated by a combination of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA), or LABA with a long-acting muscarinic antagonist (LAMA).
Decision on record
- Meeting Nov 2022 Recommended Chronic obstructive pulmonary disease
Access path
- Nov 2022Recommended
vs existing Breztri Aerosphere inhaler (cost-minimisation to…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC held no objections to the planned replacement of the existing pMDI containing budesonide, glycopyrronium and formoterol (Breztri Aerosphere) with a pMDI with a desiccated flow path (Breztri Aerosphere® DFP-EvoCap).PSD · Nov 2022
6.2 The PBAC noted that the submission requested the same AEMP per pack of the DFP- EvoCap as the current AEMP per pack for Breztri Aerosphere.PSD · Nov 2022
5.9 The submission provided a cost-minimisation approach comparing the DFP-EvoCap with the existing Breztri Aerosphere inhaler. The equi-effective doses were estimated as one DFP-EvoCap actuation to one existing Breztri Aerosphere actuation.PSD · Nov 2022
5.10 As a Category 4 submission, the economic analysis has not been independently evaluated. Estimated PBS utilisation and financial implicationsPSD · Nov 2022
5.8 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of the DFP-EvoCap compared with the existing Breztri Aerosphere inhaler, based on the in-vitro assessment of equivalence.PSD · Nov 2022
5.2 The PBAC noted and welcomed the input from individuals (1), and organisations (1) via the Consumer Comments facility on the PBS website. The patient comment described a willingness to access budesonide with glycopyrronium and formoterol to treat their condition, via the listing of a new inhaler device on the PBS.PSD · Nov 2022
5.3 The PBAC welcomed the input from the Lung Foundation Australia, which reported the results of a targeted survey of 200 patients experiencing mild to moderate and severe COPD and their families. The survey responses showed strong support for the listing.PSD · Nov 2022
Cost-effectiveness
Cost-minimisation analysis only; no ICER calculated as this is a device formulation change with equivalent active ingredients.
The PBAC considered that the DFP-EvoCap should be cost-minimised to the lowest cost alternative agent, including any combination of LAMA, LABA and corticosteroid used for the treatment of COPD, whether in fixed dose combinations or open combination (i.e. individual products). PBAC · 2022
Decision context
PopulationPatients with COPD not adequately treated by a combination of ICS with LABA, or LABA with LAMA
Risk sharingBreztri Aerosphere subject to Deed of Agreement with expenditure caps; DFP-EvoCap would be subject to same arrangements.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2022 | Recommended | existing Breztri Aerosphere inhaler (cost-minimisation to lowest cost alternative agent including any combination of LAM | — | Cost-minimisation · Cost-minimisation |
Consumer voice
One patient expressed willingness to access budesonide with glycopyrronium and formoterol via a new inhaler device. A targeted survey by Lung Foundation Australia of 200 COPD patients and families showed strong support for the listing, citing benefits including additional treatment choice, reduced exacerbations, higher adherence, reduced medication burden, improved quality of life, and cost-effect
Respondents considered it would offer an additional treatment choice for clinicians to match to patient characteristics and disease stage, and that the new device potentially offered more effective treatment with fewer exacerbations, higher adherence and a reduced the burden of taking multiple medications. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients failing ICS/LABA or LABA/LAMA combinations; TGA label permits all COPD maintenance treatment.