Budesonide / Glycopyrronium / Formoterol
Maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate to very severe COPD who require treatment with a combination of an ICS, a LABA, and a LAMA.
Decision on record
- Meeting Jul 2021 Recommended Moderate to severe COPD
Access path
- Jul 2021Recommended · restricted
vs fluticasone furoate / umeclidinium / vilanterol…
- PBS listing · Authority Required
From the public summary
BUD/GLY/FOR vs FF/UMEC/VI 1.02 (0.91, 1.15) 1.01 (0.90, 1.14) BUD/GLY/FOR vs BEC/GLY/FOR 1.13 (0.93, 1.37) 0.90 (0.74, 1.08)PSD · Jul 2021
1 BUD/GLY/FOR vs FF/UMEC/VI -25 (-47, -3) -8 (-31, 15) BUD/GLY/FOR vs BEC/GLY/FOR 9 (-27, 45) 27 (-3, 57) BUD/GLY/FOR‡ vs FF/UMEC/VI -32 (-59, -5) 1 (-28, 30) BUD/GLY/FOR‡ vs BEC/GLY/FOR 2 (-38, 42) 36 (2, 70)PSD · Jul 2021
The submission presented a cost-minimisation analysis between BUD/GLY/FOR and FF/UMEC/VI, based on the following equi-effective doses:PSD · Jul 2021
BUD/GLY/FOR (160/7.2/4.8 mcg) pMDI, two inhalations twice daily = FF/UMEC/VI (100/62.5/25 mcg) DPI, one inhalation once daily.PSD · Jul 2021
The submission described BUD/GLY/FOR as non-inferior in terms of comparative efficacy and safety compared to FF/UMEC/VI and BEC/GLY/FOR, for patients with moderate to severe COPD.PSD · Jul 2021
The ESC agreed with the evaluation that overall the clinical claim was supported by the indirect evidence presented in the submission. The claim for non-inferior efficacy was based on comparable reduction in moderate or severe exacerbations and change in lung function (FEV1), SGRQ score and rescue medication use at Week 52; the claim of non-inferior safety was based on comparable incidence of AEs at Week 52.PSD · Jul 2021
The PBAC noted and welcomed the input from Lung Foundation Australia via the Consumer Comments facility on the PBS website. The comments described having three medicines in one device (BUD/GLY/FOR) as cost effective for patients, environmentally sustainable and may help with taking doses regularly. The comments also indicated clinicians and patients with COPD would appreciate having additional treatment choices for this condition.PSD · Jul 2021
The sponsor did not propose a RSA for BUD/GLY/FOR. At the November 2020 meeting, the PBAC considered that while the AEMP for BEC/GLY/FOR would be lower than 18PSD · Jul 2021
Cost-effectiveness
Cost-minimisation analysis conducted; no numeric ICER calculated by design.
Decision context
PopulationAdults with moderate to very severe COPD who have experienced at least one severe exacerbation requiring hospitalisation, or two or more moderate exacerbations in the previous 12 months, despite regular bronchodilator therapy, or who have been stabilised on a combination of LAMA, LABA and ICS.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended · restricted | fluticasone furoate / umeclidinium / vilanterol (FF/UMEC/VI; Trelegy Ellipta) | — | RCT · Exacerbation rate |
Consumer voice
Lung Foundation Australia commended the three-in-one combination medicine (BUD/GLY/FOR) as cost-effective, environmentally sustainable, and potentially beneficial for medication adherence. They noted that additional treatment options for COPD would be appreciated by both clinicians and patients.
having three medicines in one device (BUD/GLY/FOR) as cost effective for patients, environmentally sustainable and may help with taking doses regularly Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with prior exacerbation history or stabilisation on triple therapy; TGA label includes all moderate-to-very severe COPD requiring triple combination.