Beclometasone Dipropionate With Formoterol Fumarate Dihydrate And Glycopyrronium Bromide
Maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in adult patients who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).
Access path
- Nov 2020Recommended · restricted
vs Trelegy Ellipta (fluticasone…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (STREAMLINED) listing of the fixed dose combination (FDC) of beclometasone (BEC) with formoterol (FOR) and glycopyrronium (GLY), TRIMBOW, for maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) that is not adequately treated by a combination of an inhaled corticosteroid (ICS) with long-acting beta2-agonist (LABA) or LABA with a long-acting muscarinic antagonist (LAMA).PSD · Nov 2020
The PBAC considered that the claim of non-inferior effectiveness and safety to the FDC of fluticasone furoate (FF), umeclidinium (UMEC) and vilanterol (VIL), Trelegy Ellipta, was reasonable. However, the PBAC considered for the purposes of satisfying Section 101(3B) of the National Health Act 1953, both Trelegy Ellipta, as well as any triple combination therapy via concomitant use of a LAMA, LABA and ICS are relevant alternative therapies.PSD · Nov 2020
The submission presented a cost-minimisation analysis based on ‘costs per year’ between TRIMBOW and Trelegy Ellipta. The costs per year were estimated as the product of the DPMQ and number of packs per year. The analysis assumed no additional costs or cost-offsets.PSD · Nov 2020
The submission proposed the following equi-effective doses based on the trial evidence presented:PSD · Nov 2020
Based on results from pivotal trials TRILOGY, TRINITY and TRIBUTE, the submission claimed that TRIMBOW has: Superior efficacy compared with Fostair (i.e. ICS/LABA) and TIO monotherapy (i.e.PSD · Nov 2020
LAMA). Non-inferior efficacy compared with Fostair + TIO (i.e. ICS/LABA+LAMA) administered concomitantly. Non-inferior safety compared with Fostair, Fostair + TIO and TIO monotherapy.PSD · Nov 2020
The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The comment from Lung Foundation Australia described a range of benefits of treatment with TRIMBOW including providing clinicians and patients with an additional choice of therapy that may encourage treatment adherence due to the three medicines being in one inhaler.PSD · Nov 2020
No risk sharing arrangement was proposed for TRIMBOW. The PBAC previously considered a risk-sharing arrangement for Trelegy Ellipta appropriate to address concerns raised about underestimated market share and market growth, as well as quality use of medicines issues identified in relation to use earlier in the treatment pathway than clinically appropriate (paragraph 6.64, Trelegy Ellipta PSD, December 2017 PBAC meeting).PSD · Nov 2020
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated as the submission assumed therapeutic equivalence.
Based on the cost-minimisation analysis presented in the submission the requested price for TRIMBOW was the same as for Trelegy Ellipta (AEMP = $76.78). PSD · 2020
Decision context
PopulationAdult patients with moderate to 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 dual or triple therapy, or have been stabilised on triple therapy (LAMA, LABA, and ICS).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2020 | Recommended · restricted | Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) | — | RCT · COPD exacerbations |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| TRILOGY | Ph 3 | 1,368 | 1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV… | completed |
Consumer voice
Lung Foundation Australia noted that TRIMBOW provides clinicians and patients with an additional treatment choice that may improve adherence by combining three medicines in one inhaler.
describing a range of benefits of treatment with TRIMBOW including providing clinicians and patients with an additional choice of therapy that may encourage treatment adherence due to the three medicines being in one inhaler Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with recent severe exacerbations or established triple therapy; TGA label includes all inadequately controlled patients regardless of exacerbation history.