Beclometasone Dipropionate With Formoterol Fumarate Dihydrate And Glycopyrronium
Maintenance treatment of severe asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
Access path
- Mar 2022Recommended · restricted
vs mometasone furoate with indacaterol and glycopyrronium…
- PBS listing · Authority Required
From the public summary
The PBAC deferred making a recommendation for the Authority Required (Streamlined) listing for a fixed dose combination (FDC) of beclometasone (BEC) with formoterol (FOR) and glycopyrronium (GLY) for the maintenance therapy of severe asthma as the TGA Delegate’s Overview was not available at the time of consideration.PSD · Mar 2022
However, the PBAC was of a mind to recommend the listing BEC/FOR/GLY for this indication based on its assessment that the cost of BEC/FOR/GLY should be no greater than the lowest price combination at approved ex-manufacturer price (AEMP) level of the PBS listed components of triple therapy that are available for asthma at comparable doses.PSD · Mar 2022
The cost-minimisation analysis was based on the claim of non-inferior effectiveness and safety for BEC/FOR/GLY compared to MF/IND/GLY at corresponding ICS strengths (medium and high dose). A cost-minimisation approach is consistent with the clinical claim.PSD · Mar 2022
The elements used to calculate equi-effective doses are presented in the table below. 24PSD · Mar 2022
• Non inferior to MF/IND/GLY (68/114/46 μg) for both efficacy and safety, andPSD · Mar 2022
• Superior to BEC/FOR (100/6 μg) for efficacy and non-inferior in safety. 22PSD · Mar 2022
The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The comments from Asthma Australia described a range of benefits of treatment with BEC/FOR/GLY including that, if approved, it will increase treatment options particularly for eligible patients preferring metered-dose inhaler (MDI) devices.PSD · Mar 2022
The submission did not propose a risk-sharing arrangement. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
A cost-minimisation approach is consistent with the clinical claim. PBAC · 2022
Decision context
PopulationAdults aged 18 years or over with severe asthma not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and an inhaled corticosteroid who experienced at least one severe asthma exacerbation (requiring systemic corticosteroids) in the previous 12 months despite optimised asthma therapy and correct inhaler technique
Risk sharingMedium dose BEC/FOR/GLY (100/6/10 μg) is part of a risk sharing arrangement (RSA) with other triple FDC products for the COPD indication
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | mometasone furoate with indacaterol and glycopyrronium (MF/IND/GLY) | — | RCT · FEV1, Exacerbation rate |
Consumer voice
Asthma Australia welcomed the availability of BEC/FOR/GLY treatment, noting that approval would increase treatment options for eligible patients who prefer metered-dose inhaler (MDI) devices.
if approved, it will increase treatment options particularly for eligible patients preferring metered-dose inhaler (MDI) devices Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe asthma with severe exacerbations requiring systemic corticosteroids; TGA label includes all asthma with any exacerbation.