Beclometasone Dipropionate With Formoterol Fumarate DihydrateCIPLA BECLOMETASONE/FORMOTEROL
Maintenance and reliever therapy (MART) for asthma in adults (18 years and older) with frequent asthma symptoms despite treatment with inhaled corticosteroids and/or long-acting beta-2 agonists.
Decisions on record
- Meeting Mar 2024 Recommended Asthma
- Meeting Jul 2022 Recommended Asthma in patients previously treated with oral corticosteroids or optimal doses of inhaled corticosteroids
Access path
- TGA registered · CIPLA BECLOMETASONE/FORMOTEROL
TGA label narrower than the PBS population
- Jul 2020Recommended · restricted
vs fluticasone propionate/salmeterol (FP/SAL)…
- Mar 2022Recommended · restricted
Comparator changed: fluticasone propionate/salmeterol (FP/SAL), budesonide/formoterol…
- Mar 2024Recommended · restricted
Comparator changed: fluticasone propionate 250 µg with salmeterol 25 µg → budesonide 200…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (Streamlined) listing of the fixed dose combination (FDC) of beclometasone 100 µg with formoterol 6 µg (BEC/FOR 100/6) as maintenance and reliever treatment (MART) for asthma. The PBAC considered the indirect treatment comparison presented in the submission addressed its July 2020 concerns regarding the adequacy of the data presented for MART.PSD · Mar 2024
The PBAC noted the input from Asthma Australia and the National Asthma Council of Australia (NAC) supporting listing for this indication.PSD · Mar 2024
The submission presented a cost-minimisation approach (CMA) based on the claim of non-inferior efficacy and safety compared to BUD/FOR 200/6 for the treatment of asthma. A CMA was consistent with the clinical claim.PSD · Mar 2024
Table 11 presents the elements used to calculate the equi-effective doses. The July 2020 submission did not present equi-effective doses as MART for asthma (Step 3 in the clinical management algorithm); instead, it presented equi-effective doses for maintenance therapy, corresponding to medium doses of ICS (Step 4 in the clinical 24PSD · Mar 2024
• Non-inferior in terms of effectiveness compared with BUD/FOR 200/6 as MART, andPSD · Mar 2024
• Non-inferior in terms of safety compared to BUD/FOR 200/6 as MART.PSD · Mar 2024
The PBAC noted and welcomed the input from the Lung Foundation of Australia, which supported the listing of BEC/FOR in COPD, highlighting it would provide an additional ICS/LABA treatment option for patients.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 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a cost-minimisation approach (CMA) based on the claim of non-inferior efficacy and safety compared to BUD/FOR 200/6 for the treatment of asthma. PSD · 2024
Decision context
PopulationAdults (18 years and older) with asthma who have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long-acting beta-2 agonist and require single maintenance and reliever therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | budesonide 200 µg with formoterol 6 µg (BUD/FOR 200/6) | — | RCT · Time to first severe exacerbation |
| Mar 2022 | Recommended · restricted | fluticasone propionate 250 µg with salmeterol 25 µg | — | RCT · Surrogate |
| Jul 2020 | Recommended · restricted | fluticasone propionate/salmeterol (FP/SAL), budesonide/formoterol (BUD/FOR), and beclometasone dipropionate with formote | — | RCT · Morning pre-dose PEF and change from baseline in FEV1 at 5 minutes post-dose |
Consumer voice
The Lung Foundation of Australia supported the listing of BEC/FOR in COPD, noting it would provide an additional ICS/LABA treatment option for patients.
it would provide an additional ICS/LABA treatment option for patients Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with frequent asthma symptoms despite ICS/LABA treatment; TGA label includes adequately controlled patients.