Mometasone Furoate With IndacaterolAtectura Breezhaler
Maintenance treatment of asthma in patients aged 12 years and older who have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
Access path
- TGA registered · Atectura Breezhaler
TGA label narrower than the PBS population
- Jul 2020Recommended · restricted
vs fluticasone propionate/salmeterol (FP/SAL) DPI; mometasone…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (STREAMLINED) listing of the fixed dose combination (FDC) of mometasone furoate (MF) with indacaterol (IND) for the maintenance treatment of asthma. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of MF/IND would be acceptable if it were cost-minimised against the least costly inhaled corticosteroid (ICS) with long-acting beta2 agonist (LABA) …PSD · Jul 2020
The PBAC noted the input from Asthma Australia supporting MF/IND listing for maintenance treatment of asthma.PSD · Jul 2020
The submission presented a cost-minimisation analysis based on AEMP (per day) between the three formulations of MF/IND and the corresponding formulations of FP/SAL DPI. The analysis assumed no additional costs or cost-offsets.PSD · Jul 2020
The submission proposed the following equi-effective doses based on the trial evidence presented:PSD · Jul 2020
Based on the evidence presented, the submission described MF/IND as at least non- inferior/equivalent in terms of effectiveness and safety compared with equivalent doses of FP/SAL DPI in patients with asthma, and proposed the following:PSD · Jul 2020
- MF/IND 80/150 one actuation once daily is equivalent to FP/SAL DPI 100/50 one actuation twice daily.PSD · Jul 2020
The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The comment from Asthma Australia described a range of benefits of treatment with MF/IND including the once daily dosing regimen.PSD · Jul 2020
The Sponsor stated that the proposed listing was not expected to require additional risk sharing arrangements. The listing of MF/IND is proposed on a cost-minimisation basis in a market with drugs which currently do not have ‘list and effective’ prices or expenditure caps, and the Commonwealth is not expected to be exposed to any greater risk or expenditure than from currently listed drugs if MF/IND is listed.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
Decision context
PopulationAdults and adolescents aged 12 years and older with asthma not adequately controlled with inhaled corticosteroids and 'as needed' short-acting beta2-agonists, or not adequately controlled with long-acting beta2-agonists and low dose inhaled corticosteroids.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | fluticasone propionate/salmeterol (FP/SAL) DPI; mometasone furoate (MF) alone | — | RCT · PFS |
Consumer voice
Asthma Australia provided consumer input describing benefits of MF/IND treatment, including the once daily dosing regimen.
The comment from Asthma Australia described a range of benefits of treatment with MF/IND including the once daily dosing regimen. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds prior frequent asthma episodes on oral corticosteroids or optimal inhaled corticosteroid doses as a treatment-history requirement.