Mometasone Furoate With Indacaterol And Glycopyrronium
Maintenance therapy of severe asthma in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid.
Access path
- Jul 2020Recommended · restricted
vs fluticasone propionate 500/50 micrograms with salmeterol…
- PBS listing · Authority Required
From the public summary
The PBAC deferred making a recommendation for the listing of mometasone furoate (MF), with indacaterol acetate (IND), and glycopyrronium (GLY) fixed dose combination (FDC) for maintenance therapy of severe asthma as it was unclear if TGA registration would include medium dose MF/IND/GLY.PSD · Jul 2020
The PBAC noted the TGA delegate file note stating that the submitted data indicated a positive risk-benefit profile of high dose MF/IND/GLY for the proposed use, but did not support the proposed used of medium dose MF/IND/GLY. The PBAC noted the registration application would be considered at the August 2020 Advisory Committee on Medicines (ACM) meeting.PSD · Jul 2020
The submission presented a cost-minimisation analysis based on AEMP (per day) between medium and high dose MF/IND/GLY and high dose FP/SAL plus TIO. The analysis assumed no additional costs or cost-offsets.PSD · Jul 2020
The submission proposed the following equi-effective doses based on trial evidence presented:PSD · Jul 2020
Based primarily on the Argon trial, the submission described medium and high dose MF/IND/GLY as non-inferior in terms of effectiveness and safety compared with high dose FP/SAL plus TIO in patients with severe asthma: 16PSD · Jul 2020
The Argon trial, on which the clinical claim is based, was a partial open label trial with a high risk of bias that may potentially favour MF/IND/GLY compared to FP/SAL plus TIO.PSD · Jul 2020
The PBAC noted and welcomed the input from Asthma Australia via the Consumer Comments facility on the PBS website. Asthma Australia described a range of benefits of treatment with MF/IND/GLY and supported the addition of a fixed dose triple- combination product to the PBS as an alternative option for patients with difficult-to- treat asthma, poor control of symptoms and poor lung function.PSD · Jul 2020
No risk sharing arrangement was proposed. The submission argued the proposed listing is not expected to expose the Commonwealth to any significantly greater risk or expenditure than that posed by the currently listed drugs. Neither special pricing arrangement nor expenditure caps currently apply to any asthma product.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdults aged 18 years and over with severe asthma who have experienced at least one severe exacerbation requiring documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy (at least 800 micrograms budesonide per day or equivalent with a long-acting beta2-agonist) despite formal assessment of and adherence to correct inhaler technique.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | fluticasone propionate 500/50 micrograms with salmeterol one actuation twice daily plus tiotropium 2.5 micrograms two in | — | RCT · FEV1 |
Consumer voice
Asthma Australia provided consumer input supporting the addition of a fixed dose triple-combination product (MF/IND/GLY) to the PBS as an alternative option for patients with difficult-to-treat asthma, poor symptom control and poor lung function.
Asthma Australia described a range of benefits of treatment with MF/IND/GLY and supported the addition of a fixed dose triple-combination product to the PBS as an alternative option for patients with difficult-to-treat asthma, poor control of symptoms and poor lung function. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe asthma with documented recent exacerbation on optimised high-dose ICS/LABA, versus TGA's broader inadequate control criterion.