Fluticasone Propionate With Eformoterol Fumarate
Regular maintenance treatment of asthma in patients whose asthma is not adequately controlled with inhaled corticosteroids alone or who require combination inhaled corticosteroid and long-acting beta-2 agonist therapy.
Decision on record
- Meeting Jul 2013 Recommended Asthma
Access path
- Jul 2013Recommended
vs fluticasone with salmeterol pressurised metered dose inhaler
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis presented; PBAC did not accept the sponsor's proposed pricing methodology and instead based recommendation on equi-effective dosing with fluticasone/salmeterol MDI
The PBAC did not accept this approach to pricing the fluticasone with eformoterol MDI (see Recommendation and Reasons). PBAC · 2013
Decision context
PopulationPatients with asthma requiring maintenance treatment with combination inhaled corticosteroid and long-acting beta-2 agonist, including those not adequately controlled with inhaled corticosteroids alone or requiring combination therapy following oral corticosteroid use
Risk sharingPBAC noted potential risk of off-label use in SMART and COPD indications and considered that this should be managed through pricing and/or risk share arrangements
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended | fluticasone with salmeterol pressurised metered dose inhaler | — | RCT · FEV1 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients not controlled on ICS alone or requiring combination therapy; TGA includes those already controlled on both agents.