Fluticasone Propionate With Salmeterol XinafoateEvocair MDI
Treatment of asthma in adults with frequent episodes despite oral corticosteroids or optimal inhaled corticosteroid doses, and symptomatic treatment of severe COPD (FEV1 <50% predicted) with a history of repeated exacerbations despite regular beta-2 agonist therapy.
Decisions on record
- Meeting Mar 2007 Recommended Asthma and Chronic Obstructive Pulmonary Disease (COPD)
- Meeting Dec 2002 Recommended Asthma inhaler no PSD
Access path
- TGA registered · Evocair MDI
TGA label narrower than the PBS population
- Mar 2007Recommended · restricted
vs tiotropium bromide monohydrate
- Mar 2007Recommended · restricted
- Nov 2016Not recommended
inability to back titrate the dose with a similar device, different delivery device requiring additional patient…
From the public summary
6.1 The PBAC decided not to recommend a Restricted Benefit listing of a new brand of fluticasone with salmeterol, AirFluSal® Forspiro® 500, for the treatment of asthma and COPD due to the inability to back titrate the dose with a similar device.PSD · Nov 2016
6.2 The PBAC considered that the inability to easily back titrate the dose using a similar device limited the ability of prescribers to avoid possible adverse events, and may mean that some patients would remain on a clinically inappropriate high dose of fluticasone with salmeterol.PSD · Nov 2016
5.3 The advice received wasn’t generally supportive in nature, and noted a number of concerns including: that this product had only one high dosage and would be only suitable for a small proportion of asthma patients. The organisational input noted that 3PSD · Nov 2016
The advice from the organisations was not supportive of the possibility of “a” flagging of AirFluSal® Forspiro® 500 should listing be approved by the PBAC.PSD · Nov 2016
Cost-effectiveness
Minor submission; cost-minimisation analysis only, no ICER calculated.
The minor submission estimated that there would be no net cost to the PBS. PSD · 2016
Decision context
PopulationAdults with asthma who have had frequent episodes while receiving oral corticosteroids or optimal doses of inhaled corticosteroids; patients with severe COPD (FEV1 <50% predicted) with a history of repeated exacerbations despite regular beta-2 agonist therapy.
Why it was knocked back
- inability to back titrate the dose with a similar device, different delivery device requiring additional patient training and potentially causing confusion and non-compliance, single high strength presentation limiting suitability for many patients, no clinical need identified
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Not recommended | Seretide Accuhaler 500/50 | — | Single-arm |
| Mar 2007 | Recommended · restricted | tiotropium bromide monohydrate | — | RCT |
| Mar 2007 | Recommended · restricted | tiotropium bromide monohydrate | — | RCT |
Consumer voice
Five organisations submitted input expressing concerns about the product's single high dosage limitation, inability to back-titrate, and quality of medicines concerns regarding the different inhaler device requiring additional patient training.
that this product had only one high dosage and would be only suitable for a small proportion of asthma patients Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts asthma indication to patients who failed oral or optimal inhaled corticosteroids, versus TGA's broader 'regular treatment' label.