script.reportAU
Respiratory

Fluticasone propionate with formoterol fumarate dihydrate

Brand: Flutiform®

PBAC's latest decision on Fluticasone propionate with formoterol fumarate dihydrate: Not recommended (2018). Considered for Regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2-agonist) is appropriate, in patients aged 12 years and over.

PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2018
Submissions
1
2018 → 2018

Eligible population

Patients aged 12 years and over with asthma not adequately controlled with maintenance ICS and inhaled short-acting β2-agonist used on an 'as required' basis.

Therapy area
Respiratory
Line of therapy
Second-line
Evidence base
Cost-minimisation
Economic model
Cost-minimisation
ICER note
Minor submission with no economic evaluation required; no ICER calculated.

Why PBAC said no

Reasons cited in the latest PSD: PBAC reaffirmed its March 2018 recommendation to increase restriction level to Authority Required (STREAMLINED) for all ICS/LABA FDC inhalers to encourage first-line treatment with ICS alone; sponsor's argument that fluticasone/formoterol should not be covered by Asthma in Children Review decisions was not accepted.

Similar precedents

Open on full dashboard →