PBAC's latest decision on Mannitol: Recommended with restriction (2017). Considered for Treatment of cystic fibrosis patients aged 6 years and above who are inadequately responsive to dornase alfa, to enable combination therapy with dornase alfa.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2011
Submissions
4
2011 → 2017
Eligible population
Cystic fibrosis patients aged 6 years and above who are inadequately responsive to dornase alfa and wish to add mannitol to their treatment regimen.
Therapy area
Respiratory
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
FEV1
Pivotal trial size
734 patients
Key trials
CF-301, CF-302, CF-201, CF-204, IIS-B-118
Comparator
placebo + best supportive care (which may or may not include dornase alfa)
Economic model
CUA
ICER note
Cost utility model was presented but no specific ICER value is stated in the public document.
Submission history
Mar 2011: Recommended with restriction · Restricted
Nov 2011: Not recommended
Jul 2015: Recommended with restriction · Restricted
Jul 2017: Recommended with restriction · Restricted