Gastroenterology
Mesalazine
Brand: Asacol®
PBAC's latest decision on Mesalazine: Recommended (2020). Considered for Treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.
PBAC outcome
Recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
7
2014 → 2020
Eligible population Adults with mild to moderate ulcerative colitis requiring maintenance of remission.
Therapy area Gastroenterology Line of therapy Not applicable Evidence base RCT Primary endpoint Non-inferiority Pivotal trial size 871 patients Key trials TP0503-I, TP0503-II Comparator Asacol 800 (mesalazine 800 mg enteric coated tablets) Economic model Cost-minimisation ICER note Cost-minimisation analysis; no ICER calculated. Recommendation based on cost-minimisation relative to Asacol 800 on a per-mg basis. Submission history Nov 2014 : Recommended with restriction · Authority RequiredNov 2014 : Recommended · Authority RequiredNov 2015 : Recommended with restriction · Authority RequiredMar 2017 : Not recommended · Not applicableJul 2018 : Recommended with restriction · Authority RequiredMar 2020 : Recommended · RestrictedNov 2020 : Recommended · RestrictedSimilar precedents
Open on full dashboard →
Part of script.report — an independent tracker of every PBAC Public Summary Document and the PBS expenditure that follows. Built from public data on pbs.gov.au . Not affiliated with the Australian Department of Health, PBAC, or any pharmaceutical company.
script.report extracts information discussed in PBAC Public Summary Documents (PSDs), not independently calculated values. Where figures such as ICERs are shown, they reflect what was discussed or referenced in committee documentation — not confirmed inputs. For authoritative cost-effectiveness data, refer to the original PSD.