Mesalazine: 6 agencies, 1999–2023
This page collects every recorded health technology assessment decision for one molecule across the agencies in our archive, and compares them. The comparison is the point: each agency publishes its own verdict, none publishes how that verdict sits against the others.
What the record shows
No agency in this archive has refused mesalazine: all 22 decisive outcomes across 5 agencies were positive or positive with restrictions.
PBAC (Australia) has been easier on mesalazine than on its own caseload: it refused 0 of 8 decisive submissions here (0%), against a base rate of 24% across everything it has assessed.
The file has been open for more than a decade: 24.7 years separate the first record, 1 Feb 1999 at PHARMAC (New Zealand), from the most recent, 25 Oct 2023 at HAS (France).
No assessment is on file from TLV (Sweden), CIPM (Spain) and G-BA (Germany), each among the eight highest-volume agencies here.
Not every gap is a refusal: for mesalazine, 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The programme is broad: 10 distinct indication wordings are recorded for mesalazine by the agencies that label one in English (AWMSG, PBAC and SMC).
8 of these 27 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
PHARMAC (New Zealand) was first to assess mesalazine, on 1 Feb 1999; CONITEC (Brazil) did not open a file until 12 May 2023 — an unusually long tail of 24.2 years between the earliest and latest system to look at it.
The record arrives in waves: 7 separate years each carry two or more decisions, spread across 13 years in total.
5 of the 6 agencies here assessed mesalazine more than once, HAS (France) most often at 10 entries — repeat review is the norm for this molecule rather than the exception.
6 of the 18 agencies in this archive hold a record for mesalazine.
The full ledger for mesalazine reads 22 recommended, 3 not assessed, 1 other and 1 withdrawn.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 25 Oct 2023 | Listing (Transparency Committee) | SMR substantial · ASMR V | source |
| CONITEC (Brazil) | 12 May 2023 | Retocolite ulcerativa idiopática leve a moderada em pacientes acima de 18 anos de idade em todas as extensões em terapia… | incorporated into SUS | source |
| PBAC (Australia) | 2020 | Ulcerative proctitisUlcerative colitis Crohn disease | The PBAC recommended the change in maximum quantity for mesalazine suppositories and modif… | source |
| AWMSG (Wales) | 3 Feb 2017 | Treatment of acute episodes of mild to moderate ulcerative colitis | outside AWMSG criteria | source |
| SMC (Scotland) | 11 Feb 2008 | Mild acute exacerbations for ulcerative colitis | accepted | source |
22 further decisions for mesalazine, across 6 agencies, are not shown here. They link to 13 further source documents.
Related molecules
- budesonide — same ATC class A07E — Antidiarrheals / intestinal anti-inflammatories
- beclometasone — same ATC class A07E — Antidiarrheals / intestinal anti-inflammatories
- beclometasone / formoterol — same ATC class A07E — Antidiarrheals / intestinal anti-inflammatories
- beclometasone / formoterol / glycopyrronium — same ATC class A07E — Antidiarrheals / intestinal anti-inflammatories
- prednisolone — same ATC class A07E — Antidiarrheals / intestinal anti-inflammatories
- betamethasone / calcipotriol — same ATC class A07E — Antidiarrheals / intestinal anti-inflammatories
Coverage: 27 decisions for mesalazine from 6 agencies, 1999 to 2023. Data to 7 Sep 2026. ATC class A07E — Antidiarrheals / intestinal anti-inflammatories. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.