MesalazineASACOL
Recommended GastroenterologyRestrictedNot applicable line 💬 consumer voice
Treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.
7
Submissions
5 resub
2014–20
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2020 Recommended Ulcerative colitis
- Meeting Mar 2020 Recommended Ulcerative proctitis Ulcerative colitis Crohn disease
- Meeting Jul 2018 Recommended Ulcerative colitis; Crohn disease
- Meeting Mar 2017 Recommended Ulcerative colitis
- Meeting Nov 2015 Recommended Ulcerative colitis
- Meeting Nov 2014 Recommended 4 g granules: modified release, 30 x 4 sachets, Pentasa® Ferring Pharmaceuticals Pty Ltd New listing (Minor submission) Inflammatory bowel disease (Crohn disease and ulcerative colitis) Authority Required (STREAMLINED) listing of a new strength for the treatment of Crohn disease and ulcerative colit
- Meeting Nov 2014 Recommended 3 g granules: modified release, 30 sachets, Salofalk® Aspen Australia Pty Ltd New listing (Minor submission) Ulcerative colitis Authority Required (STREAMLINED) listing of a new strength for the treatment of ulcerative colitis where hypersensitivity to sulfonamides exists or where intolerance to sul
- Meeting Jul 2011 Recommended Anti-inflammatory for bowel disease no PSD
11 earlier decisions
- Jul 2010 Recommended Anti-inflammatory for bowel disease no PSD
- Jul 2010 Recommended Anti-inflammatory for bowel disease no PSD
- Jul 2010 Recommended Anti-inflammatory for bowel disease no PSD
- Nov 2009 Recommended Ulcerative colitis no PSD
- Nov 2009 Recommended Ulcerative colitis no PSD
- Nov 2008 Recommended Ulcerative colitis/Crohn’s Disease no PSD
- Jul 2008 Recommended Ulcerative colitis no PSD
- Mar 2008 Recommended Intestinal anti-inflammatory no PSD
- Nov 2007 Recommended Inflammatory bowel conditions no PSD
- Nov 2006 Recommended Intestinal antiinflammatory no PSD
- Mar 2002 Recommended Colitis no PSD
Access path
- TGA registered · ASACOL
TGA label equal than the PBS population
- Nov 2014Recommended · restricted
Comparator changed: mesalazine 2 g granules (modified release) → mesalazine 1.5 g granules
- Nov 2014Recommended · restricted
Comparator changed: mesalazine 2 g granules (modified release) → mesalazine 1.5 g granules
- Nov 2015Recommended
Comparator changed: mesalazine 1.5 g granules → Salofalk® and Pentasa® (other mesalazine…
- Mar 2017Recommended · restricted
Comparator changed: Salofalk® and Pentasa® (other mesalazine products) → Mezavant (1.2 g…
- Jul 2018Recommended · restricted
Comparator changed: Mezavant (1.2 g mesalazine prolonged release tablet); also Salofalk…
- Mar 2020Recommended
Listing: Authority Required → Restricted
- Nov 2020Recommended · restricted
Evidence: Cost-minimisation → RCT
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the General Schedule, Restricted Benefit listing of mesalazine, 1600 mg enteric coated tablets for the treatment of ulcerative colitis under the same circumstances as the currently PBS listed Asacol 800.PSD · Nov 2020
6.2 The PBAC recommended the listing of Asacol 1600 on a cost-minimisation basis, based on the price per mg of the currently PBS listed Asacol 800. The equi-effective doses are: one Asacol 1600 tablet and two Asacol 800 tablets. Consistent with its advice in March 2017 for the Asacol 800, the PBAC considered that the Asacol 1600 could be cost-minimised to any oral formulation of mesalazine on the PBS.PSD · Nov 2020
Economic analysis
5.6 The proposed approved ex-manufacturer price (AEMP) was $''''''''''''', based on the price per mg of the currently PBS listed Asacol 800 (AEMP $''''''''''''''').PSD · Nov 2020
5.7 As a minor submission, the economic analysis has not been independently evaluated.PSD · Nov 2020
Clinical claim
5.4 The submission claimed one tablet of Asacol 1600 is non-inferior to two tablets of Asacol 800 or four tablets of Asacol 400. The submission also claimed the TGA accepted that two tablets of Asacol 400 was equivalent to one tablet of Asacol 800 and that one tablet of Asacol 1600 was equivalent to four tablets of Asacol 400.PSD · Nov 2020
5.5 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Nov 2020
Consumer comments
5.2 The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. Crohn’s & Colitis Australia (CCA) supported the 2PSD · Nov 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Recommendation based on cost-minimisation relative to Asacol 800 on a per-mg basis.
The PBAC recommended the listing of Asacol 1600 on a cost-minimisation basis, based on the price per mg of the currently PBS listed Asacol 800. PBAC · 2020
Price cut / RSA neededCost-effectiveness accepted ×5
Decision context
PopulationAdults with mild to moderate ulcerative colitis requiring maintenance of remission.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2020 | Recommended · restricted | Asacol 800 (mesalazine 800 mg enteric coated tablets) | — | RCT · Non-inferiority |
| Mar 2020 | Recommended | — | — | Cost-minimisation |
| Jul 2018 | Recommended · restricted | oral formulation of mesalazine on the PBS with the lowest price per milligram of mesalazine | — | Cost-minimisation · Cost-minimisation |
| Mar 2017 | Recommended · restricted | Mezavant (1.2 g mesalazine prolonged release tablet); also Salofalk and Pentasa (other oral mesalazine formulations) | — | RCT · Clinical and endoscopic remission |
| Nov 2015 | Recommended | Salofalk® and Pentasa® (other mesalazine products) | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Recommended · restricted | mesalazine 2 g granules (modified release) | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Recommended · restricted | mesalazine 1.5 g granules | — | Cost-minimisation · Cost-minimisation |
Consumer voice
One consumer organisation, Crohn's & Colitis Australia, supported the addition of Asacol 1600 to provide greater choice for consumers.
Crohn's & Colitis Australia (CCA) supported the addition of Asacol 1600 to provide greater choice for consumers. Consumer comments · PSD
treatment choiceaccess
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts describe identical indications: treatment of mild to moderate ulcerative colitis and maintenance of remission in adults, with no population restrictions.