BudesonideBudenofalk Capsules
Short-term treatment of mild to moderate ulcerative colitis, limited to the rectum (ulcerative proctitis), in adult patients.
Decisions on record
- Meeting Nov 2024 Recommended Ulcerative colitis
- Meeting Mar 2024 Recommended Crohn disease (CD)
- Meeting Jul 2023 Recommended Eosinophilic oesophagitis (EoE) no PSD
- Meeting Mar 2023 Recommended Eosinophilic oesophagitis (EoE)
- Meeting Nov 2021 Recommended Eosinophilic oesophagitis (EoE)
- Meeting Nov 2021 Withdrawn Mild to moderate Crohn disease
- Meeting Mar 2021 Not recommended Eosinophilic oesophagitis
- Meeting Nov 2019 Recommended Asthma
8 earlier decisions
- Mar 2019 Recommended Crohn disease
- Mar 2019 Recommended Mild to moderate Crohn disease
- Jul 2018 Recommended Mild to moderate Crohn disease
- Nov 2017 Not recommended Crohn disease
- Aug 2017 Recommended Indication not stated no PSD
- Jul 2017 Not recommended Unrestricted
- Jul 2017 Not recommended Asthma and chronic obstructive pulmonary disease (COPD)
- Jul 2013 Recommended Ulcerative colitis
Access path
- TGA registered · Budenofalk Capsules
TGA label equal than the PBS population
- Jul 2013Recommended
vs prednisolone enema
- Jul 2017Not recommended
clinical data did not support a claim of non-inferior effectiveness against budesonide foam enemas, unreliable indirect…
- Nov 2017Not recommended
Comparator changed: budesonide foam enema → mesalazine
- ↻ resubmittedJul 2018Recommended
Comparator changed: mesalazine → mixed comparator (mesalazine and prednisolone)
- Mar 2019Recommended
Comparator changed: mixed comparator (mesalazine and prednisolone) → budesonide (Entocort)
- Mar 2019Recommended · restricted
Comparator changed: mixed comparator (mesalazine and prednisolone) → budesonide (Entocort)
- Mar 2021Not recommended
Comparator changed: mixed comparator of mesalazine and prednisolone → standard of care…
- ↻ resubmittedNov 2021Recommended · restricted
Comparator changed: standard of care (no active treatment) / placebo → placebo
- Jul 2023Recommended
- Mar 2024Recommended
Evidence: RCT → Cost-minimisation
- Nov 2024Recommended
Comparator changed: Entocort (budesonide 3 mg modified release capsules, 90 capsules) →…
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the General Schedule unrestricted benefit listing of budesonide 4 mg suppository (BUS) under the same circumstances as the PBS-listed budesonide foam (rectal foam 2 mg per application, 14 applications, aerosol 16.8 g, 2; BUF).PSD · Nov 2024
6.2 The PBAC noted the submission requested the listing of BUS under the same conditions as the existing listing for BUF, with a maximum number of 3 repeats. The PBAC considered that this was appropriate.PSD · Nov 2024
5.12 The submission presented a cost-minimisation approach of BUS compared with BUF.PSD · Nov 2024
5.13 The equi-effective doses were estimated as BUS 4 mg daily over 8 weeks and BUF 2 mg daily over 8 weeks.PSD · Nov 2024
5.11 The submission claimed non-inferior comparative effectiveness and comparative safety of BUS compared with BUF.PSD · Nov 2024
5.2 The PBAC noted and welcomed the input from an individual and from Crohn’s & Colitis Australia via the Consumer Comments facility on the PBS website. Both expressed their support for the listing of Budenofalk 100 capsules on the PBS as another 5PSD · Mar 2024
4.17 As outlined in paragraph 4.10, a RSA based on submission predicated use to reduce any residual uncertainty regarding the number of patients treated was one of the early re-entry pathway amendments recommended by the PBAC in March 2021 (paragraph 7.11, budesonide PSD, March 2021 PBAC meeting). The resubmission stated the PSD also allude to a 100% cap (see paragraph 4.6).PSD · Nov 2021
4.18 The resubmission acknowledged the PBAC’s March 2021 request for a RSA. However, the resubmission argued a '''''''% rebate above a spending cap was not required as:PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a cost-minimisation approach of BUS compared with BUF. PSD · 2024
Decision context
PopulationAdult patients with acute ulcerative proctitis (mild to moderate ulcerative colitis limited to the rectum).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | budesonide foam (BUF) | — | RCT · Other |
| Mar 2024 | Recommended | Entocort (budesonide 3 mg modified release capsules, 90 capsules) | — | Cost-minimisation · Cost-minimisation |
| Jul 2023 | Recommended | — | — | RCT · Histological remission |
| Nov 2021 | Recommended · restricted | placebo | $30k–50k | RCT · Clinicohistologic remission (induction); maintenance of clinicohistologic remission (maintenance) |
| Mar 2021 | Not recommended | standard of care (no active treatment) / placebo | — | RCT · Other |
| Mar 2019 | Recommended | budesonide (Entocort) | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Recommended · restricted | mixed comparator of mesalazine and prednisolone | — | Cost-minimisation · Cost-minimisation |
| Jul 2018 | Recommended | mixed comparator (mesalazine and prednisolone) | — | RCT · Clinical remission |
| Nov 2017 | Not recommended | mesalazine | — | RCT |
| Jul 2017 | Not recommended | budesonide foam enema | — | RCT · Remission |
| Jul 2013 | Recommended | prednisolone enema | — | RCT · Endoscopic response |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EOS-1 | Ph 3 | 88 | Rate of clinico-pathological remission | completed |
Consumer voice
Crohn's and Colitis Australia supported the listing of BUS, highlighting benefits over BUF including ease of self-administration, reduced toxicity compared to prednisolone suppository, and improved delivery to inflamed areas.
BUS offers several benefits over BUF for ulcerative colitis patients including ease of self-administration, reduced toxicity compared to prednisolone suppository, and improved delivery to inflamed areas. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA and PBAC indications specify identical population: mild to moderate ulcerative proctitis in adult patients.