VedolizumabEntyvio
Dose escalation from 8-weekly to 4-weekly intravenous maintenance treatment in adults with moderate to severe ulcerative colitis or severe Crohn disease who experience loss of clinical response on 8-weekly dosing.
Decisions on record
- Meeting Nov 2025 Not recommended Severe Crohn disease and moderate to severe ulcerative colitis – dose escalation from every 8 weeks to every 4 weeks
- Meeting Jul 2024 Recommended Chronic pouchitis
- Meeting Mar 2024 Recommended Crohn disease and ulcerative colitis
- Meeting Nov 2020 Recommended Ulcerative colitis Crohn's disease
- Meeting Aug 2017 Recommended Severe ulcerative colitis and Crohn disease no PSD
- Meeting Mar 2015 Recommended Crohn’s disease
- Meeting Mar 2015 Recommended Ulcerative colitis
- Meeting Jul 2014 Not recommended Takeda Pharmaceuticals Australia Pty Ltd New listing (Major submission) Ulcerative colitis (UC) Section 100 (Highly Specialised Drugs Program) Public and Private Hospital Authority Required listing for treatment of moderate to severe ulcerative colitis (UC) in patients who have failed conventional t
Access path
- TGA registered · Entyvio
TGA label narrower than the PBS population
- Jul 2014Not recommended
vs standard of care (5-aminosalicylates, corticosteroids, and…
- ↻ resubmittedMar 2015Recommended · restricted
Comparator changed: standard of care (5-aminosalicylates, corticosteroids, and…
- Mar 2015Recommended · restricted
Comparator changed: standard of care (5-aminosalicylates, corticosteroids, and…
- Nov 2020Recommended · restricted
Comparator changed: infliximab → vedolizumab intravenous (VDZ IV)
- Mar 2024Recommended
Comparator changed: vedolizumab intravenous (VDZ IV) → vedolizumab IV under current PBS…
- Jul 2024Recommended · restricted
Comparator changed: vedolizumab IV under current PBS restriction (standard 0, 2, 6 week…
- Nov 2025Not recommended
Comparator changed: placebo plus standard of care → vedolizumab 8-weekly (Q8W)…
From the public summary
6.1 The PBAC did not recommend vedolizumab 300mg IV Q4W for the treatment of patients with MSUC or severe CD. The submission suggested that the requested listings would be cost neutral, however, costs to the MBS and Services Australia incurred by providing additional infusions for Q4W dosing were not included in the usage estimates and financial implications should be accounted for to be considered truly cost neutral.PSD · Nov 2025
6.2 The secondary reason for the PBAC not recommending vedolizumab Q4W was due to a poorly defined clinical need for dose escalation. The clinical trial populations were defined as patients who had a clinical response to induction treatment. The population proposed by the submission was requested for patients who responded to induction treatment and require a dose escalation to maintain an adequate response to treatment.PSD · Nov 2025
5.11 As a Category 3 submission, the economic analysis was not independently evaluated.PSD · Nov 2025
5.12 The submission presented a cost-minimisation approach (CMA) (see Table 2) that includes a SPA rebate of @@@@% of the cost of additional Q4W doses minus co- payments, administration costs and MBS costs, claiming that this would make the PBS listing cost neutral to the PBS/RPBS.PSD · Nov 2025
5.7 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Q4W maintenance compared with Q8W maintenance for patients who achieved a clinical response to induction therapy.PSD · Nov 2025
5.8 The PBAC considered the claim of non-inferior comparative effectiveness was adequately supported by data for patients who have responded to induction therapy (induction responders) and were not or would not be Q8W ineligible. The PBAC noted that evidence comparing Q8W treatment to Q4W treatment in induction responders who have demonstrated a loss of adequate response to Q8W treatment has not been presented.PSD · Nov 2025
5.2 The PBAC noted and welcomed input from Crohn’s and Colitis Australia (CCA). They described how compassionate access programs are unsustainable, create direct relationships between patients and pharmaceutical companies, and do not promote equitable access. Additional comments from CCA identified a practical need for follow on changes to dosing and restrictions, noting that Q4W should be accompanied by access to weekly (Q1W) subcutaneous formulations.PSD · Nov 2025
5.3 The submission was primarily based on an access program that the sponsor has implemented in Australia since September 2018 to provide additional vedolizumab 300 mg IV doses to enable Q4W maintenance dosing for eligible patients.PSD · Nov 2025
Cost-effectiveness
No ICER analysis presented; this is a dose-escalation/balance of supply submission with proposed cost-neutrality via Special Pricing Arrangement amendment.
The submission initially presented a cost minimisation approach (CMA) of vedolizumab IV under the current PBS restriction versus vedolizumab IV under the proposed PBS restriction over a two-year time horizon (104 weeks) resulting in a nil cost to Government. PSD · 2024
Decision context
PopulationAdults with moderate to severe ulcerative colitis or severe Crohn disease on vedolizumab 8-weekly intravenous maintenance who have insufficient response and would not be sufficiently maintained on 8-weekly dosing.
Risk sharingSpecial Pricing Arrangement (SPA) proposed to offset the net budget impact of doses additional to Q8W dosing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Not recommended | vedolizumab 8-weekly (Q8W) intravenous maintenance treatment | — | Single-arm · Clinical remission |
| Jul 2024 | Recommended · restricted | placebo plus standard of care | — | RCT · mPDAI remission |
| Mar 2024 | Recommended | vedolizumab IV under current PBS restriction (standard 0, 2, 6 week dosing) | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | vedolizumab intravenous (VDZ IV) | — | RCT · Clinical remission |
| Mar 2015 | Recommended · restricted | infliximab and adalimumab | — | RCT · Clinical remission |
| Mar 2015 | Recommended · restricted | infliximab | — | RCT · Clinical response and clinical remission |
| Jul 2014 | Not recommended | standard of care (5-aminosalicylates, corticosteroids, and immunomodulators) | — | RCT |
Consumer voice
Crohn's and Colitis Australia identified that compassionate access programs are unsustainable and inequitable, and advocated for follow-on changes including access to weekly subcutaneous formulations alongside Q4W dosing, citing environmental and quality-of-life benefits.
compassionate access programs are unsustainable, create direct relationships between patients and pharmaceutical companies, and do not promote equitable access Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to loss of response on Q8W dosing; TGA label includes initial inadequate response and intolerance scenarios.