A differentiation benchmark for a hypothetical new advanced therapy, built from public trial, label and HTA data. November 2026.
NICE has recommended all ten medicines it has appraised individually in this population since 2015, each on a commercial arrangement, and the last five with an instruction to use the least expensive suitable option. In Germany the G-BA found added benefit not proven for all nine it assessed, in every patient group.
Four medicines reach about 50% remission at one year, yet they read as anything from a 25-point to a 41-point gain, because their placebo arms run from 10.4% to 25.1%.
Obefazimod and tulisokibart both reported Phase 3 wins in June 2026, in company toplines, and twelve more Phase 3s are running or about to start. All twelve have a registered primary completion by April 2029, three of them by January 2027, and two are head to head: risankizumab v vedolizumab, and a guselkumab-golimumab co-antibody v guselkumab. Only the first compares licensed medicines.
Each row is the remission rate on the medicine minus the rate on placebo, in percentage points. Better is always to the right, and the concept range for a new entrant is shaded. Hover or tap a row for the rates, the evidence level and the source.
TREATMENT BURDEN
| MEDICINE | SCHEDULE AS STUDIED | WHAT COMES WITH IT |
|---|---|---|
| Upadacitinib | Oral: 45 mg once daily for 8 weeks, then 15 or 30 mg once daily | US boxed warning; US use after a TNF blocker, or another systemic therapy if TNF blockers are inadvisable; EU use restricted in higher-risk patients unless no suitable alternative exists |
| Tofacitinib | Oral: 10 mg twice daily for 8 weeks, then 5 or 10 mg twice daily | US boxed warning; US use only after a TNF blocker; the same EU restriction |
| Filgotinib | Oral: 200 mg once daily | The same EU restriction; no US licence |
| Ozanimod | Oral: once daily after a 7-day titration | ECG and other assessments before the first dose |
| Etrasimod | Oral: 2 mg once daily | ECG and other assessments before the first dose |
| Vedolizumab | IV at weeks 0, 2 and 6, then every 8 weeks | Infusion visits throughout the pivotal schedule; the US label allows a switch to subcutaneous 108 mg every 2 weeks from week 6 |
| Ustekinumab | One IV dose, then subcutaneous every 8 or 12 weeks | One infusion visit |
| Mirikizumab | IV at weeks 0, 4 and 8, then subcutaneous every 4 weeks | Three infusion visits |
| Risankizumab | IV at weeks 0, 4 and 8, then subcutaneous every 8 weeks | Three infusion visits |
| Guselkumab | IV or subcutaneous at weeks 0, 4 and 8, then subcutaneous every 4 or 8 weeks | Three infusion visits in QUASAR; none with subcutaneous induction (ASTRO, US label) |
| Obefazimod | Oral: 25 or 50 mg once daily | US filing planned by the end of 2026. In the company's post hoc analysis of Phase 3 maintenance, malignancies other than non-melanoma skin cancer ran at 0.91 per 100 patient-years on 50 mg, 0.00 on 25 mg and 0.00 on placebo, and non-melanoma skin cancer at 1.37, 1.09 and 0.68. In Part 2, investigators considered the two non-skin cases unrelated and two of the four skin cancers probably related; the company cites UC background ranges of 0.30 to 0.70 and 0.70 to 1.40 |
Concept: once-daily oral or infrequent self-injection after induction as the minimum; once-daily oral with no JAK class warning as the target; the same with no ECG before the first dose as the aspiration.
Schedules are as studied in each pivotal trial. US warnings and indications are from current US labels, the EU restriction from the EMA's JAK inhibitor referral, and the obefazimod figures from the company's Form 6-K of 29 June 2026 and its September 2026 results.
The pivotal Phase 3 programme for each new medicine, the full etrolizumab programme, and every adult Phase 3 of a new medicine or new comparison that is running or about to start, from our trial register and ClinicalTrials.gov. Bars run from start to registered study completion, which can include long-term extensions. Markers sit at the date each result was published or announced, at the registered end date for stopped trials, and at registered primary completion for running trials.
From our database of 23,515 decisions, with every decision in this table checked against the agency's own record. So far, every medicine NICE has appraised has reached the list, including the two whose best whole-trial induction result is lowest on this grid (ustekinumab 10.2, filgotinib 10.8). None of the nine the G-BA assessed received a finding of added benefit, and NICE's last four appraisals rested on a cost comparison.
| MEDICINE | NICE | CONDITIONS ON THE NICE RECOMMENDATION | SMC | G-BA ADDED BENEFIT |
|---|---|---|---|---|
| Vedolizumab | ✓Recommended TA342, Jun 2015 | Discount in the patient access scheme | ✓Accepted 1045/15, May 2015, full submission | •Not proven Jan 2015 |
| Tofacitinib | ✓Recommended TA547, Nov 2018 | Agreed discount | ✓Accepted SMC2122, Feb 2019, full submission | •Not proven Feb 2019 |
| Ustekinumab | ✓Recommended TA633, Jun 2020 | After a TNF-alpha inhibitor, or if one is unsuitable; at the agreed price or lower | ✓Accepted SMC2250, Apr 2020, full submission | No assessment in our archive |
| Filgotinib | ✓Recommended TA792, Jun 2022 | Commercial arrangement | ✓Accepted SMC2467, May 2022, abbreviated submission | •Not proven May 2022 |
| Ozanimod | ✓Recommended TA828, Oct 2022 | Commercial arrangement; after conventional treatment only if infliximab is unsuitable | ✓Accepted SMC2478, Oct 2022, full submission | •Not proven Jun 2022 |
| Upadacitinib | ✓Recommended TA856, Jan 2023 | Commercial arrangement; use the least expensive suitable option | ✓Accepted SMC2510, Oct 2022, abbreviated submission | •Not proven Feb 2023 |
| Mirikizumab | ✓Recommended TA925, Oct 2023 | After a TNF-alpha inhibitor, or if one is unsuitable; commercial arrangement; least expensive; cost comparison | ✓Accepted SMC2650, Apr 2024, abbreviated submission | •Not proven Jan 2024 |
| Etrasimod | ✓Recommended TA956, Mar 2024 | Commercial arrangement; least expensive; cost comparison | ✓Accepted SMC2655, Jun 2024, abbreviated submission | •Not proven Oct 2024 |
| Risankizumab | ✓Recommended TA998, Aug 2024 | After a TNF-alpha inhibitor, or if one is unsuitable; commercial arrangement; least expensive; cost comparison | ✓Accepted SMC2686, Jan 2025, abbreviated submission | •Not proven Feb 2025 |
| Guselkumab | ✓Recommended TA1094, Aug 2025 | After a TNF-alpha inhibitor, or if one is unsuitable; commercial arrangement; least expensive; cost comparison | ✓Accepted SMC2848, Nov 2025, abbreviated submission | •Not proven Nov 2025 |
NICE's last four appraisals rested on a cost comparison, so the question became what the medicine costs rather than how much better it is. In Germany, the law says a medicine with no added benefit on its dossier and no reference-price group should be priced so that annual costs are no higher than the comparator's, or the most economical comparator's where there are several (SGB V section 130b(3)). In Scotland, six of the last seven went through the abbreviated route.
The last layer is price headroom. A cost-effectiveness model run at the minimum, target and aspirational profiles gives the price each one supports, and shows whether an asset belongs on NICE's cost-comparison route or has the evidence for a full cost-utility case.
DIFFERENTIATION BENCHMARKS ›Population and comparators. From the eligibility criteria of recent Phase 3 programmes and our trial register: industry-sponsored interventional trials from Phase 2 onward since 2010, rebuilt on 4 November 2026 from an extract whose latest registration dates from August 2026. We therefore also searched ClinicalTrials.gov directly on 5 November 2026 for later registrations and read the live record of each running and stopped trial. Reported rows use the register's dates, corrected to the live record where it had moved (QUASAR, ABTECT-1, ABTECT-2). TNF-alpha inhibitors are not plotted: this grid covers the medicines that came after them, though NICE describes them as the most used biologics in this condition.
Values. Every plotted figure is the remission rate on the medicine minus the rate on placebo: our arithmetic, from patient counts where the source gives them and published rates where it does not. We subtract before rounding, so a plotted figure can differ by 0.1 from the rounded rates beside it. Whole-trial figures come from primary publications, and from the US label for vedolizumab at week 6. Subgroup figures come from current US labels, except filgotinib, which has no US licence, etrolizumab, and obefazimod, which has no label yet. Obefazimod results are company releases and congress abstracts, and tulisokibart's a company topline without rates; we found no full peer-reviewed report by 5 November 2026. Obefazimod's maintenance data were presented at UEG Week in October 2026. The public abstracts (OP097, OP260) give the same week 44 counts as the June topline. The slides are listed for healthcare professionals only, and we have not used them.
Comparability. These are cross-trial comparisons, not head-to-head results. Filled markers are randomised Phase 3 arms; hollow markers are Phase 2. Phase 2 results are plotted only where a medicine has a running Phase 3 and a full journal report of its Phase 2 trial; congress-only Phase 2 data are left out. Induction read-outs run from week 6 to week 14 and one-year read-outs from week 40 of maintenance to week 66. Definitions and analysis sets differ, so one trial can read differently by source: risankizumab's induction result is 20.3% v 6.2% in JAMA and 24% v 8% in its US label, ustekinumab's is 15.5% v 5.3% in NEJM and 19% v 7% in its label, and subcutaneous guselkumab's is 27.6% v 6.5% in its journal report and 26% v 7% in its label. Where the publications we could read report an adjusted difference, it differs from our simple difference by up to 1.7 points. HIBISCUS and LAUREL enrolled only TNF-naive patients. Subgroups are defined as prior TNF blocker failure (tofacitinib), biologic failure (upadacitinib, ustekinumab), biologic or JAK inhibitor failure (mirikizumab, guselkumab in QUASAR), biologic, JAK inhibitor or S1P modulator failure (risankizumab, guselkumab in ASTRO), inadequate response to an advanced therapy (obefazimod), TNF blocker exposure (ozanimod) and biologic or JAK inhibitor exposure (etrasimod). Filgotinib's row is its separate biologic-experienced study. Etrolizumab's is the HICKORY cohort, all previously treated with a TNF inhibitor. Etrasimod's one-year figure is treat-through; the others re-randomise induction responders.
Concept range. Illustrative, set from the benchmarks for this example, with the reasoning stated above each scale. In a client benchmark it is set with clinician and payer research and the asset's own data.
Phase 3 set. Vedolizumab's pivotal GEMINI 1 (NCT00783718) began in 2009, before the register's 2010 start, so its row on the timeline is the VARSITY head-to-head. Stopped trials are advanced therapies in moderately to severely active disease, shown by registry status alone. ClinicalTrials.gov gives a reason for three: the sponsor ended the ontamalimab IBD programme, izencitinib stopped on a company decision after an interim analysis, and cobitolimod for futility. It gives none for andecaliximab. Ontamalimab also has a second induction trial (NCT03259334), terminated with the first, and a completed maintenance trial (NCT03290781). Trials that have reported but remain open, such as COMMAND (NCT03398135), sit under their programme's reported row. Left out: paediatric, long-term extension, biosimilar and single-country bridging trials, new formulations of licensed medicines (guselkumab's subcutaneous induction trial, ASTRO, NCT05528510, is on the grid above), other trials of medicines already shown, trials in mild to moderate disease or of non-advanced therapies, an investigator-led trial in acute severe disease (RESCUE UC, upadacitinib first v infliximab, NCT06660693), AJM300 in Japan (NCT03531892), spesolimab (NCT03482635) and two trials with unknown status (SHR0302, NCT05181137; etrasimod, NCT04176588).
Payer record. NICE conditions are summarised, not quoted, from each recommendation. SMC routes are from each advice page. G-BA verdicts are from its published resolution data and hold across every patient group in each resolution. Ustekinumab has no resolution in our archive for this indication. The obefazimod safety figures are the company's own post hoc analysis.
| MEASURE | MEDICINE | TRIAL OR ARM | EVIDENCE | POINTS | MEDICINE V PLACEBO | SOURCE |
|---|---|---|---|---|---|---|
| Induction, whole trial | Upadacitinib 45 mg | U-ACHIEVE, week 8 | Phase 3 | 21.5 | 26.0% v 4.5% (83/319 v 7/154) | U-ACHIEVE and U-ACCOMPLISH, Lancet 2022 |
| Induction, whole trial | Upadacitinib 45 mg | U-ACCOMPLISH, week 8 | Phase 3 | 29.4 | 33.4% v 4.0% (114/341 v 7/174) | U-ACHIEVE and U-ACCOMPLISH, Lancet 2022 |
| Induction, whole trial | Duvakitug | 900 mg, week 14 | Phase 2, n = 137 | 27.4 | 47.8% v 20.5% (22/46 v 9/44) | RELIEVE UCCD, Lancet Gastroenterol Hepatol 2026 |
| Induction, whole trial | Duvakitug | 450 mg, week 14 | Phase 2, n = 137 | 15.7 | 36.2% v 20.5% (17/47 v 9/44) | RELIEVE UCCD, Lancet Gastroenterol Hepatol 2026 |
| Induction, whole trial | Tulisokibart | ARTEMIS-UC, week 12 | Phase 2, n = 135, cohort 1 | 25 | 26% v 1% | ARTEMIS-UC, NEJM 2024 |
| Induction, whole trial | Afimkibart | 150 mg, week 14 | Phase 2 | 23.4 | 35.0% v 11.6% (21/60 v 5/43) | TUSCANY-2, Lancet Gastroenterol Hepatol 2025 |
| Induction, whole trial | Afimkibart | 450 mg, week 14 | Phase 2 | 20.2 | 31.8% v 11.6% (28/88 v 5/43) | TUSCANY-2, Lancet Gastroenterol Hepatol 2025 |
| Induction, whole trial | Afimkibart | 50 mg, week 14 | Phase 2 | 18.2 | 29.8% v 11.6% (14/47 v 5/43) | TUSCANY-2, Lancet Gastroenterol Hepatol 2025 |
| Induction, whole trial | Guselkumab | QUASAR, intravenous, week 12 | Phase 3 | 14.7 | 22.6% v 7.9% (95/421 v 22/280) | QUASAR, Lancet 2025 |
| Induction, whole trial | Guselkumab | ASTRO, subcutaneous, week 12 | Phase 3 | 21.1 | 27.6% v 6.5% (77/279 v 9/139) | ASTRO, Lancet Gastroenterol Hepatol 2026 |
| Induction, whole trial | Etrasimod 2 mg | ELEVATE UC 52, week 12 | Phase 3 | 19.6 | 27.0% v 7.4% (74/274 v 10/135) | ELEVATE, Lancet 2023 |
| Induction, whole trial | Etrasimod 2 mg | ELEVATE UC 12, week 12 | Phase 3 | 9.6 | 24.8% v 15.2% (55/222 v 17/112) | ELEVATE, Lancet 2023 |
| Induction, whole trial | Obefazimod 50 mg | ABTECT-1, week 8 | Phase 3 | 19.2 | 21.7% v 2.5% (69/318 v 4/158) | ABTECT induction topline, company release, Jul 2025 |
| Induction, whole trial | Obefazimod 50 mg | ABTECT-2, week 8 | Phase 3 | 13.5 | 19.8% v 6.3% (63/318 v 10/159) | ABTECT induction topline, company release, Jul 2025 |
| Induction, whole trial | Icotrokinra 400 mg | ANTHEM-UC, week 12 | Phase 2, n = 63 v 63 | 19 | 30% v 11% | ANTHEM-UC, NEJM 2026 |
| Induction, whole trial | Risankizumab | INSPIRE, week 12 | Phase 3 | 14.2 | 20.3% v 6.2% (132/650 v 20/325) | INSPIRE and COMMAND, JAMA 2024 |
| Induction, whole trial | Tofacitinib 10 mg | OCTAVE Induction 1, week 8 | Phase 3 | 10.3 | 18.5% v 8.2% | OCTAVE, NEJM 2017 |
| Induction, whole trial | Tofacitinib 10 mg | OCTAVE Induction 2, week 8 | Phase 3 | 13 | 16.6% v 3.6% | OCTAVE, NEJM 2017 |
| Induction, whole trial | Etrolizumab | HIBISCUS I, week 10 | Phase 3 | 12.5 | 19.4% v 6.9% (28/144 v 5/72) | HIBISCUS, Lancet Gastroenterol Hepatol 2022 |
| Induction, whole trial | Etrolizumab | HIBISCUS II, week 10 | Phase 3 | 7.1 | 18.2% v 11.1% (26/143 v 8/72) | HIBISCUS, Lancet Gastroenterol Hepatol 2022 |
| Induction, whole trial | Ozanimod | True North, week 10 | Phase 3 | 12.4 | 18.4% v 6.0% | True North, NEJM 2021 |
| Induction, whole trial | Vedolizumab | GEMINI 1, week 6 | Phase 3, n = 225 v 149 | 12 | 17% v 5% | Entyvio US label |
| Induction, whole trial | Mirikizumab | LUCENT-1, week 12 | Phase 3 | 10.9 | 24.2% v 13.3% | LUCENT, NEJM 2023 |
| Induction, whole trial | Filgotinib 200 mg | SELECTION, study A, week 10 | Phase 3 | 10.8 | 26.1% v 15.3% | SELECTION, Lancet 2021 |
| Induction, whole trial | Ustekinumab | UNIFI, week 8 | Phase 3 | 10.2 | 15.5% v 5.3% | UNIFI, NEJM 2019 |
| Induction, whole trial | New entrant concept range | Illustrative | Set from the benchmarks | 15 / 20 / 25 | Minimum / target / aspiration | This page |
| Induction, prior failure | Upadacitinib 45 mg | Study UC-1, week 8 | Phase 3 | 17.5 | 18% v <1% (168 v 78 patients; placebo plotted as 0.5%) | Rinvoq US label |
| Induction, prior failure | Upadacitinib 45 mg | Study UC-2, week 8 | Phase 3 | 28 | 30% v 2% (173 v 89 patients) | Rinvoq US label |
| Induction, prior failure | Etrasimod 2 mg | Study UC-1, week 12 | Phase 3 | 16 | 18% v 2% (80 v 41 patients) | Velsipity US label |
| Induction, prior failure | Etrasimod 2 mg | Study UC-2, week 12 | Phase 3 | 6 | 19% v 13% (74 v 38 patients) | Velsipity US label |
| Induction, prior failure | Obefazimod 50 mg | ABTECT-1, week 8 | Phase 3 | 12.6 | 14.1% v 1.4% (21/149 v 1/69) | ABTECT abstracts LB01 and LB06, UEG Journal 2025 |
| Induction, prior failure | Obefazimod 50 mg | ABTECT-2, week 8 | Phase 3 | 7.5 | 12.6% v 5.1% (20/159 v 4/79) | ABTECT abstracts LB01 and LB06, UEG Journal 2025 |
| Induction, prior failure | Etrolizumab | HICKORY, week 14 | Phase 3 | 12.2 | 18.5% v 6.3% (71/384 v 6/95) | HICKORY, Lancet Gastroenterol Hepatol 2022 |
| Induction, prior failure | Tofacitinib 10 mg | Study UC-I, week 8 | Phase 3 | 9 | 11% v 2% (243 v 64 patients) | Xeljanz US label |
| Induction, prior failure | Tofacitinib 10 mg | Study UC-II, week 8 | Phase 3 | 12 | 12% v 0% (222 v 60 patients) | Xeljanz US label |
| Induction, prior failure | Ustekinumab | UNIFI, week 8 | Phase 3 | 10.1 | 14.5% v 4.3% (24/166 v 7/161) | Stelara US label |
| Induction, prior failure | Guselkumab | QUASAR, intravenous, week 12 | Phase 3 | 9 | 13% v 4% (208 v 136 patients) | Tremfya US label |
| Induction, prior failure | Guselkumab | ASTRO, subcutaneous, week 12 | Phase 3 | 10 | 14% v 4% (107 v 55 patients) | Tremfya US label |
| Induction, prior failure | Risankizumab | INSPIRE, week 12 | Phase 3, n = 331 v 168 | 8 | 14% v 6% | Skyrizi US label |
| Induction, prior failure | Filgotinib 200 mg | SELECTION, study B, week 10 | Phase 3, n = 262 v 142 | 7.3 | 11.5% v 4.2% | SELECTION, Lancet 2021 |
| Induction, prior failure | Mirikizumab | LUCENT-1, week 12 | Phase 3, n = 331 v 107 | 7 | 15% v 8% | Omvoh US label |
| Induction, prior failure | Ozanimod | True North, week 10 | Phase 3 | 5.4 | 10.0% v 4.6% (13/130 v 3/65) | Zeposia US label |
| Induction, prior failure | New entrant concept range | Illustrative | Set from the benchmarks | 10 / 15 / 20 | Minimum / target / aspiration | This page |
| About one year | Obefazimod | 50 mg, week 44 | Phase 3 | 40.9 | 51.3% v 10.4% (100/195 v 20/192) | ABTECT maintenance abstracts OP097 and OP260, UEG Week 2026 |
| About one year | Obefazimod | 25 mg, week 44 | Phase 3 | 40.4 | 50.8% v 10.4% (98/193 v 20/192) | ABTECT maintenance abstracts OP097 and OP260, UEG Week 2026 |
| About one year | Upadacitinib | 30 mg, week 52 | Phase 3 | 39.9 | 51.9% v 12.1% (80/154 v 18/149) | U-ACHIEVE and U-ACCOMPLISH, Lancet 2022 |
| About one year | Upadacitinib | 15 mg, week 52 | Phase 3 | 30.5 | 42.6% v 12.1% (63/148 v 18/149) | U-ACHIEVE and U-ACCOMPLISH, Lancet 2022 |
| About one year | Guselkumab | 200 mg every 4 weeks, week 44 | Phase 3 | 31.1 | 50.0% v 18.9% (95/190 v 36/190) | QUASAR, Lancet 2025 |
| About one year | Guselkumab | 100 mg every 8 weeks, week 44 | Phase 3 | 26.3 | 45.2% v 18.9% (85/188 v 36/190) | QUASAR, Lancet 2025 |
| About one year | Tofacitinib | 10 mg twice daily, week 52 | Phase 3 | 29.5 | 40.6% v 11.1% | OCTAVE, NEJM 2017 |
| About one year | Tofacitinib | 5 mg twice daily, week 52 | Phase 3 | 23.2 | 34.3% v 11.1% | OCTAVE, NEJM 2017 |
| About one year | Filgotinib 200 mg | SELECTION, week 58 | Phase 3 | 26 | 37.2% v 11.2% | SELECTION, Lancet 2021 |
| About one year | Vedolizumab | GEMINI 1, every 8 weeks, week 52 | Phase 3 | 25.9 | 41.8% v 15.9% | GEMINI 1, NEJM 2013 |
| About one year | Etrasimod 2 mg | ELEVATE UC 52, week 52 | Phase 3 | 25.5 | 32.1% v 6.7% (88/274 v 9/135) | ELEVATE, Lancet 2023 |
| About one year | Mirikizumab | LUCENT-2, week 40 of maintenance | Phase 3 | 24.8 | 49.9% v 25.1% | LUCENT, NEJM 2023 |
| About one year | Ustekinumab | Every 8 weeks, week 44 | Phase 3 | 19.8 | 43.8% v 24.0% | UNIFI, NEJM 2019 |
| About one year | Ustekinumab | Every 12 weeks, week 44 | Phase 3 | 14.4 | 38.4% v 24.0% | UNIFI, NEJM 2019 |
| About one year | Ozanimod | True North, week 52 | Phase 3 | 18.5 | 37.0% v 18.5% | True North, NEJM 2021 |
| About one year | Risankizumab | 180 mg, week 52 | Phase 3 | 15.1 | 40.2% v 25.1% (72/179 v 46/183) | INSPIRE and COMMAND, JAMA 2024 |
| About one year | Risankizumab | 360 mg, week 52 | Phase 3 | 12.5 | 37.6% v 25.1% (70/186 v 46/183) | INSPIRE and COMMAND, JAMA 2024 |
| About one year | Etrolizumab | LAUREL, week 62 | Phase 3 | 9 | 29.6% v 20.6% (32/108 v 21/102) | LAUREL, Lancet Gastroenterol Hepatol 2022 |
| About one year | Etrolizumab | HICKORY, week 66 | Phase 3 | 3.9 | 24.1% v 20.2% (27/112 v 23/114) | HICKORY, Lancet Gastroenterol Hepatol 2022 |
| About one year | New entrant concept range | Illustrative | Set from the benchmarks | 25 / 30 / 40 | Minimum / target / aspiration | This page |
A benchmark for one population takes two to three weeks at a fixed fee, or three to four with the pipeline and payer record shown here.
Tell us the indication and the decision it has to support.