TA888 · STA
Only recommended if the disease has not responded well enough or lost response to a previous biological treatment, or a previous biological treatment was not tolerated, or TNF-alpha inhibitors are not suitable. Only available after CE mark for on-body device is granted. Commercial arrangement (simple discount patient access scheme) required.
Source documents
Intervention
Conditions
Comparators
| Name | Type | Established | Committee preferred |
|---|---|---|---|
| adalimumab | active drug | Yes | — |
| infliximab | active drug | Yes | — |
| ustekinumab | active drug | Yes | — |
| vedolizumab | active drug | Yes | Yes |
Clinical trials
| Trial | Design | Phase | Pivotal |
|---|---|---|---|
| ADVANCE | RCT | 3 | Yes |
| MOTIVATE | RCT | 3 | Yes |
| FORTIFY | RCT | 3 | Yes |
Economic model
Methodological decisions (9)
Clinical equivalence of risankizumab versus comparators for cost-comparison analysis
Company: Network meta-analyses showed risankizumab similarly clinically effective to comparators
ERG: Network meta-analyses did not support equivalent clinical effectiveness; wide credible intervals and point estimates uncertain
Committee: Only enough certainty that risankizumab has at least equivalent benefits to vedolizumab; uncertainty regarding TNF-alpha inhibitors and ustekinumab
ICER impact: uncertain_direction
Company proposed splitting network meta-analyses into 2 separate networks (risankizumab and ustekinumab vs adalimumab, infliximab and vedolizumab) based on drug mechanism of action and other characteristics. EAG and committee preferred a single network approach, noting that network connections should be based on comparator connections rather than drug characteristics.
Company: Split networks approach because of differences in drug mechanism of action, induction duration and half-life, and because single network analyses lacked face validity with placebo remission rates appearing too high.
ERG: Single network more appropriate; connections should be based on comparator connections not drug characteristics. Ustekinumab and vedolizumab have similar half-life and are comparable treatment options.
Committee: Single network approach
ICER impact: uncertain_direction
Company used fixed effects model for network meta-analyses. EAG and committee preferred random effects model given differences between trials in baseline risks, stratification, and observed temporal effect in placebo remission rates.
Company: Fixed effects model; exploration of random effects model produced wide confidence intervals and values favouring placebo over biological treatments.
ERG: Random effects model more appropriate given observed differences between trials including temporal effect on placebo remission rates.
Committee: Random effects model
ICER impact: uncertain_direction
Company's risk difference approach without adjustment for heterogeneity or temporal effect. EAG preferred adjustment for temporal effect observed in placebo remission rates across trials.
Company: Risk difference approach without explicit adjustment for temporal effect or baseline risks.
ERG: Preferred to include adjustment for temporal effect observed in placebo remission rates.
Committee: Adjustment for temporal effect needed
ICER impact: uncertain_direction
Committee noted at first meeting that updated analyses were needed using risk ratios rather than risk differences to compare risankizumab with other biological treatments, as this may be more informative given study heterogeneity and would allow more straightforward exploration of data to improve precision.
Company: Not explicitly stated for risk ratio approach in this chunk
ERG: Not explicitly stated for risk ratio approach in this chunk
Committee: Risk ratios rather than risk differences, exploring both random effects and fixed effects models
ICER impact: uncertain_direction
Network meta-analysis approach: fixed vs random effects model and risk difference vs risk ratio
Company: Risk difference approach with wide confidence intervals; company explored random effects but noted results favoured placebo
ERG: Random effects model with risk ratios rather than risk differences; adjustment for temporal effect in placebo remission rates
Committee: EAG approach preferred - random effects model using risk ratios with adjustment for temporal effect, exploring both random and fixed effects
ICER impact: uncertain_direction
Cost-utility model structure based on CDAI health states vs reflective of clinical pathways
Company: CDAI-based model with decision tree induction phase and Markov maintenance phase
ERG: Model does not reflect lifelong relapsing-remitting nature and current treatment pathways
Committee: Model not suitable for decision-making due to not reflecting treatment pathway with multiple biological treatments
ICER impact: increases
Maximum treatment duration assumption in cost-utility model
Company: 1-year maximum treatment duration, consistent with previous NICE appraisals for Crohn's disease
ERG: 20-year maximum treatment duration reflecting lifelong nature of Crohn's disease
Committee: 20-year maximum treatment duration more reflective of clinical practice
ICER impact: decreases
Whether model should allow multiple sequential biological treatments or only one
Company: Model assumes all people have conventional care after first biological treatment
ERG: Model should reflect lifelong relapsing-remitting nature allowing multiple biological treatments
Committee: Model must reflect current clinical pathway where people can have more than 1 biological treatment
ICER impact: increases
Evidence gaps
Commercial arrangement
Special considerations