IMPACT OF MODELING LOSS OF EXCLUSIVITY ON COST-EFFECTIVENESS IN ULCERATIVE COLITIS IN THE UK
Author(s)
Roksana Anita Dutkiewicz, PhD1, Stella Stylianou, MSc2, Thomas Phillip Kloska, MSCi2.
1Costello Medical, Cambridge, United Kingdom, 2Costello Medical, London, United Kingdom.
1Costello Medical, Cambridge, United Kingdom, 2Costello Medical, London, United Kingdom.
OBJECTIVES: Cost-effectiveness (CE) is often evaluated over a lifetime horizon but assumes constant drug costs, ignoring potential price reductions from loss of exclusivity (LoE). To explore the impact of modelling LoE on CE, risankizumab for ulcerative colitis (UC) was used as a case study.
METHODS: A Markov model with decision tree induction and maintenance phases was used based on UC NICE precedent, with lifetime horizon and healthcare perspective. Clinical inputs were based on relevant trials for risankizumab (INSPIRE/COMMAND), vedolizumab (GEMINI 1), and ustekinumab (UNIFI). Vedolizumab (LoE in one year) and ustekinumab (off-patent) were included as comparators. The model explored 70% and 90% post-LoE price reductions for risankizumab and vedolizumab, reflecting UK parliamentary estimates, with variation in risankizumab LoE timing.
RESULTS: The ICER for risankizumab, without LoE, was £279,374 (vedolizumab) and £485,495 (ustekinumab). Applying a 70% discount upon LoE for risankizumab and vedolizumab, assuming a four-year LoE for risankizumab, ICERs increased to £284,473 (vedolizumab) and reduced to £472,867 (ustekinumab). Under a 90% discount, results modestly changed (£285,929 and £469,259, respectively). Aligning the LoE to one-year for risankizumab yielded lower ICERs, especially for off-patent ustekinumab comparison. With a 70% discount, ICERs were £231,451 (vedolizumab) and £380,469 (ustekinumab). Under a 90% discount, ICERs were £217,758 and £350,461, respectively.
CONCLUSIONS: The impact of LoE on CE was driven more by timing than magnitude of discount. ICER changes were modest and did not change CE conclusions. However, UC is characterised by high costs and discontinuation during induction, limiting impact of maintenance period costs, where LoE is relevant. LoE might have a greater influence in indications with longer treatment durations and persistently high treatment costs. Although modelling future LoE is scarcely accepted by HTA bodies, inclusion may alleviate pricing pressures and demonstrate CE before intervention patent expiry, however the impact of comparator patent expiry also needs to be considered.
METHODS: A Markov model with decision tree induction and maintenance phases was used based on UC NICE precedent, with lifetime horizon and healthcare perspective. Clinical inputs were based on relevant trials for risankizumab (INSPIRE/COMMAND), vedolizumab (GEMINI 1), and ustekinumab (UNIFI). Vedolizumab (LoE in one year) and ustekinumab (off-patent) were included as comparators. The model explored 70% and 90% post-LoE price reductions for risankizumab and vedolizumab, reflecting UK parliamentary estimates, with variation in risankizumab LoE timing.
RESULTS: The ICER for risankizumab, without LoE, was £279,374 (vedolizumab) and £485,495 (ustekinumab). Applying a 70% discount upon LoE for risankizumab and vedolizumab, assuming a four-year LoE for risankizumab, ICERs increased to £284,473 (vedolizumab) and reduced to £472,867 (ustekinumab). Under a 90% discount, results modestly changed (£285,929 and £469,259, respectively). Aligning the LoE to one-year for risankizumab yielded lower ICERs, especially for off-patent ustekinumab comparison. With a 70% discount, ICERs were £231,451 (vedolizumab) and £380,469 (ustekinumab). Under a 90% discount, ICERs were £217,758 and £350,461, respectively.
CONCLUSIONS: The impact of LoE on CE was driven more by timing than magnitude of discount. ICER changes were modest and did not change CE conclusions. However, UC is characterised by high costs and discontinuation during induction, limiting impact of maintenance period costs, where LoE is relevant. LoE might have a greater influence in indications with longer treatment durations and persistently high treatment costs. Although modelling future LoE is scarcely accepted by HTA bodies, inclusion may alleviate pricing pressures and demonstrate CE before intervention patent expiry, however the impact of comparator patent expiry also needs to be considered.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE183
Topic
Economic Evaluation, Health Technology Assessment
Disease
Gastrointestinal Disorders