P0883 Risankizumab versus reference and biosimilar ustekinumab in moderate-to-severe Crohn’s disease: A cost-effectiveness model from the German perspective

Abstract Background Crohn’s Disease (CD) is a chronic, relapsing, systemic, inflammatory bowel disease that is highly prevalent in Europe (incidence rates in Germany: 322 per 100,000) with a significant impact on quality of life.1,2,3 Interleukin (IL) 23 inhibitor risankizumab and IL 12/23 inhibitor ustekinumab are recommended by current treatment guidelines for treatment of moderate-to-severe CD.2 Previously submitted health technology assessments were based on indirect comparisons between risankizumab and reference ustekinumab. Recently, a head-to-head Phase 3b clinical trial (SEQUENCE) evaluated the efficacy and safety of risankizumab vs ustekinumab in moderate-to-severe CD.4 Also, lower priced ustekinumab biosimilar products have been introduced to the market. Therefore, we assessed the cost-effectiveness of risankizumab compared with reference and biosimilar ustekinumab over a lifetime horizon. Methods A Markov model was constructed for the management of moderate-to-severe CD patients with previous failure of tumour necrosis factor alpha (TNFα) over a lifetime from a German payer perspective. Clinical data are based on SEQUENCE trial and the same efficacy results were applied for reference and biosimilar ustekinumab. Direct costs included treatment costs, healthcare resource use during remission and non-remission, surgery costs, and adverse event-related costs. Costs were estimated in 2025 Euros. The model provided estimates of total costs, quality-adjusted-life-years (QALYs), and incremental cost effectiveness ratio (ICER) per QALY. Further, a probabilistic sensitivity analysis was run by varying inputs by 5% for 1,000 simulations. Results For risankizumab, total costs were €99,776 and QALYs were 17.17 (Table 1). Totals costs for reference and biosimilar ustekinumab were €60,445 and €32,938, respectively. QALYs for ustekinumab were 16.78. The difference in costs between risankizumab and the reference ustekinumab was €39,331 and QALYs were 0.38, resulting in an ICER of €102,246 per QALY. When biosimilar ustekinumab was assessed against risankizumab, the ICER increased to €173,754 per QALY. Sensitivity analysis showed at a willingness to pay threshold of €35,000 (assumed to be NICE upper threshold of £30,000 converted to Euros), the probability of risankizumab being cost-effective was 0% compared to both reference and biosimilar ustekinumab (Figure 1). Conclusion Using clinical data from SEQUENCE trial, results from the cost-effectiveness model indicate that reference ustekinumab is more cost effective than risankizumab for moderate-to-severe CD with previous TNFα failure, which is more marked with biosimilar ustekinumab due to lower cost. References: 1. Kumar A, Yassin N, et al. Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therap Adv Gastroenterol. 2023 Dec 22;16:17562848231218615. 2. Gordon H, Minozzi S, et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment. J Crohns Colitis. 2024 Oct 15;18(10):1531-1555. 3. Zhang Y, Chu X, Wang L, Yang H. Global patterns in the epidemiology, cancer risk, and surgical implications of inflammatory bowel disease. Gastroenterol Rep (Oxf). 2024 Jul 9;12 4. Peyrin-Biroulet L, Chapman JC, et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn’s Disease. N Engl J Med. 2024 Jul 18;391(3):213-223. Conflict of interest: Mehl, Andrea: Employee of Sandoz Koptelova, Natalia: employee of Hexal AG Srivastava, Abhinav: Sandoz employee and shareholder Tao, Charles: Employee of Cencora Chaplin, Stephen: Employee of Cencora Schreiber, Stefan Wolfgang: Personal Fees: AbbVie, Alfasigma, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Theravance