OP61 Cost-Utility Analyses Of Biologics For Refractory Ulcerative Colitis

• Published in: International journal of technology assessment in health care Vol. 33; no. S1; p. 27
• Main Authors: Davies, Sophia Campbell, Inserra, Chiara, Muserra, Gaetana, Piacenza, Mariagrazia, Ardizzone, Sandro, Saporito, Tommaso
• Format: Journal Article
• Language: English
• Published: New York, USA Cambridge University Press 2017
• Subjects: Biological products; Clinical trials; Cost analysis; Costs; Discounts; Drugs; Economic analysis; Economic impact; Health care; Impact analysis; Inflammatory bowel disease; Infliximab; Laboratory tests; Markov chains; Medical research; Monoclonal antibodies; Oral Presentations; Patients; Regional analysis; Remission; Tumor necrosis factor-α; Ulcerative colitis; Willingness to pay
• ISSN: 0266-4623; 1471-6348
• DOI: 10.1017/S0266462317001465

INTRODUCTION: Although many biologics (Bs) have been approved for the treatment of moderate-to-severe Ulcerative Colitis (UC) in patients who have responded inadequately to conventional therapy, the selection of Bs is controversial due to the lack of head-to-head trials. Indirect economic comparisons of these costly drugs are available from National Healthcare perspectives that are not the Italian ones. Therefore, the objective is to evaluate cost-utility of Bs for the treatment of refractory moderate-to-severe UC both in Italy and in the Lombardy Region. METHODS: A Markov model (considering three transition states: remission, clinical response, relapse) was constructed using the software R 3.3.1 markovchain-package to evaluate incremental cost-utility ratios (ICUR) of adalimumab (ADA), infliximab (IFX), infliximab biosimilar (IFX-B), golimumab (GOL) and vedolizumab (VED) treatments of patients over a 10-year time horizon from the perspective of the Italian (N) and Lombardy Region (R) healthcare system. Clinical parameters were derived from clinical trials. Costs (actualized by – 1.5 percent) were obtained from the National database and Regional public tender. Utility was expressed as QALY (Quality-Adjusted Life Years). RESULTS: Costs per treatment were different from a N and R perspective (ADA -55 percent; IFX -16.7 percent; IFX-B -29.6 percent; GOL -9.6 percent; VED -10 percent). Direct healthcare costs (treatment cost, visits, laboratory tests, hospital admissions) were calculated over 10 years of treatment per patient: ADA (N: EUR114,227, R: EUR68,314, -40.2 percent), IFX (N: EUR130,595, R: EUR103,081, -21 percent), IFX-B (N: EUR110,438, R: EUR78,852, -28.6 percent), GOL (N: EUR118,602, R: EUR96,922, -18.3 percent), VED (N: EUR113,852, R: EUR102,932, -9.6 percent) with associated QALY respectively of 6.68, 6.66, 6.66, 6.70, 7.02. From a N perspective, IFX-B was dominating compared to all other treatments. The ICUR of VED/IFX-B was EUR9,483 for 10 years (willingness to pay EUR948/QALY). From a R perspective, ADA was dominating compared to all other treatments. The ICUR of VED/ADA was EUR101,818 for 10 years (Willingness to Pay, WTP EUR10,182/QALY). CONCLUSIONS: National and Regional cost-utility analyses produced different results. As Regional price discounts can occur, local analysis is needed to estimate the economic impact of therapies to ensure optimal choice.