Cost-Effectiveness Analysis of Crohn’s Disease Treatment with Vedolizumab and Ustekinumab After Failure of Tumor Necrosis Factor-α Antagonist

Abstract

ObjectiveThe aim was to evaluate the cost-effectiveness of Crohn’s disease (CD) treatment with vedolizumab and ustekinumab after failure of therapy with tumor necrosis factor-α antagonists (anti-TNFs).MethodsThe Markov model incorporated the lifetime horizon, synthesis-based estimates of biologics’ efficacy in relation to anti-TNF exposure, and administration of biologics reflecting clinical practice (e.g., sequence of biologics, retreatment, 12-month treatment). The utilities, non-medical costs and indirect costs were derived from a study of 200 adult patients with CD, while the healthcare costs were from a study of 1393 adults with CD who used biologics in Poland. The quality-adjusted life years (QALYs) and costs (the societal perspective) were discounted with the annual rates of 3.5 and 5%, respectively.ResultsThe addition of vedolizumab (ustekinumab) to the sequence of available anti-TNFs (after first-line infliximab or after second-line adalimumab) led to a gain of 0.364 (0.349) QALYs at an additional cost of €5600.24 (€6593.82). The incremental cost-effectiveness ratios (ICERs) were €15,369 [95% confidence interval (CI) 7496–61,354] and €18,878 (95% CI 9213–85,045) per QALY gained with vedolizumab and ustekinumab, respectively. Sensitivity analyses revealed a high impact on the ICERs of the relapse rate after discontinuation of biologic treatment. The highest value of vedolizumab/ustekinumab was estimated after the failure of therapies with both anti-TNFs.ConclusionsCD treatment with ustekinumab or vedolizumab after failure of anti-TNF therapy appears to be cost-effective at a threshold of €31,500. The replacement of the second-line anti-TNF with ustekinumab/vedolizumab and the course of the disease after discontinuation of biologics are influential drivers of the cost-effectiveness.Electronic supplementary materialThe online version of this article (10.1007/s40273-018-0653-2) contains supplementary material, which is available to authorized users.

Ustekinumab for the treatment of paradoxical skin reactions and cutaneous manifestations of inflammatory bowel diseases

“…The major limiting factor to ustekinumab use is cost, although a recent study has shown that its use after failure of anti‐TNF therapy is cost‐effective at a threshold of €31 500 ($35 743), leading to a gain of 0.349 quality‐adjusted life years (QALYs) at an additional cost of €6593.82 ($7481) 28 . By this evaluation, the use of ustekinumab for the majority of patients in this review, who had failed several anti‐TNF medications for treatment of their IBD‐associated cutaneous disease, was cost‐effective.…”

Cost-effectiveness of ustekinumab in moderate to severe Crohn’s disease in Sweden

“…Another analysis of ustekinumab’s cost-effectiveness versus vedolizumab as a third line agent after failure with two TNF-alpha inhibitors found that vedolizumab had higher costs of $168,648 as well as a larger QALY gain of 0.029, resulting in an ICER of $5,815,448 [ 69 ]. A polish study found treatment with ustekinumab after failing one TNF-antagonist associated to a QALY gain of 0.349 and an ICER of €18,878 compared to adalimumab after infliximab failure [ 28 ]. The variations in outcomes of cost-effectiveness analyses of biologics in CD emphasise the importance of further research in the field, and a need for a greater consensus over model design and assumptions.…”

“…Additionally, properly modelling treatment sequences would require currently unavailable efficacy data, or ill-founded assumptions. Although the model allows for maintenance transitions from the moderate to severe health state, the structure does not capture increased relapse risk after discontinuing biologics [ 28 , 72 , 73 ], and—as previously discussed—does not consider the impact of surgery on future surgeries.…”

“…Previous cost-effectiveness studies of ustekinumab in Crohn’s have been undertaken in British [ 27 ] and Polish [ 28 ] settings. Considering that cost-effectiveness analyses are highly contingent on local specifics such as cost and utility data, incidence and prevalence, as well as the health care system and clinical practice, the previous ustekinumab analyses are insufficient to draw conclusions for a Swedish context.…”

Treatment patterns and intensification within 5 year of follow-up of the first-line anti-TNFα used for the treatment of IBD: Results from the VERNE study

“…A meta-analysis has shown that, after the failure of an anti-TNF α, the probability of remission using a second anti-TNF α substantially decreases, and the efficacy of the second anti-TNF α clearly depends on the reason for switching treatment, with the highest remission rates for patients with drug intolerance (61%) and the lowest for patients with PNR (30%) or LOR (45%) [47] . Therefore, a sensible approach after the failure of the first anti-TNF α could be to switch to another biologic with a different mode of action [48] , especially in IBD patients with PNR or LOR [49 , 50] . Nevertheless, therapeutic drug level monitoring, when available, may be useful in guiding decisions related to the type of biologic to use after the failure of the first anti-TNF α.…”