scholarly journals Funding the New Biologics – A Health Economic Critique of the CCOHTA Report: Infliximab for the Treatment of Crohn’s Disease

2002 ◽  
Vol 16 (12) ◽  
pp. 873-876 ◽  
Author(s):  
Craig R Mitton
Keyword(s):  
Health Care ◽  
Crohn’S Disease ◽  
Cost Effectiveness ◽  
Crohn's Disease ◽  
Balance Sheet ◽  
Cost Utility ◽  
Infliximab Therapy ◽  
Health States ◽  
Life Years ◽  
Number Of Patients

The report of the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) on the use of infliximab in the treatment of refractory Crohn’s disease stated that the medication did not meet ‘conventional standards of cost-effectiveness’. It had several methodological weaknesses, however, including the derivation of the quality-adjusted life-years (QALYs) gained and the interpretation of the incremental cost utility ratios (ICURs). The validity of economic analyses is highly dependent on the underlying assumptions that are made about the implications of health care states and treatments. The authors of the report mapped utilities from three health states, taken from an American study, onto the nine health states that were considered in their economic analysis. The QALYs that were derived might not have been sensitive to small changes in health outcomes. Moreover, the indirect costs of Crohn’s disease and its complications were ignored. Therefore, it is possible that the benefits of infliximab therapy were underestimated. The high ICURs that were quoted in the report do not necessarily mean that infliximab is not valuable, because opportunity costs were not considered. Instead of calculating the ICUR, a preferable approach would be to determine the benefit of this therapy, compared with that which could be derived from alternative uses of the same amount of health care resources. A ‘balance sheet’ approach would allow decision-makers to determine whether the additional cost of infliximab therapy would be justified by the health care gains that it produces. It is inappropriate to assign an arbitrary cut-off point to cost effectiveness, as defined by ICURs, especially when considering new and expensive treatments for severely ill patients who have few other therapeutic alternatives. Because only a small number of patients would require infliximab, the overall expenditure that would be required to make it available may be manageable.

Management for severe Crohn's disease: A lifetime cost-utility analysis

2004 ◽  
Vol 20 (3) ◽  
pp. 274-279 ◽  
Author(s):  
Isabelle Jaisson-Hot ◽  
Bernard Flourié ◽  
Louis Descos ◽  
Cyrille Colin
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Maintenance Therapy ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Infliximab Therapy ◽  
Health State ◽  
Utility Analysis ◽  
Life Years ◽  
Markov Decision Model

Objectives:Infliximab is a costly therapy for active Crohn's disease resistant to corticosteroids and immunosuppressive medication. The purpose of this study was to examine whether a treatment including infliximab (episodic re-infusions for relapse or maintenance therapy every 8 weeks) was relevant compared with conventional management (surgery and medical treatment without infliximab) for nonfistulizing resistant Crohn's disease.Methods:We performed a life-time cost-utility analysis with an analytic Markov decision model from the perspective of the third-party payer system. Utility measurement using Standard Gamble was used to adjust the survival time for each health state of the disease. Direct costs were estimated from standard management based on expert opinion. A sensitivity analysis was conducted to gauge the effects of uncertainty in the values assigned to variables.Results:The incremental effectiveness with infliximab therapy is .761 Quality-Adjusted Life Years (QALYs) for an added cost ranging from 48,478.79 euros to 596,990.35 euros, depending on treatment procedure. The incremental cost utility ratio expressed in euros per QALYs saved varied from 63,700.82 euros (episodic re-infusions) to over 762,245.09 euros (maintenance therapy).Conclusions:Infliximab therapy could be cost-effective in the case of relapse treatment only, whereas the marginal cost-utility ratio exceeds conventional benchmarks for maintenance therapy. This analysis will be supplemented by conducting further randomized controlled trials and prospective observational study, focused on the costs of illness (direct and indirect), patient preferences, the disease's clinical course, and infliximab safety.

scholarly journals Funding the New Biologics – CCOHTA Report on the Cost Effectiveness of Infliximab for Crohn’s Disease: Pearls and Pitfalls

2002 ◽  
Vol 16 (12) ◽  
pp. 877-879 ◽  
Author(s):  
John K Marshall
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Economic Analysis ◽  
Safety Data ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
State Transitions ◽  
Health State ◽  
Life Years ◽  
The Cost

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) published an economic analysis, using a Markov model, of infliximab therapy for Crohn’s disease that is refractory to other treatments. This was the first fully published economic analysis that addresses this treatment option. Health state transitions were based on data from Olmsted County, Minnesota, health state resource profiles were created using expert opinion and a number of assumptions were made when designing the model. The analysis was rigorous, the best available efficacy and safety data were used, state-of-the art sensitivity analyses were undertaken and an ‘acceptability curve‘ was constructed. The model found that infliximab was effective in increasing quality-adjusted life years when offered in a variety of protocols, but it was associated with high incremental cost utility ratios compared with usual care. The results should be interpreted, however, in view of a number of limitations. The time horizon for the analysis was short (one year), because of a lack of longer-term efficacy data, and might have led to an underestimation of the benefits from averting surgery. Because the analysis was performed from the perspective of a Canadian provincial ministry of health, only direct medical costs were considered. Patients with active Crohn’s disease are likely to incur significant indirect costs, which could be mitigated by this medication. The analysis should be updated as new data become available. Moreover, small changes in the cost of the medication could make the treatment cost effective, according to this model. Economic analyses, such as the one undertaken by the CCOHTA, cannot by themselves solve dilemmas in the allocation of limited health care resources, and other considerations must be included when formulating policy. This is especially important for patients with severe Crohn’s disease, who have significant disability and for whom few therapeutic options exist.

scholarly journals Prevalence of Fistulizing Crohn’s Disease in the United States: Estimate From a Systematic Literature Review Attempt and Population-Based Database Analysis

2019 ◽  
Vol 25 (11) ◽  
pp. 1773-1779 ◽  
Author(s):  
David A Schwartz ◽  
Ignacio Tagarro ◽  
Mary Carmen Díez ◽  
William J Sandborn
Keyword(s):  
United States ◽  
Health Care ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Literature Review ◽  
Systematic Literature Review ◽  
The United States ◽  
Population Based ◽  
Number Of Patients ◽  
Reported Data

Abstract Background Fistulas may arise as a relevant complication of Crohn’s disease (CD). Despite their clinical significance and the substantial burden imposed on patients, limited data are available on the epidemiology of fistulizing CD in the United States. Methods A systematic literature review was conducted to identify data published between 1970 and 2017 on the epidemiology of fistulas in patients with CD, with the aim to estimate the number of prevalent cases in the United States. Retrieved titles and abstracts were screened by 2 independent researchers for inclusion criteria (US population-based studies reporting data on the epidemiology of fistulizing CD). To validate the literature-based estimate, data from a US claims database (Truven Health MarketScan database) were analyzed. This database has broad geographic coverage, with health care data for >60 million patients during the period of the analysis. Results The literature search retrieved 7 articles for full-text review, and only 1 met the criteria for inclusion. This study described the cumulative incidence of fistulas in a CD population from Minnesota over 20 years. From the reported data, the estimated number of prevalent cases with fistulizing CD in the United States was ~76,600 in 2017 (~52,900 anal, ~7400 rectovaginal, ~2300 enterocutaneous, and ~14,100 internal). Analysis from the US health care database resulted in an estimated number of ~75,700 patients, confirming the robustness of the original estimate from the literature. Conclusions Based on 2 separate analyses, the estimated number of patients with fistulizing CD in the United States is ~77,000 patients.

scholarly journals Economic Evaluation of Daratumumab and Pomalidomide and Dexamethasone Versus Isatuximab and Pomalidomide and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 19-20
Author(s):  
Neda Alrawashdh ◽  
Abdulaali Almutairi ◽  
Ali McBride ◽  
Ivo Abraham
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Cost Effectiveness ◽  
Time Horizon ◽  
Cost Utility ◽  
Phase Iii ◽  
Health States ◽  
Time Horizons ◽  
Life Years ◽  
The Cost

Background. Although several new treatments are available for patients with multiple myeloma (MM), most patients eventually relapse at a median time of 8.0 months (95%CI: 6.3-8.9). Patients with relapsed and refractory MM (R/R MM) who have had several lines of previous therapy or who are refractory to lenalidomide and proteasome inhibitors require alternative options. Daratumumab and isatuximab are monoclonal antibodies that bind to the human CD38 receptor. Phase II/III clinical trials showed that isatuximab (ISA) or daratumumab (DARA) in combination with pomalidomide (POM-d) and low-dose dexamethasone (DEXA) significantly improve progression-free survival (PFS) in patients with R/R MM. No studies have assessed the comparative efficacy and cost-effectiveness of both regimens in management of R/R MM. We performed an indirect comparison of both regimens in terms of PFS and overall survival (OS) and evaluated the cost-effectiveness and cost-utility of DARA+POM-d+DEXA and ISA+POM-d+DEXA from a US payer's perspective. Methods. A partitioned survival model was developed to create three health states (pre-progression, progression, and death). The model was run three times with different time horizons (one, three and five years). To simulate health outcomes for each treatment regimen, transition probabilities between the three health states were derived from parametric exponential and lognormal distributions fitted to Kaplan-Meier (KM) curves of PFS and OS of the phase Ib clinical trial (Chari et al.; Blood 2017) for DARA+POM-d+DEXA and the phase III clinical trial (Attal et al.; Lancet 2019) for ISA+POM-d+DEXA. Wholesale acquisition costs (WAC) were obtained from RedBook for each regimen. Pre-progression costs included costs of regimens; premedication (50 mg diphenhydramine, 650 mg acetaminophen, 50 mg ranitidine); managing side effects; routine care and monitoring; and medication administration. Costs were inflated based on the medical consumer price index to the second quarter of 2020. Utilities were obtained from literature and assumed the same for both interventions. Annual discount rate of 3.5% was applied for costs and outcomes beyond the first year. The life years (LY) and quality adjusted LY (QALY) for each treatment, and the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) were estimated in both base and probabilistic sensitivity analyses (PSA:10,000 simulations). The cost-effectiveness plane (CEP) and cost-effectiveness acceptability curves (CEAC) were plotted. Results. In the naïve patient simulation, median PFS and OS were estimated to be 9.5 months and 18 months for DARA+POM-d+DEXA, and 14.5 months and 26 months for ISA+POM-d +DEXA. As shown in the table below, ISA+POM-d+DEXA is associated with greater LY and QALY gains at one-, three- and five-year time horizons. The costs of ISA+POM-d+DEXA at one- and three- year time horizons are less than that of DARA+POM-d+DEXA, which resulted in saving (decremental) ICERs. At 5 years' time horizon, ISA+POM-d+DEXA was associated with incremental benefits (0.57 LY, 0.35 QALY) and incremental costs of $88,271 when compared with DARA+POM-d+DEXA. Per the CEAC plot, the probability that ISA+POM-d+DEXA is cost-effective was 100%, 65% and 23% at a willingness to pay threshold (WTP) of $100,000 per QALY in one-, three- and five-year time horizons. Conclusions. Clinically, ISA+POM-d+DEXA is associated with incremental survival gains of ~1 month and quality-adjusted survival gains of 0.5 month than DARA+POM-d+DEXA when patients are treated for one year. The benefits increase with treatment duration to reach ~7 months life year gains and 4 months quality-adjusted life year gains if patients treated for 5 years. Due to its lower total costs, Isatuximab based-regimen yielded saving ICERs at one and three years. However, ISA+POM-d+DEXA cost exceeded DARA+POM-d+DEXA at 5 years' time horizon to yield an ICER above the WTP. Disclosures McBride: Merck: Speakers Bureau; Pfizer: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Bristol-Myers Squibb: Consultancy; Coherus BioSciences: Consultancy, Speakers Bureau. Abraham:Celgene: Consultancy; Terumo: Consultancy; Rockwell Medical: Consultancy; Janssen: Consultancy; Mylan: Consultancy; Sandoz: Consultancy; Coherus BioSciences: Research Funding, Speakers Bureau; MorphoSys: Consultancy.

Cost-Effectiveness of Adding Imatinib to Chemotherapy in Adult Patients with Chromosom-Positive Acute Lymphoblastic Leukemia (Ph+ALL): A Canadian Perspective

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2401-2401 ◽  
Author(s):  
Khalid El Ouagari ◽  
Kimbach Tran ◽  
Jennifer Stephens ◽  
Marc Botteman
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
High Risk ◽  
Disease Progression ◽  
Lymphoblastic Leukemia ◽  
Treatment Options ◽  
Disease Free Survival ◽  
Model Framework ◽  
Health States ◽  
Life Years

Abstract BACKGROUND: Ph+ALL is a rare, high-risk, aggressive form of acute leukemia, affecting primarily adults and the elderly. Patients with high-risk forms of ALL typically have extremely poor prognosis and incur high disease-related costs. Successful use of imatinib in patients with Ph+CML has led to the administration of imatinib in recent clinical studies for patients with Ph+ALL. Given the changing treatment landscape of Ph+ALL and the recent development of additional targeted treatments for this disease, an appraisal of the economic burden associated with Ph+ALL is warranted for evaluation of appropriate treatment options and the potential value associated with novel therapies. This study explores the cost effectiveness of imatinib plus conventional chemotherapy (CC) regimens versus CC alone in adult Ph+ALL patients. METHODS: A Markov model simulated a hypothetical cohort of 1000 adult Ph+ALL patients receiving imatinib+CC or CC alone. Patients were distributed over time into three health states: alive without disease progression (DFS), alive with disease progression (DS), or dead. Probabilities of being in the states were derived from the published literature. In the absence of relevant data pertaining to Ph+ALL, assumptions about costs and utilities were derived from a cost analysis of CML. A Canadian health care payer perspective was considered, therefore only direct medical costs were included in the analysis. Patients were followed for a total of ten years in monthly intervals. All outcomes were discounted at a 5% rate per annum. RESULTS: Based on the model framework and assumptions, the total discounted survival was 1.09 years for CC and 4.13 years for imatinib+CC. Total discounted disease free survival was 0.76 year for CC and 2.69 years for imatinib+CC. Assuming utility weights of 0.854 and 0.596 for DFS and DS, respectively, the total discounted quality adjusted life years (QALY) were estimated to be 0.84 versus 3.16 for CC and imatinib+CC, respectively. Thus, the net incremental gain in discounted quality adjusted survival was 2.32 QALYs. The monthly costs of DFS and DS were estimated at $168 and $848, respectively. The net costs associated with imatinib were $101,929. The incremental cost per QALY of imatinib+CC v. CC alone was approximately $44,048 (i.e., $101,929 divided by 2.32 QALYs). CONCLUSIONS: Our results suggest that imatinib in the treatment of Ph+ALL is a cost-effective use of health-care resources, and should be considered in patients who are appropriate candidates for such therapy.

Cost effectiveness of carfilzomib (CAR), ixazomib (IXA), elotuzumab (ELO), or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) vs LEN+DEX in relapsed/refractory multiple myeloma (R/R MM).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8030-8030 ◽  
Author(s):  
Nimer Alsaid ◽  
Ali McBride ◽  
Amit Balkrishna Agarwal ◽  
Abdulaali Mutairi ◽  
Faiz Anwer ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Meta Analysis ◽  
Indirect Comparison ◽  
Progression Free Survival ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Health States ◽  
Chemotherapy Administration ◽  
Life Years

8030 Background: CAR, IXA, ELO, and DAR in triplet combination with LEN+DEX have shown superior efficacy over LEN+DEX in R/R MM, but their comparative efficacy and cost effectiveness has not been estimated. Methods: Network meta-analysis [NMA] and Bücher method were used to indirectly estimate comparative progression-free survival (PFS) efficacy. A 2-state Markov model (progression-free, progressed or death) was specified. Inputs included: cost of chemotherapy, administration, adverse events (AE) management, disease monitoring; utilities for health states; and disutilities for AEs. Incremental cost effectiveness (ICER) and cost utility ratios (ICUR) were calculated for resp. PFS life years (PFS LY) and quality adjusted life years (PFS QALY) gained in base case and probabilistic sensitivity analyses (PSA). Results: NMA and Bücher indirect comparison methods yielded similar PFS hazard ratios (HR), revealing superiority of DAR+LEN+DEX over other triplets in terms of PFS (Table). Using the exponential distribution to fit PFS data, our cost effectiveness analysis indicated that all 4 triplet regimens were associated with additional PFS LY and QALY gained over LEN+DEX at additional cost. DAR+LEN+DEX was associated with the greatest PFS LY and QALY gained at the lowest relative cost, yielding superior ICER and ICUR estimates compared to other triplet regimens. Conclusions: The superior PFS efficacy of DAR+LEN+DEX is associated with positive cost effectiveness and cost utility in the setting of R/R MM. [Table: see text]

scholarly journals Cost effectiveness of nusinersen for patients with infantile-onset spinal muscular atrophy in US

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Praveen Thokala ◽  
Matt Stevenson ◽  
Varun M. Kumar ◽  
Shijie Ren ◽  
Alexandra G. Ellis ◽  
...  
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Motor Function ◽  
Muscular Atrophy ◽  
Sensitivity Analyses ◽  
Short Term ◽  
Health States ◽  
Life Years ◽  
Term Data

Abstract Background Patients with infantile-onset spinal muscular atrophy (SMA), a rare, genetic neuromuscular disease, do not achieve key motor function milestones (e.g., sitting) and have short life expectancy in the absence of treatment. Nusinersen is a disease-modifying therapy for patients with SMA. Objective The aim of this study was to estimate the cost-effectiveness of nusinersen compared to best supportive care (BSC) in patients diagnosed with infantile-onset SMA in the US. Methods A de novo economic model was developed with the following health states: “permanent ventilation”, “not sitting”, “sitting”, “walking”, and “death”. Short-term data were sourced from the pivotal clinical trials and studies of nusinersen (ENDEAR and SHINE). Motor function milestones achieved at the end of follow-up in the clinical trials were assumed to be sustained until death. Mortality risks were based on survival modelling of relevant published Kaplan–Meier data. Costs, life years (LYs), and quality-adjusted life years (QALYs) were discounted at 3% per annum, and the analyses were performed from a US health care sector perspective. Scenario analyses and sensitivity analyses were conducted to assess the robustness of the results to key parameters. Results In our base-case analysis, nusinersen treatment achieves greater QALYs and more LYs (3.24 and 7.64, respectively) compared with BSC (0.46 QALYs and 2.40 LYs, respectively), resulting in an incremental cost per QALY gained of approximately $1,112,000 and an incremental cost per LY gained of $590,000 for nusinersen compared to BSC. The incremental cost effectiveness ratios did not fall below $990,000 per QALY gained in scenario and sensitivity analyses. Results were most sensitive to the length of survival, background health care costs, and utility in the “not sitting” and “sitting” health states. Conclusions The estimated incremental cost-effectiveness of nusinersen from a US health care sector perspective exceeded traditional cost-effectiveness thresholds. Cost-effectiveness was dependent on assumptions made regarding survival, costs, utilities, and whether the motor function milestones were sustained over lifetime. Given the relatively short-term effectiveness data available for the treatment, a registry to collect long-term data of infantile-onset SMA patients is recommended.

scholarly journals The Cost-effectiveness of Initial Immunomodulators or Infliximab Using Modern Optimization Strategies for Crohn’s Disease in the Biosimilar Era

2019 ◽  
Author(s):  
Abhinav Vasudevan ◽  
Francis Ip ◽  
Danny Liew ◽  
Daniel R Van Langenberg
Keyword(s):  
Crohn’S Disease ◽  
Cost Effectiveness ◽  
Crohn's Disease ◽  
Combination Therapy ◽  
Cost Effective ◽  
Extended Model ◽  
Life Years ◽  
Cost Effective Treatment ◽  
Therapy Costs ◽  
The Cost

Abstract Background Treatment cost, efficacy, and safety are integral considerations when optimizing management of Crohn’s disease (CD). This study assessed the cost-effectiveness of initial immunomodulator and anti–tumor necrosis factor (anti-TNF) agents for the treatment of CD from a US third-party perspective, incorporating current treatment algorithms, optimization strategies, and reduced costs availed by biosimilars. Method A 1-year Markov model was developed to simulate the cost and quality-adjusted life-years (QALYs) of initial azathioprine, infliximab, and combination therapy for moderate to severe CD. Treatment was changed based on tolerability and clinical disease activity at 3-monthly intervals. Efficacy data were based on published literature. Results Initial azathioprine had the lowest cost and utility ($35,337 and 0.63 QALYs), whereas combination therapy was the costliest yet conferred the highest health benefits ($57,638 and 0.67 QALYs). The incremental cost-effectiveness of infliximab and combination therapy compared with azathioprine were both in excess of $500,000 per QALY gained. Initial azathioprine remained the most cost-effective treatment on sensitivity analysis compared with infliximab and combination therapy, with 90% reductions in anti-TNF therapy costs and a 5-year time horizon, although combination therapy had an acceptable cost-effectiveness when costs were reduced in the extended model. Initial infliximab, ustekinumab, and vedolizumab were dominated by combination therapy. Conclusions In the biosimilar era, initial azathioprine with escalation to infliximab appeared more cost-effective in the short term compared with infliximab or combination therapy, although initial combination therapy yields acceptable ICERs in the long term with continued reductions in anti-TNF therapy costs and will likely be the preferred treatment strategy in the future.

scholarly journals Cost-effectiveness and Clinical Outcomes of Early Anti–Tumor Necrosis Factor–α Intervention in Pediatric Crohn’s Disease

2019 ◽  
Vol 26 (8) ◽  
pp. 1239-1250
Author(s):  
Naazish S Bashir ◽  
Thomas D Walters ◽  
Anne M Griffiths ◽  
Shinya Ito ◽  
Wendy J Ungar
Keyword(s):  
Health Care ◽  
Crohn’S Disease ◽  
Cost Effectiveness ◽  
Crohn's Disease ◽  
Incremental Cost ◽  
Standard Care ◽  
Public Health Care ◽  
Tnf Α ◽  
Factor Α ◽  
Necrosis Factor

Abstract Background Anti–tumor necrosis factor–α (anti-TNF-α) treatments are increasingly used to treat pediatric Crohn’s disease, even without a prior trial of immunomodulators, but the cost-effectiveness of such treatment algorithms has not been formally examined. Drug plan decision-makers require evidence of cost-effectiveness to inform funding decisions. The objective was to assess the incremental cost-effectiveness of early intervention with anti-TNF-α treatment vs a conventional step-up strategy per steroid-free remission-week gained from public health care and societal payer perspectives over 3 years. Methods A probabilistic microsimulation model was constructed for children with newly diagnosed moderate to severe Crohn’s disease receiving anti-TNF-α treatment and concomitant treatments within the first 3 months of diagnosis compared with children receiving standard care consisting of steroids and/or immunomodulators with the possibility of anti-TNF-α treatment after 3 months of diagnosis. A North American multicenter observational study with 360 patients provided input into clinical outcomes and health care resource use. Results Early intervention with anti-TNF-α treatment was more costly, with an incremental cost of CAD$31,112 (95% confidence interval [CI], $2939–$91,715), and more effective, with 11.3 more weeks in steroid-free remission (95% CI, 10.6–11.6) compared with standard care, resulting in an incremental cost per steroid-free remission-week gained of CAD$2756 from an Ontario public health care perspective and CAD$2968 from a societal perspective. The incremental cost-effectiveness ratio was sensitive to the price of infliximab. Conclusions The results suggest that although early anti-TNF-α was not cost-effective, it was clinically beneficial. These findings, along with other randomized controlled trial evidence, may inform formulary decision-making.

Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn’s disease: the LIR!C Trial

Gut ◽  
2019 ◽  
Vol 68 (10) ◽  
pp. 1774-1780 ◽  
Author(s):  
E Joline de Groof ◽  
Toer W Stevens ◽  
Emma J Eshuis ◽  
Tjibbe J Gardenbroek ◽  
Judith E Bosmans ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Cost Effectiveness ◽  
Crohn's Disease ◽  
Controlled Trial ◽  
Cost Effective ◽  
Mean Difference ◽  
Infliximab Treatment ◽  
Resection Group ◽  
Life Years ◽  
Cost Effective Treatment

ObjectiveEvaluate the cost-effectiveness of laparoscopic ileocaecal resection compared with infliximab in patients with ileocaecal Crohn’s disease failing conventional therapy.DesignA multicentre randomised controlled trial was performed in 29 centres in The Netherlands and the UK. Adult patients with Crohn’s disease of the terminal ileum who failed >3 months of conventional immunomodulators or steroids without signs of critical strictures were randomised to laparoscopic ileocaecal resection or infliximab. Outcome measures included quality-adjusted life-years (QALYs) based on the EuroQol (EQ) 5D-3L Questionnaire and the Inflammatory Bowel Disease Questionnaire (IBDQ). Costs were measured from a societal perspective. Analyses were performed according to the intention-to-treat principle. Missing cost and effect data were imputed using multiple imputation. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty.ResultsIn total, 143 patients were randomised. Mean Crohn’s disease total direct healthcare costs per patient at 1 year were lower in the resection group compared with the infliximab group (mean difference €−8931; 95% CI €−12 087 to €−5097). Total societal costs in the resection group were lower than in the infliximab group, however not statistically significant (mean difference €−5729, 95% CI €−10 606 to €172). The probability of resection being cost-effective compared with infliximab was 0.96 at a willingness to pay (WTP) of €0 per QALY gained and per point improvement in IBDQ Score. This probability increased to 0.98 at a WTP of €20 000/QALY gained and 0.99 at a WTP of €500/point of improvement in IBDQ Score.ConclusionLaparoscopic ileocaecal resection is a cost-effective treatment option compared with infliximab.Clinical trial registration numberDutch Trial Registry NTR1150; EudraCT number 2007-005042-20 (closed on 14 October 2015).

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