Background Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor (TKI) with efficacy in patients with ALK-rearranged non-small-cell lung cancer (NSCLC) previously treated with a second-generation ALK inhibitor or with first-and second-generation ALK inhibitors. We examined the cost-effectiveness of second-or third-line+ (2L+ or 3L+) lorlatinib in Sweden, versus chemotherapy. Methods A partitioned survival model with three health states (progression free, progressed, or death) was used. Lorlatinib relative efficacy versus chemotherapy was derived using unanchored matching adjusted indirect treatment comparisons from a phase 2 clinical trial. Utility data were derived from the same trial and published studies. Costs (year 2019) were obtained from Swedish national data. Costs and benefits were discounted at 3% per annum using a societal perspective (base case). Model robustness was evaluated with deterministic and probabilistic sensitivity analyses. Results For 2L+, the average discounted total quality-adjusted life year (QALY) gain was 1.29 years. Total incremental costs were Swedish krona (SEK) 731,791, resulting in an incremental cost-effectiveness ratio (ICER) of SEK 566,278 per QALY gained. Non-discounted survival gain amounted to 1.94 years. For 3L+, the average discounted total QALY gain was 1.25 years. Total incremental costs were SEK 754,801, resulting in an ICER of SEK 603,934 per QALY gained. Nondiscounted survival gain was 1.88 years. Sensitivity analyses were consistent. Conclusions ICERs ranged from SEK 421,000 to SEK 384,066 less than the boundary for a cost-effective treatment for a high-severity disease in Sweden (SEK 988,000), suggesting 2L+ or 3L+ lorlatinib is a cost-effective treatment for ALKpositive NSCLC versus chemotherapy.
OBJECTIVES:To evaluate whether infliximab, a modern off-label biologic, is costeffective for treating sarcoid posterior uveitis compared to methotrexate and systemtic steroids. Sarcoid posterior uveitis is a progressive eye disease that can lead to blindness if untreated. Ophthalmologists have utilized infliximab, a TNF-alpha inhibitor, which reverses effects of uveitis. METHODS: A semi-Markov model followed patients' therapy from the onset of sarcoid posterior uveitis using the societal perspective. The lifetime model simulated health states that could lead to successful reversal of uveitis with standard or intensified treatment with systemic steroids, methotrexate, or infliximab. Probabilities, health utilities, and costs were included in the model based on findings from literature. Costs and effects were discounted at 3% ($US; 2010 values). We conducted univariate sensitivity analyses, threshold analyses, and a Bayesian multivariate probablistic sensitivity analysis using 10,000 Monte Carlo simulations. Results were interpretted from a predetermined willingness-to-pay of $50,000/QALY. RESULTS: In order of cost, base case results showed systemic steroids most affordable ($26,871; 14.58 QALYs), followed by methotrexate ($40,351; 15.92 QALYs), and then infliximab ($46,547; 15.04 QALYs). Methotrexate was cost-effective compared to steroids, with an incremental cost-effectiveness ratio of $10,053/QALY. Methotrexate dominated infliximab. Univariate sensitivity analyses suggested that the model was sensitive to the utility of a patient's successful recovery from uveitis (0.84 QALYs). If patients' health utility after successful recovery is below 0.750, then infliximab has a greater net benefit than methotrexate. The multivariate probabilistic sensitivity analysis showed that methotrexate dominated infliximab in 60% of the simulations. CONCLUSIONS: This cost-effectiveness analysis suggests that despite major advances in the use of biologics for treating sight-threatening sarcoid posterior uveitis, methotrexate remains a less expensive and more cost-effective strategy. Methotrexate should be adopted as the standard of care for treatment considering its incremental cost-effectiveness at a reasonable willingness-to-pay. Other therapeutic options, such as infliximab, may be considered for certain cases.OBJECTIVES: Cost-effectiveness models in age-related macular degeneration use the utilities based on the better-seeing eye, because this mainly influence quality of life. Most models use the utility as if we only treat better-seeing eyes, although in trials the majority of the treated eyes are the poorer-seeing eyes. This discrepancy results in overestimating the QALY. Therefore a correction should be applied. The objective of this study is to estimate the influence on the (incremental) cost-effec-A506
Objectives: Upon disease progression or early termination of a trial, cancer patients in the control arm of clinical studies commonly switch to the experimental drug or receive other post-study treatments. The objective of this study was to assess the willingness of HTA agencies to accept the statistical methods that are available to adjust overall survival (OS) estimates for resulting bias. MethOds: PubMed and the ADIS R&D Insights database were searched to identify pivotal trials involving treatment switching. Related HTA appraisals, published between January 2011 and February 2014, were then selected from the HTA agencies websites for further analysis. Reports from 10 agencies were considered for review. Results: Sixteen pivotal trials and 45 related HTA appraisals were selected for in-depth analysis. It was widely acknowledged by all HTA agencies that treatment switching could confound the OS estimates when an inferior drug is used as a comparator. Our analysis suggests that statistical adjustment methods are discussed more often and more thoroughly by agencies that base their decisions on cost-effectiveness outcomes. On one end, NICE accepts and reviews the selection and implementation of such methods in detail, and has recently developed its own guidelines on the appropriate handling of treatment switching. Various examples have been identified and accepted in SMC and PBAC submissions. TLV, ZiNL, pCODR and INESSS have accepted statistical adjustments in at least one case. No evidence of such adjustments was identified in the selected HAS reports. On the other end, recent case examples among IQWiG submissions suggest that they do not accept the use of these methods. cOnclusiOns: The rationale to adjust for treatment switching and the methods used need to be justified towards agencies accepting the correction techniques. Other payers will rather want to base their decision on results of the last "unbiased" dataset. research oN methoDs -prefereNce stuDIes pr1 survIval or mortalIty: framINg of the rIsk attrIbute IN a DIscrete choIce experImeNtObjectives: To empirically test whether and how framing of a risk attribute in a Discrete Choice Experiment (DCE) affects study results with respect to the relative importance of the attributes, trading behavior and potential uptake rates. MethOds: By means of ongoing data collection, two versions of a DCEquestionnaire containing nine D-efficiently designed choice tasks were distributed among a representative sample of the Dutch population aged 55-65years. The DCE consisted of four attributes related to the decision whether to participate in genetic screening for colorectal cancer (CRC). Three fixed attributes were; risk of being genetically predisposed, risk of developing CRC, and frequency of follow-up colonoscopies. The included risk attribute was framed positively as survival rate and negatively as mortality rate. Mixed logit models were conducted to estimate the relative importance of the attributes. Dominant decision behavior was determined and potential uptake rates...
To evaluate whether infliximab, a modern off-label biologic, is costeffective for treating sarcoid posterior uveitis compared to methotrexate and systemtic steroids. Sarcoid posterior uveitis is a progressive eye disease that can lead to blindness if untreated. Ophthalmologists have utilized infliximab, a TNF-alpha inhibitor, which reverses effects of uveitis. METHODS: A semi-Markov model followed patients' therapy from the onset of sarcoid posterior uveitis using the societal perspective. The lifetime model simulated health states that could lead to successful reversal of uveitis with standard or intensified treatment with systemic steroids, methotrexate, or infliximab. Probabilities, health utilities, and costs were included in the model based on findings from literature. Costs and effects were discounted at 3% ($US; 2010 values). We conducted univariate sensitivity analyses, threshold analyses, and a Bayesian multivariate probablistic sensitivity analysis using 10,000 Monte Carlo simulations. Results were interpretted from a predetermined willingness-to-pay of $50,000/QALY. RESULTS: In order of cost, base case results showed systemic steroids most affordable ($26,871; 14.58 QALYs), followed by methotrexate ($40,351; 15.92 QALYs), and then infliximab ($46,547; 15.04 QALYs). Methotrexate was cost-effective compared to steroids, with an incremental cost-effectiveness ratio of $10,053/QALY. Methotrexate dominated infliximab. Univariate sensitivity analyses suggested that the model was sensitive to the utility of a patient's successful recovery from uveitis (0.84 QALYs). If patients' health utility after successful recovery is below 0.750, then infliximab has a greater net benefit than methotrexate. The multivariate probabilistic sensitivity analysis showed that methotrexate dominated infliximab in 60% of the simulations. CONCLUSIONS: This cost-effectiveness analysis suggests that despite major advances in the use of biologics for treating sight-threatening sarcoid posterior uveitis, methotrexate remains a less expensive and more cost-effective strategy. Methotrexate should be adopted as the standard of care for treatment considering its incremental cost-effectiveness at a reasonable willingness-to-pay. Other therapeutic options, such as infliximab, may be considered for certain cases.
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