Economic evaluation of the TAX 324 trial comparing docetaxel plus cisplatin and 5-fluorouracil (TPF) versus standard treatment with cisplatin and 5-fluorouracil (PF) as induction chemotherapy followed by concurrent chemoradiation therapy in locally advanced squamous cell carcinoma of the head and neck (SCCHN)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6079-6079
Author(s):  
A. Parthan ◽  
M. R. Posner ◽  
C. Brammer ◽  
P. Beltran ◽  
J. Jansen

6079 Background: The TAX 324 phase III trial showed that induction chemotherapy with TPF followed by chemoradiotherapy improves survival and time to progression in patients with locally advanced SCCHN compared with PF [Posner MR, et al. ASCO 2006]. A Markov state-transition model was developed to estimate the cost-effectiveness of TPF. Methods: The Markov model includes four health states (based on WHO criteria for measuring objective response): stable, responsive, progressive disease, and death. TAX 324 efficacy data were used to derive transition probabilities between health states. Adverse event rates were also derived from TAX 324. Data for resource utilization and costs from a UK perspective were derived from the literature and clinician inputs from an advisory board. The global score of the Health Related Quality of Life Questionnaire Core-30 (QLQ-C30) was mapped to the EQ-5D in order to derive utilities and quality adjusted life years (QALYs). Results: A patient in the TPF arm survived longer versus PF (5.4 vs. 2.7 years). Comparison of TPF vs. PF resulted in an incremental gain of 2.7 life years and 2.1 QALYs. The incremental discounted costs/QALY gained for TPF vs. PF was £1,988/QALY, which is below the £20,000 cost-effectiveness threshold suggested by NICE as a guide to the acceptability of a technology. At this threshold, there is a 96.1% probability that TPF is cost-effective compared with PF. Conclusion: Docetaxel, when given as induction chemotherapy followed by concurrent chemoradiotherapy in combination with cisplatin and 5-fluorouracil (TPF), leads to a substantial increase in life expectancy, and is cost-effective compared with PF for locally advanced SCCHN. No significant financial relationships to disclose.

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6090-6090
Author(s):  
J. Jansen ◽  
J. B. Vermorken ◽  
D. Boote ◽  
F. Joulain ◽  
A. Parthan

6090 Background: The phase III EORTC 24971 clinical trial (TAX 323) showed that induction chemotherapy followed by radiation therapy increases time to progression and improves outcomes in unresectable SCCHN patients. [Remenar et al. ASCO 2006; Abs 5516] Induction chemotherapy with cisplatin/5-FU (PF) is a standard regimen for patients with locally advanced SCCHN. The economic impact of adding docetaxel to cisplatin/5-FU (TPF) in this setting was assessed using a Markov state-transition model. Methods: The Markov model includes four health states (based on WHO criteria for measuring objective response): stable, response, progression, and death. Efficacy data from the TAX 323 clinical trial were used to derive transition probabilities between the health states. Adverse event rates were also derived from TAX 323. Data for resource utilization and costs for the UK were derived from the literature and from an advisory board of clinicians. In order to calculate quality adjusted life years (QALYs), utilities were derived by mapping the global score on the Health Related Quality of Life Questionnaire Core-30 (QLQ-C30) to the EQ-5D. Results: Patients survived longer in the TPF arm versus PF (2.5 vs. 2.0 years). Total costs for TPF and PF were £31,203 and £26,944, respectively. The incremental discounted cost per QALY gained for TPF versus PF was £9,859/QALY, which is below the £20,000 cost-effectiveness threshold suggested by NICE as a guide to the acceptability of a technology. Conclusion: Docetaxel, when given as induction chemotherapy in combination with cisplatin/5-FU, is cost-effective compared with PF in locally advanced unresectable SCCHN patients. Treating SCCHN patients with TPF followed by radiation represents good value for money based on the results of the analysis. No significant financial relationships to disclose.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Kateir Mariel Contreras ◽  
Viviana Orozco Ortiz ◽  
Eduardo José Puche ◽  
Paola Karina Garcia ◽  
Camilo Alberto Gonzalez ◽  
...  

Abstract Background and Aims Azathioprine has been for decades the drug of choice for maintenance therapy in patients with generalized ANCA vasculitis in remission. However, recent studies show that rituximab, a high-cost biological agent, which can be administrated in two different schedules, might be more effective, so it is necessary to know the cost- effectiveness. Our goal was to compare the cost-effectiveness of the 3 maintenance schemes: standard therapy with azathioprine; fixed-dose rituximab and rituximab tailored according to CD19 lymphocyte level and ANCA titres, from the perspective of the Colombian healthcare system. Method We designed a 5-year annual cycle Markov model with the following stages: remission, minor relapse, mayor relapse and death. Transition probabilities were obtained from a systematic review of the literature (Scopus and Pubmed). Following national guidelines for economic studies, costs (in 2018, 1 euro = 3489 Colombian pesos) were estimated based on national drug registries, and official tariff manuals for procedures and other resources. Main outcome was quality-adjusted life years (QALY), using lupus nephropathy as a proxy; values were obtained from Tufts CEA Registry and validated by local expert panel through a modified Delphi technique. Cost-effectiveness threshold was three-times per capita GDP (16.872 euros). Discount rate was 5%. Univariate and probabilistic sensitivity analyses were performed. Results Overall discounted 5-years costs were € 1149 for azathioprine; € 4025 for tailored rituximab and € 5221 for fixed rituximab. QALY gains were 2.94, 3.63 and 3.64, respectively. Both tailored and fixed rituximab were cost-effective (cost per QALY gained: € 4168 and € 5817 respectively), but tailored dosing was preferable due to its lower cost. Sensitivity analyses did not modify these results significantly. Conclusion To our knowledge this is the first economic evaluation that compare azathioprine with tailored and fixed rituximab regimens as a vasculitis maintenance treatment in adults with ANCA generalized. Due to its lower effectiveness azathioprine should not be the first line of treatment. Tailored rituximab should be a better option than fixed schedule due to its lower cost with similar effectiveness.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17553-e17553
Author(s):  
Raymond Mailhot ◽  
Jane Kim ◽  
Abby Hollander ◽  
Jeff M. Michalski ◽  
Nancy Tarbell ◽  
...  

e17553 Background: Proton therapy has been endorsed as a radiotherapy (RT) modality with the potential to avert many RT associated comorbidities. Currently, few proton centers exist, and no evidence-based data as yet adequately informs allotment of care. Childhood cancer survivors of central nervous system (CNS) malignancies have high prevalences of growth hormone deficiency (GHD) after hypothalamic exposure, notable for its cost of treatment greater than $10,000/year. We propose methodology to help guide proton referral of pediatric patients with CNS tumors through cost-effective analysis comparisons for proton and photon hypothalamic received dose. Methods: A Markov cohort model was designed to assess the expected costs and effectiveness for specific RT doses to the hypothalamus. Patients entered the model receiving proton or photon RT for CNS tumors at four and twelve years of age and were followed for 60 more years of life. Patients could experience two health states: GHD or healthy. Risk of GHD was based on data by Merchant et al. Costs were measured in USD and captured cost of GHD and cost of RT. Cost of proton course relative to photon was estimated at $160K. Effectiveness was measured in quality-adjusted life years (QALYs). The main outcome measure used for comparison was the incremental cost-effectiveness ratio (ICER). We assumed a societal willingness to pay threshold of $50,000/QALY. Results: Data were used to generate tables incorporating the differential cost of proton RT to project ICERs for different combinations of hypothalamic RT dose as displayed in the Table below. Conclusions: Despite the high cost of proton therapy, the cost of GHD alone can yield proton RT a cost-effective (even cost-minimizing) strategy when compared to photon RT. This work provides a guide for identifying a set of patients for which proton therapy is particularly cost-effective. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6625-6625
Author(s):  
Naomi RM Schwartz ◽  
Meghan Rose Flanagan ◽  
Joseph B Babigumira ◽  
Lotte Maria Gertruda Steuten ◽  
Joshua A. Roth

6625 Background: Neratinib after adjuvant trastuzumab significantly improves disease-free survival (DFS) in human epidermal growth factor receptor 2-postiive (HER2+) breast cancer, but the median absolute DFS gain is only 1.3 months. There has been much controversy in the clinical and lay media as to whether the substantial cost of neratinib is justified by its effects, including a prominent ASCO Post article from Dr. Vogl about a year ago. We performed a cost-utility analysis to formally assess the value of adding neratinib based on Phase III ExteNET trial results. Methods: We developed a Markov state-transition model to assess the value of neratinib in Stage I-III HER2+ breast cancer. Five-year recurrence rates were derived from ExteNet. Mortality and recurrence rates after 5 years were derived from the HERceptin Adjuvant (HERA) trial. Costs were derived from wholesale acquisition costs and peer-reviewed literature. Health state utilities were derived from ExteNET and prior publications. Outcomes included life years (LY), quality-adjusted life years (QALYs), direct medical expenditures, and cost per QALY gained. The analysis took a payer perspective over a lifetime horizon and results were discounted at 3% per year. One-way and probabilistic analyses were conducted to evaluate uncertainty. As neratinib conferred more clinical benefit in hormone receptor-positive (HR+) disease, we also assessed value in that specific subgroup. Results: Base case results are presented in Table. At typical U.S. willingness to pay thresholds of $100,000 and $150,000 per QALY gained, neratinib had 16.7% and 27.2%, probabilities of cost-effectiveness, respectively. In the HR+ subgroup, neratinib had a cost of $275,311 per QALY gained (19.9% & 31.2% probability of cost-effectiveness at $100,000 & $150,000 per QALY). Conclusions: In the first independent assessment of the value of neratinib after adjuvant trastuzumab, neratinib is not projected to be cost-effective, even among patients who derived the most clinical benefit. Future analyses should reassess the cost-effectiveness of neratinib treatment as trial data mature. Base case results. [Table: see text]


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 43-43
Author(s):  
Rahul Ramesh Khairnar ◽  
Joseph Levy ◽  
Mark Mishra

43 Background: A hydrogel rectal spacer (HRS) is an FDA-approved medical device used to increase the separation between the rectum and the prostate. A recent phase III trial demonstrated a small reduction in the incidence of RT toxicities associated with use of HRS. We conducted a cost-effectiveness analysis of HRS use in PC patients undergoing intensity modulated radiation therapy (IMRT). Methods: A multi-state Markov model was constructed to examine the cost-effectiveness of HRS in men with localized PC receiving IMRT in the US (arms: IMRT alone vs. IMRT + HRS). Subgroups included delivery site of IMRT (hospital vs. ambulatory) and baseline sexual function (SF) (general population vs. those with good SF). Based on previous studies, recurrence and survival were assumed equal for both arms. Data on SF, gastrointestinal and genitourinary toxicities incidence, as well as potential risks associated with HRS implantation were obtained from a recently published clinical trial. Health utilities and costs were derived from the literature and 2018 Physician Fee Schedule. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis (PSA) and value-based threshold analysis were conducted. Costs and utilities were discounted at 3% annually. Results: The per-person 5-year incremental cost for HRS administered in a hospital was $4,008 and the incremental effectiveness was 0.0273 QALYs. The incremental cost-effectiveness ratio (ICER) was $146,746 (95% credible interval from PSA $125,638 – $178,049) for PC patients undergoing HRS insertion in a hospital vs. $73,359 ($66,732 – $86,767) for patients undergoing HRS insertion in an ambulatory facility. For men with good SF, the ICER was $55,153 ($46,002 – $76,090) and $26,542 ($17,399 – $46,044) in hospital vs. ambulatory facility. Conclusions: This study is the first to evaluate the cost-effectiveness of HRS based on long-term toxicity data. Based on the current Medicare Physician Fee Schedule, HRS is cost-effective in men with good SF at a willingness to pay threshold of $100,000 and it is marginally cost-effective for the entire population depending on the facility where the HRS is inserted.


Sarcoma ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-14 ◽  
Author(s):  
Jordan Amdahl ◽  
Stephanie C. Manson ◽  
Robert Isbell ◽  
Ayman Chit ◽  
Jose Diaz ◽  
...  

In the phase III PALETTE trial, pazopanib improved progression-free survival (PFS) compared with placebo in patients with advanced/metastatic soft tissue sarcomas (mSTS) who had received prior chemotherapy. We used a multistate model to estimate expected PFS, overall survival (OS), lifetime STS treatment costs, and quality-adjusted life-years (QALYs) for patients receiving pazopanib, placebo, trabectedin, ifosfamide, or gemcitabine plus docetaxel as second-line mSTS therapies. The cost-effectiveness of pazopanib was expressed as the incremental costs per QALY gained. Estimates of PFS/OS, adverse events, and utilities for pazopanib and placebo were from the PALETTE trial. Estimates of relative effectiveness of the other comparators were from an unadjusted indirect comparison versus pazopanib. Costs were from published sources. Pazopanib is estimated to increase QALYs by 0.128 and costs by£7,976 versus placebo; cost per QALY gained with pazopanib versus placebo is estimated to be£62,000. Compared with the other chemotherapies, pazopanib provides similar QALYs at a lower cost. Pazopanib may not be cost-effective versus placebo but may be cost-effective versus the most commonly used active treatments, although this conclusion is uncertain. Given the unmet need for effective treatments for mSTS, pazopanib may be an appropriate alternative to some currently used medications in the United Kingdom.


2021 ◽  
Author(s):  
Melike Yildirim ◽  
Bradley Gaynes ◽  
Pinar Keskinocak ◽  
Brian Pence ◽  
Julie L Swann

Objective. Screening has an essential role in preventive medicine. Ideally, screening tools detect patients early enough to manage the disease and reduce symptoms. We aimed to determine the cost-effectiveness of routine screening schedules. Methods. We used a discrete-time nonstationary Markov model to simulate the progression of depression. We adopted annual transition probabilities, which were dependent on patient histories, such as the number of previous episodes, treatment status, and time spent without treatment state based on the available data. We used Monte Carlo techniques to simulate the stochastic model for 20 years or during the lifetime of individuals. Baseline and screening scenario models with screening frequencies of annual, 2-year, and 5-year were compared based on incremental cost-effectiveness ratios (ICER). Results. In the general population, all screening strategies were cost-effective compared to the baseline. However, male and female populations differed based on cost over quality-adjusted life years (QALY). Females had lower ICERs, and annual screening had the highest ICER for females, with 11,134 $/QALY gained. In contrast, males had around three times higher ICER, with annual screening costs of 34,065$/QALY gained. Conclusions. Considering the high lifetime prevalence and recurrence rates of depression, detection and prevention efforts can be one critical cornerstone to support required care. Our analysis combined the expected benefits and costs of screening and assessed the effectiveness of screening scenarios. We conclude that routine screening is cost-effective for all age groups of females and young, middle-aged males. Male population results are sensitive to the higher costs of screening.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3427-3427 ◽  
Author(s):  
Simone Critchlow ◽  
Miranda Cooper ◽  
Ilse van Oostrum ◽  
Verna L Welch ◽  
T. Alexander Russell-Smith

Introduction: Inotuzumab ozogamicin (InO), is a novel anti-CD22 antibody-calicheamicin conjugate approved in R/R B-ALL due to its high hematologic remission rate (81%) based on the phase 3 INO-VATE trial comparing to investigators choice (IC). The TOWER trial demonstrated the efficacy and safety of blinatumomab (Blina) for treatment of Ph- B-ALL versus IC. The relative effectiveness of InO versus Blina was investigated by applying indirect treatment comparison (ITC) methods. A UK-based cost-effectiveness model (CEM) submitted to the Scottish Medicines Consortium (SMC) explored the impact of treatment differences with regard to mean life years (LY) gained and quality-adjusted life years (QALY). Methods: As R/R ALL is a terminal disease if left untreated, achievement of complete response/complete response with incomplete count recovery (CR/CRi) in conjunction with stem cell transplant (SCT) is essential for long-term survival. The three most important outcomes related to treatment are thus the level of response determined by CR/CRi, the rate of SCT, and overall survival (OS). Without potentially curative therapy such as SCT, there is no evidence to suggest long-term survival is possible. Therefore, to compare InO to Blina, comparisons of these outcomes were explored using patient-level data from the INO-VATE ALL trial and aggregate data from the TOWER trial. The CEM structure contained four health states categorising patients based on 'No CR/CRi & no SCT', 'CR/CRi and no SCT' and patients receiving SCT ('SCT/Post SCT') - with progression-free survival (PFS) and OS modelled within these states. States were clinically validated as relevant to treatment of the disease. Death was the fourth health state. Different methods were incorporated to allocate Blina patients to the respective health-states. For levels of response (CR/CRi) and SCT a matching-adjusted indirect comparison (MAIC) and a Bucher ITC were explored. As CR/CRi and SCT rates are not mutually exclusive, a multinomial ITC was also conducted. Once allocated into respective health states, OS and PFS were modelled. Three ITC methods were used to compare OS; a simulated treatment comparison (STC), MAIC and a standard network meta-analysis. In the absence of PFS data for Blina, PFS was assumed to have the same relative treatment effect as OS. Quality of life data within the model for the 'No CR/CRi & no SCT' and 'CR/CRi and no SCT' were informed from InO trial data, while SCT quality of life was informed from the literature with time-varying utilities. Costs were incorporated from a UK perspective using 2017 sources and were those submitted to the SMC. Results were annually discounted at 3.5%. Results: Health state proportions for Ph- InO patients were used as the basis to estimate corresponding Blina proportions and show 49.3% of patients treated with InO reach SCT. With higher odds for CR/CRi and SCT for InO, the ITC results consistently indicate Blina leads to lower proportions of patients receiving SCT (19.1-22.5%) and CR/CRi (25.2-33.3%). ITCs comparing OS outcomes for InO versus blinatumomab show negligible differences between treatments, consistently across the three methods. All combinations of the various methods were explored using the list price for both treatments. The results of the CEM ranged from 0.91-1.14 incremental QALYs for InO versus Blina, while LYs ranged from 2.03-2.59 resulting from higher rates of SCT. The incremental cost-effectiveness ratio (ICER) ranged from £3,700 to £7,010 for InO versus Blina. Extensive scenario analysis indicates that InO is a cost-effective option compared to Blina at a willingness to pay threshold of £20,000 per QALY. The SMC recommended InO as a cost-effective use of resources citing an ICER of £6,754 in the CEM when using the MAIC; InO was associated with a mean survival gain of >29 months over Blina corresponding to this ICER. Conclusions: Outcomes from the ITC indicate that InO provides patients with a greater probability of achieving CR/CRi and/or receiving a subsequent SCT versus Blina. As CR/CRi followed by SCT are essential for long-term survival and potential cure, the mean OS gain in the model cited in the SMC recommendation is intuitive as it aligns with the superior CR/CRi and SCT odds ratios associated with InO. Further research is required to determine the long-term PFS and OS following SCT in R/R B-ALL, beyond what can be reliably captured within clinical trials. Disclosures Critchlow: BresMed Health Solutions Ltd.: Consultancy. Cooper:BresMed Health Solutions Ltd.: Consultancy. van Oostrum:Ingress Health: Employment; Pfizer: Consultancy; Merck: Consultancy; Janssen: Consultancy; AstraZeneca: Consultancy. Welch:Pfizer Inc: Employment, Equity Ownership. Russell-Smith:Pfizer: Employment, Equity Ownership.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22076-e22076
Author(s):  
Elena Parvez ◽  
Teodora Dumitra ◽  
Dimitra Panagiotoglou ◽  
Sarkis H. Meterissian ◽  
Sinziana Dumitra

e22076 Background: The MSLT-II trial demonstrated no survival benefit of completion lymphadenectomy (CLND) compared to nodal observation (NO) and subsequent therapeutic lymphadenectomy (TLND) in the case of macroscopic nodal relapse in patients with melanoma and SLN metastases. NO avoids the upfront cost and morbidity of CLND. However, patients followed with NO must undergo intensive surveillance and if TLND is required, it is associated with a higher complication rate than CLND. The cost-effectiveness of NO versus CLND in light of data from MSLT-II has not been previously studied. Methods: A Markov model with a 10-year time horizon was constructed to simulate two hypothetical cohorts of patients with SLN metastases undergoing NO and subsequent TLND for nodal recurrence or upfront CLND. Transition probabilities between disease states were derived from the MSLT-II trial. Remaining parameters including complication rates and health state utilities were obtained from an extensive review of the literature. Direct health care system costs were obtained from published US Medicare cost data and the literature. Primary outcomes were cost and quality-adjusted life years (QALYs) saved. Incremental cost-effectiveness ratio (ICER) was used to compare treatment strategies. Sensitivity analysis was performed in order to evaluate model uncertainty. A threshold of acceptance of $100,000/QALY was used. Results: Total projected cost over the study period for CLND was $28,609.87, while that of NO was lower at $20,865.27, resulting in $7,744.60 saved for the NO treatment strategy. Ten-year utility was 4.840 for CLND compared to 5.379 for NO, resulting in a gain of 0.539 QALYs in the NO arm. The NO strategy is dominant in the model as it results in both cost-savings and a gain in health effects, with an average ICER of -$14,368.46/QALY gained. Conclusions: From the payer perspective, the strategy of NO compared to CLND in patients with melanoma and SLN metastases is associated with an improvement in health outcomes and reduction in cost. Taking into account MSLT-II trial data, this study demonstrates NO is more cost-effective than CLND.


2015 ◽  
Vol 33 (26) ◽  
pp. 2885-2892 ◽  
Author(s):  
Isabelle Borget ◽  
Julia Bonastre ◽  
Bogdan Catargi ◽  
Désirée Déandréis ◽  
Slimane Zerdoud ◽  
...  

Purpose In the ESTIMABL phase III trial, the thyroid ablation rate was equivalent for the two thyroid-stimulating hormone (TSH) stimulation methods (thyroid hormone withdrawal [THW] and recombinant human TSH [rhTSH]) and the two iodine-131 (131I) activities (1.1 or 3.7 GBq). The objectives of this article were to present health-related quality-of-life (HRQoL) results and a cost-effectiveness evaluation performed alongside this trial. Patients and Methods HRQoL and utility were longitudinally assessed, from random assignment to the follow-up visit at 8 ± 2 months for the 752 patients with thyroid cancer, using the Short Form-36 and the EuroQoL-5D questionnaires, respectively. A cost-effectiveness analysis was performed from the societal perspective in the French context. Resource use (hospitalization for 131I administration, rhTSH, sick leaves, and transportation) was collected prospectively. We used the net monetary benefit approach and computed cost-effectiveness acceptability curves for both TSH stimulation methods and 131I activities. Sensitivity analyses of the costs of rhTSH were performed. Results At 131I administration, THW caused a clinically significant deterioration of HRQoL, whereas HRQoL remained stable with rhTSH. This deterioration was transient with no difference 3 months later. rhTSH was more effective than THW in terms of quality-adjusted life-years (QALYs; +0.013 QALY/patient) but more expensive (+€474/patient). The probability that rhTSH would be cost effective at a €50,000/QALY threshold was 47% in France. The use of 1.1 GBq of 131I instead of 3.7 GBq reduced per-patient costs by €955 (US$1,018) but with slightly decreased efficacy (−0.007 QALY/patient). Conclusion rhTSH avoids the transient THW-induced deterioration of HRQoL but is unlikely to be cost effective at its current price.


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