Cost-Effectiveness Of Pharmacokinetic Dosing Of 5-Fluorouracil In Metastatic Colorectal Cancer In The United Kingdom

Becker, RV; Hollenbeak, C.; Choma, Adrienne; Salamone, Salvatore J.

doi:10.1016/j.jval.2013.03.680

Cited by 8 publications

(27 citation statements)

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“…Dose adjustment of 5-FU based on plasma 5-FU level is feasible, and it is clear that PK-based dosing can significantly improve clinical outcomes by reducing toxicities and improving efficacy. The potential economic benefit of PK-based versus BSA dosing of 5-FU was investigated in patients with mCRC in the United Kingdom (UK) who were treated with various 5-FU combination regimens [86]. A decision tree model was used to perform a counterfactual simulation of the cost-effectiveness of PK versus BSA dosing of 5-FU in various standard chemotherapy regimens in the UK population, and all patients were assumed to have received first-line therapy for 6 or 12 cycles or until disease progression.…”

Section: Pharmacoeconomics Of 5-fu Tdmmentioning

confidence: 99%

Therapeutic drug monitoring of 5-fluorouracil

Lee

Beumer

Chu

2016

Cancer Chemother Pharmacol

178

147

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Purpose For over 50 years, 5-FU has played a critical role in the systemic chemotherapy of cancer patients. 5-FU serves as the main backbone of combination chemotherapy for patients with colorectal cancer (CRC) in both the adjuvant and metastatic disease settings. Herein, we review the current status of 5-FU therapeutic drug monitoring (TDM) and discuss its potential role in the clinical practice setting. Method PubMed and abstracts from the American Society of Clinical Oncology (ASCO) were searched up through September 2015 for clinical data relating to 5-FU TDM. Results 5-FU dosing has been typically determined by using body surface area (BSA). However, it is now well-established that BSA-based 5-FU dosing is correlated with a wide variation of 5-FU systemic exposure. Pharmacokinetic (PK) studies of 5-FU systemic exposure have shown a wide range of interpatient variation of 5-FU plasma drug levels. Over the past 30 years, increasing efforts have been placed on optimizing 5-FU dosing with the main goals of increasing antitumor efficacy while reducing drug-associated toxicity. There is growing evidence to show that 5-FU dosing based on plasma 5-FU drug level is feasible and that 5-FU TDM can improve clinical outcomes by improving efficacy of 5-FU-based combination regimens and reducing toxicities. Conclusion Dose adjustment of 5-FU is feasible and PK-based dosing can significantly improve clinical outcomes by reducing toxicities and improving efficacy.

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Section: Pharmacoeconomics Of 5-fu Tdmmentioning

confidence: 99%

Therapeutic drug monitoring of 5-fluorouracil

Lee

Beumer

Chu

2016

Cancer Chemother Pharmacol

178

147

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“…An overview of the economic evaluations is presented in Table 2. Nine cost utility analyses were presented across 8 publications 13–16,21–24 . Cost analyses were presented in 2 publications 25,26 .…”

Section: Resultsmentioning

confidence: 99%

“…Several fluoropyrimidine‐based regimens were examined across the studies. These included FOLFOX regimens (5‐FU, oxaliplatin and leucovorin) 14,22,24 and FOLFIRI (5‐FU, irinotecan and leucovorin) 14 for colorectal cancer, TPF (docetaxel, cisplatin and 5‐FU) for head and neck cancer, 22 FOLFIRINOX (5‐FU, oxaliplatin, irinotecan and leucovorin) for pancreatic cancer 17 . The 2 remaining publications assessed TDM interventions for tamoxifen 21 and pegasparaginase 26 .…”

Section: Resultsmentioning

confidence: 99%

A comprehensive review of economic evaluations of therapeutic drug monitoring interventions for cancer treatments

Vithanachchi

Maujean

Downes

et al. 2020

Brit J Clinical Pharma

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This is the peer reviewed version of the following article: A comprehensive review of economic evaluations of therapeutic drug monitoring interventions for cancer treatments, British Journal of Clinical Pharmacology, Early ViewR, which has been published in final form at 10.1111/bcp.14494. This article may be used for noncommercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving (

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“…A number of further literature reviews are undertaken and presented in full in the following appendices: Cost-effectiveness studies of pharmacokinetic 5-fluorouracil dosing in metastatic colorectal cancer Becker et al 178 (funded by Saladax) in an International Society for Pharmacoeconomics and Outcomes Research poster presentation summarising the results of a cost-utility modelling exercise that compared My5-FU dose adjustment with BSA dosing among patients with mCRC. This adopted a lifetime horizon, and discounted costs and benefits at 3.0%.…”

Section: Literature Review: Economicsmentioning

confidence: 99%

Fluorouracil plasma monitoring: systematic review and economic evaluation of the My5-FU assay for guiding dose adjustment in patients receiving fluorouracil chemotherapy by continuous infusion

Freeman

Connock

Cummins³

et al. 2015

Health Technol Assess

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Background5-Fluorouracil (5-FU) is a chemotherapy used in colorectal, head and neck (H&N) and other cancers. Dose adjustment is based on body surface area (BSA) but wide variations occur. Pharmacokinetic (PK) dosing is suggested to bring plasma levels into the therapeutic range to promote fewer side effects and better patient outcomes. We investigated the clinical effectiveness and cost-effectiveness of the My5-FU assay for PK dose adjustment to 5-FU therapy.ObjectivesTo systematically review the evidence on the accuracy of the My5-FU assay compared with gold standard methods [high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS)]; the effectiveness of My5-FU PK dosing compared with BSA; the effectiveness of HPLC and/or LC-MS compared with BSA; the generalisability of published My5-FU and PK studies; costs of using My5-FU; to develop a cost-effectiveness model.Data sourcesWe searched MEDLINE, EMBASE, Science Citation Index and other databases between January and April 2014.MethodsTwo reviewers independently screened titles and abstracts with arbitration and consensus agreement. We undertook quality assessment. We reconstructed Kaplan–Meier plots for progression-free survival (PFS) and overall survival (OS) for comparison of BSA and PK dosing. We developed a Markov model to compare My5-FU with BSA dosing which modelled PFS, OS and adverse events, using a 2-week cycle over a 20 year time horizon with a 3.5% discount rate. Health impacts were evaluated from the patient perspective, while costs were evaluated from the NHS and Personal Social Services perspective.ResultsA total of 8341 records were identified through electronic searches and 35 and 54 studies were included in the clinical effectiveness and cost-effectiveness reviews respectively. There was a high apparent correlation between My5-FU, HPLC and LC-MS/mass spectrometer but upper and lower limits of agreement were –18% to 30%. Median OS were estimated as 19.6 [95% confidence interval (CI) 17.0 to 21.0] months for PK versus 14.6 (95% CI 14.1 to 15.3) months for BSA for 5-FU + folinic acid (FA); and 27.4 (95% CI 23.2 to 38.8) months for PK versus 20.6 (95% CI 18.4 to 22.9) months for BSA for FOLFOX6 in metastatic colorectal cancer (mCRC). PK versus BSA studies were generalisable to the relevant populations. We developed cost-effectiveness models for mCRC and H&N cancer. The base case assumed a cost per My5-FU assay of £61.03. For mCRC for 12 cycles of a oxaliplatin in combination with 5-fluorouracil and FA (FOLFOX) regimen, there was a quality-adjusted life-year (QALY) gain of 0.599 with an incremental cost-effectiveness ratio of £4148 per QALY. Probabilistic and scenario analyses gave similar results. The cost-effectiveness acceptability curve showed My5-FU to be 100% cost-effective at a threshold of £20,000 per QALY. For H&N cancer, again, given caveats about the poor evidence base, we also estimated that My5-FU is likely to be cost-effective at a threshold of £20,000 per QALY.LimitationsQuality and quantity of evidence were very weak for PK versus BSA dosing for all cancers with no randomised controlled trials (RCTs) using current regimens. For H&N cancer, two studies of regimens no longer in use were identified.ConclusionsUsing a linked evidence approach, My5-FU appears to be cost-effective at a willingness to pay of £20,000 per QALY for both mCRC and H&N cancer. Considerable uncertainties remain about evidence quality and practical implementation. RCTs are needed of PK versus BSA dosing in relevant cancers.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Cost-Effectiveness Of Pharmacokinetic Dosing Of 5-Fluorouracil In Metastatic Colorectal Cancer In The United Kingdom

Cited by 8 publications

References 0 publications

Therapeutic drug monitoring of 5-fluorouracil

Therapeutic drug monitoring of 5-fluorouracil

A comprehensive review of economic evaluations of therapeutic drug monitoring interventions for cancer treatments

Fluorouracil plasma monitoring: systematic review and economic evaluation of the My5-FU assay for guiding dose adjustment in patients receiving fluorouracil chemotherapy by continuous infusion

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