Cost Effectiveness of <i>EML4-ALK</i> Fusion Testing and First-Line Crizotinib Treatment for Patients With Advanced <i>ALK</i>-Positive Non–Small-Cell Lung Cancer

Djalalov, S.; Beca, Jaclyn; Hoch, Jeffrey S.; Krahn, Murray; Tsao, Ming‐Sound; Cutz, Jean Claude; Leighl, Natasha B.

doi:10.1200/jco.2013.53.1186

Cited by 80 publications

(65 citation statements)

References 26 publications

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“…An example of this is crizotinib, which is an effective treatment for patients with an ALK aberration in metastatic non-small cell lung cancer (NSCLC). If EML4-ALK fusion testing was performed on all stage IV non-squamous NSCLC patients, <5% of the population would be identified for crizotinib treatment [13]. Therefore, in this scenario, one would have to order 20 tests to identify 1 patient who may benefit from the therapy; so, from the perspective of the healthcare system, they have to pay for 20 tests and 1 course of therapy to find the 1 patient with ALK aberration who may benefit from crizotinib [14,15].…”

Section: Valuing Biomarkers or Molecular Diagnostics On A Par With Thmentioning

confidence: 99%

“…If drugs were priced this way, pharmaceutical companies would only be reimbursed for the manufacturing costs of a product without taking into account the huge investment in research and development, and this approach would completely limit any innovation in the field. Similarly, a cost-based pricing approach for diagnostics dis-incentivises biomarker developers from pursuing evidence which demonstrates clinical value and limits their willingness to invest in further research [13]. An EU Commission Staff working document Use of ‘-omics' Technologies in the Development of Personalised Medicine, published in October 2013, highlighted this point: ‘the current paradigm where the highest “value” is attributed to therapies rather than to diagnostics may need to be revisited to ensure that high-quality diagnostics are also valued appropriately.…”

Section: Key Principles In the Validation Of Molecular Diagnosticsmentioning

confidence: 99%

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Establishing the Evidence Bar for Molecular Diagnostics in Personalised Cancer Care

Schneider

Horgan

Michiels

et al. 2015

Public Health Genomics

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While personalised cancer medicine holds great promise, targeting therapies to the biological characteristics of patients is limited by the number of validated biomarkers currently available. The implementation of biomarkers has undergone many challenges with few biomarkers reaching cancer patients in the clinic. There have been many biomarkers that have been published and claimed to be therapeutically useful, but few become part of the clinical decision-making process due to technical, validation and market access issues. To reduce this attrition rate, there is a significant need for policy makers and reimbursement agencies to define specific evidence requirements for the introduction of biomarkers into clinical practice. Once these requirements are more clearly defined, in an analogous manner to pharmaceuticals, researchers and diagnostic companies can better focus their biomarker research and development on meeting these specific requirements, which should lead to the more rapid introduction of new molecular oncology tests for patient benefit.

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Section: Valuing Biomarkers or Molecular Diagnostics On A Par With Thmentioning

confidence: 99%

Section: Key Principles In the Validation Of Molecular Diagnosticsmentioning

confidence: 99%

Establishing the Evidence Bar for Molecular Diagnostics in Personalised Cancer Care

Schneider

Horgan

Michiels

et al. 2015

Public Health Genomics

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“…However, this requires that the costs of both the biomarker and the targeted agent are commensurate with their impact on patient outcomes. Value is still a critical factor here, and serious issues remain with the ability of many of current biomarkers to deliver the necessary precision [75]. …”

Section: Converting Cost To Value: Charting a Pathway To Affordable Qmentioning

confidence: 99%

Personalised and Precision Medicine in Cancer Clinical Trials: Panacea for Progress or Pandora's Box?

Lawler¹,

Sullivan

2015

Public Health Genomics

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Cancer clinical trials have been one of the key foundations for significant advances in oncology. However, there is a clear recognition within the academic, care delivery and pharmaceutical/biotech communities that our current model of clinical trial discovery and development is no longer fit for purpose. Delivering transformative cancer care should increasingly be our mantra, rather than maintaining the status quo of, at best, the often miniscule incremental benefits that are observed with many current clinical trials. As we enter the era of precision medicine for personalised cancer care (precision and personalised medicine), it is important that we capture and utilise our greater understanding of the biology of disease to drive innovative approaches in clinical trial design and implementation that can lead to a step change in cancer care delivery. A number of advances have been practice changing (e.g. imatinib mesylate in chronic myeloid leukaemia, Herceptin in erb-B2-positive breast cancer), and increasingly we are seeing the promise of a number of newer approaches, particularly in diseases like lung cancer and melanoma. Targeting immune checkpoints has recently yielded some highly promising results. New algorithms that maximise the effectiveness of clinical trials, through for example a multi-stage, multi-arm type design are increasingly gaining traction. However, our enthusiasm for the undoubted advances that have been achieved are being tempered by a realisation that these new approaches may have significant cost implications. This article will address these competing issues, mainly from a European perspective, highlight the problems and challenges to healthcare systems and suggest potential solutions that will ensure that the cost/value rubicon is addressed in a way that allows stakeholders to work together to deliver optimal cost-effective cancer care, the benefits of which can be transferred directly to our patients.

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“…In addition, the tumor content may be insufficient for molecular testing (21). Amount of tissue required and labor intensiveness depend on the techniques employed, e.g., IHC requires less tissue and is less costly than fluorescent in situ hybridization (FISH) or sequencing, costing $40CAD compared with $388CAD for FISH (22). Therefore, the availability of tissue and method of testing are of clinical and economic importance.…”

Section: Costs Of Lung Cancer Managementmentioning

confidence: 99%

Economic Impact of Tissue Testing and Treatments of Metastatic NSCLC in the Era of Personalized Medicine

Graham

Leighl

2014

Front. Oncol.

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A paradigm-shift in the management of non-small cell lung cancer (NSCLC) has resulted in many new therapies becoming available for patients with advanced disease. Stratification of treatment by histologic and molecular subtype is recommended to obtain the greatest clinical benefit for patients while minimizing adverse effects of treatment. However, these advances in diagnosis and treatment of NSCLC have come at a financial cost. This review highlights the economic impact of screening for molecular abnormalities and targeted treatment for advanced NSCLC. Major determinants of cost are drug acquisition and molecular testing. As technologies advance, molecular testing costs may reduce. However, we must collaborate with payers and manufacturers to ensure that high drug costs do not limit patient accessibility to potentially beneficial treatment.

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Cost Effectiveness of EML4-ALK Fusion Testing and First-Line Crizotinib Treatment for Patients With Advanced ALK-Positive Non–Small-Cell Lung Cancer

Abstract: EML4-ALK fusion testing in stage IV nonsquamous NSCLC with crizotinib treatment for ALK-positive patients is not cost effective in the setting of high drug costs and a low biomarker frequency in the population.

Cited by 80 publications

References 26 publications

Establishing the Evidence Bar for Molecular Diagnostics in Personalised Cancer Care

Establishing the Evidence Bar for Molecular Diagnostics in Personalised Cancer Care

Personalised and Precision Medicine in Cancer Clinical Trials: Panacea for Progress or Pandora's Box?

Economic Impact of Tissue Testing and Treatments of Metastatic NSCLC in the Era of Personalized Medicine

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