Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis

Cutress, R.I.; McDowell, A.; Gabriel, Francis G.; Gill, J.; Jeffrey, M.; Agrawal, Avi; Wise, M.; Raftery, James; Cree, Ian A.; Yiangou, C.

doi:10.1136/jcp.2009.072942

Cited by 35 publications

(27 citation statements)

References 26 publications

(29 reference statements)

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“…40 Finally, a cost analysis assessment of the OSNA technique was performed at a large UK district general hospital and indicated that there was an implicit savings in reducing the number of secondary surgeries, such as reduced bed occupancy, and this savings may comfortably offset the expense of intraoperative molecular analysis. 45 Another way to allow intraoperative axillary dissection to proceed would be to improve on the intraoperative, cryostat section diagnosis; however frozen sections, have a sensitivity that range from 17% to 92% for micrometastases and from 84% to 94% for macromestastases 19 and do require well trained laboratory technicians.…”

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confidence: 99%

Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

et al. 2012

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Objective: To assess the reliability of using the One-Step Nucleic Acid Amplification (OSNA) assay as a single test on whole sentinel lymph nodes (SLN) as a method of intraoperative diagnosis and staging of SLNs in breast cancer.Background: Combining histological and molecular assessment of metastasis on the same SLN may not fully reproduce the actual load of cancer cells present in the SLN and create problems in decisions regarding axillary dissection.

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confidence: 99%

Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

et al. 2012

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“…One study measured the costs of intraoperative options that are not relevant to the UK (touch imprint and frozen section) 121 and one study analysed the diagnostic pathway leading to SLN biopsy or ALND. 9,122 The remaining two studies 56,123 were identified as relevant to our review. A second report of the study by Cutress et al 123 was available from the NHS Technology Adoption Centre 124 and was used to complement the information from Cutress et al 123 See Appendix 5 for the quality assessment of all available studies reported in journal articles and Appendix 6 for details of the excluded studies.…”

Section: Description Of the Included Studiesmentioning

confidence: 99%

“…Both were single-centre observational studies that compared an intraoperative test with histopathology as the gold standard for assessing SLNB. The study by Cutress et al 123 was set in the UK and assessed the GeneSearch assay whereas the study by Guillen-Paredes et al 56 was conducted in Spain and evaluated the OSNA assay. Both found their respective intraoperative test to be cost-effective compared with histopathology, with both assays being cost-saving while reducing theatre time and length of hospital stay.…”

Section: Description Of the Included Studiesmentioning

confidence: 99%

“…It must be noted that the study by Cutress et al, 123 although providing a unique source of evidence on resource use and costs of intraoperative molecular testing in the UK, provides limited, if any, evidence on the economic outcomes of a specific intraoperative test as it refers to a test that has been withdrawn from the market (GeneSearch). Metasin, one of the intraoperative testing technologies being evaluated in …”

Section: Description Of the Included Studiesmentioning

confidence: 99%

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A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer

Huxley

Jones-Hughes

Snowsill

et al. 2015

Health Technology Assessment

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BackgroundIn breast cancer patients, sentinel lymph node biopsy is carried out at the same time as the removal of the primary tumour to postoperatively test with histopathology for regional metastases in the sentinel lymph node. Those patients with positive test results are then operated on 2–4 weeks after primary surgery to remove the lymph nodes from the axilla (axillary lymph node dissection, ALND). New molecular tests RD-100i [one-step nucleic acid amplification (OSNA); based on messenger RNA amplification to identify the cytokeratin-19 (CK19) gene marker] (Sysmex, Norderstedt, Germany) and Metasin (using theCK19and mammaglobin gene markers) (Cellular Pathology, Princess Alexandra Hospital NHS Trust, Harlow, UK) are intended to provide an intraoperative diagnosis, thereby avoiding the need for postoperative histopathology and, in positive cases, a second operation for ALND.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of using OSNA and Metasin in the NHS in England for the intraoperative diagnosis of sentinel lymph nodes metastases, compared with postoperative histopathology, the current standard.Data sourcesElectronic databases including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library and the Health Economic Evaluations Database as well as clinical trial registries, grey literature and conference proceedings were searched up to July 2012.Review methodsA systematic review of the evidence was carried out using standard methods. Single-gate studies were used to estimate the accuracy of OSNA with histopathology as the reference standard. The cost-effectiveness analysis adapted an existing simulation model of the long-term costs and health implications of early breast cancer diagnostic outcomes. The model accounted for the costs of an extended first operation with intraoperative testing, the loss of health-related quality of life (disutility) from waiting for postoperative test results, disutility and costs of a second operation, and long-term costs and disutility from lymphoedema related to ALND, adjuvant therapy, locoregional recurrence and metastatic recurrence.ResultsA total of 724 references were identified in the searches, of which 17 studies assessing test accuracy were included in the review, 15 on OSNA and two on Metasin. Both Metasin studies were unpublished. OSNA sensitivity of 84.5% [95% confidence interval (CI) 74.7% to 91.0%] and specificity of 91.8% (95% CI 87.8% to 94.6%) for patient nodal status were estimated in a meta-analysis of five studies [unadjusted for tissue allocation bias (TAB)]. At these values and a 20% node-positive rate, OSNA resulted in lifetime discounted cost-savings of £498 and a quality-adjusted life-year (QALY) loss of 0.048 relative to histopathology, that is, £4324 saved per QALY lost. The most favourable plausible scenario for OSNA in terms of the node-positive rate (range 10–40%), diagnostic accuracy values (91.3% sensitivity and 94.2% specificity, from three reports that adjusted for TAB), the costs of histopathology, OSNA and second surgery, and long-term costs and utilities resulted in a maximum saving per QALY lost of £10,500; OSNA sensitivity and specificity would need to be ≥ 95% for this figure to be ≥ £20,000.LimitationsThere is limited evidence on the diagnostic test accuracy of intraoperative tests. The quality of information on costs of resource utilisation during the diagnostic pathway is low and no evidence exists on the disutility of waiting for a second surgery. No comparative studies exist that report clinical outcomes of intraoperative diagnostic tests. These knowledge gaps have more influence on the decision than current uncertainty in the performance of postoperative histopathology in standard practice.ConclusionsOne-step nucleic acid amplification is not cost-effective for the intraoperative diagnosis of sentinel lymph node metastases. OSNA is less accurate than histopathology and the consequent loss of health benefits in this patient group is not compensated for by health gains elsewhere in the health system that may be obtained with the cost-savings made. The evidence on Metasin is insufficient to evaluate its cost-effectiveness.Study registrationThis study is registered as PROSPERO CRD42012002889.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Their collaboration was sought by NTAC in gathering evidence of cost savings that adoption of BLNA would generate, and findings from a study conducted by them were subsequently published in a peer-reviewed journal. 216 However, Stevens et al 217 point out that 'What is important is that any system for identifying and evaluating new technologies is linked to the system for knowledge dissemination and implementation. It must not stand in splendid isolation'.…”

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confidence: 99%

Facilitating technology adoption in the NHS: negotiating the organisational and policy context – a qualitative study

Llewellyn

Procter

Harvey

et al. 2014

Health Services and Delivery Research

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Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis

Cited by 35 publications

References 26 publications

Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer

Facilitating technology adoption in the NHS: negotiating the organisational and policy context – a qualitative study

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