Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
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Background and Objective:
Adding gene expression profiles (GEPs) to the current diagnostic work-up of aggressive large B-cell lymphomas may lead to the reclassification of patients, treatment changes and improved outcomes. A GEP test is in development using TempO-Seq® technology to distinguish Burkitt lymphoma (BL) and primary mediastinal large B-cell lymphoma (PMBCL) from diffuse large B-cell lymphoma (DLBCL), and to classify patients with DLBLC and to predict the benefit of (e.g.) adding bortezomib to R-CHOP therapy (RB-CHOP). This study aims to estimate the potential impact of a GEP test on costs and health outcomes to inform pricing and evidence generation strategies.
Methods:
Three decision models were developed comparing diagnostic strategies with and without GEP signatures over a lifetime horizon using a UK health and social care perspective. Inputs were taken from a recent clinical trial, literature and expert opinion. We estimated the maximum price of the test using a threshold of Great Britain Pound (GBP) 30,000 per quality-adjusted life-year (QALY). Sensitivity analyses were conducted.
Results:
The estimated maximum threshold price for a combined test to be cost effective is GBP 15,352. At base-case values, the BL signature delivers QALY gains of 0.054 at an additional cost of GBP 275. This results in a net monetary benefit at a threshold of GBP 30,000 per QALY of GBP 1345. For PMBCL, the QALY gain was 0.0011 at a cost saving of GBP 406 and the net monetary benefit was GBP 437. The hazard ratio for the impact of treating BL less intensively must be at least 1.2 for a positive net monetary benefit. For identifying patients with the DLBCL subtype responsive to bortezomib, QALY gain was 0.2465 at a cost saving of GBP 6175, resulting in a net monetary benefit of GBP 13,570. In a probabilistic sensitivity analysis using 1000 simulations, a testing strategy was superior to a treat all with R-CHOP strategy in 81% of the simulations and with a cost saving in 92% assuming a cost price of zero.
Conclusions:
Our estimates show that the combined test has a high probability of being cost effective. There is good quality evidence for the benefit of subtyping DLBCL but the evidence on the number of patients reclassified to or from BL and PMBCL and the impact of a more precise diagnosis and the cost of treatment is weak. The developers can use the price estimate to inform a return on investment calculations. Evidence will be required of how well the TempO-Seq® technology performs compared to the testing GEP technology used for subtyping in the recent clinical trial. For BL and PMBCL elements of the test, evidence would be required of the number of patients reclassified and improved costing information would be useful. The diagnostic and therapeutic environment in haematological malignancies is fast moving, which increases the risk for developers of diagnostic tests.
Bouttell, Janet
Author
Lai, Tzu-Jung and Roxburgh, Campbell and Boyd, Kathleen Anne and Bouttell, Janet (2024) Clinical effectiveness of robotic versus laparoscopic and open surgery: an overview of systematic reviews. BMJ Open, 14 (9): e076750. ISSN 2044-6055
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listFraser, Heather
Author
Taylor, Rod and Burrell, Emma and O’Hare, Claire and Thomson, Elizabeth and Placzek, Anna and Bollen, Jessica and Cleland, John G.F. and Cowie, Ansley and Dalal, Hasnain and Deaton, Christi and Doherty, Patrick and Dudman, Katie and Fraser, Heather and Frost, Julia and Greaves, Colin J. and Hartshorne-Evans, Nick and Hillsdon, Melvyn and Ibbotson, Tracy and Jarallah, Mohammad and Jolly, Kate and McConnachie, Alex and McIntosh, Emma and Smith, Valerie and Squire, Iain and Taylor, Louise and van Beurden, Sam and Lang, Chim C. and REACH-HFpEF investigators (2025) Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial. BMJ Open, 15 (5): e094254. ISSN 2044-6055
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listGoodlad, John R.
Author
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listHopkins, David
Author
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listMcKay, Pam
Author
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair J. and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2025) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients. Clinical Science, 139 (1). pp. 29-41. ISSN 0143-5221
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2024) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients using 18F-FDG positron emission tomography. bioRxiv.
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listOien, Karin A.
Author
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
Frei, Anja L. and McGuigan, Anthony and Sinha, Ritik R.A.K. and Jabbar, Faiz and Gneo, Luciana and Tomasevic, Tijana and Iveson, Tim and Saunders, Mark P. and Oien, Karin A. and Maka, Noori and Pezzella, Francesco and Campo, Leticia and Browne, Molly and Glaire, Mark and Kildal, Wanja and Danielsen, Havard E. and Hay, Jennifer and Edwards, Joanne and Sansom, Owen and Kelly, Caroline and Tomlinson, Ian and Kerr, Rachel and Kerr, David and Domingo, Enric and TransSCOT consortium and Church, David N. and Koelze, Viktor H. (2024) Multiplex analysis of intratumoural immune infiltrate and prognosis in patients with stage II–III colorectal cancer from the SCOT and QUASAR 2 trials: A retrospective analysis. Lancet Oncology, 25 (2). pp. 198-211. ISSN 1470-2045
See full publications listSeligmann, Bruce
Author
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listVon Delft, Stephan
Author
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
See full publications listHawkins, Neil
Author
Bouttell, Janet and Fraser, Heather and Goodlad, John R. and Hopkins, David and McKay, Pam and Oien, Karin A. and Seligmann, Bruce and Von Delft, Stephan and Hawkins, Neil (2024) Adding a gene expression profile test to aid differential diagnosis and treatment in aggressive large B-cell lymphoma: an early exploratory economic evaluation. Applied Health Economics and Health Policy, 22 (2). pp. 243-254. ISSN 1175-5652
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