Cost–utility analysis of mogamulizumab in advanced mycosis fungoides and Sézary syndrome cutaneous T-cell lymphoma
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: This study assessed the cost–utility of mogamulizumab, a novel monoclonal antibody, versus established clinical management (ECM) in UK patients in previously treated advanced mycosis fungoides (MF)/Sézary syndrome (SS). Materials & methods: Lifetime partitioned survival model based on overall survival, next treatment-free survival and the use of allogeneic stem cell transplant was developed. Inputs were from the pivotal MAVORIC trial, real-world evidence and published literature. Extensive sensitivity analyses were conducted. Results: Discounted incremental quality-adjusted life years (QALYs), costs and incremental cost–effectiveness ratio were 3.08, £86,998 and £28,233. Results were most sensitive to the survival extrapolations, utilities and costs after loss of disease control. Conclusion: Mogamulizumab is a cost-effective alternative to ECM in UK patients with previously treated advanced MF/SS.
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References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Public Health England. National Cancer Registration and Analysis Services. Registration of cutaneous t-cell lymphoma (CTCL) in England. http://www.ncin.org.uk/view?rid=3275
2.
Lymphoma Action. What is lymphoma? https://lymphoma-action.org.uk/about-lymphoma/what-lymphoma
3.
Parker SRS, Bethaney JV. Cutaneous T cell lymphoma-mycosis fungoides and Sezary syndrome: an update. G Ital Dermatol Venereol. 144(4), 467–485 (2009).
4.
Agar NS, Wedgeworth E, Crichton S et al. Survival outcomes and prognostic factors in mycosis fungoides/Sézary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal. J. Clin. Oncol. 28(31), 4730–4739 (2010).
5.
Campbell JJ, Clark RA, Watanabe R, Kupper TS. Sezary syndrome and mycosis fungoides arise from distinct T-cell subsets: a biologic rationale for their distinct clinical behaviors. Blood 116(5), 767–771 (2010).
6.
Olsen E, Vonderheid E, Pimpinelli N et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood 110(6), 1713–1722 (2007).
7.
Scarisbrick JJ, Prince HM, Vermeer MH et al. Cutaneous Lymphoma International Consortium study of outcome in advanced stages of mycosis fungoides and Sézary syndrome: effect of specific prognostic markers on survival and development of a prognostic model. J. Clin. Oncol. 33(32), 3766–3773 (2015).
•• Provides survival from diagnosis, prognostic for the largest cohort of advanced mycosis fungoides and Sézary syndrome patients markers.
8.
Willemze R, Jaffe ES, Burg G et al. WHO-EORTC classification for cutaneous lymphomas. Blood 105(10), 3768–3785 (2005).
9.
Olsen EA, Whittaker S, Kim YH et al. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J. Clin. Oncol. 29(18), 2598–2607 (2011).
10.
Muszbek N, Glen F, Heaton D, McNamara L. Analysis of hospital episode statistics data to demonstrate the secondary care treatment pathway and outcomes of patients with cutaneous T-cell lymphoma in England. Virtual ISPOR Europe (2020). https://europe2020-ispor.ipostersessions.com/Default.aspx?s=europe_2020_gallery&token=jzclcvFzgd0imUc.hCqZY3b0hXGxf5a6KjngBFHNVRA
11.
Demierre M-F, Gan S, Jones J, Miller DR. Significant impact of cutaneous T-cell lymphoma on patients' quality of life: results of a 2005 National Cutaneous Lymphoma Foundation Survey. Cancer 107(10), 2504–2511 (2006).
12.
Orlowska D, Selman LE, Beynon T et al. “It's a traumatic illness, traumatic to witness”: a qualitative study of the experiences of bereaved family caregivers of patients with cutaneous T-cell lymphoma. Br. J. Dermatol. 179(4), 882–888 (2018).
13.
Beynon T, Selman L, Radcliffe E et al. “We had to change to single beds because I itch in the night”: a qualitative study of the experiences, attitudes and approaches to coping of patients with cutaneous T-cell lymphoma. Br. J. Dermatol. 173(1), 83–92 (2015).
14.
Selman LE, Beynon T, Radcliffe E et al. “We're all carrying a burden that we're not sharing”: a qualitative study of the impact of cutaneous T-cell lymphoma on the family. Br. J. Dermatol. 172(6), 1581–1592 (2015).
15.
Williams K, Gibson A, McNamara L, Jones T, Lloyd AJ. Health state utilities associated with caring for an individual with cutaneous T-cell lymphoma (CTCL). J Med Econ. 23(10), 1142–1150 (2020).
• The only available utility values for caregivers in mycosis fungoides and Sézary syndrome.
16.
Trautinger F, Eder J, Assaf C et al. European Organisation for Research and Treatment of Cancer consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome – Update 2017. Eur. J. Cancer 77, 57–74 (2017).
17.
Gilson D, Whittaker SJ, Child FJ et al. British Association of Dermatologists and U.K. Cutaneous Lymphoma Group guidelines for the management of primary cutaneous lymphomas 2018. Br. J. Dermatol. 180(3), 496–526 (2019).
18.
National Institute for Health and Care Excellence (NICE). Brentuximab vedotin for treating CD30-positive cutaneous T-cell lymphoma | Guidance [TA577] (2019). https://www.nice.org.uk/guidance/ta577/documents/html-content-3
•• Guidance for mogamulizumab by the National Institute for Health and Care Excellence (NICE) in the UK.
19.
Scarisbrick JJ, Whittaker S, Evans AV et al. Prognostic significance of tumor burden in the blood of patients with erythrodermic primary cutaneous T-cell lymphoma. Blood 97(3), 624–630 (2001).
20.
National Institute for Health and Care Excellence (NICE).Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome [TA754] | Guidance| NICE (2021). https://www.nice.org.uk/guidance/ta754
21.
Scottish Medicines Consortium (SMC). Advice on new medicines: mogamulizumab 4mg/ml concentrate for solution for infusion (Poteligeo®) (2021). https://www.scottishmedicines.org.uk/media/6023/mogamulizumab-poteligeo-final-may-2021-amended-240521-for-website.pdf
•• Guidance for mogamulizumab by the Scottish Medicines Consortium (SMC) in the UK.
22.
European Medicines Agency (EMA). Orphan designation (EU/3/16/1756) for mogamulizumab. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3161756
23.
Medicines and Healthcare products Regulatory Agency (MHRA). Promising Innovative Medicine (PIM) Designation – Step I of the Early Access to Medicines Scheme (EAMS) (2018). https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375327/PIM_designation_guidance.pdf
24.
Kim YH, Bagot M, Pinter-Brown L et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. The Lancet Oncology. 19(9), 1192–1204 (2018).
•• Pivotal trial publication for mogamulizumab for patients with previously treated mycosis fungoides and Sézary syndrome.
25.
Leoni M, Ito T, Jones T, Li J. Efficacy and safety of mogamulizumab in previously treated, advanced-stage mycosis fungoides and Sézary syndrome patients: a post hoc analysis of the MAVORIC study PCN54. Presented at: International Society for Pharmacoeconomics and Outcomes Research EU (ISPOR-EU) Copenhagen, Denmark (2019).
26.
Kim YH, Ortiz-Romero PL, Pro B et al. Time to next treatment in patients with previously treated cutaneous T-cell lymphoma (CTCL) receiving mogamulizumab or vorinostat: a MAVORIC post-hoc analysis. International Conference on Malignant Lymphoma (ICML). Hematological Oncology (2019). https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.7539
27.
Quaglino et al. Quality of life in cutaneous T-cell lymphoma subjects treated with the anti-CCR4 monoclonal antibody mogamulizumab versus vorinostat: results from the phase 3 mavoric trial | Cochrane Library. https://www.cochranelibrary.com/central/doi/10.1002/central/CN-01790514/full?cookiesEnabled
28.
European Medicines Agency. Poteligeo: European Public Assessment Report (EPAR). https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo
29.
National Institute for Health and Care Excellence (NICE). NICE health technology evaluations: the manual. Process and methods [PMG36] (2022). https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation
•• Methodological guidelines for health economic evaluations from the National Institute for Health and Care Excellence (NICE) in the UK
30.
Briggs A, Sculpher M, Claxton K. Decision Modelling for Health Economic Evaluation. Oxford University Press, UK (2006).
31.
Stahl JE. Modelling methods for pharmacoeconomics and health technology assessment: an overview and guide. Pharmacoeconomics 26(2), 131–148 (2008).
32.
Scottish Medicines Consortium (SMC). Brentuximab vedotin (Adcentris) – detailed advice (2019). https://www.scottishmedicines.org.uk/media/4980/brentuximab-vedotin-adcetris-final-december-2019-for-website.pdf
33.
Muszbek N, Glen F, Heaton D, McNamara L. End of life secondary care resource use and costs in mycosis fungoides and Sézary syndrome: an analysis of hospital episode statistics (2020). https://europe2020-ispor.ipostersessions.com/Default.aspx?s=europe_2020_gallery&token=jzclcvFzgd0imUc.hCqZY3b0hXGxf5a6KjngBFHNVRA
34.
European Medicines Agency. Summary of Product Characteristics. Poteligeo® (Mogamulizumab) (2019). https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo
35.
Neil Hawkins, Noemi Muszbek, Rachel Evans, Linda McNamara, Trefor Jones. Overall survival with mogamulizumab vs. current standard of care in the UK in mycosis fungoides or Sézary syndrome cutaneous T-cell lymphoma (2022).
•• Results of the population-adjusted indirect comparison of the overall survival with mogamulizumab compared to current UK clinical pactice
36.
Prince HM, Kim YH, Horwitz SM et al. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. The Lancet. 390(10094), 555–566 (2017).
37.
European Medicines Agency (EMA). Targretin (bexarotene): EPAR – product Information (2020). https://www.ema.europa.eu/en/medicines/human/EPAR/targretin
38.
Hawkins N, Muszbek N, Evans R, Dequen-O'Byrne P, Jones T, McNamara L. Adjusting for treatment crossover in the MAVORIC trial: survival in advanced mycosis fungoides and Sézary syndrome. Journal of Comparative Effectiveness Research. 11(11), 805–813 (2022).
•• Results of the crossover adjustment of the overall survival in the mogamulizumab pivotal trial.
39.
Latimer NR, Abrams KR. NICE DSU Technical Support Document 16: adjusting survival time estimates in the presence of treatment switching. Decision Support Unit, ScHARR (2014). https://www.ncbi.nlm.nih.gov/books/NBK310374/pdf/Bookshelf_NBK310374.pdf
40.
GetData Graph Digitizer. Digitize graphs and plots - GetData Graph Digitizer – graph digitizing software. http://getdata-graph-digitizer.com/index.php
41.
Latimer N. NICE DSU Technical Support Document 14: Survival analysis for economic evaluations alongside clinical trials – extrapolation with patient-level data. Decision Support Unit, ScHARR. (2013). https://www.ncbi.nlm.nih.gov/books/NBK310374/pdf/Bookshelf_NBK310374.pdf
42.
Kassambara A, Kosinski M, Biecek P, Fabian S. Package ‘survminer’ (2019). https://cran.r-project.org/web/packages/survminer/survminer.pdf
43.
J. JCMPA. Package ‘flexsurv’ (2019). https://cran.r-project.org/web/packages/flexsurv/flexsurv.pdf
44.
Akaike H. Information theory and an extension of the maximum likelihood principle. In: Selected Papers of Hirotugu Akaike Parzen E, Tanabe K, Kitagawa G (Eds). Springer, NY, USA, 199–213 (1998). https://doi.org/10.1007/978-1-4612-1694-0_15
45.
Schwarz G. Estimating the dimension of a model. Ann. Statist. 6(2), 461–464 (1978).
46.
National Institute for Health and Care Excellence (NICE). BNF: British National Formulary (2020). https://bnf.nice.org.uk/
47.
Electronic market information tool (eMIT). Drugs and pharmaceutical electronic market information tool (eMIT). GOV.UK (2020). https://www.gov.uk/government/publications/drugs-and-pharmaceutical-electronic-market-information-emit
48.
European Medicines Agency (EMA). Targretin (2018). https://www.ema.europa.eu/en/medicines/human/EPAR/targretin
49.
European Medicines Agency (EMA). IntronA: European product assessment report (EPAR) (2020). https://www.ema.europa.eu/en/documents/product-information/introna-epar-product-information_en.pdf
50.
European Medicines Agency (EMA). Adcetris – European public assessment report (EPAR) (2020). https://www.ema.europa.eu/en/medicines/human/EPAR/adcetris
51.
European Medicines Agency (EMA). Summary of product characterstics – Pegasys (2020). https://www.ema.europa.eu/en/medicines/human/EPAR/pegasys
52.
NHS London Cancer Alliance. West London Cancer Network,07 Protocol: CHOP & rituximab (2008). http://www.londoncanceralliance.nhs.uk/media/42661/2%2007%20R-CHOP%20Version%202%200%20Jul08.pdf
53.
Kyowa Kirin Ltd. Open-label, multi-center, randomized study of anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) versus vorinostat in subjects with previously treated cutaneous T-cell lymphoma (CTCL). Clinical Study Report (2017).
54.
National Health Service (NHS). NHS reference costs 2018 to 2019 (2019). https://improvement.nhs.uk/resources/reference-costs/
55.
National Institute for Health and Care Excellence (NICE). Pixantrone monotherapy for treating multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma (TA306) | Guidance. https://www.nice.org.uk/guidance/ta306
56.
National Institute for Health and Care Excellence (NICE). Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies [TA567] | Guidance | NICE. https://www.nice.org.uk/guidance/ta567
57.
National Institute for Health and Care Excellence (NICE). Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer [TA600] | Guidance | NICE (2019). https://www.nice.org.uk/guidance/TA600
58.
National Institute for Health and Care Excellence (NICE). Atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer | Guidance [TA584] (2019). https://www.nice.org.uk/guidance/TA584
59.
Curtis L, Burns A. PSSRU: Unit Costs of Health and Social Care 2019 (2019). http://www.pssru.ac.uk
60.
Williams K, Gibson A, McNamara L, Jones T, Lloyd A. Health state utilities associated with caring for an individual with cutaneous T-cell lymphoma (CTCL). J Med Econ 23(10), 1142–1150 (2020).
61.
National Institute for Health and Care Excellence (NICE). Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome [ID1405] – Committee papers [Internet] (2020). https://www.nice.org.uk/guidance/gid-ta10305/documents/committee-papers
62.
National Institute for Health and Care Excellence (NICE). Single technology appraisal – appeal hearing: advice on mogamulizumab for previously treated mycosis fungoides and Sezary syndrome [ID1405]. Decision of the panel (2021). https://www.nice.org.uk/guidance/ta754/history
63.
Kim YH, Liu HL, Mraz-Gernhard S, Varghese A, Hoppe RT. Long-term outcome of 525 patients with mycosis fungoides and Sezary syndrome: clinical prognostic factors and risk for disease progression. Arch. Dermatol. 139(7), 857–866 (2003).
64.
Talpur R, Singh L, Daulat S et al. Long-term outcomes of 1,263 patients with mycosis fungoides and Sézary syndrome from 1982 to 2009. Clin. Cancer Res. 18(18), 5051–5060 (2012).
65.
Grimm SE, Witlox W, Wolff R et al. Correction to: mogamulizumab for previously treated mycosis fungoides and Sézary syndrome: an evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics 40(5), 575 (2022).
66.
Grimm SE, Witlox W, Wolff R et al. Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome: an evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics 40(5), 509–518 (2022).
67.
National Institute for Health and Care Excellence (NICE). Mogamulizumab for treated mycosis fungoides or Sézary syndrome cutaneous T-cell lymphoma – final scope (2019). https://www.nice.org.uk/guidance/gid-ta10305/documents/final-scope
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© 2023 Noemi Muscbek. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
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Received: 21 February 2023
Accepted: 22 May 2023
Published online: 20 June 2023
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Cost–utility analysis of mogamulizumab in advanced mycosis fungoides and Sézary syndrome cutaneous T-cell lymphoma. (2023) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2023-0028
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