Cost-effectiveness and budget impact analyses of tisagenlecleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma from Singapore’s private insurance payer’s perspective

References

• World Health Organization (WHO). Diffuse large B-cell lymphoma. Review of cancer medicines on the WHO list of essential medicines; 2014 [cited 2020 June]. Available from: http://www.who.int/selection_medicines/committees/expert/20/applications/DiffuseLargeBCellLymphoma.pdf.
   Google Scholar
• Smith A, Crouch S, Lax S, et al. Lymphoma incidence, survival and prevalence 2004–2014: sub-type analyses from the UK's haematological malignancy research network. Br J Cancer. 2015;112(9):1575–1584.
   PubMed Web of Science ®Google Scholar
• Lim RB, Loy EY, Lim GH, et al. Gender and ethnic differences in incidence and survival of lymphoid neoplasm subtypes in an Asian population: secular trends of a population-based cancer registry from 1998 to 2012. Int J Cancer. 2015;137(11):2674–2687.
   PubMed Web of Science ®Google Scholar
• Bishton MJ, Hughes S, Richardson F, et al. Delineating outcomes of patients with diffuse large b cell lymphoma using the national comprehensive cancer network-international prognostic index and positron emission tomography-defined remission status; a population-based analysis. Br J Haematol. 2016;172(2):246–254.
   PubMed Web of Science ®Google Scholar
• Rovira J, Valera A, Colomo L, et al. Prognosis of patients with diffuse large B cell lymphoma not reaching complete response or relapsing after frontline chemotherapy or immunochemotherapy. Ann Hematol. 2015;94(5):803–812.
   PubMed Web of Science ®Google Scholar
• Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl 5):v116–25.
   PubMed Web of Science ®Google Scholar
• Morrison VA, Hamlin P, Soubeyran P, et al. Diffuse large B-cell lymphoma in the elderly: impact of prognosis, comorbidities, geriatric assessment, and supportive care on clinical practice. An International Society of Geriatric Oncology (SIOG) expert position paper. J Geriatr Oncol. 2015;6(2):141–152.
   PubMed Web of Science ®Google Scholar
• Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era [clinical trial, phase III; comparative study; multicenter study; randomized controlled trial; research support, non-U.S. Gov't]. J Clin Oncol. 2010;28(27):4184–4190.
   PubMed Web of Science ®Google Scholar
• Crump M, Kuruvilla J, Couban S, et al. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014;32(31):3490–3496.
   PubMed Web of Science ®Google Scholar
• Chen YB, Lane AA, Logan BR, et al. Impact of conditioning regimen on outcomes for patients with lymphoma undergoing high-dose therapy with autologous hematopoietic cell transplantation. J Am Soc Blood Marrow Transplant. 2015;21(6):1046–1053.
   PubMed Web of Science ®Google Scholar
• Gordon R, Thompson C, Carolan J, et al. A costing study of blood and marrow transplantation services in NSW: final report; 2009 [cited 2020 June]. Available from: https://ro.uow.edu.au/cgi/viewcontent.cgi?article=1496&context=ahsri.
   Google Scholar
• ClinicalTrials.gov Registry. Study of efficacy and safety of CTL019 in adult DLBCL patients (JULIET), NCT02445248; 2015 [cited 2020 June]. Available from: https://clinicaltrials.gov/ct2/show/NCT02445248.
   Google Scholar
• Riedell PA, Walling C, Nastoupil LJ, et al. A multicenter retrospective analysis of clinical outcomes, toxicities, and patterns of use in institutions utilizing commercial axicabtagene ciloleucel and tisagenlecleucel for relapsed/refractory aggressive B-cell lymphomas. Blood. 2019;134(Supplement_1):1599–1599.
   Web of Science ®Google Scholar
• Riedell P, Brower J, Nastoupil L. A multicenter retrospective analysis of outcomes and toxicities with commercial axicabtagene ciloleucel and tisagenlecleucel for relapsed/referactory aggressive B-cell lymphomas. Biol Blood Marrow Transplant. 2020;26:S8–S742020.
   Web of Science ®Google Scholar
• Jaglowski S, Hu Z, Zhang Y. Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for adults with diffuse large B-cell lymphoma (DLBCL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry. Blood; Oral presentation (number 766) 61st American Society of Hematology (ASH) Annual Meeting, Orlando, FL.: 134 (Supplement_1): 766; 2019.
   Google Scholar
• Sesques P, Ferrant E, Safar V, et al. Commercial anti-CD19 CAR T cell therapy for patients with relapsed/refractory aggressive B cell lymphoma in a European center. Am J Hematol. 2020;95(11):1324–1333.
   PubMed Web of Science ®Google Scholar
• Iabconi G, editor. Real-world evidence of the use of tisagenlecleucel for patients with relapsed/refractory aggressive B-cell lymphomas. The Spanish experience. 2020; Poster presented at the 2nd European CAR T-Cell Meeting, February 1, 2020, Sitges, Spain.
   Google Scholar
• Svoboda J, Ballard H, Chong E, et al. Use of bendamustine for lymphodepletion before tisagenlecleucel (anti-CD19 CAR t cells) for aggressive B-cell lymphomas. Blood. 2019;134(Supplement_1):1606–1606.
   Web of Science ®Google Scholar
• Chong E, Gerson J, Landsburg D, et al. Outcomes in aggressive B-cell non-hodgkin lymphomas with anti-CD19 CAR T-Cell (CTL019) products not meeting commercial release specifications. Blood. 2019;134(Supplement_1):594–594.
   Web of Science ®Google Scholar
• Kuhnl A. Real-world data of high-grade lymphoma patients treated with CD19 CAR-T in England. Blood; 61st American Society of Hematology (ASH) Annual Meeting, December 7–10, 2019, Orlando, FL. 2019.
   Google Scholar
• Novartis. Novartis receives approval for Kymriah (tisagenlecleucel) by Health Sciences Authority as Singapore’s first commercially approved CAR-T therapy; 2021 [cited 2021 March]. Available from: https://www.novartis.com.sg/news/media-releases/novartis-receives-approval-kymriah-tisagenlecleucel-health-sciences-authority.
   Google Scholar
• MOH Singapore. Government health expenditure and healthcare financing; [cited 2021 Feb]. Available from: https://www.moh.gov.sg/resources-statistics/singapore-health-facts/government-health-expenditure-and-healthcare-financing.
   Google Scholar
• Cher BP, Gan KY, Aziz MIA, et al. Cost utility analysis of tisagenlecleucel vs salvage chemotherapy in the treatment of relapsed/refractory diffuse large B-cell lymphoma from Singapore's healthcare system perspective. J Med Econ. 2020;23(11):1321–1329.
   PubMed Web of Science ®Google Scholar
• Nicedsu.org.uk. Nice DSU technical support document 19: partitioned survival analysis for decision modelling in health care: a critical review; 2017. Available from: http://nicedsu.org.uk/wp-content/uploads/2017/06/Partitioned-Survival-Analysis-final-report.pdf
   Google Scholar
• Schuster SJ, Svoboda J, Chong EA, et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas. N Eng J Med. 2017;377(26):2545–2554.
   PubMed Web of Science ®Google Scholar
• Agency for Care Effectiveness. ACE clinical guidance (ACG) process and methods; 2020 [cited 2020 June]. Available from: https://www.ace-hta.gov.sg/our-process-and-methods.html.
   Google Scholar
• NICE. Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies [ID1166]; 2019 [cited 2020 June]. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10269.
   Google Scholar
• MSAC. Public Summary Document, Tisagenlecleucel (CTL019) for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL); 2019 [cited 2020 August]. Available from: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/A2B10F9A03293BC8CA2583CF001C7A4D/$File/1519.1%20Final%20updated%20PSD%20Nov%2019_redacted.pdf.
   Google Scholar
• Hutubessy R, Chisholm D, Edejer TT. Generalized cost-effectiveness analysis for national-level priority-setting in the health sector. Cost Eff Resour Alloc. 2003;1(1):8.
   PubMedGoogle Scholar
• Department of Statistics Singapore. Department of Statistics Singapore; 2019 [cited 2020 December]. Available from: https://www.singstat.gov.sg/modules/infographics/economy.
   Google Scholar
• MAS. Monetary Authority of Singapore. Exchange rates; 2021 [cited 2021 April]. Available from: https://eservices.mas.gov.sg/Statistics/msb/ExchangeRates.aspx.
   Google Scholar
• Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR study. Blood. 2017;130(16):1800–1808.
   PubMed Web of Science ®Google Scholar
• Van Den Neste E, Schmitz N, Mounier N, et al. Outcome of patients with relapsed diffuse large B-celllymphoma who fail second-line salvage regimens inthe International CORAL study. Bone Marrow Transplant. 2016;51(1):51–57.
   PubMed Web of Science ®Google Scholar
• Guyot P, Ades AE, Ouwens MJ, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan–Meier survival curves. BMC Med Res Methodol. 2012;1;12:9.
   Web of Science ®Google Scholar
• National Guideline Alliance. Non-Hodgkin's lymphoma: diagnosis and management. London: National Institute for Health and Care Excellence (UK). Jul. (NICE Guideline, No. 52.); 2016 [cited 2020 November]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK374283/.
   Google Scholar
• Department of Statistics Singapore. Complete life tables for Singapore resident population, 2017–2018; 2019 [cited 2020 June]. Available from: https://www.singstat.gov.sg/publications/population/complete-life-table.
   Google Scholar
• Maurer MJ, Ghesquieres H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066–1073.
   PubMed Web of Science ®Google Scholar
• NCCN. NCCN clinical practice guidelines in oncology; diffuse large b cell lymphoma; 2019 [cited 2020 June]. Available from: https://www.nccn.org/professionals/physician_gls/default.aspx#b-cell.
   Google Scholar
• Corazzelli G, Capobianco G, Arcamone M, et al. Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma. Cancer Chemotherapy and Pharmacology. 2009;64(5):907–916.
   PubMed Web of Science ®Google Scholar
• Purdum A, Tieu R, Reddy SR, et al. Direct costs associated with relapsed diffuse large b-cell lymphoma therapies. The Oncol. 2019;24(9):1229–1236.
   PubMed Web of Science ®Google Scholar
• Phua L, Lee S, Ng K, et al. Cost-effectiveness analysis of atezolizumab in advanced triple-negative breast cancer. BMC Health Serv Res. 2020;20(1):581.
   Google Scholar
• Compagno N, Malipiero G, Cinetto F, et al. Immunoglobulin replacement therapy in secondary hypogammaglobulinemia. Front Immunol. 2014;5:626.
   PubMed Web of Science ®Google Scholar
• Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380(1):45–56.
   PubMed Web of Science ®Google Scholar
• Kim SH, Kim SO, Lee SI, et al. Deriving a mapping algorithm for converting SF-36 scores to EQ-5D utility score in a Korean population. Health Qual Life Outcomes. 2014;12:145.
   PubMed Web of Science ®Google Scholar
• Guadagnolo BA, Punglia RS, Kuntz KM, et al. Cost-effectiveness analysis of computerized tomography in the routine follow-up of patients after primary treatment for Hodgkin's disease. J Clin Oncol. 2006;24(25):4116–4122.
   PubMed Web of Science ®Google Scholar
• GLOBOCAN; 2018 [cited 2020 June]. Available from: https://gco.iarc.fr/.
   Google Scholar
• National Registry of Diseases Office. Singapore Cancer Registry Report No. 8. Cancer incidence and mortality 2003 – 2012 and selected trends 1973 – 2012 in Singapore. Singapore Cancer Registry; 2015 [cited 2020 December]. Available from: https://www.nrdo.gov.sg/docs/librariesprovider3/default-document-library/cancertrends_7312_web128e09a5c9d76bafab5aff000014cdee.pdf?sfvrsn=0.
   Google Scholar
• National Cancer Centre Singapore. Cancer incidence in Singapore; 2015 [cited 2020 June]. Available from: https://www.nccs.com.sg/patient-care/cancer-types/cancer-statistics.
   Google Scholar
• Arboe B, Olsen MH, Gorlov JS, et al. Treatment intensity and survival in patients with relapsed or refractory diffuse large B-cell lymphoma in Denmark: a real-life population-based study. CLEP. 2019;11:207–216.
   Web of Science ®Google Scholar
• Chen Q, Staton AD, Ayer T, et al. Exploring the potential cost-effectiveness of precision medicine treatment strategies for diffuse large B-cell lymphoma. Leuk Lymphoma. 2018;59(7):1700–1709.
   PubMed Web of Science ®Google Scholar
• Huntington S, Keshishian A, McGuire M, et al. Costs of relapsed diffuse large B-cell lymphoma among Medicare patients. Leukemia Lymphoma. 2018;59(12):2880–2887.
   PubMed Web of Science ®Google Scholar
• Danese MD, Griffiths RI, Gleeson ML, et al. Second-line therapy in diffuse large B-cell lymphoma (DLBCL): treatment patterns and outcomes in older patients receiving outpatient chemotherapy. Leuk Lymphoma. 2017;58(5):1094–1104.
   PubMed Web of Science ®Google Scholar
• Muszbek N, Kadambi A, Lanitis T, et al. The cost-effectiveness of pixantrone for third/fourth-line treatment of aggressive non-Hodgkin's lymphoma. Clin Ther. 2016;38(3):503–515.
   PubMed Web of Science ®Google Scholar
• Lin JK, Muffly LS, Spinner MA, et al. Cost effectiveness of chimeric antigen receptor T-cell therapy in multiply relapsed or refractory adult large B-cell lymphoma. J Clin Oncol. 2019;37(24):2105–2119.
   PubMed Web of Science ®Google Scholar
• Yang H, Qi C, Zhang J, et al. Cost-effectiveness of tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma – a Canadian societal perspective. Poster presentation (number PCN177). Presented at ISPOR Europe 2018; November 10–14, 2018; Barcelona, Spain. 2018.
   Google Scholar
• Wakase S, Teshima T, Zhang J, et al. Cost effectiveness analysis of tisagenlecleucel for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma in Japan. Transplant Cell Ther. 2021;S2666-6367(21)00748-X.
   Google Scholar
• Ministry of Health Singapore. Comparison of integrated shield plans; 2021 [cited 2021 March]. Available from: https://www.moh.gov.sg/cost-financing/healthcare-schemes-subsidies/medishield-life/comparison-of-integrated-shield-plans.
   Google Scholar