Time and personnel costs associated with adverse event (AE) management among patients with chronic lymphocytic leukemia (CLL)

References

• American Cancer Society. What Is chronic lymphocytic leukemia? 2022 [cited 2022 Feb 10]. Available from: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html
   Google Scholar
• Frey S, Blankart CR, Stargardt T. Economic burden and quality-of-life effects of chronic lymphocytic leukemia: a systematic review of the literature. Pharmacoeconomics. 2016;34(5):479–498.
   PubMed Web of Science ®Google Scholar
• Stephens JM, Gramegna P, Laskin B, et al. Chronic lymphocytic leukemia: economic burden and quality of life: literature review. Am J Ther. 2005;12(5):460–466.
   PubMedGoogle Scholar
• Hallek M. Chronic lymphocytic leukemia: 2020 update on diagnosis, risk stratification and treatment. Am J Hematol. 2019;94(11):1266–1287.
   PubMed Web of Science ®Google Scholar
• Furstenau M, Hallek M, Eichhorst B. Sequential and combination treatments with novel agents in chronic lymphocytic leukemia. Haematologica. 2019;104(11):2144–2154.
   PubMed Web of Science ®Google Scholar
• Danilov AV, Persky DO. Incorporating acalabrutinib, a selective next-generation Bruton tyrosine kinase inhibitor, into clinical practice for the treatment of haematological malignancies. Br JHaematol. 2021;193(1):15–25.
   PubMed Web of Science ®Google Scholar
• Harris V, Borlagdan J, Muluneh B. Oral oncolytic treatment for chronic lymphocytic leukemia. J Oncol Pharm Pract. 2022;28(4):935–944.
   PubMed Web of Science ®Google Scholar
• Abbvie Inc. FDA approves imbruvica (ibrutinib) for the first-line treatment of chronic lymphocytic leukemia: Drugs.com; 2016 [cited 2020 Feb 14]. Available from: https://www.drugs.com/newdrugs/fda-approves-imbruvica-ibrutinib-first-line-chronic-lymphocytic-leukemia-4353.html
   Google Scholar
• United States Food and Drug Administration. FDA approves imbruvica (ibrutinib) to treat chronic lymphocytic leukemia: Drugs.com; 2014 [cited 2020 Feb 14]. Available from: https://www.drugs.com/newdrugs/fda-approves-imbruvica-ibrutinib-chronic-lymphocytic-leukemia-4007.html
   Google Scholar
• United States Food and Drug Administration. Labeling-Package Insert: iMBRUVICA® (ibrutinib) 2020 [cited 2022 Jan 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf
   Google Scholar
• Byrd JC, Hillmen P, Ghia P, et al. Acalabrutinib versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: results of the First Randomized Phase III Trial. J Clin Oncol. 2021;39(31):3441–3452. DOI:10.1200/JCO.21.01210.
   PubMed Web of Science ®Google Scholar
• Mato AR, Nabhan C, Thompson MC, et al. Toxicities and outcomes of 616 ibrutinib-treated patients in the United States: a real-world analysis. Haematologica. 2018;103(5):874–879. DOI:10.3324/haematol.2017.182907
   PubMed Web of Science ®Google Scholar
• Mato AR, Nabhan C, Barr PM, et al. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016;128(18):2199–2205. DOI:10.1182/blood-2016-05-716977
   PubMed Web of Science ®Google Scholar
• O’brien S, Hillmen P, Coutre S, et al. Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2018;18(10):648–657 e15. DOI:10.1016/j.clml.2018.06.016
   PubMed Web of Science ®Google Scholar
• Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015;373(25):2425–2437. DOI:10.1056/NEJMoa1509388
   PubMed Web of Science ®Google Scholar
• Byrd JC, Brown JR, O’brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213–223. DOI:10.1056/NEJMoa1400376
   PubMed Web of Science ®Google Scholar
• Byrd JC, Harrington B, O’brien S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374(4):323–332. 10.1056/NEJMoa1509981
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration. Labeling-Package Insert: cALQUENCE® (acalabrutinib) 2019 [cited 2022 Jan 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf
   Google Scholar
• Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278–1291.
   PubMed Web of Science ®Google Scholar
• Ghia P, Pluta A, Wach M, et al. ASCEND: phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia. J Clin Oncol. 2020;38(25):2849–2861. DOI:10.1200/JCO.19.03355.
   PubMed Web of Science ®Google Scholar
• Davids MS, Telford C, Abhyankar S, et al. Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. Leukemia & Lymphoma. 2021;62(10):1–16. DOI:10.1080/10428194.2021.1913144.
   PubMed Web of Science ®Google Scholar
• Furman RR, Byrd JC, Owen RG, et al. Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies. Leukemia. 2021;35(11):3201–3211. DOI:10.1038/s41375-021-01252-y
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration. Labeling-package insert: venclexta® (venetoclax) 2019 [cited 2022 Jan 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208573s011s014s015lbl.pdf
   Google Scholar
• Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL And coexisting conditions. N Engl J Med. 2019;380(23):2225–2236. DOI:10.1056/NEJMoa1815281
   PubMed Web of Science ®Google Scholar
• Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107–1120. DOI:10.1056/NEJMoa1713976
   PubMed Web of Science ®Google Scholar
• Fischer K, Al-Sawaf O, Hallek M. Preventing and monitoring for tumor lysis syndrome and other toxicities of venetoclax during treatment of chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program. 2020;2020(1):357–362.
   PubMedGoogle Scholar
• Wong W, Yim YM, Kim A, et al. Assessment of costs associated with adverse events in patients with cancer. PLoS ONE. 2018;13(4):e0196007. DOI:10.1371/journal.pone.0196007
   PubMed Web of Science ®Google Scholar
• Wong JCW, Cloutier M. Estimating the costs of adverse events in economic models: is there a “right” approach? Value Outcomes Spotlight. 2019;5(3):27–29.
   Google Scholar
• Pesonen M, Kankaanpaa E, Jylha V. Adverse drug events in cost-effectiveness analyses of interventions for diabetic conditions: a scoping review protocol. JBI Evid Synth. 2022;20(12):3058–3066.
   PubMedGoogle Scholar
• Kim DD, Basu A. How does cost-effectiveness analysis inform health care decisions? AMA J Ethics. 2021;23(8):639–647.
   Google Scholar
• Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force. Value Health. 2014;17(1):5–14. DOI:10.1016/j.jval.2013.08.2291
   PubMed Web of Science ®Google Scholar
• Peryer G, Golder S, Junqueira D, et al. Chapter 19: adverse effects. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, editors, Cochrane handbook for systematic reviews of interventions version 6.3 (updated February 2022). Cochrane; 2022. www.training.cochrane.org/handbook
   Google Scholar
• Etikan I, Musa SA, Alkassim RS. Comparison of convenience sampling and purposive sampling. Am J Theor Appl Stat. 2016. 5(1):1–4. DOI:10.11648/j.ajtas.20160501.11
   Google Scholar
• United States Bureau of Labor Statistics. [cited 2020 Feb 14]. Available from: https://www.bls.gov/oes/
   Google Scholar
• Eltorai AEM, Eltorai AS, Fuentes C, et al. Financial implications of physician specialty choice. R I Med J. 2018;101(8):50–55.
   Google Scholar
• Isidori A, de Leval L, Gergis U, et al. Management Of patients with hematologic malignancies during the COVID-19 pandemic: practical considerations and lessons to be learned. Front Oncol. 2020;10:1439.
   PubMed Web of Science ®Google Scholar
• Koffman B, Mato A, Byrd JC, et al. Management of CLL patients early in the COVID-19 pandemic: an international survey of CLL experts. Am J Hematol. 2020;95(8):E199–203. DOI:10.1002/ajh.25851
   PubMed Web of Science ®Google Scholar