Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma

References

• Lalami Y, Paesmans M, Aoun M, et al. A prospective randomised evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia. Support Care Cancer. 2004;12:725–730.
   PubMed Web of Science ®Google Scholar
• Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist. 2005;10:427–437.
   PubMed Web of Science ®Google Scholar
• Kuderer N, Dale D, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor or febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol. 2007;25:3158–3167.
   PubMed Web of Science ®Google Scholar
• Paessens B, von Schilling C, Berger K, et al. Health resource consumption and costs attributable to chemotherapy-induced toxicity in German routine hospital care in lymphoproliferative disorder and NSCLC patients. Ann Oncol. 2011;22:2310–2319.
   PubMed Web of Science ®Google Scholar
• Weycker D, Barron R, Kartashov A, et al. Incidence, treatment, and consequences of chemotherapy-induced febrile neutropenia in the inpatient and outpatient settings. J Oncol Pharm Pract. 2014;20:190–198.
   PubMed Web of Science ®Google Scholar
• Weycker D, Li X, Edelsberg J, et al. Risk and consequences of chemotherapy-induced febrile neutropenia in patients with metastatic solid tumors. J Oncol Pract. 2015;11:47–54.
   PubMed Web of Science ®Google Scholar
• Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33:3199–3212.
   PubMed Web of Science ®Google Scholar
• Crawford J, Becker PS, Armitage JO, et al. Myeloid growth factors, Version 2.2017. Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017;15:1520–1541.
   PubMed Web of Science ®Google Scholar
• Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eu J Cancer. 2011;47:8–32.
   PubMed Web of Science ®Google Scholar
• Tai E, Guy GP, Dunbar A, et al. Cost of cancer-related neutropenia or fever hospitalizations, United States, 2012. J Oncol Pract. 2017;13:e552–e561.
   PubMed Web of Science ®Google Scholar
• Raposo CG, Marin AP, Barón MG. Colony-stimulating factors: clinical evidence for treatment and prophylaxis of chemotherapy-induced febrile neutropenia. Clin Transl Oncol.. 2006;8:729–734.
   PubMedGoogle Scholar
• Amgen. Neulasta® highlights of prescribing information; 2018 Jun [updated 2019 Apr; cited 2019 May 14]. Available from: https://www.pi.amgen.com/∼/media/amgen/repositorysites/pi-amgen-com/neulasta/neulasta_pi_hcp_english.ashx.
   Google Scholar
• Joshi RS, Egbuna OI, Cairns AS, et al. Performance of the pegfilgrastim on-body injector as studied with placebo buffer in healthy volunteers. Curr Med Res Opin. 2017;33:379–384.
   PubMed Web of Science ®Google Scholar
• Stuessy P, Sanchez FA, Schober M. Retrospective review of pegfilgrastim on-body injector delivery rates in a large health system [abstract e18273]. J Clin Oncol. 2017;35:e18273.
   Web of Science ®Google Scholar
• Mahler LJ, DiBlasi R, Perez A, et al. On-body injector: an administration device for pegfilgrastim. Clin J Oncol Nurs. 2017;21:121–122.
   PubMed Web of Science ®Google Scholar
• Townley C, Porter C, McMullen N. Comparing grade 4 neutropenia associated with pegfilgrastim administered via the Onpro device versus manual injection with a prefilled syringe. J Hematol Oncol Pharm. 2018;8:3397.
   Google Scholar
• National Cancer Institute. SEER Cancer Stat Facts: Lung and bronchus cancer; [cited 2019 May 14]. Available from: https://seer.cancer.gov/statfacts/html/lungb.html.
   Google Scholar
• National Cancer Institute. SEER Cancer Stat Facts: Non-Hodgkin lymphoma; [cited 2019 May 14]; Available from: https://seer.cancer.gov/statfacts/html/nhl.html.
   Google Scholar
• Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med. 1991;325:164–170.
   PubMed Web of Science ®Google Scholar
• Holmes FA, O’Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002;20:727–731.
   PubMed Web of Science ®Google Scholar
• Green MD, Koebl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14:29–35.
   PubMed Web of Science ®Google Scholar
• Gascón P, Fuhr U, Sorgel F, et al. Development of a new G-CSF product based on biosimilarity assessment. Ann Oncol. 2010;21:1419–1429.
   PubMed Web of Science ®Google Scholar
• Blackwell K, Semiglazov V, Krasnozhon D, et al. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015;26:1948–1953.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. CHMP Assessment report for Zarzio. EMEA/CHMP/651339/2008; 2008. [cited 2019 May 14]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000917/WC500046528.pdf.
   Google Scholar
• Pinto L, Liu Z, Doan Q, et al. Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a meta-analysis of randomized controlled trials. Curr Med Res Opin. 2007;23:2283–2295.
   PubMed Web of Science ®Google Scholar
• Cooper KL, Madan J, Whyte S, et al. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer. 2011;11:404.
   PubMed Web of Science ®Google Scholar
• Wang L, Baser O, Kutikova L, et al. The impact of primary prophylaxis with granulocyte colony-stimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2015;23:3131–3140.
   PubMed Web of Science ®Google Scholar
• McBride A, Campbell K, Bikkina M, et al. Reply: cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. J Med Econ. 2018;21:606–609.
   PubMed Web of Science ®Google Scholar
• Klastersky J, Awada A. Prevention of febrile neutropenia in chemotherapy-treated cancer patients: pegylated versus standard myeloid colony stimulating factors. Do we have a choice? Crit Rev Oncol Hematol. 2011;78:17–23.
   PubMed Web of Science ®Google Scholar
• Gascón P, Aapro M, Ludwig H, et al. Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study). Support Care Cancer. 2016;24:911–925.
   PubMed Web of Science ®Google Scholar
• Weycker D, Hackett J, Edelsberg JS, et al. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother. 2006;40:402–407.
   PubMed Web of Science ®Google Scholar
• Timmer-Bonte JN, deBoo TM, Smit HJ, et al. Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: a Dutch randomized phase III study. J Clin Oncol. 2005;23:7974–7984.
   PubMed Web of Science ®Google Scholar
• Chrischilles E, Delgado DJ, Stolshek BS, et al. Impact of age and colony-stimulating factor use on hospital length of stay for febrile neutropenia in CHOP-treated non-Hodgkin’s lymphoma. Cancer Control. 2002;9:203–211.
   PubMedGoogle Scholar
• Ösby E, Hagberg H, Kvaløy S, et al. CHOP is superior to CNOP in elderly patients with aggressive lymphoma while outcome is unaffected by filgrastim treatment: results of a Nordic Lymphoma Group randomized trial. Blood. 2003;101:3840–3848.
   PubMed Web of Science ®Google Scholar
• Centers for Medicare and Medicaid Services. Medicare Part B drug average sales price. 2018 ASP drug pricing files: April 2018 ASP pricing file; 2018. [cited 2019 May 15]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2018ASPFiles.html.
   Google Scholar
• Centers for Medicare and Medicaid Services. Details for title: CMS-1676-F; 2018. [cited 2019 May 15]. Available from: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1676-F.html.
   Google Scholar
• Official Data Foundation. Medical care priced at $1,000 in 2000 -> $1,882.09 in 2019; 2018. [cited 2019 May 15]. Available from: www.officialdata.org/Medical-care/price-inflation.
   Google Scholar
• Aapro M, Ludwig H, Bokemeyer C, et al. Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study). Ann Oncol. 2016;27:2039–2045.
   PubMed Web of Science ®Google Scholar
• Bokemeyer C, Gascón P, Aapro M, et al. Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study. Support Care Cancer. 2017;25:1819–1828.
   PubMed Web of Science ®Google Scholar