Budget Impact Of Including Avelumab As A Second-Line Treatment For Locally Advanced Or Metastatic Urothelial Cancer In The United States: Commercial And Medicare Payer Perspectives

References

• National Cancer Institute. Cancer stat facts: bladder cancer. Surveillance, epidemiology, and end results program. https://seer.cancer.gov/statfacts/html/urinb.html Publication date unknown Accessed 9 2018.
   Google Scholar
• Siegel R, Miller K, Jemal ACancer statistics, 2017. CA Cancer J Clin. 2017;67(1):7–30.28055103
   PubMed Web of Science ®Google Scholar
• American Cancer Society. Bladder Cancer. American Cancer Society. Available from: https://www.cancer.org/content/cancer/en/cancer/bladder-cancer/ Published 2017 Accessed September 2018.
   Google Scholar
• Daneshmand S Epidemiology and Risk Factors of Urothelial (transitional cell) Carcinoma of the Bladder. UptoDate. Available from: http://www.uptodate.com/contents/epidemiology-and-risk-factors-of-urothelial-transitional-cell-carcinoma-of-the-bladder Published 2017 Accessed 9 2017.
   Google Scholar
• Bukhari N, Al-Shamsi HO, Azam F. Update on the treatment of metastatic urothelial carcinoma. ScientificWorldJournal 2018;2018:5682078.29977169
   PubMedGoogle Scholar
• Sridhar S. Evolving treatment of advanced urothelial cancer. J Oncol Pract. 2017;13(5):309–315.28489981
   PubMed Web of Science ®Google Scholar
• Bharmal M, Guenther S, Rosen G, et al. Second-line therapy in patients with locally advanced or metastatic urothelial cancer: a systematic literature review. Value Health. 2017;20(9): A414.
   Web of Science ®Google Scholar
• Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J Clin Oncol. 2011;29:2432–2438.21555688
   PubMed Web of Science ®Google Scholar
• Galsky MD, Pal SK, Lin SW, et al. Real-world effectiveness of chemotherapy in elderly patients with metastatic bladder cancer in the United States. Bladder Cancer. 2018;4(2):227–238.29732393
   PubMed Web of Science ®Google Scholar
• Simeone J, Nordstrom B, Patel K, et al. Treatment patterns and overall survival in metastatic urothelial carcinoma in a real-world US setting. Cancer Epidemiol. 2019;60:121–127. Epub ahead of print. doi:10.1016/j.canep.2019.03.01330953972
   PubMedGoogle Scholar
• Powles T, Duran I, van der Heijden MS, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicenter, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748–757.29268948
   PubMed Web of Science ®Google Scholar
• Oing C, Rink M, Oechsle K, et al. Second line chemotherapy for advanced and metastatic urothelial carcinoma: vinflunine and beyond—a comprehensive review of the current literature. J Urol. 2016;195(2):254–263.26410730
   PubMed Web of Science ®Google Scholar
• Patel M, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet. 2018;19(1):51–64.29217288
   PubMed Web of Science ®Google Scholar
• Bharmal M, Guenther S, Kearney M, et al. Epidemiology of locally advanced or metastatic urothelial cancer in the US, Europe, and Japan. Value Health. 2017;20(9):A419.
   Web of Science ®Google Scholar
• America’s Health Insurance Plans (AHIP). Medicare advantage demographics report, 2013. America’s Health Insurance Plans (AHIP). Available from: https://www.ahip.org/wp-content/uploads/2016/02/MADemo_Report_2-3-16.pdf Published 2016 Accessed 9 2018.
   Google Scholar
• Noone AM, Howlader N, Krapcho M, et al. SEER Cancer Statistics Review, 1975–2015. Bethesda, MD: National Cancer Institute, https://seer.cancer.gov/csr/1975_2015/ based on November 2017 SEER data submission, posted to the SEER web site, April 2018 Accessed 8 2018.
   Google Scholar
• United States Census Bureau Health insurance coverage status and type of coverage by selected characteristics. United States Census Bureau. Available from: https://www.census.gov Published 2018 Accessed 9 2018.
   Google Scholar
• Bellmunt J, Orsola A, Leow JJ, et al.Bladder cancer: ESMO Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25 Suppl 3(3):iii40–8.25096609
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®), bladder cancer, version 2.2018. Oncolife Medical Center. Available from: http://oncolife.com.ua/doc/nccn/Bladder_Cancer.pdf#page=26 Published 2018 Accessed 11 2018.
   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):5–14.24438712
   PubMed Web of Science ®Google Scholar
• Pannier A, Dunn JD AMCP format for formulary submissions, version 4.0. J Manag Care Spec Pharm. 2016;22(5):448.27123908
   PubMed Web of Science ®Google Scholar
• United States Department of Labor. Medical consumer price index. Bureau of Labor Statistics. Available from: https://www.bls.gov Published 2018 Accessed 8 2018.
   Google Scholar
• IBM Watson Health. IBM Micromedex RED BOOK®. Truven Health Analytics Inc. Available from: http://truvenhealth.com/products/micromedex/product-suites/clinical-knowledge/red-book Published 2018 Accessed 8 2018.
   Google Scholar
• Centers for Medicare & Medicaid Services (CMS). ASP Drug Pricing Files. CMS.gov. 2018a Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2018ASPFiles.html Published July 2018 Accessed 8 2018.
   Google Scholar
• Avelumab [package insert]. Rockland, MA: EMD Serono Inc; 2018.
   Google Scholar
• Atezolizumab [package insert]. South San Francisco, CA: Genentech Inc; 2018.
   Google Scholar
• Durvalumab [package insert]. Wilmington, DE: AstraZeneca; 2018.
   Google Scholar
• Nivolumab [package insert]. Princeton, NJ: Bristol-Myers Squibb; 2018.
   Google Scholar
• Pembrolizumab [package insert]. Frederick, MD: Merck Sharpe & Dohme Corp; 2018.
   Google Scholar
• Doshi GK, Bhanegaonkar A, Bharmal M, et al.SPEAR-bladder (study informing treatment pathway decision in bladder cancer): first-through Third-Line Time to Treatment Failure in the US. J Clin Oncol. 2018;36(S15):4544.
   Web of Science ®Google Scholar
• Bellmunt J, de Wit R, Vaughn DJ, et al.Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11):1015–1026.28212060
   PubMed Web of Science ®Google Scholar
• Powles T, O’Donnell PH, Massard C, et al.Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma. JAMA Oncol. 2017;3(9):e172411.28817753
   PubMed Web of Science ®Google Scholar
• Sharma P, Baron A, Necchi A, et al.Nivolumab monotherapy in patients with advanced platinum-resistant urothelial carcinoma: efficacy and safety update and association between biomarkers and overall survival in CheckMate 275. Cancer Res. 2018;78(13 Suppl): Abstract nr CT178.
   Web of Science ®Google Scholar
• Apolo AB, Ellerton J, Infante JR, et al. Avelumab Treatment of Metastatic Urothelial Carcinoma (mUC) in the phase 1b JAVELIN Solid Tumor study: updated analysis with ≥ 12 months of follow-up in all patients. Poster session presented at ESMO 2017. Proceedings of the European Society for Medical Oncology Congress; 9 8–12; Madrid, Spain.
   Google Scholar
• Healthcare Bluebook. Search for a procedure, test or service. Healthcare Bluebook. Available from: https://www.healthcarebluebook.com/ Publication date unknown Accessed 8 2018.
   Google Scholar
• Centers for Medicare & Medicaid Services (CMS). (2018b). Clinical diagnostic laboratory fee schedule. CMS.gov. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html Published 2018 Accessed 8 2018.
   Google Scholar
• Centers for Medicare & Medicaid Services (CMS). (2018c). Physician fee schedule look-up tool. CMS.gov. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html Published 2018 Accessed 8 2018.
   Google Scholar
• US Department of Health & Human Services. Healthcare cost and utilization project. Agency for Healthcare Research and Quality. Available from: https://hcupnet.ahrq.gov/#setup Published 2015 Accessed 9 2018.
   Google Scholar
• Toner RW, Pizzi L, Leas B, et al.Costs to hospitals of acquiring and processing blood in the US: a Survey of hospital-based blood banks and transfusion services. Appl Health Econ Health Policy. 2011;9(1):29–37.21174480
   PubMedGoogle Scholar
• Dietrich B, Srinivas S Urothelial carcinoma: the evolving landscape of immunotherapy for patients with advanced disease. Res Rep Urol 2018;10:7–16.29417045
   PubMed Web of Science ®Google Scholar
• Kearney M, Esposito D, Russo L, et al.Locally advanced or metastatic urothelial carcinoma in the United States: economic burden and healthcare utilization. Value Health. 2018;21(S1): S45.
   Google Scholar
• Flannery K, Cao X, He J, et al.Real-world treatment costs and resource utilization among patients with metastatic bladder cancer. Ann Oncol. 2017;28(suppl. 5): v395–v402.
   Google Scholar
• Flannery K, Cao X, He J, et al.Survival rates and health care costs for patients with advanced bladder cancer treated and untreated with chemotherapy. Clin Genitourin Cancer. 2018;16(4) e909–e917.29735397
   PubMed Web of Science ®Google Scholar
• Malangone-Monaco E, Wilson K, Varker H, et al. A real-world study of chemotherapy treatment and costs in metastatic urothelial cancer (mUC) patients in the United States. J Clin Oncol. 2017;35(15):e16009–e16009. doi:10.1200/JCO.2017.35.15_suppl.e16009
   Web of Science ®Google Scholar
• Rao S, Gooden K, Landsmen-Blumberg P, et al.Treatment patterns and economic burden of illness in patients with advanced bladder cancer receiving second-line therapy. J Clin Oncol 2017;35(6_suppl):320. doi:10.1200/JCO.2017.35.6_suppl.320.
   Web of Science ®Google Scholar