5,457
Views
14
CrossRef citations to date
0
Altmetric
Oncology

Cost-effectiveness of denosumab for the prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States

, , , , , , & show all
Pages 37-47 | Received 17 Jun 2019, Accepted 30 Jul 2019, Published online: 26 Aug 2019

References

  • Coleman RE. Bisphosphonates: clinical experience. Oncologist. 2004;9:14–27.
  • Body JJ, Quinn G, Talbot S, et al. Systematic review and meta-analysis on the proportion of patients with breast cancer who develop bone metastases. Crit Rev Oncol Hematol. 2017;115:67–80.
  • McDougall JA, Bansal A, Goulart BH, et al. The clinical and economic impacts of skeletal-related events among Medicare enrollees with prostate cancer metastatic to bone. Oncologist. 2016;21:320–326.
  • Oster G, Lamerato L, Glass AG, et al. Natural history of skeletal-related events in patients with breast, lung, or prostate cancer and metastases to bone: a 15-year study in two large US health systems. Support Care Cancer. 2013;21:3279–3286.
  • Sathiakumar N, Delzell E, Morrisey MA, et al. Mortality following bone metastasis and skeletal-related events among women with breast cancer: a population-based analysis of U.S. Medicare beneficiaries, 1999–2006. Breast Cancer Res Treat. 2012;131:231–238.
  • Sathiakumar N, Delzell E, Morrisey MA, et al. Mortality following bone metastasis and skeletal-related events among men with prostate cancer: a population-based analysis of US Medicare beneficiaries, 1999-2006. Prostate Cancer Prostatic Dis. 2011;14:177–183.
  • Coleman R, Body JJ, Aapro M, et al. Bone health in cancer patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2014;25:iii124–iii37.
  • von Moos R, Body JJ, Egerdie B, et al. Pain and analgesic use associated with skeletal-related events in patients with advanced cancer and bone metastases. Support Care Cancer. 2016;24:1327–1337.
  • von Moos R, Body JJ, Egerdie B, et al. Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid. Support Care Cancer. 2013;21:3497–3507.
  • Patrick DL, Cleeland CS, von Moos R, et al. Pain outcomes in patients with bone metastases from advanced cancer: assessment and management with bone-targeting agents. Support Care Cancer. 2015;23:1157–1168.
  • Hechmati G, Cure S, Gouepo A, et al. Cost of skeletal-related events in European patients with solid tumours and bone metastases: data from a prospective multinational observational study. J Med Econ. 2013;16:691–700.
  • Zhong Y, Valderrama A, Yao J, et al. Economic evaluation of treating skeletal-related events among prostate cancer patients. Value Health. 2018;21:304–309.
  • Body JJ, Chevalier P, Gunther O, et al. The economic burden associated with skeletal-related events in patients with bone metastases secondary to solid tumors in Belgium. J Med Econ. 2013;16:539–546.
  • Hagiwara M, Delea TE, Chung K. Healthcare costs associated with skeletal-related events in breast cancer patients with bone metastases. J Med Econ. 2014;17:223–230.
  • Hagiwara M, Delea TE, Saville MW, et al. Healthcare utilization and costs associated with skeletal-related events in prostate cancer patients with bone metastases. Prostate Cancer Prostatic Dis. 2013;16:23–27.
  • Barlev A, Song X, Ivanov B, et al. Payer costs for inpatient treatment of pathologic fracture, surgery to bone, and spinal cord compression among patients with multiple myeloma or bone metastasis secondary to prostate or breast cancer. JMCP. 2010;16:693–702.
  • Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016;172:262–273.
  • Body JJ, Facon T, Coleman RE, et al. A study of the biological receptor activator of nuclear factor-kappaB ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastases from breast cancer. Clin Cancer Res. 2006;12:1221–1228.
  • Lipton A, Fizazi K, Stopeck AT, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. Eur J Cancer. 2012;48:3082–3092.
  • Van Poznak C, Somerfield MR, Moy B. Role of bone-modifying agents in metastatic breast cancer: an American Society of Clinical Oncology-Cancer Care Ontario focused guideline update summary. JOP. 2017;13:822–824.
  • Koo K, Lam K, Mittmann N, et al. Comparing cost-effectiveness analyses of denosumab versus zoledronic acid for the treatment of bone metastases. Support Care Cancer. 2013;21:1785–1791.
  • Ford J, Cummins E, Sharma P, et al. Systematic review of the clinical effectiveness and cost-effectiveness, and economic evaluation, of denosumab for the treatment of bone metastases from solid tumours. Health Technol Assess. 2013;17:1–386.
  • Dellis A, Papatsoris A. Cost-effectiveness of denosumab as a bone protective agent for patients with castration resistant prostate cancer. Expert Rev Pharmacoecon Outcomes Res. 2016;16:5–10.
  • Shapiro CL, Moriarty JP, Dusetzina S, et al. Cost-effectiveness analysis of monthly zoledronic acid, zoledronic acid every 3 months, and monthly denosumab in women with breast cancer and skeletal metastases: CALGB 70604 (Alliance). JCO. 2017;35:3949–3955.
  • Stopeck A, Rader M, Henry D, et al. Cost-effectiveness of denosumab vs zoledronic acid for prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States. J Med Econ. 2012;15:712–723.
  • Xie J, Diener M, Sorg R, et al. Cost-effectiveness of denosumab compared with zoledronic acid in patients with breast cancer and bone metastases. Clin Breast Cancer. 2012;12:247–258.
  • Snedecor SJ, Carter JA, Kaura S, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a cost-effectiveness analysis. J Med Econ. 2013;16:19–29.
  • Snedecor SJ, Carter JA, Kaura S, et al. Cost-effectiveness of denosumab versus zoledronic acid in the management of skeletal metastases secondary to breast cancer. Clin Ther. 2012;34:1334–1349.
  • Garrison LP, Jr, Kamal-Bahl S, Towse A. Toward a broader concept of value: identifying and defining elements for an expanded cost-effectiveness analysis. Value Health. 2017;20:213–216.
  • Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372:724–734.
  • York Health Economics Consortium. A glossary of health economic terms. 2016 [cited 2018 Jul 19]. Available from: http://www.yhec.co.uk/tools-resources/glossary/.
  • Adalsteinsson E, Toumi M. Benefits of probabilistic sensitivity analysis – a review of NICE decisions. J Mark Access Health Policy. 2013;1[doi: 10.3402/jmahp.v1i0.21240].
  • Ara R, Wailoo A. Using health state utility values in models exploring the cost-effectiveness of health technologies. Value Health. 2012;15:971–974.
  • Simoens S. Health economic assessment: a methodological primer. IJERPH. 2009;6:2950–2966.
  • University of Maryland School of Pharmacy. Transferability of economic evaluation studies: is there a generally accepted alternative price benchmark to the WAC price? 2017 [cited 2018 May 23]. Available from: https://faculty.rx.umaryland.edu/jslejko/files/2016/05/ISPOR-2017-W14-Part-1.pdf.
  • Ubel PA, Hirth RA, Chernew ME, et al. What is the price of life and why doesn’t it increase at the rate of inflation? Arch Intern Med. 2003;163:1637–1641.
  • Arellano J, Hernandez RK, Wade SW, et al. Prevalence of renal impairment and use of nephrotoxic agents among patients with bone metastases from solid tumors in the United States. Cancer Med. 2015;4:713–720.
  • Stopeck AT, Lipton A, Body JJ, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28:5132–5139.
  • Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377:813–822.
  • Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29:1125–1132.
  • Qian Y, Bhowmik D, Kachru N, et al. Longitudinal patterns of bone-targeted agent use among patients with solid tumors and bone metastases in the United States. Support Care Cancer. 2017;25:1845–1851.
  • Hatoum HT, Lin SJ, Smith MR, et al. Zoledronic acid and skeletal complications in patients with solid tumors and bone metastases: analysis of a national medical claims database. Cancer. 2008;113:1438–1445.
  • Data on File. Study 20060392 (STARS). Thousand Oaks (CA): Amgen Inc; 2017.
  • Cristino J, Finek J, Jandova P, et al. Cost-effectiveness of denosumab versus zoledronic acid for preventing skeletal-related events in the Czech Republic. J Med Econ. 2017;20:799–812.
  • Pavlakis N, Schmidt R, Stockler M. Bisphosphonates for breast cancer. Cochrane Database of Systematic Reviews. 2005;(3):CD003474.
  • Saad F, Gleason DM, Murray R, et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst. 2002;94:1458–1468.
  • Matza LS, Chung K, Van Brunt K, et al. Health state utilities for skeletal-related events secondary to bone metastases. Eur J Health Econ. 2014;15:7–18.
  • Data on File. Thousand Oaks (CA): Amgen Inc.; 2017.
  • Jayasekera J, Onukwugha E, Bikov K, et al. The economic burden of skeletal-related events among elderly men with metastatic prostate cancer. Pharmacoeconomics. 2014;32:173–191.
  • Delea T, Langer C, McKiernan J, et al. The cost of treatment of skeletal-related events in patients with bone metastases from lung cancer. Oncology. 2004;67:390–396.
  • Nash Smyth E, Conti I, Wooldridge JE, et al. Frequency of skeletal-related events and associated healthcare resource use and costs in US patients with multiple myeloma. J Med Econ. 2016;19:477–486.
  • Qian DW, Bhowmik D, Kachru N. Utilization patterns of bone-targeting agents among patients with multiple myeloma: analysis of real-world data. Blood. 2015;126:4501.
  • Centers for Medicare & Medicaid Services. Payment allowance limits for Medicare Part B drugs. Quarter 3. 2017 [cited 2017 Nov 9]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2017ASPFiles.html.
  • Cancer Research Economics Support Team. Discounting in economic evaluations in health care: a brief review. 2015 [cited 2018 May 23]. Available from: http://www.crest.uts.edu.au/pdfs/FactSheet_Discounting.pdf.
  • Tan MC, Regier DA, Esdaile JM, et al. Health economic evaluation: a primer for the practicing rheumatologist. Arthritis Rheum. 2006;55:648–656.
  • Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371:796–797.
  • Braithwaite RS, Meltzer DO, King JT, Jr, et al. What does the value of modern medicine say about the $50,000 per quality-adjusted life-year decision rule? Med Care. 2008;46:349–356.
  • Nadler E, Eckert B, Neumann PJ. Do oncologists believe new cancer drugs offer good value? Oncologist. 2006;11:90–95.
  • Kennedy L, Bhatta S, Hechmati G, et al. Response to cost-effectiveness analysis of zoledronic acid once per month, zoledronic acid once every 3 months, and denosumab once per month in women with breast cancer and skeletal metastases. JCO. 2018;36:1051.
  • Nicolatou-Galitis O, Schiodt M, Mendes RA, et al. Medication-related osteonecrosis of the jaw: definition and best practice for prevention, diagnosis, and treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019;127:117–135.
  • Otto S, Pautke C, Van den Wyngaert T, et al. Medication-related osteonecrosis of the jaw: Prevention, diagnosis and management in patients with cancer and bone metastases. Cancer Treat Rev. 2018;69:177–187.
  • Ramsey SD, Willke RJ, Glick H, et al. Cost-effectiveness analysis alongside clinical trials II–an ISPOR Good Research Practices Task Force report. Value Health. 2015;18:161–172.
  • Amadori D, Aglietta M, Alessi B, et al. Efficacy and safety of 12-weekly versus 4-weekly zoledronic acid for prolonged treatment of patients with bone metastases from breast cancer (ZOOM): a phase 3, open-label, randomised, non-inferiority trial. Lancet Oncol. 2013;14:663–670.
  • Himelstein AL, Foster JC, Khatcheressian JL, et al. Effect of longer-interval vs standard dosing of zoledronic acid on skeletal events in patients with bone metastases: a randomized clinical trial. JAMA. 2017;317:48–58.
  • Hortobagyi GN, Zheng M. Zoledronic acid dosing in patients with metastatic breast cancer–reply. JAMA Oncol. 2018;4:586.
  • Xie J, Namjoshi M, Wu EQ, et al. Economic evaluation of denosumab compared with zoledronic acid in hormone-refractory prostate cancer patients with bone metastases. J Manag Care Pharm. 2011;17:621–643.
  • Bell MJ, Miller JD, Namjoshi M. Comparative budget impact of formulary inclusion of zoledronic acid and denosumab for prevention of skeletal-related events in patients with bone metastases. Presented at: International Society For Pharmacoeconomics and Outcomes Research 16th Annual Meeting; 2011 May 21–25; Baltimore, MD.
  • Gridelli C, Ferrara C, Guerriero C, et al. Informal caregiving burden in advanced non-small cell lung cancer: the HABIT study. J Thorac Oncol. 2007;2:475–480.