4,116
Views
8
CrossRef citations to date
0
Altmetric
Oncology

Cost-effectiveness of dabrafenib and trametinib in combination as adjuvant treatment of BRAF V600E/K mutation-positive melanoma from a US healthcare payer perspective

, , , , , , , & show all
Pages 1243-1252 | Received 20 Mar 2019, Accepted 20 Jun 2019, Published online: 04 Aug 2019

References

  • Boyle GM. Therapy for metastatic melanoma: an overview and update. Expert Rev Anticancer Ther. 2011;11:725–737.
  • Surveillance‚ Epidemiology‚ and End Results Program. Cancer stat facts: melanoma of the skin; 2017 [cited 2017 May 1]. Available from: https://seer.cancer.gov/statfacts/html/melan.html.
  • Balch CM, Gershenwald JE, Soong SJ, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009;27:6199–6206.
  • Eggermont AM, Maio M, Robert C. Immune checkpoint inhibitors in melanoma provide the cornerstones for curative therapies. Seminars Oncol. 2015;42:429–435.
  • Niezgoda A, Niezgoda P, Czajkowski R. Novel approaches to treatment of advanced melanoma: a review on targeted therapy and immunotherapy. Biomed Res Int. 2015;2015:1.
  • Long GV, Flaherty KT, Stroyakovskiy D, et al. Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study. Ann Oncol. 2017;28:1631–1639.
  • Robert C, Karaszewska B, Schachter J, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015;372:30–39.
  • Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017;377:1813.
  • Hauschild A, Santinami M, Long GV, et al. COMBI -AD: adjuvant dabrafenib plus trametinib for resected stage III BRAF V600-mutant melanoma. Ann Oncol. 2017;28:v605–v49.
  • Hauschild A, Dummer R, Schadendorf D, et al. Longer follow-up confirms relapse-free survival benefit with adjuvant dabrafenib plus trametinib in patients with resected BRAF V600–mutant stage III melanoma. JCO. 2018;36:3441–3449.
  • Weinstein MC, O'Brien B, Hornberger J, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices–modeling studies. Value Health. 2003;6:9–17.
  • Weinstein MC, Siegel JE, Gold MR, et al. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA. 1996;276:1253–1258.
  • Bureau of Labor Statistics. CPI-All urban consumers. Medical care in US city average, all urban. 2018 [cited 2018 Jan 18]. Available from: https://data.bls.gov/cgi-bin/surveymost?cu.
  • Jackson C. Package ‘flexsurv’. Flexible parametric survival and multi-state models; 2016 May 11 [cited 2016 Sep 26]. Available at: https://cran.r-project.org/web/packages/flexsurv/flexsurv.pdf.
  • Eggermont AM, Chiarion-Sileni V, Grob JJ, et al. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. N Engl J Med. 2016;375:1845–1855.
  • Salama AK, de Rosa N, Scheri RP, et al. Hazard-rate analysis and patterns of recurrence in early stage melanoma: moving towards a rationally designed surveillance strategy. PLoS One. 2013;8:e57665.
  • Arias E, Heron M, Xu J. United States life tables, 2014. Natl Vital Stat Rep. 2017;66(4):1–64.
  • Grob JJ, Amonkar MM, Karaszewska B, et al. Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial. Lancet Oncol. 2015;16:1389–1398.
  • Paly V, Colby C, Gilloteau I, et al. Predictors of utility over time among patients with treatment-naive advanced melanoma from the phase 3 checkmate 066 trial. Value Health. 2015;18:A474.
  • Sullivan PW, Ghushchyan V. Preference-based EQ-5D index scores for chronic conditions in the United States. Med Decis Making. 2006;26:410–420.
  • Akman T, Oztop I, Baskin Y, et al. The role of BRAF mutation in patients with high-risk malignant melanoma treated with high-dose adjuvant interferon therapy. Med Oncol. 2015;32:440.
  • Barbour AP, Tang YH, Armour N, et al. BRAF mutation status is an independent prognostic factor for resected stage IIIB and IIIC melanoma: implications for melanoma staging and adjuvant therapy. Eur J Cancer. 2014;50:2668–2676.
  • Boursault L, Haddad V, Vergier B, et al. Tumor homogeneity between primary and metastatic sites for BRAF status in metastatic melanoma determined by immunohistochemical and molecular testing. PLoS One. 2013;8:e70826.
  • Heppt MV, Siepmann T, Engel J, et al. Prognostic significance of BRAF and NRAS mutations in melanoma: a German study from routine care. BMC Cancer. 2017;17:536.
  • Johansson CC, Egyhazi S, Masucci G, et al. Prognostic significance of tumor iNOS and COX-2 in stage III malignant cutaneous melanoma. Cancer Immunol Immunother. 2009;58:1085–1094.
  • Knol AC, Pandolfino MC, Vallee A, et al. Comparative analysis of BRAF, NRAS and c-KIT mutation status between tumor tissues and autologous tumor cell-lines of stage III/IV melanoma. Exp Dermatol. 2015;24:70–73.
  • Mann GJ, Pupo GM, Campain AE, et al. BRAF mutation, NRAS mutation, and the absence of an immune-related expressed gene profile predict poor outcome in patients with stage III melanoma. J Invest Dermatol. 2013;133:509–517.
  • Moreau S, Saiag P, Aegerter P, et al. Prognostic value of BRAF V600 mutations in melanoma patients after resection of metastatic lymph nodes. Ann Surg Oncol. 2012;19:4314–4321.
  • Picard M, Pham Dang N, D'Incan M, et al. Is BRAF a prognostic factor in stage III skin melanoma? A retrospective study of 72 patients after positive sentinel lymph node dissection. Br J Dermatol. 2014;171:108–114.
  • Rutkowski P, Gos A, Jurkowska M, et al. Molecular alterations in clinical stage III cutaneous melanoma: correlation with clinicopathological features and patient outcome. Oncol Lett. 2014;8:47–54.
  • Shinozaki M, Fujimoto A, Morton DL, et al. Incidence of BRAF oncogene mutation and clinical relevance for primary cutaneous melanomas. Clin Cancer Res. 2004;10:1753–1757.
  • Thomas NE, Edmiston SN, Alexander A, et al. Association between NRAS and BRAF mutational status and melanoma-specific survival among patients with higher-risk primary melanoma. JAMA Oncol. 2015;1:359–368.
  • Weber J, Mandala M, Del Vecchio M, et al. Adjuvant nivolumab versus Ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377:1824.
  • BioMerieux B. THxID™ BRAF [package insert] 2013. Available from: http://www.biomerieux-usa.com/sites/subsidiary_us/files/braf-package-insert-1.pdf.
  • CMS Clinical Diagnostic Laboratory Fee Schedule [database on the Internet]. Center for Medicare and Medicaid Services (CMS); 2017 [cited 2017 Aug 22]. Available from: https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/17CLAB.zip.
  • Red Book online® [database on the Internet]. Truven Health Analytics; 2017 [cited 2017 Sep 6].
  • CMS Physician Fee Schedule Relative Value File [database on the Internet]. Center for Medicare and Medicaid Services (CMS); 2017 [cited 2017 Aug 22]. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVU17A.zip.
  • Larkin J, Minor D, D'Angelo S, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator's choice chemotherapy in checkmate 037: a randomized, controlled, open-label phase III trial. J Clin Oncol. 2018;36:383–390.
  • Tarhini A, Ghate SR, Ionescu-Ittu R, et al. Postsurgical treatment landscape and economic burden of locoregional and distant recurrence in patients with operable nonmetastatic melanoma. Melanoma Res. 2018;28(6):618–628.
  • National Comprehensive Cancer Network. NCCN Guidelines Version 1. 2018; 2017 [cited 2017 Oct 12]. Available from: www.nccn.org/professionals/physician.
  • Arondekar B, Curkendall S, Monberg M, et al. Economic burden associated with adverse events in patients with metastatic melanoma. J Manag Care Spec Pharm. 2015;21(2):158–164.
  • Wang J, Chmielowski B, Pellissier J, et al. Cost-effectiveness of pembrolizumab versus ipilimumab in ipilimumab-naive patients with advanced melanoma in the United States. J Manag Care Spec Pharm. 2017;23:184–194.
  • MPI Group. The cost of dispensing study. 2015 [cited 2017 Oct 31]. Available from: https://mopa.memberclicks.net/assets/docs/cost%20of%20dispensing.pdf
  • 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.
  • Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018;378:1789–1801.