Budget impact analysis of a novel gene expression assay for the diagnosis of malignant melanoma

References

• Siegel R, Ma J, Zou Z, et al. Cancer statistics, 2014. CA Cancer J Clin 2014;64:9-29
   PubMed Web of Science ®Google Scholar
• Surveillance, Epidemiology, and End Results (SEER) Program. SEER Stat Fact Sheets: Melanoma of the Skin. http://seer.cancer.gov/statfacts/html/melan.html. Accessed January 28, 2014
   Google Scholar
• Flaherty KT, Infante JR, Daud A, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med 2012;367:1694-703
   PubMed Web of Science ®Google Scholar
• Sosman JA, Kim KB, Schuchter L, et al. Survival in BRAF V600–Mutant advanced melanoma treated with Vemurafenib. N Engl J Med 2012;366:707-14
   PubMed Web of Science ®Google Scholar
• Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with Ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23
   PubMed Web of Science ®Google Scholar
• Rigel DS, Russak J, Friedman R. The evolution of melanoma diagnosis: 25 years beyond the ABCDs. CA Cancer J Clin 2010;60:301-16
   PubMed Web of Science ®Google Scholar
• Shoo BA, Sagebiel RW, Kashani-Sabet M. Discordance in the histopathologic diagnosis of melanoma at a melanoma referral center. J Am Acad Dermatol 2010;62:751-6
   PubMed Web of Science ®Google Scholar
• Argenziano G, Cerroni L, Zalaudek I, et al. Accuracy in melanoma detection: a 10-year multicenter survey. J Am Acad Dermatol 2012;67:54-9
   PubMed Web of Science ®Google Scholar
• Hawryluk EB, Sober AJ, Piris A, et al. Histologically challenging melanocytic tumors referred to a tertiary care pigmented lesion clinic. J Am Acad Dermatol 2012;67:727-35
   PubMedGoogle Scholar
• Lodha S, Saggar S, Celebi JT, et al. Discordance in the histopathologic diagnosis of difficult melanocytic neoplasms in the clinical setting. J Cutan Pathol 2008;35:349-52
   PubMed Web of Science ®Google Scholar
• Piepkorn MW, Barnhill RL, Cannon-Albright LA, et al. A multiobserver, population-based analysis of histologic dysplasia in melanocytic nevi. J Am Acad Dermatol 1994;30:707-14
   PubMedGoogle Scholar
• Farmer ER, Gonin R, Hanna MP. Discordance in the histopathologic diagnosis of melanoma and melanocytic nevi between expert pathologists. Hum Pathol 1996;27:528-31
   PubMed Web of Science ®Google Scholar
• Brochez L, Verhaeghe E, Grosshans E, et al. Inter-observer variation in the histopathological diagnosis of clinically suspicious pigmented skin lesions. J Pathol 2002;196:459-66
   PubMed Web of Science ®Google Scholar
• Santillan AA, Messina JL, Marzban SS, et al. Pathology review of thin melanoma and melanoma in situ in a multidisciplinary melanoma clinic: impact on treatment decisions. J Clin Oncol 2010;28:481-6
   PubMedGoogle Scholar
• Ng JC, Swain S, Dowling JP, et al. the impact of partial biopsy on histopathologic diagnosis of cutaneous melanoma. Arch Dermatol 2010;146:234-9
   PubMedGoogle Scholar
• Armour K, Mann S, Lee S. Dysplastic naevi: to shave, or not to shave? Australas J Dermatol 2005;46:70-5
   PubMedGoogle Scholar
• McGinnis KS, Lessin SR, Elder DE, et al. Pathology review of cases presenting to a multidisciplinary pigmented lesion clinic. Arch Dermatol 2002;138:617-21
   PubMedGoogle Scholar
• Veenhuizen KC, De Wit PE, Mooi WJ, et al. Quality assessment by expert opinion in melanoma pathology. J Pathol 1997;182:266-72
   PubMed Web of Science ®Google Scholar
• Weinstock MA, Barnhill RL, Rhodes AR, et al. Reliability of the histopathologic diagnosis of melanocytic dysplasia. Arch Dermatol 1997;133:953-8
   PubMedGoogle Scholar
• Corona R, Mele A, Amini M, et al. Interobserver variability on the histopathologic diagnosis of cutaneous melanoma and other pigmented skin lesions. J Clin Oncol 1996;14:1218-23
   PubMed Web of Science ®Google Scholar
• Cornish D, Holterhues C, van de Poll-Franse LV, et al. A systematic review of health-related quality of life in cutaneous melanoma. Ann Oncol 2009;20(6 Suppl):vi51-8
   PubMedGoogle Scholar
• Atkinson TM, Noce NS, Hay J, et al. Illness-related distress in women with clinically localized cutaneous melanoma. Ann Surg Oncol 2013;20:675-9
   PubMedGoogle Scholar
• Morton RL, Rychetnik L, McCaffery K, et al. Patients' perspectives of long-term follow-up for localised cutaneous melanoma. Eur J Surg Oncol 2013;39:297-303
   PubMedGoogle Scholar
• Troxel DB. Pitfalls in the diagnosis of malignant melanoma: findings of a risk management panel study. Am J Surg Pathol 2003;27:1278-83
   PubMed Web of Science ®Google Scholar
• Ohsie SJ, Sarantopoulos GP, Cochran AJ, et al. Immunohistochemical characteristics of melanoma. J Cutan Pathol 2008;35:433-44
   PubMed Web of Science ®Google Scholar
• Prieto VG, Shea CR. Immunohistochemistry of melanocytic proliferations. Arch Pathol Lab Med 2011;135:853-9
   PubMedGoogle Scholar
• Zhang G, Li G. Novel multiple markers to distinguish melanoma from dysplastic nevi. PLoS One 2012;7:e45037
   Google Scholar
• Gerami P, Jewell SS, Morrison LE, et al. Fluorescence in Situ Hybridization (FISH) as an ancillary diagnostic tool in the diagnosis of melanoma. Am J Surg Pathol 2009;33:1146-56
   PubMed Web of Science ®Google Scholar
• Gerami P, Zembowicz A. Update on Fluorescence in Situ Hybridization in melanoma: state of the art. Arch Pathol Lab Med 2011;135:830-7
   PubMedGoogle Scholar
• Gerami P, Li G, Pouryazdanparast P, et al. A highly specific and discriminatory FISH assay for distinguishing between benign and malignant melanocytic neoplasms. Am J Surg Pathol 2012;36:808-17
   PubMed Web of Science ®Google Scholar
• Moore MW, Gasparini R. FISH as an effective diagnostic tool for the management of challenging melanocytic lesions. Diagn Pathol 2011;6:76-81
   PubMedGoogle Scholar
• Vanison C, Tanna N, Murthy AS. Comparative genomic hybridization for the diagnosis of melanoma. Eur J Plast Surg 2010;33:45-8
   PubMedGoogle Scholar
• North JP, Vemula SS, Bastian BC. Chromosomal copy number analysis in melanoma diagnostics. Methods Mol Biol 2014;1102:199-226
   PubMedGoogle Scholar
• Wang L, Rao M, Fang Y, et al. A genome-wide high-resolution array-CGH analysis of cutaneous melanoma and comparison of array-CGH to FISH in diagnostic evaluation. J Mol Diagn 2013;15:581-91
   PubMed Web of Science ®Google Scholar
• Dadras SS. Molecular diagnostics in melanoma: current status and perspectives. Arch Pathol Lab Med 2011;135:860-9
   PubMedGoogle Scholar
• Rock C, Clarke LE, Warf MB, et al. Development and validation of a gene expression signature to distinguish malignant melanoma from benign nevi. ASCO Annual Meeting 2014
   Google Scholar
• Clarke LE, Berking C, Tahan S, et al. The clinical impact of a gene expression signature that differentiates benign nevi from malignant melanoma. SMR International Congress 2013
   Google Scholar
• Carlson B. Payers try new approaches to manage molecular diagnostics. Biotechnol Healthc 2010;7:26-30
   Google Scholar
• United Health Center for Health Reform & Modernization. Personalized medicine: trends and prospects for the new science of genetic testing and molecular diagnostics. Monnetonka, MN: 2012
   Google Scholar
• Reddy KK, Farber MJ, Bhawan J, et al. Atypical (Dysplastic) Nevi: outcomes of surgical excision and association with melanoma. JAMA Dermatol 2013;149:928-34
   PubMedGoogle Scholar
• Goodson AG, Florell SR, Boucher KM, et al. Low rates of clinical recurrence following biopsy of benign to moderately atypical dysplastic melanocytic nevi. J Am Acad Dermatol 2010;62:591-6
   PubMedGoogle Scholar
• Centers for Medicare & Medicaid Services. Clinical Laboratory and Physician Fee Schedules. Atlanta, GA; American Medical Association: 2013.
   Google Scholar
• Emory Genetics Laboratory. Informed consent for array CGH Analysis. Decatur, GA: 2010
   Google Scholar
• Greenwood Genetic Center. Diagnostic Laboratory Tests, Charges, & CPT Codes 2013
   Google Scholar
• Truven Healthcare Micromedex Solutions. Red Book Drug References 2013
   Google Scholar
• National Comprehensive Cancer Network. Melanoma (Version 2.2013)
   Google Scholar
• U.S. Food and Drug Administration. Full Prescribing Information: YERVOY (ipilimumab). BLA no. 125377 2013.
   Google Scholar
• U.S. Food and Drug Administration. Full Prescribing Information: ZELBORAF (vemurafenib). NDA no. 202429 2013.
   Google Scholar
• U.S. Food and Drug Administration. Full Prescribing Information: TAFINLAR (dabrafenib). NDA no. 202806 2013.
   Google Scholar
• U.S. Food and Drug Administration. Full Prescribing Information: MEKINIST (trametinib). NDA no. 204114 2013.
   Google Scholar
• Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 2000;18:158-66
   PubMed Web of Science ®Google Scholar
• Flaherty KT, Lee SJ, Zhao F, et al. Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma. J Clin Oncol 2013;31:373-9
   PubMed Web of Science ®Google Scholar
• Okuyama S, Gonzalez R, Lewis KD. Pegylated interferon alpha-2b as adjuvant treatment of Stage III malignant melanoma: an evidence-based review. Core Evid 2010;5:39-48
   PubMedGoogle Scholar
• Cormier JN, Xing Y, Ding M, et al. Population-based assessment of surgical treatment trends for patients with melanoma in the era of sentinel lymph node biopsy. J Clin Oncol 2005;23:6054-62
   PubMed Web of Science ®Google Scholar
• Bichakjian CK, Halpern AC, Johnson TM, et al. Guidelines of care for the management of primary cutaneous melanoma. J Am Acad Dermatol 2011;65:1032-47
   PubMed Web of Science ®Google Scholar
• Balch CM, Gershenwald JE, Soong SJ, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009;27:6199-206
   PubMed Web of Science ®Google Scholar
• Wong SL, Balch CM, Hurley P, et al. Sentinel lymph node biopsy for melanoma: American Society of Clinical Oncology and Society of Surgical Oncology joint clinical practice guideline. J Clin Oncol 2012;30:2912-8
   PubMed Web of Science ®Google Scholar
• Balch CM, Soong SJ, Gershenwald JE, et al. Prognostic factors analysis of 17,600 melanoma patients: validation of the American Joint Committee on Cancer Melanoma Staging System. J Clin Oncol 2001;19:3622-34
   PubMed Web of Science ®Google Scholar
• Linos E, Swetter SM, Cockburn MG, et al. Increasing burden of melanoma in the United States. J Invest Dermatol 2009;129:1666-74
   PubMed Web of Science ®Google Scholar
• Martinez SR, Shah DR, Maverakis E, et al. Geographic variation in utilization of sentinel lymph node biopsy for intermediate thickness cutaneous melanoma. J Surg Oncol 2012;106:807-10
   PubMedGoogle Scholar
• McMasters KM, Reintgen DS, Ross MI, et al. Sentinel lymph node biopsy for melanoma: how many radioactive nodes should be removed? Ann Surg Oncol 2001;8:192-7
   PubMed Web of Science ®Google Scholar
• Morton DL, Cochran AJ, Thompson JF, et al. Sentinel node biopsy for early-stage melanoma. Ann Surg 2005;242:302-11
   PubMed Web of Science ®Google Scholar
• Fox MC, Lao CD, Schwartz JL, et al. Management options for metastatic melanoma in the era of novel therapies: a primer for the practicing dermatologist. Part I: management of stage III disease. J Am Acad Dermatol 2013;68:1.e1-9
   Google Scholar
• Alexandrescu DT. Melanoma costs: a dynamic model comparing estimated overall costs of various clinical stages. Dermatol Online J 2009;15:1
   Google Scholar
• Fox MC, Lao CD, Schwartz JL, et al. Management options for metastatic melanoma in the era of novel therapies: a primer for the practicing dermatologist. Part II: management of stage IV disease. J Am Acad Dermatol 2013;68:13.e1-13
   Google Scholar
• Cromwell KD, Ross MI, Xing Y, et al. Variability in melanoma post-treatment surveillance practices by country and physician specialty: a systematic review. Melanoma Res 2012;22:376-85
   PubMedGoogle Scholar
• Kansal AR, Shaul AJ, Stern S, et al. Cost-effectiveness of a FISH assay for the diagnosis of melanoma in the USA. Expert Rev Pharmacoecon Outcomes Res 2013;13:371-80
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Soong SJ, Harrison RA, McCarthy WH, et al. Factors affecting survival following local, regional, or distant recurrence from localized melanoma. J Surg Oncol 1998;67:228-33
   PubMed Web of Science ®Google Scholar
• Karakousis CP, Balch CM, Urist MM, et al. Local recurrence in malignant melanoma: long-term results of the multiinstitutional randomized surgical trial. Ann Surg Oncol 1996;3:446-52
   PubMed Web of Science ®Google Scholar