PMID- 25615005 OWN - NLM STAT- MEDLINE DCOM- 20151009 LR - 20240110 IS - 2376-1032 (Electronic) IS - 2376-0540 (Print) IS - 2376-0540 (Linking) VI - 21 IP - 2 DP - 2015 Feb TI - Economic burden associated with adverse events in patients with metastatic melanoma. PG - 158-64 LID - 10.18553/jmcp.2015.21.2.158 AB - BACKGROUND: There are currently many approved agents for the treatment of metastatic melanoma (MM), the most aggressive form of skin cancer. Treatments may include systemic therapies such as ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, interferon alpha, dacarbazine- or temozolomide-based combination chemotherapy/biochemotherapy, paclitaxel, paclitaxel/cisplatin, and paclitaxel/carboplatin, as well as the targeted therapies vemurafenib, dabrafenib, and trametinib for patients with BRAF V600 mutation. However, all treatment options are associated with different adverse events (AEs) and, in some instances, considerable toxicity. The occurrence of such treatment-related AEs can lead to higher health care resource utilization and increasing treatment and patient management costs. An understanding of the economic burden of these AEs will therefore enable better management of health care expenditures, not just for existing therapies, but also for new and novel treatments in development. OBJECTIVE: To estimate the incremental health care costs of specific AEs among patients with MM treated with paclitaxel, vemurafenib, ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, or interferon alpha, along with AEs known to be associated with dabrafenib and trametinib. METHODS: This cohort study employed a retrospective administrative claims-based analysis of MarketScan commercial and Medicare supplemental databases from July 1, 2004, to April 30, 2012. Patients included those aged >/= 18 years who had diagnosed melanoma (ICD-9-CM code 172.xx)with >/= 1 diagnosis of metastasis and >/= 1 claim for any of the 7 study treatments. Health care encounters for AEs of interest were based on ICD-9-CM diagnosis/procedure codes. Incremental cost per AE was determined by comparing the 30-day expenditures in patients with the event to patients without the event based on a shadow event date. Multivariate generalized linear models (GLMs) with a log-link function and gamma distribution were utilized to control for baseline differences between groups. RESULTS: A total of 2,621 patients with MM were included. Mean age was 56.0 years (SD +/- 13.0); 64% were male; and 24% had a diagnosis of primary or secondary brain cancer at the time of MM diagnosis. GLM-based estimate of 30-day incremental costs by AE category were metabolic, $9,135 (95% CI = $6,404-$12,392); hematologic/lymphatic, $8,450 (95% CI = $6,528-$10,633); cardiovascular, $6,476 (95% CI = $4,667-$8,541); gastrointestinal, $6,338 (95% CI = $4,740-$8,122); skin/subcutaneous, -$900 (95% CI = -$1,899-$237); central nervous system/psychiatric, $5,903 (95% CI = $3,842-$8,313); and pain, $5,078 (95% CI = $3,392-$7,012). CONCLUSIONS: Incremental costs associated with many MM treatment-related AEs are substantial. New approaches to prevent and/or better manage these events may reduce overall health care costs. FAU - Arondekar, Bhakti AU - Arondekar B AD - GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA 19112. bhakti.2.arondekar@gsk.com. FAU - Curkendall, Suellen AU - Curkendall S FAU - Monberg, Matthew AU - Monberg M FAU - Mirakhur, Beloo AU - Mirakhur B FAU - Oglesby, Alan K AU - Oglesby AK FAU - Lenhart, Gregory M AU - Lenhart GM FAU - Meyer, Nicole AU - Meyer N LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Manag Care Spec Pharm JT - Journal of managed care & specialty pharmacy JID - 101644425 RN - 0 (Antineoplastic Agents) SB - IM MH - Adult MH - Aged MH - Antineoplastic Agents/*adverse effects MH - *Cost of Illness MH - Female MH - Health Care Costs MH - Humans MH - Male MH - Melanoma/drug therapy/*economics/pathology MH - Middle Aged MH - Neoplasm Metastasis PMC - PMC10397691 COIS- Funding for this study was provided by GlaxoSmithKline (HO-12-928). Arondekar, Monberg, Mirakhur, and Oglesby are employees of GlaxoSmithKline (GSK). Arondekar, Monberg, Mirakhur, and Oglesby own stock in GSK. Meyer is employed by Truven Health, who had a contract with GSK for conducting this study, as was Curkendall, at the time of this study. Oglesby attended the American Society of Clinical Oncology (ASCO) annual meeting in 2013. Lenhart has nothing to disclose. Arondekar, Curkendall, Monberg, Mirakhur, Lenhart, and Meyer contributed the study concept and design. Monberg and Meyer acquired the data, and Arondekar, Curkendall, Oglesby, and Lenhart performed the statistical analysis. Arondekar, Monberg, and Oglesby drafted the manuscript, and Arondekar, Curkendall, Mirakhur, and Oglesby critically revised the manuscript for important intellectual content. Arondekar, Monberg, and Mirakhur obtained funding, and Arondekar and Monberg provided administrative support. Analysis and interpretation of data and final approval of the submitted manuscript were contributed by all authors. EDAT- 2015/01/24 06:00 MHDA- 2015/10/10 06:00 PMCR- 2015/02/01 CRDT- 2015/01/24 06:00 PHST- 2015/01/24 06:00 [entrez] PHST- 2015/01/24 06:00 [pubmed] PHST- 2015/10/10 06:00 [medline] PHST- 2015/02/01 00:00 [pmc-release] AID - 2015(21)2: 158-164 [pii] AID - 10.18553/jmcp.2015.21.2.158 [doi] PST - ppublish SO - J Manag Care Spec Pharm. 2015 Feb;21(2):158-64. doi: 10.18553/jmcp.2015.21.2.158.