PMID- 32463768 OWN - NLM STAT- MEDLINE DCOM- 20210308 LR - 20230803 IS - 2376-1032 (Electronic) IS - 2376-0540 (Print) IS - 2376-0540 (Linking) VI - 26 IP - 6 DP - 2020 Jun TI - Real-World Costs of Adverse Events in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer. PG - 729-740 LID - 10.18553/jmcp.2020.26.6.729 [doi] AB - BACKGROUND: Non-small cell lung cancer (NSCLC) is the most common form of lung cancer in the United States. Immunotherapies and cytotoxic chemotherapies used to treat advanced NSCLC carry a substantial risk of adverse events (AEs), but real-world data on the incidence and costs associated with the unique AE profiles of these treatments are sparse. OBJECTIVE: To examine the AE incidence and costs among patients initiating non-driver mutation-targeted first-line therapy for metastatic NSCLC (mNSCLC) in clinical practice. METHODS: This was a retrospective administrative claims study conducted among commercial and Medicare Advantage health plan members who initiated first-line, nontargeted systemic anti-NSCLC therapy between January 1, 2008, and February 28, 2018. Patients were assigned to mutually exclusive treatment cohorts (cytotoxic chemotherapy [CHEM], immuno-oncology agents [IO], or immuno-oncology + cytotoxic chemotherapy [IO-CHEM]) and were observed from the index date (start of first-line therapy) through the earliest of health plan disenrollment, death, or March 31, 2018. AE incidence rates and associated health care costs were measured from the index date through the earliest of the start of a new therapy, 180 days after the end of first-line therapy, or the end of the study period. The factors influencing whether patients incurred high AE-related health care costs were assessed using multivariable models adjusted for patient demographic and clinical characteristics. RESULTS: The final study population (mean [SD] age 68.6 [9.5] years, 53.9% male) included 8,818 in the CHEM cohort, 482 in the IO cohort, and 412 in the IO-CHEM cohort. Overall, 74.4% had at least 1 AE during follow-up. The AE incidence rate was lowest for the IO cohort, with incidence rate ratios (95% CI) of 1.4 (1.3-1.6) for the CHEM cohort and 1.4 (1.2-1.6) for the IO-CHEM cohort. Mean AE-related costs were lowest for the IO cohort ($16,319) and highest for the CHEM cohort ($23,009; P < 0.001). In the multivariable analysis, the odds of incurring any AE costs were similar for the IO and IO-CHEM cohorts compared with the CHEM cohort (OR = 0.82; P = 0.135 and OR = 0.98; P = 0.888, respectively). Among patients who incurred AE costs, those in the IO cohort were less likely than those in the CHEM cohort to have high costs (OR = 0.60; P = 0.030); the difference between the IO-CHEM and CHEM cohorts was not statistically significant. CONCLUSIONS: Among real-world patients initiating nontargeted first-line therapy for mNSCLC, those receiving immunotherapy experienced fewer AEs and had lower total AE-related costs than those treated with cytotoxic chemotherapy. Immunotherapy-treated patients were no more likely than chemotherapy-treated patients to incur AE-related costs and were less likely to have high AE costs if they incurred any at all. These findings indicate that immunotherapy-related AEs are not a differentiating factor in cost of care for this patient population in clinical practice. DISCLOSURES: This study was sponsored by AstraZeneca. Ryan is an employee of AstraZeneca. Engel-Nitz, Johnson, and Bunner are employees of Optum, which was contracted by AstraZeneca to conduct this study, and shareholders in UnitedHealth Group. Engel-Nitz has also worked on cancer-related studies for which Optum received funding from Bayer AG, Clovis Oncology, Eli Lilly, EMD Serono, Exact Sciences, Janssen, and Novartis. Johnson worked on cancer-related studies for which Optum received funding from Eli Lilly, Medtronic, Sanofi, and UnitedHealthcare. Bunner has worked on cancer-related studies for which Optum received funding from Celgene and Incyte. FAU - Engel-Nitz, Nicole M AU - Engel-Nitz NM AD - Optum, Eden Prairie, Minnesota. FAU - Johnson, Michael P AU - Johnson MP AD - Optum, Eden Prairie, Minnesota. FAU - Bunner, Scott H AU - Bunner SH AD - Optum, Eden Prairie, Minnesota. FAU - Ryan, Kellie J AU - Ryan KJ AD - AstraZeneca, Gaithersburg, Maryland. LA - eng PT - Journal Article PL - United States TA - J Manag Care Spec Pharm JT - Journal of managed care & specialty pharmacy JID - 101644425 SB - IM MH - Administrative Claims, Healthcare/statistics & numerical data MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/economics MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/economics/mortality/secondary MH - *Cost of Illness MH - Cost-Benefit Analysis/statistics & numerical data MH - Drug-Related Side Effects and Adverse Reactions/*economics/epidemiology/etiology MH - Female MH - Follow-Up Studies MH - Health Care Costs/*statistics & numerical data MH - Humans MH - Incidence MH - Lung Neoplasms/*drug therapy/economics/mortality/pathology MH - Male MH - Medicare/economics/statistics & numerical data MH - Middle Aged MH - Retrospective Studies MH - Survival Analysis MH - United States PMC - PMC10391087 COIS- This study was sponsored by AstraZeneca. Ryan is an employee of AstraZeneca. Engel-Nitz, Johnson, and Bunner are employees of Optum, which was contracted by AstraZeneca to conduct this study, and shareholders in UnitedHealth Group. Engel-Nitz has also worked on cancer-related studies for which Optum received funding from Bayer AG, Clovis Oncology, Eli Lilly, EMD Serono, Exact Sciences, Janssen, and Novartis. Johnson worked on cancer-related studies for which Optum received funding from Eli Lilly, Medtronic, Sanofi, and UnitedHealthcare. Bunner has worked on cancer-related studies for which Optum received funding from Celgene and Incyte. EDAT- 2020/05/29 06:00 MHDA- 2021/03/09 06:00 PMCR- 2020/06/01 CRDT- 2020/05/29 06:00 PHST- 2020/05/29 06:00 [entrez] PHST- 2020/05/29 06:00 [pubmed] PHST- 2021/03/09 06:00 [medline] PHST- 2020/06/01 00:00 [pmc-release] AID - 10.18553/jmcp.2020.26.6.729 [doi] PST - ppublish SO - J Manag Care Spec Pharm. 2020 Jun;26(6):729-740. doi: 10.18553/jmcp.2020.26.6.729.