Abstract

BACKGROUND: Cancer diagnostic pathways are highly variable and not clearly established in the United States, which can lead to a diagnosis process that takes more time and exposes patients to invasive or unnecessary procedures, delays in treatment, worsening patient outcomes, and elevated health care resource utilization (HRU) and health care system costs. OBJECTIVE: To investigate current trends in time to diagnosis and diagnostic-related HRU preceding the patient's cancer diagnosis across all cancer types in the United States. METHODS: A retrospective claims analysis was conducted on patients newly diagnosed with cancer identified from 2018-2019 using Optum's de-identified Clinformatics Data Mart database, which includes Medicare Advantage and commercially insured members. Patients were identified using International Classification of Diseases, Tenth Revision codes and were required to have at least 2 outpatient visits at least 30 days apart or at least 1 inpatient cancer visit without prior cancer claims. The first diagnostic test was identified based on an algorithm of a 60-day gap between diagnostic tests prior to diagnosis. The index date was defined as the first diagnostic test date or an office visit less than 4 weeks prior to the first diagnostic test date. Patient characteristics, time to diagnosis, and HRU were descriptively analyzed for all patients and by cancer type. RESULTS: Among the 458,818 patients newly diagnosed with cancer included in this analysis, the mean age was 70.6 years, approximately half were female, and most were White people (65.0%) with Medicare Advantage coverage (74.0%). Patients with cancer had an overall mean (SD) time to diagnosis of 156.2 (164.9) days and 15.4% of patients waited longer than 180 days before a cancer diagnosis. High heterogeneity among cancer types was observed, with a mean time to diagnosis ranging from 121.6 days (bladder cancer) to 229.0 days (multiple myeloma). Imaging resource use during the diagnostic pathway was high for radiology (60.7%), computerized tomography (50.8%), magnetic resonance imaging (48.6%), and ultrasound (42.6%). A total of 69.3% of patients had endoscopy without biopsy, 36.5% had endoscopy with biopsy, 62.5% had other biopsies, and most patients did general urine and serum tests (91.3%) and nongenetic cancer-specific laboratory tests (84.3%). Resource use was highly varied by cancer type but tended to increase with a longer time to diagnosis. CONCLUSIONS: The proportion of patients experiencing a diagnostic process of longer than 180 days is clinically and economically meaningful. Diagnostic-related HRU was significant and highly variable, highlighting the inefficiencies in the cancer diagnostic process in the United States and the need for policies, guidelines, or medical interventions to streamline cancer diagnostic pathways to optimize patient outcomes and reduce health care system burden. DISCLOSURES: Dr Cong is an employee of Grail, LLC, which supported this study. Drs Gitlin and McGarvey are employees of BluePath Solutions, and Ms Shivaprakash was an employee of BluePath Solutions, which received financial support from Grail, LLC, for study-related research activities. This study was sponsored by Grail, LLC, a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated October 29, 2021. The sponsor had no role in the collection, management, and analysis of the data. The sponsor contributed to study design and data interpretation.

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