Complications and Economic Burden Associated with Obtaining Tissue for Diagnosis and Molecular Analysis in Patients with Non-Small Cell Lung Cancer (NSCLC) in the US (Preprint)

BACKGROUND Tissue biopsy to identify targetable genomic and immunologic alterations is the mainstay of managing patients with non-small cell lung cancer (NSCLC); however, little is known about the associated economic impact and complication rates. OBJECTIVE This study assesses the frequency, complications and costs of diagnostic and post-progression biopsy. METHODS This retrospective, observational study was conducted using administrative claims data from over 30 million commercially insured individuals in the US (2006-2014). Data were analyzed for the overall population and by time of biopsy (diagnostic or post-progression). RESULTS Of 20,013 eligible patients, 13,411 (67%) received a diagnostic biopsy, whereas only 2,056 (10%) received a post-progression biopsy; mean cost: $9,977 and $16,806, respectively. Complication rates were similar at diagnosis and post-progression, on the day of biopsy (10% vs 7%) and within 30 days (63% vs 61%). Mean costs were higher among patients with a complication vs those without, on the day of biopsy (diagnostic: $12,030 vs $6,508; post-progression: $22,593 vs $7,812) and within 30 days (diagnostic: $24,968 vs $15,988; post-progression: $30,293 vs $12,494) (P< .001 for all comparisons). CONCLUSIONS From 2006 to 2014, post-progression biopsies were not common practice in NSCLC. Complication rates were similar at diagnosis and post-progression, with mean costs higher among patients with a complication than those without. With increasing demands for effective novel targeted therapies and safe testing methods for patients, providers, and payers, these data may be valuable in determining the budget impact and comparing complication rates with newer, less invasive molecular testing methods, including plasma circulating tumor DNA testing.