Clinical and economic burden of first-line chemoimmunotherapy by risk status in chronic lymphocytic leukemia.

Objectives: To evaluate the trend in cytogenetic/molecular testing rate in chronic lymphocytic leukemia (CLL) and assess the clinical and economic burden of first-line (1 L) treatment with chemoimmunotherapy (CIT) by risk status.

Methods: This retrospective cohort study identified patients with CLL from a U.S. managed care population. Medical records were obtained for eligible patients who initiated 1 L CIT between 1/1/2007 and 7/31/2019 and underwent prognostic testing to classify them as high risk (del(17p), TP53 mutation, del(11q), unmutated IGHV or complex karyotype) or as non-high risk by FISH only (non-del(17p) and non-del(11q)). Study outcomes included testing rate, time to next treatment (TTNT) or death, time to treatment failure (defined as time to change of therapy, non-chemotherapy intervention, hospice care or death), and total plan paid costs (medical + pharmacy) per patient per month (PPPM) in the 1 L period. Cox proportional hazard models and generalized linear models were used to calculate adjusted hazard ratio or rate ratio.

Results: Among the 1,808 patients with CLL, 612 were FISH or IGHV tested and the rate of testing increased from 30% to 44% from 2007-2019. High-risk patients (n = 119) had 65% higher risk of next treatment or death (median time: 2.4 vs 3.7 years), 65% higher risk of treatment failure (median time: 3.0 vs 4.9 years), and 33% higher costs ($12,194 vs $9,055, p = 0.027) during 1 L treatment than non-high risk patients (n = 134).

Conclusions: High-risk CLL patients treated with 1 L chemoimmunotherapy have poorer clinical and economic outcomes compared to non-high risk patients. Assessment of genetic risk remains suboptimal.