HORSHAM, PA — Chronic lymphocytic leukemia/small lymphocytic lymphoma is the most common adult leukemia, accounting for about 37% of all leukemias in the United States.

Yet, a new study suggested that limited real-word evidence is available on the outcomes of ibrutinib use among previously untreated patients. To help answer those questions, industry researchers from Janssen Scientific Affairs focused on the VHA population diagnosed with CLL/SLL.1

In a report in the Journal of Managed Care & Specialty Pharmacy, the authors said among the objectives were to evaluate time to next treatment among veterans with CLL/SLL who initiated ibrutinib vs. chemoimmunotherapy in first line, as well as to evaluate  ibrutinib In the first line vs. one ibrutinib in the second line and later. In a related issue, researchers also compared healthcare resource utilization and costs between the first line ibrutinib and chemoimmunotherapy cohorts.

The study determined that first line ibrutinib treatment, compared with chemoimmunotherapy or later administration of ibrutinib, is associated with significantly longer time to new treatment among veteran patients. In addition, it found that lower health care resource utilization and medical costs with first line ibrutinib offset higher pharmacy costs incurred by the patients.

Included in the study were adults with CLL/SLL with claims for first line single-agent ibrutinib or chemoimmunotherapy identified in VHA data from April 1, 2013 to March 31, 2018. The index date was defined as the first prescription claim date. Researchers then defined a subset of patients who received second and third line ibrutinib.

Overall, 614 patients were included in each of the first line ibrutinib and first line chemoimmunotherapy cohorts, with 149 in each of the first line ibrutinib vs. second line and later ibrutinib cohorts.

Results indicated that the first line ibrutinib cohort had significantly longer time-to-next-treatment compared with each of the first line chemoimmunotherapy and second line-plus ibrutinib cohorts (P <0.0001 and P =0.0001, respectively). Researchers reported that cohort also was less likely to have a next line of treatment than the first line chemoimmunotherapy cohort (HR = 0.52; 95% CI = 0.42-0.65; P < 0.0001) and the second line—plus ibrutinib cohort (HR = 0.39; 95% CI = 0.22-0.69; P = 0.0012).

The study determined that the first-line ibrutinib cohort had significantly fewer inpatient visits (rate ratio [RR] = 0.38; 95% CI = 0.28-0.52; P ≤ 0.05) and outpatient visits per patient per month costs (RR =0.72; 95% CI = 0.68-0.77; P ≤ 0.5), compared with the first line chemoimmunotherapy.

“Additionally, the 1L ibrutinib cohort had $7,308 significantly lower monthly medical costs (95% CI = -$9,892 to -$4,895; P ≤ 0.05) versus the 1L CIT cohort, resulting in comparable monthly total health care cost (medical and pharmacy) between real-world 1L patients treated by ibrutinib and CIT (-$2,160; 95% CI = -$4,840-$347; P > 0.05),” the authors wrote.

Background information in the article noted that the presence of del(17p)/TP53 mutation, physical fitness/age, and duration of previous response with earlier treatment are the most critical determinants of therapeutic options, adding, “In CLL, which is diagnosed predominantly in an elderly population, the toxicities of therapy are of special concern. Toxicities can result in the interruption of therapy, diminish the opportunity for response, and can result in morbidity.”

While adverse patient outcomes can result in increased costs, the authors pointed out that  treatment with ibrutinib has been well tolerated, and the most common adverse events have generally been” low grade and transient.”

Researchers said the length of their study was also an important factor. “Notably, our study is unique in having a longer follow-up; we observed that at 48 months of follow-up, the percentage of the 1L ibrutinib cohort remaining free from needing a next-line treatment was only 8% lower than at 24 months, and, in the 1L CIT cohort, twice the number of patients remained free from needing a next-line treatment at 48 months,” they reported. “We also found that patients who initiated ibrutinib in 1L had significantly longer TTNT than patients with ibrutinib in 2L/3L, which suggests the potential benefit of early treatment with ibrutinib.”

  1. Huang Q, Borra S, Li J, et al. Time to Next Treatment, Health Care Resource Utilization, and Costs Associated with Ibrutinib Use Among U.S. Veterans with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Real-World Retrospective Analysis [published online ahead of print, 2020 Sep 3]. J Manag Care Spec Pharm. 2020;1-10. doi:10.18553/jmcp.2020.20095