Cost effectiveness of therapeutic drug monitoring for imatinib administration in chronic myeloid leukemia

Abstract

BackgroundImatinib mesylate (IM) is a first-line treatment option for patients with chronic myeloid leukemia (CML). Patients who fail or are intolerant to IM therapy are treated with more expensive second and third-generation tyrosine kinase inhibitors. Patients show wide variation in trough concentrations in response to standard dosing. Thus, many patients receive subtherapeutic or supratherapeutic doses. Therapeutic drug monitoring (TDM) may improve dose management that, in turn, may reduce costs and improve outcomes. However, TDM also adds to the cost of patient care. The objective of this study was to determine the cost-effectiveness of TDM for generic IM therapy.MethodsWe developed a microsimulation model for the trough plasma concentration of IM which is related to a cytogenetic or molecular response. We compared two cohorts: one with TDM and one without TDM (NTDM). The lifetime incremental cost-effectiveness ratio (ICER) was calculated using quality-adjusted life years (QALYs) as the effectiveness measure. One-way and probabilistic sensitivity analyses were performed.ResultsThe lifetime cost and QALY of treatment with TDM were $2,137K [95% Ci: 2,079K; 2,174K] and 12.37 [95% CI: 12.07; 12.55], respectively. The cost and QALY of NTDM were $2,132K [95% CI: 2,091K; 2,197K] and 12.23 [95% CI: 11.96; 12.50], respectively. The incremental cost and QALY for TDM relative to NTDM was $4,417 [95% CI: -52,582; 32,097]) and 0.15 [95% CI: -0.13; 0.28]. The ICER for TDM relative to NTDM was $30,450/QALY. Probabilistic sensitivity analysis showed that TDM was cost-effective relative to NTDM in 90% of the tested scenarios at a willingness-to-pay threshold of $100,000/QALY.ConclusionsAlthough the impact of TDM is modest, the cost-effectiveness over a lifetime horizon (societal perspective, ($30,450/QALY) falls within the acceptable range (< $100k/QALY).

A Study to Explore the Role of IDH1 (R132) Mutation on Imatinib Toxicity and Effect of ABCG2/OCT1 Expression on N-Desmethyl Imatinib Plasma Level in Egyptian Chronic Myeloid Leukemia Patients

“…This study supports that using therapeutic drug monitoring (TDM) is highly useful in patients with CML treated with IM for adjustment of the dose as suggested by Kim et al. 24 . The current study showed a statistically significantly higher trough IM (1361 ng/ml) among good responders (N=25) compared to lower levels in bad responders (N=25) (1019 ng/ml) ( P=0.007) .…”

Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial

“…7 Therapeutic drug monitoring can reduce drug exposure variability and has been shown to be useful in predicting the efficacy of imatinib for chronic myeloid leukemia, 25 but with a modest budget impact. 26 In conclusion, lapatinib administration before breakfast can minimize the effects of food on lapatinib concentration and reduce the incidence of diarrhea and a rash compared with at bedtime dosing. This approach is easy to apply with no added cost or inconvenience to patients, and has the potential to permit dose escalation.…”

“…In breast cancer, however, EGFR is not the principal therapeutic target and is not highly co‐expressed with HER2 7 . Therapeutic drug monitoring can reduce drug exposure variability and has been shown to be useful in predicting the efficacy of imatinib for chronic myeloid leukemia, 25 but with a modest budget impact 26 …”

Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol

“…Second, at first glance, performing TDM in routine care seems expensive. However, considering the direct and indirect costs of treating patients at suboptimal doses, e.g., the costs resulting from treatment progression in underdosed patients and the costs of treating toxicity in overdosed patients, TDM has already been found to be cost-effective for two targeted oral anticancer drugs (tamoxifen [ 44 ] and imatinib [ 44 , 45 ]). Third, ‘traditional’ TDM requires patients to come to their treatment center for venous blood sample collection.…”