Cost‐utility analysis of idelalisib in combination with rituximab in relapsed or refractory chronic lymphocytic leukaemia

Objective

To evaluate the incremental cost‐utility ratio (ICUR) of idelalisib in combination with rituximab (IR) versus rituximab monotherapy (R) in the treatment of patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL), from the Spanish National Health System (NHS) perspective.

Methods

A partitioned survival Markov model for a lifetime horizon (30 years) was developed to estimate costs (€, 2016) and quality‐adjusted life years (QALY) with IR and R. Initial cohort included patients with CLL receiving a second or subsequent line (2L) of treatment with IR or R. Survival data were based on CLL clinical trial. Drug, administration, monitoring, adverse events and clinical management of CLL costs were included in the model. Costs and outcomes were discounted using a 3% annually. Deterministic and probabilistic sensitivity analyses (PSA) were performed.

Results

Compared to R, 2L IR treatment resulted in QALY gain of 3.147 (4.965 versus 1.818). Total costs were €118 254 for IR versus €23 874 for R. ICUR was €29 990/QALY gained with IR versus R. In the PSA, IR was cost‐effective in 78% of iterations using a threshold of €45 000/QALY.

Conclusion

IR can be considered a cost‐effective treatment compared to R, in the treatment of R/R CLL patients for the Spanish NHS.     

Multiparametric Ultrasound Evaluation of the Thyroid: Elastography as a Key Tool in the Risk Prediction of Undetermined Nodules (Bethesda III and IV)—Histopathological Correlation

The purpose of this study was to select thyroid nodules most at risk for malignancy among those cytologically undetermined by fine-needle aspiration biopsy (FNAB), using B-mode, color duplex Doppler and 2-D shear wave shear wave elastography (2-D-SWE). This was a prospective diagnostic accuracy study with 62 Bethesda III/IV nodules according to FNAB (atypia/follicular lesion of undetermined significance or follicular neoplasia/Hürthle cell neoplasm). Ultrasonography (US) data were compared with resection histologic results, revealing 35 of 62 benign nodules (56.4%) and 27 of 62 carcinomas (43.6%). Conventional US was uses to evaluate nodule echogenicity, dimensions, contours, presence of halo and microcalcifications. Doppler US was used to assess the vascularization (exclusively or predominantly peripheral or central) and mean resistance index of three nodule arteries. Elastography was used to evaluate the nodule elastographic pattern; mean nodule deformation index; deformation ratio between nodule and adjacent thyroid parenchyma; and mean deformation ratio between nodule and pre-thyroid musculature (MDR). Statistical analysis included χ², Fisher's exact, Student's t, Mann–Whitney tests and multivariable analysis by multiple logistic regression. Areas under the receiver operating characteristic curves (AUC-ROCs) were used for accuracy analysis. Fifty-eight participants (54.7 ± 14.0 y, 51 women) were studied. The parameters that were statistically significant to the univariate analysis were hypo-echogenicity, nodule diameter greater than width and all parameters analyzed from Doppler and elastography. Multivariate analysis revealed that the MDR (in kPa) was the best parameter for risk analysis of indeterminate nodules. Nodules with MDRs >1.53 exhibited a greater chance of malignancy (AUC-ROC = 0.98). We conclude that 2-D-SWE is able to select malignant nodules among those cytologically indeterminate, thus avoiding unnecessary surgery in these cytologic groups.