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Economic evaluation of obinutuzumab in combination with chlorambucil in first-line treatment of patients with chronic lymphocytic leukemia in Spain

View Article: PubMed Central - PubMed

ABSTRACT

Objective: To evaluate the cost-effectiveness of obinutuzumab in combination with chlorambucil (GClb) versus rituximab plus chlorambucil (RClb) in the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) and with comorbidities that make them unsuitable for full-dose fludarabine-based therapy, from the perspective of the Spanish National Health System.

Methods: A Markov model was developed with three mutually exclusive health states: progression-free survival (with or without treatment), progression, and death. Survival time for the two treatments was modeled based on the results of CLL11 clinical trial and external sources. Each health state was associated with a utility value and direct medical costs. The utilities were obtained from a utility elicitation study conducted in the UK. Costs and general background mortality data were obtained from published Spanish sources. Deterministic and probabilistic analyses were conducted, with a time frame of 20 years. The health outcomes were measured as life years (LYs) gained and quality-adjusted life years (QALYs) gained. Efficiency was measured as the cost per LY or per QALY gained of the most effective regimen.

Results: In the deterministic base case analysis, each patient treated with GClb resulted in 0.717 LYs gained and 0.673 QALYs gained versus RClb. The cost per LY and per QALY gained with GClb versus RClb was €23,314 and €24,838, respectively. The results proved stable in most of the univariate and probabilistic sensitivity analyses, with a probabilistic cost per QALY gained of €24,734 (95% confidence interval: €21,860–28,367).

Conclusion: Using GClb to treat patients with previously untreated CLL for whom full-dose fludarabine-based therapy is unsuitable allows significant gains in terms of LYs and QALYs versus treatment with RClb. Treatment with GClb versus RClb can be regarded as efficient when considered the willingness to pay thresholds commonly used in Spain.

No MeSH data available.


Kaplan–Meier curves for PFS and OS and predicted PFS and OS from the model.Abbreviations: GClb, obinutuzumab + chlorambucil; OS, overall survival; PFS, progression-free survival; RClb, rituximab + chlorambucil.
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f2-ceor-8-475: Kaplan–Meier curves for PFS and OS and predicted PFS and OS from the model.Abbreviations: GClb, obinutuzumab + chlorambucil; OS, overall survival; PFS, progression-free survival; RClb, rituximab + chlorambucil.

Mentions: Due to the immaturity of the overall survival (OS) data of the CLL11 trial at the time of data cut-off (median OS was not reached),17 the probability of transiting from progression to death was obtained from the CLL5, a Phase III clinical trial,19 which compared fludarabine versus Clb as the first-line therapy in patients with CLL. The probability of death after progression was based on an exponential function according to the Akaike information criterion and visual inspection. Age at progression was used as a covariate to account for age differences in the populations. Sensitivity analysis on this input was performed using the CLL8 trial, which compared FCR versus fludarabine and cyclophosphamide as the first-line therapy in patients with CLL.20 The projection of OS was then based on the extrapolated PFS and postprogression survival curves. Predicted survival curves are depicted in Figure 2.


Economic evaluation of obinutuzumab in combination with chlorambucil in first-line treatment of patients with chronic lymphocytic leukemia in Spain
Kaplan–Meier curves for PFS and OS and predicted PFS and OS from the model.Abbreviations: GClb, obinutuzumab + chlorambucil; OS, overall survival; PFS, progression-free survival; RClb, rituximab + chlorambucil.
© Copyright Policy
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5036824&req=5

f2-ceor-8-475: Kaplan–Meier curves for PFS and OS and predicted PFS and OS from the model.Abbreviations: GClb, obinutuzumab + chlorambucil; OS, overall survival; PFS, progression-free survival; RClb, rituximab + chlorambucil.
Mentions: Due to the immaturity of the overall survival (OS) data of the CLL11 trial at the time of data cut-off (median OS was not reached),17 the probability of transiting from progression to death was obtained from the CLL5, a Phase III clinical trial,19 which compared fludarabine versus Clb as the first-line therapy in patients with CLL. The probability of death after progression was based on an exponential function according to the Akaike information criterion and visual inspection. Age at progression was used as a covariate to account for age differences in the populations. Sensitivity analysis on this input was performed using the CLL8 trial, which compared FCR versus fludarabine and cyclophosphamide as the first-line therapy in patients with CLL.20 The projection of OS was then based on the extrapolated PFS and postprogression survival curves. Predicted survival curves are depicted in Figure 2.

View Article: PubMed Central - PubMed

ABSTRACT

Objective: To evaluate the cost-effectiveness of obinutuzumab in combination with chlorambucil (GClb) versus rituximab plus chlorambucil (RClb) in the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) and with comorbidities that make them unsuitable for full-dose fludarabine-based therapy, from the perspective of the Spanish National Health System.

Methods: A Markov model was developed with three mutually exclusive health states: progression-free survival (with or without treatment), progression, and death. Survival time for the two treatments was modeled based on the results of CLL11 clinical trial and external sources. Each health state was associated with a utility value and direct medical costs. The utilities were obtained from a utility elicitation study conducted in the UK. Costs and general background mortality data were obtained from published Spanish sources. Deterministic and probabilistic analyses were conducted, with a time frame of 20 years. The health outcomes were measured as life years (LYs) gained and quality-adjusted life years (QALYs) gained. Efficiency was measured as the cost per LY or per QALY gained of the most effective regimen.

Results: In the deterministic base case analysis, each patient treated with GClb resulted in 0.717 LYs gained and 0.673 QALYs gained versus RClb. The cost per LY and per QALY gained with GClb versus RClb was €23,314 and €24,838, respectively. The results proved stable in most of the univariate and probabilistic sensitivity analyses, with a probabilistic cost per QALY gained of €24,734 (95% confidence interval: €21,860–28,367).

Conclusion: Using GClb to treat patients with previously untreated CLL for whom full-dose fludarabine-based therapy is unsuitable allows significant gains in terms of LYs and QALYs versus treatment with RClb. Treatment with GClb versus RClb can be regarded as efficient when considered the willingness to pay thresholds commonly used in Spain.

No MeSH data available.