chronic myeloleukemia

First Line Treatment Choice for Chronic Myelogenous Leukemia: Modeling of Clinical and Economic Factors

MYELOID TUMORS , , , ,

VA Shuvaev, KM Abdulkadyrov, IS Martynkevich, MS Fominykh

Russian Scientific Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024

For correspondence: Vasilii Anatol’evich Shuvaev, PhD, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024; Tel.: +7(921)636-54-72; e-mail: shuvaev77@mail.ru

For citation: Shuvaev VA, Abdulkadyrov KM, Martynkevich IS, Fominykh MS. First Line Treatment Choice for Chronic Myelogenous Leukemia: Modeling of Clinical and Economic Factors.. Clinical oncohematology. 2015;8(1):78–83 (In Russ).

ABSTRACT

Background. Second generation tyrosine kinase inhibitors (nilotinib and dasatinib) have advantages over imatinib in frequency and rate of cytogenetic and molecular responses obtaining in chronic myelogenous leukemia (CML) treatment. At the same time, they produced more severe adverse effects and are more expensive than imatinib. At present, CML patients with stable deep molecular response are considered as candidates for enrollment into clinical trials studying the management of treatment-free remission. Constant growth of expenses for CML diagnosing and treatment require a pharmacoeconomic analysis in order to optimize expenses and provide cost-effectiveness data for introduction of novel highly effective drugs.

Objective. Pharmacoeconomic modeling of the choice of CML treatment using first and second generation tyrosine kinase inhibitors in first-line therapy with an analysis of sensitivity of clinico-economic factors.

Methods. Pharmacoeconomic modeling of CML diagnosing and treatment. Cost-utility analysis of first and second generation tyrosine kinase inhibitors in first-line treatment. Sensitivity analysis with identification of most important clinical and economic factors affecting treatment results. Simulation for feasibility analysis of the nationwide use of first and second generation tyrosine kinase inhibitors in first-line therapy.

Results. Sensitivity analyses of pharmacoeconomic models showed its robustness. The threshold limits for drug costs and frequency of achievement of a complete molecular response affecting economic feasibility of the choice of first and second generation tyrosine kinase inhibitors were determined.

Conclusions. These pharmacoeconomic models may be applied for improvement of diagnostic and therapeutic standards.

Keywords: chronic myeloleukemia, tyrosine kinase inhibitors, imatinib, nilotinib, dasatinib, pharmacoeconomics, cost-effectiveness.

Received: September 11, 2014

Accepted: November 7, 2014

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Imatinib Generics: Myths and Reality (Literature Review and Our Experience)

CLINICAL PRESENTATION, DIAGNOSIS, AND MANAGEMENT OF MYELOID MALIGNANCIES , , , ,

K.M. Abdulkadyrov, V.A. Shuvaev, M.S. Fominykh

Russian Research Institution of Hematology and Transfusiology, FMBA, Saint Petersburg, Russian Federation

For citation: Abdulkadyrov K.M., Shuvaev V.A., Fominykh M.S. Imatinib Generics: Myths and Reality (Literature Review and Our Experience). Klin. onkogematol. 2014; 7(3): 311–6 (In Russ.).

ABSTRACT

The article describes the registration process of generic drugs in the Russian Federation. The article presents literature data and results of our own studies of the use of imatinib generics — PhilachromineÒ and GenfatinibÒ — in patients with chronic myelogenous leukemia. The tolerability (incidence of adverse events) and therapeutic efficacy (the number of optimal responses to therapy) were analyzed in comparison with historical control of patients, treated with GlivecÒ. 14 patients with chronic myeloleukemia treated with Philachromine® as a first-line treatment and 81 patients previously treated with GlivecÒ (54 of them received PhilachromineÒ and 27 patients received GenfatinibÒ) were included in study. Therapeutic efficacy and tolerability of generics (PhilachromineÒ and GenfatinibÒ) were similar to those of GlivecÒ within the compared observation period.

Keywords: chronic myeloleukemia, tyrosine kinase inhibitors, imatinib, generics, generic substitution, biological efficacy.

Address correspondence to: shuvaev77@mail.ru

Accepted: May 21, 2014

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