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PHARMACOECONOMIC MODELLING OF TARGET THERAPY CHRONIC MYELOGENOUS LEUKEMIA: EARLY AND LATE SWITCHING
Author(s): ,
Vasily Shuvaev
Affiliations:
Russian Research Institute of Hematology and Transfusiology,Saint-Petersburg,Russian Federation
,
Oleg Shukhov
Affiliations:
Hematology Research Center,Moscow,Russian Federation
,
Mikhail Fominykh
Affiliations:
Russian Research Institute of Hematology and Transfusiology,Saint-Petersburg,Russian Federation
,
Ekaterina Chelysheva
Affiliations:
Hematology Research Center,Moscow,Russian Federation
,
Irina Martynkevich
Affiliations:
Russian Research Institute of Hematology and Transfusiology,Saint-Petersburg,Russian Federation
,
Anna Turkina
Affiliations:
Hematology Research Center,Moscow,Russian Federation
Kudrat Abdulkadyrov
Affiliations:
Russian Research Institute of Hematology and Transfusiology,Saint-Petersburg,Russian Federation
(Abstract release date: 05/19/16) EHA Library. Shuvaev V. 06/09/16; 134998; PB2098
Dr. Vasily Shuvaev
Dr. Vasily Shuvaev
Contributions
Abstract
Abstract: PB2098

Type: Publication Only

Background
Early molecular response (EMR) achievement (BCR-ABL≤10% by IS) at 3 months of tyrosine kinase inhibitors (TKI) treatment of chronic myelogenous leukemia (CML) is recognized as an important prognostic marker of subsequent therapy efficiency and survival. The time point of TKI switch from first to second generations is one of the main differences between different CML treatment guidelines. The attractive perspective of further improvement in CML management is treatment free remission phase (TFR), – stop the TKI therapy in patients with deep sustained molecular response under thorough molecular monitoring.

Aims
The pharmacoeconomic modelling of comparison between early (3 moths) and late (6 months) switching from Imatinib to second generation TKI (TKI2) depending on EMR achievement (BCR-ABL≤10% at 3 months of treatment) with subsequent TKI therapy cessation in patients with stable long-lasting (2 years) deep molecular response (MR4.0=BCR-ABL≤0,01% by IS).

Methods
We have used previously described Markov chain model for CML management1. We constructed two model variances for early (3 months) and late (6 months) time points of switches from Imatinib to TKI2 depending on EMR achievement with subsequent TFR phase for patients with MR4.0 2-years duration. The model size was 700 newly diagnosed CML patients yearly and time horizon was 5 years. The transition rates (TKI response rates, MR4.0 rates, successful TFR rates) have been chosen from clinical trials (ENESTnd, TIDEL-II, STIM, FILMC, DADI and own data). We have recalculated the total costs from Russian roubles to Euros for clearly representation (February 2016).

Results
Early versus late switching lead to more frequent successful transition to TFR (13,59% for early switch and 10,46% for late switch). The early switching takes 8.54% more expenses (figure 1), but provided 6099 additional quality-adjusted life years (QALY). Incremental cost-effectiveness ratio for early compared to late switching is 543.2€ per 1 additional QALY, that is reasonable to economically based implementation. Sensitivity analysis shows that in case of TKI second generic substitution the costs for early and late switching should be equal. It can yield extra cost-free efficiency.

Conclusion
The pharmacoeconomic modelling can simulate budget burden for various modifications of diagnostic and therapeutic techniques in CML management with evaluation of its economical and clinical worth.Reference: 1V.A.Shuvaev, A.S.Abdulkadyrova, I.S.Martynkevich, V.Y.Udaleva, M.S.Fominykh, I.I.Zotova, R.A.Golovchenko, A.A.Zhernyakova, L.S.Martynenko, E.V.Petrova, M.A.Kozlovskaya, M.P.Ivanova, N.Y.Cybakova, A.V.Schmidt, K.M.Abdulkadyrov. Bonus free life’s in CML – pharmacoeconomic modeling first and second generation TKIs in first-line CML treatment with therapy cessation ELN Information letter October 2013. – p.14.



Session topic: E-poster

Keyword(s): Chronic myeloid leukemia, Cost analysis, Cost effectiveness, Imatinib
Abstract: PB2098

Type: Publication Only

Background
Early molecular response (EMR) achievement (BCR-ABL≤10% by IS) at 3 months of tyrosine kinase inhibitors (TKI) treatment of chronic myelogenous leukemia (CML) is recognized as an important prognostic marker of subsequent therapy efficiency and survival. The time point of TKI switch from first to second generations is one of the main differences between different CML treatment guidelines. The attractive perspective of further improvement in CML management is treatment free remission phase (TFR), – stop the TKI therapy in patients with deep sustained molecular response under thorough molecular monitoring.

Aims
The pharmacoeconomic modelling of comparison between early (3 moths) and late (6 months) switching from Imatinib to second generation TKI (TKI2) depending on EMR achievement (BCR-ABL≤10% at 3 months of treatment) with subsequent TKI therapy cessation in patients with stable long-lasting (2 years) deep molecular response (MR4.0=BCR-ABL≤0,01% by IS).

Methods
We have used previously described Markov chain model for CML management1. We constructed two model variances for early (3 months) and late (6 months) time points of switches from Imatinib to TKI2 depending on EMR achievement with subsequent TFR phase for patients with MR4.0 2-years duration. The model size was 700 newly diagnosed CML patients yearly and time horizon was 5 years. The transition rates (TKI response rates, MR4.0 rates, successful TFR rates) have been chosen from clinical trials (ENESTnd, TIDEL-II, STIM, FILMC, DADI and own data). We have recalculated the total costs from Russian roubles to Euros for clearly representation (February 2016).

Results
Early versus late switching lead to more frequent successful transition to TFR (13,59% for early switch and 10,46% for late switch). The early switching takes 8.54% more expenses (figure 1), but provided 6099 additional quality-adjusted life years (QALY). Incremental cost-effectiveness ratio for early compared to late switching is 543.2€ per 1 additional QALY, that is reasonable to economically based implementation. Sensitivity analysis shows that in case of TKI second generic substitution the costs for early and late switching should be equal. It can yield extra cost-free efficiency.

Conclusion
The pharmacoeconomic modelling can simulate budget burden for various modifications of diagnostic and therapeutic techniques in CML management with evaluation of its economical and clinical worth.Reference: 1V.A.Shuvaev, A.S.Abdulkadyrova, I.S.Martynkevich, V.Y.Udaleva, M.S.Fominykh, I.I.Zotova, R.A.Golovchenko, A.A.Zhernyakova, L.S.Martynenko, E.V.Petrova, M.A.Kozlovskaya, M.P.Ivanova, N.Y.Cybakova, A.V.Schmidt, K.M.Abdulkadyrov. Bonus free life’s in CML – pharmacoeconomic modeling first and second generation TKIs in first-line CML treatment with therapy cessation ELN Information letter October 2013. – p.14.



Session topic: E-poster

Keyword(s): Chronic myeloid leukemia, Cost analysis, Cost effectiveness, Imatinib

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