First line treatment of chronic phase chronic myeloid leukaemia patients with the generic formulations of imatinib mesylate

Eşkazan, Ahmet Emre; Ayer, Mesut; Kantarcıoğlu, Bülent; Arıca, Deniz; Demirel, Naciye; Aydın, Demet; Yalniz, Fevzi F.; Elverdi, Tuğrul; Salihoğlu, Ayşe; Ar, Muhlis Cem; Aydın, Şeniz Öngören; Başlar, Zafer; Aydın, Yıldız; Tuzuner, Nukhet; Özbek, Uğur; Soysal, Teoman

doi:10.1111/bjh.12937

Cited by 21 publications

(15 citation statements)

References 6 publications

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“…Indeed, there are concerns that the cost of TKI therapies for CML is unsustainable, and may threaten access to effective treatment and the stability of our national health care systems in general. 9 A generic version of imatinib is now available in the United States, which may provide an alternative agent with similar efficacy, 27, 28 though it is not yet known whether this will improve access to such agents.…”

Section: Discussionmentioning

confidence: 99%

Association between insurance status at diagnosis and overall survival in chronic myeloid leukemia: A population‐based study

Perry

Brunner

Zou

et al. 2017

Cancer

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Background Chronic myeloid leukemia (CML) can be treated effectively with tyrosine kinase inhibitor (TKI) therapy directed at BCR-ABL, but access to care, medication cost, and adherence may be barriers to treatment. We sought to determine whether insurance status at diagnosis influences CML patient outcomes. Methods We used the Surveillance, Epidemiology, and End Results Program (SEER) database and identified 5784 patients age 15 or older, diagnosed with CML between 2007 and 2012, with insurance status documented at diagnosis. Primary outcomes were 5-year overall survival. Covariates of interest included age at diagnosis, race, ethnicity, sex, county-level socioeconomic status, and marital status. Overall survival was evaluated by log-rank test and Kaplan-Meier estimates. Results Among patients age 15 to 64, insurance status was associated with overall survival (p<0.001), where being uninsured or having Medicaid was associated with worse 5-year OS compared to insured patients (uninsured 72.7%, Medicaid 73.1%, insured 86.6%). For patients over age 65, insurance had less of an impact on OS (p=0.07), with similar 5-year OS rates between patients with Medicaid and those with other insurance (40.2% vs. 43.4%). In multivariable analysis of patients age 15-64, both uninsured (HR 1.93, p<0.001) and Medicaid patients (HR 1.83, p<0.001) had an increased hazard of death compared to insured patients; age under 40, female sex, and married persons also had a lower hazard of death. Conclusion Our findings suggest that CML patients under age 65 who are uninsured or have Medicaid have significantly worse survival compared to patients with other insurance coverage.

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Section: Discussionmentioning

confidence: 99%

Association between insurance status at diagnosis and overall survival in chronic myeloid leukemia: A population‐based study

Perry

Brunner

Zou

et al. 2017

Cancer

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“…To disprove our hypothesis, we conducted a second study, where we compared patients who were started and continued with the original imatinib to those who have been using generics from the very beginning on. There as well, we could not demonstrate any significant difference in terms of efficacy (HR, cytogenetic, MR) and tolerability between these two groups that were well balanced regarding the age, gender and risk scores [17]. Thus, early evidence provided by our two retrospective studies suggests that the IM generics in Turkey are not only effective in the upfront setting but may also replace the drug in patients on original IM without causing any loss of MR on short notice.…”

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confidence: 57%

Generics in chronic myeloid leukemia: current arguments for and against and the established evidence

Soysal

Eşkazan

2014

Expert Review of Hematology

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Tyrosine kinase inhibitors became the mainstay of management in patients with chronic myeloid leukemia. The substantially high treatment cost has unfortunately been a major issue. Recent market entry of the imatinib generics are expected to lower the price and increase the availability of the drug worldwide. However, concerns about their efficacy and safety seem to slacken the approval of the generics in many countries. In this editorial, we discuss the current evidence on imatinib generics based mainly on Turkish experience and other limited data available.

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“…10 In the literature, there are some studies indicating the non-inferiority of generic TKIs in comparison to the original molecule. [11][12][13] However, there are different reports about generic TKIs which make clinicians to hesitate to switch to generic form. In the literature, some authors suggested that original molecule is superior to generics.…”

Section: Discussionmentioning

confidence: 99%

Generic Imatinib Mesylate is as Effective as Original Glivec in the Clinical Management of CML.

Malkan¹

2015

UHOD

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Unsustainable drug prices in chronic myeloid leukemia (CML) and cancer may be causing harm to patients. The aim of this multicenter study is to assess the efficacy of generic imatinib mesylate (IM) over Glivec in terms of hematological, cytogenetic, and molecular responses in CML. The data of 120 CML patients, who were treated with generic or original form of IM, were obtained from six different hematology clinics in Turkey between the years of 2009-2014 and analyzed retrospectively. Initial evaluation revealed that only one patient who was using original molecule switched to second generation tyrosine kinase inhibitor (TKI). In this period, hematological response(HR) was observed in 99.2% of the patients, cytogenetic response (CR) was observed in 88.7% of the patients (47 of 53), and molecular response (MR) was observed in 75% of the patients. Clinicians had a tendency to prefer generic molecules in each sequent visit, and this switch rate was statistically significant (p< 0.001). 11 patients, who were using original molecules during all cohorts, switched to second generation TKI. On the other hand, only one patient, who was using generic molecules, switched to second generation TKI. Our paper may help to clarify the doubts about the efficacy of generic IM compared to original molecule. In our study we did not find any significant difference in HR, CR, and MR for original and generic drugs in each visit. Herein, we find low rates of need to switch to second generation TKIs with generic IM and no difference in treatment responses between generic and original molecules that confirms the non-inferiority of generic TKIs over original molecules.

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First line treatment of chronic phase chronic myeloid leukaemia patients with the generic formulations of imatinib mesylate

Cited by 21 publications

References 6 publications

Association between insurance status at diagnosis and overall survival in chronic myeloid leukemia: A population‐based study

Association between insurance status at diagnosis and overall survival in chronic myeloid leukemia: A population‐based study

Generics in chronic myeloid leukemia: current arguments for and against and the established evidence

Generic Imatinib Mesylate is as Effective as Original Glivec in the Clinical Management of CML.

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