Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs

Abstract

Since the introduction of imatinib, the management of chronic myeloid leukemia (CML) has changed considerably. Tyrosine kinase inhibitors (TKIs) are the mainstay of CML treatment; however, the high financial burden of TKIs can be problematic for both the patients and health care systems. After the emergence of generics, reimbursement policies of many countries have changed, and generics offered an alternative treatment option for CML patients. There are many papers published on the use of generics in CML patients with conflicting results regarding both efficacy and safety. In this paper, we systematically reviewed the current literature on generic imatinib use in CML, and 36 papers were evaluated. Both in vitro and in vivo studies of generic imatinib showed comparable results with branded imatinib in terms of bioequivalence and bioavailability. In most studies, generics were comparable with the original molecule in terms of efficacy and safety, both in newly diagnosed patients and after switching from Gleevec. Some generic studies showed contradictory findings regarding efficacy and toxicity, and these differences can be attributed to some factors including the use of different generics in different countries. Both in hypothetical models and in real life, introduction of generic imatinib caused significant reduction in health care costs. In conclusion, generics are not inferior to original imatinib in terms of efficacy with an acceptable toxicity profile. Notwithstanding the generally favorable efficacy and safety of generics worldwide to date, we most probably still need more time to draw firmer conclusions on the longer-term outcomes of generics.

Guidelines for the treatment of chronic myeloid leukemia from the NCCN and ELN: differences and similarities

“…While the ELN indicates that a short-term hydroxyurea may be The NCCN considers generic imatinib a suitable substitute for original imatinib due to FDA approval [10]. The ELN places special emphasis on generic imatinib and states that a generic imatinib is an acceptable alternative to brandname imatinib due to its lower price [36][37][38][39][40]. Particularly in the United States, access to generic imatinib via online pharmacies (such as The Mark Cuban Cost Plus Drug Company) permits substantial drug cost reductions and relieves patients' financial burden.…”

De‐escalation or discontinuation of tyrosine kinase inhibitor in patients with chronic myeloid leukemia: A multicentral, open‐label, prospective trial in China

“…The data on the HRQOL of patients during TFR are still limited. Several studies [24–26] evaluating TFR show stable or improved HRQOL after TKI discontinuation, but 20%−30% of patients manifesting as increased musculoskeletal pain after stopping therapy, little is known about the emotional impact of attempting TFR. Therefore, we used EORTC QLQ‐C30 questionnaire to assess HRQOL in the de‐escalation and discontinuation groups.…”

“…The data on the HRQOL of patients during TFR are still limited. Several studies [24][25][26] evaluating TFR show stable or improved HRQOL after TKI discontinuation, but 20%−30% of patients manifesting as…”

The Economic Burden of Chronic Myeloid Leukemia in Patients with Later Lines: Findings from a Real-World Analysis in Italy

“…The expenditure for TKIs was excluded from the healthcare cost analysis; however, their economic burden was reported as mean annualized cost based on treatment length. Since only a few patients were found to be treated with generic imatinib, we are not able to provide data regarding the economic impact of generic TKIs versus the branded; however, we foresee that generics will play crucial role in reshaping the economic burden associated with CML [ 20 ].…”