Background:
Tyrosine Kinase Inhibitors (TKIs) are the cornerstone of chronic myeloid leukemia (CML) treatment.
Imatinib and nilotinib, first generation and second generation TKIs, has been mainly used in treatment of CML in our country. However, their
consumption in Iran has not been studied since their entrance to our market. Methods: The study was conducted in the two steps. First, annual
consumption and trend of use was determined using Iranian pharmaceutical wholesale data since entrance to market until 2017. Average daily dose (ADD) of imatinib and nilotinib for main indication was defined as 0.6 g and 0.8 g, respectively. Total annual
consumption was calculated as number of ADDs used per1000 inhabitants per day. Compound annual growth rate (CAGR) was estimated for each drug using the aforementioned metric. In the second step, we obtained information from 13 Aban pharmacy records on nilotinib and imatinib prescriptions filled during 2011-2014. Extracted data included number of prescriptions, number of drugs per prescription, type of insurance company and insurance coverage. Fordescriptive analysis and analytical data SPSS (Version 24) and for trend analysis Joinpoint regression (Joinpoint, version 4.7.0.0) were used. Result:
Imatinib consumption increased with a statistically significant positive slope from 2003 to 2013 and a non-significant decreasing trend from 2013 to 2017.Since nilotinib entrance to our market in 2011, its
consumption had an ascending trend until 2017. This trend had a steep statistically significant slope from 2014 to 2017. CAGR of imatinib and nilotinib was 0.3 and 0.58, respectively. Among 8663 prescriptions, 89.5% were for imatinib and the rest for nilotinib. Prescribing rate of nilotinib showed an ascending trend during 2011-2014 while the rate of imatinib prescribing did not show a significant trend in this period. Comparison of changes in insurance coverage of imatinib and nilotinib in studied prescription showed that coverage of nilotinib costs by insurance improved significantly from 15% to 78% (average percentage). However, imatinib insurance coverage changed from70% in 2011 to 83% in 2014. (p<0.001). For both of imatinib and nilotinib, we observed a significant difference in the mean number of prescribed drugs among different insurance coverage. The average number of drugs was significantly higher for prescriptions for which 100% of the cost was covered by insurance company (p-value <0.001 for all comparisons). Conclusion:
Imatinib and
Nilotinib consumption increased since their entrance to our market. However, nilotinib showed more substantial increase which could have been affected by insurance policies.