Patient perspective on TKI treatment and monitoring in CML
- 1. Real-World Analysis of Tyrosine Kinase Inhibitor Treatment and Monitoring in Patients with Chronic Myeloid Leukemia in China: from Patients’ Perspective Qian Jiang, M.D. Peking University People's Hospital, Beijing, China
- 2. Introduction
- 3. Epidemiology of CML in China • Annual incidence of CML: 0.39-0.55 per 100,000 • Median age at diagnosis: 45-50 year old • Male to female ratio: 1.5:1 Wang AH, et al. J Exp Clin Cancer Res. 2010, 3;29:20. Wang JX, et al. Zhonghua Xue Ye Xue Za Zhi. 2009, 30:721-725
- 4. CML Treatment Pattern 6 Years Ago Wang JX, et al. Zhonghua Xue Ye Xue Za Zhi. 2009, 30:721-725 Kim DW, et al. Leuk Res. 2010, 34:1459-71. n=1824
- 5. Number of Patients on TKIs 0 500 1000 1500 2000 2500 Casenumber 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Year 0 100 200 300 400 500 Casenumber 2010 2011 2012 Year 系列1 系列2 TKI No. of patients Glivec 30,000 Tasigna 3,400 Sprycel 700 • Imatinib was approved as the first-line TKI, Dasatinib and nilotinib, as the second-line options • TKIs are reimbursed in some provinces. • Partial payment for Patient Assistance Program (PAP) is the mainstay of access to TKIs. • Up to 2012, the number of patients on original TKIs: Data from CCF & CFC
- 6. TKIs available in Developed Countries
- 7. TKIs available in China Chinese generic imatinib Chinese generic dasatinib Indian generic TKIs
- 8. Brand name PAP Model (mo.) Payment without PAP/Year （$） Payment with PAP/Year （$） Payment with PAP & Reimbursement /Year （$） Approved Indication Glivec 3+9 44,500 11,100 3,300 First line Tasigna 3+12 56,200-69,700 11,200-13,900 3,300-4,100 Second line Sprycel 3+9 61,100 15,300 6,100-18,300 Second line Chinese generic imatinib NA 5,800 1,700 First line Chinese generic dasatinib NA 8,800 Second line Indian generic Imatinib/dasatinib NA 500-2,400 NA TKI Payment
- 9. Study Design • This was an open-label and non-interventional, cross-sectional study • Physicians and New Sunshine Charity Foundation designed the study, collected the questionnaires and analyzed the data • From May to October, 2014, anonymous questionnaires were distributed to adults with CML receiving TKI treatment in China via the Internet and in printed copies at patient advocacy groups, PAP pharmacies and the out-patient clinics at Peking University People's Hospital • The study was approved by the ethics committee of Peking University People‘s Hospital • The questionnaire focused on demographics, disease-related variables before starting the TKI or TKI(s) given, response and tolerance, monitoring, duration of TKI therapy, annual out-of-pocket expense, and major impediment to receiving TKI
- 10. Results
- 11. Demographics & Disease-related Variables Before TKI Treatment • 1038 questionnaires were collected • 949 questionnaires were evaluable including 358 electronic copies (38%) and 591 printed copies (62%) Variable Value Gender, n (%) Male 557 (58.0) Female 357 (37.1) Declined 47 (4.9) Age, y median (range) 41 (18-88) Household register, n (%) Urban 629 (65.5) Rural 239 (24.9) Declined 93 (9.7) Educational level, n (%) Secondary school and below 411 (42.8) University and above 456 (47.5) Declined 94 (9.8) First diagnosis time, y median (range) 2011 (1980-2014) Disease phase at diagnosis, n (%) CP 899 (93.5) AP 49 (5.1) BP 10 (1.0) Declined 3 (0.3) Treatment Prior to TKI, n (%) Hydroxyurea (more than 1 mo) 298 (31.0) Interferon (more than 6 mo) 110 (11.4) Chemotherapy 41 (4.3) Transplant 7 (0.7) Chinese traditional medicine 140 (14.6)
- 12. The Distribution of Patients’ Interval from the Diagnosis to TKI Treatment (I) ＜1y 74.5% 1y-2y 12.8% 2y-3y 3.2% 3y-5y 4.1% ＞5y 5.5%
- 13. The Distribution of Patients’ Interval from the Diagnosis to TKI Treatment (II) Time when patients began TKI treatment 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 2001* 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014** ＞5y 3-5y 2-3y 1-2y ＜1y n 20 8 2 11 24 29 39 61 79 66 140 183 193 106
- 14. The Distribution of TKIs Used (I) Tasgina 10.6% Glivec 66.1% Chinese generic dasatnib 0.7% Chinese generic imatinib 6.4% Others 0.6% Sprycel 4.2% Indian generic imatinib 11.2% Indian generic dasatinib 0.1% Imatinib 83%; Branded drugs 81%; Nilotinib or dasatinib as initial therapy on clinical trials 15%
- 15. The Distribution of TKIs Used (II) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Branded drugs Generic drugs n 20 8 2 11 24 29 39 61 79 66 140 183 193 106 Time when patients began TKI treatment Subjects receiving generics had a longer interval from the diagnosis to TKI treatment than those on branded drugs: 55/240 (23%) vs. 120/703 (17); P=0.044
- 16. TKI Responses • Median TKI treatment duration was 3 years (range, <1-13 years) • 708 of 834 respondents (85%) achieved CCyR • 497 of 859 respondents (46%) achieved CMR
- 17. Impact of TKI Treatment Adverse Effects on Quality of Life 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 44.1% 38.6% 32.5% 19.6% 19.0% 15.0% 12.4% 22.6% 1 30.1% 2 21.5% 3 28.7% 4 9.3% 5 10.4% QOL from 1–5 (1 being “no impact”, 5 being “high impact”)
- 18. Annual Out-of-pocket TKI Cost (I) Free 17.1% <＄4,000 17.9% ＄4,000-＄8,000 8.1% ＄8,000-＄12,000 46.3% ≥＄12,000 10.6% Multivariate analyses showed that urban population (HR=2.0, P=0.004), increasing age (HR=1.6, P=0.040), starting TKI therapy within 1 year from diagnosis (HR=0.6, P=0.026), receiving 2nd generation TKI (HR=3.7, P=0.001) and branded drug (HR=37.0, P<0.001) were associated with annual out-of-pocket expenses > $8,000 USD
- 19. Annual Out-of-pocket TKI Cost (II) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% ＞＄12,000 ＄8,000-＄12,000 ＄4,000-＄8,000 ＜＄4,000 free n 20 8 2 11 24 29 39 61 79 66 140 183 193 106 Time when patients began TKI treatment
- 20. Obstacles to Receiving TKI Therapy Satisfied 1.7% Side effect 17.2% Heavy financial burden 61.8% Unsatisfied treatment outcome 7.4% Inconvenient PAP drug access 9.6% Others 2.3% Others: 20 respondents reported it was inconvenient to get or take the drug, worries about disease progression, future drug side effects and pressure from their family and/or society
- 21. Monitoring During TKI Treatment • 795 respondents (84%) had done ≥1 CBC, 406 (43%) had ≥1 bone marrow cytogenetic analysis and 795 (91%) had ≥1 BCR-ABL level test by Q-PCR. • The frequency of regular visit to clinic: Irregular detection 4.2% Every month 29.1% Every 3 months 38.1% Every 6 months 23.6% Every 12 months 5.0%
- 22. The Frequency of Molecular Monitoring Irregular detection 13.6% Never 10.7% Every 3 months 32.8% Every 6 months 33.5% Every 12 months 9.4%
- 23. Reasons of Never and Irregular Molecular Monitoring (n=106) No cost sharing by medical insurance 18.9% No necessity for monitoring 10.4% No eligible laboratory in nearby hospitals 10.4% No requirement by physicians 60.4% Multivariate analysis showed increasing age (HR=2.0, P<0.001), rural households (HR=2.0, P<0.001), shorter interval from diagnosis to TKI treatment (HR=1.5, P=0.035), briefer TKI therapy (HR=3.5, P<0.001), and use of generics (HR=3.0, P<0.001) were associated with never or irregular molecular monitoring
- 24. Conclusions (I) • The current survey reflected the real-world of CML treatment and monitoring patterns in China from patients’ perspective • More than 70% of the respondents received a TKI within 1 year from diagnosis • Imatinib is the most commonly used TKI • The 2nd generation TKIs are mainly used as a second- or third-line therapy • Branded (non-generic) TKIs are still the mainstream
- 25. Conclusions (II) • Majority of the respondents achieved optimal response and were well tolerate on TKI • Financial burden is the biggest obstacle to receive TKI therapy • One-third of the respondents did not performed regular monitoring on TKI • It is expected to lower the prices of anticancer drugs, expand the coverage of medical insurance and develope generic drugs • Standard molecular monitoring needs to be highlighted
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