title: The impact of medical insurance coverage and molecular monitoring frequency on outcomes in chronic myeloid leukemia: real-world evidence in China.
abstract: OBJECTIVE
  Imatinib (Glivec) has been covered by critical disease insurance for treatment of chronic myeloid leukemia (CML) in Jiangsu province of China since 2013. Further, free molecular monitoring has been provided to patients at top clinical centers as part of a pilot study that has changed the local treatment pattern and outcomes of patients with CML. This study evaluates the impact of medical insurance coverage and the molecular monitoring frequency on outcomes of patients with CML treated at a central hospital in Jiangsu, China, according to patient-level data.
  
  
  METHODS
  The study investigated 335 CML patients receiving medical treatment in a central hospital between January 1, 2011 and December 31, 2014. Demographic and clinical characteristics were extracted from the patients' clinical records. Univariate and multivariate analyses using the logistic regression model were performed to identify the differences in outcomes of major molecular response (MMR) or complete cytogenetic response (CCyR) between patients who were insured vs uninsured, or between patients with frequency of PCR monitoring ≤2 times vs ≥3 times per year.
  
  
  RESULTS
  Both the achievement of MMR (BCR-ABLIS≤0.1%) (50.4% vs 37.5%) and CCyR (80.7% vs 62.8%) at 12 months have shown significant differences that favored patients with insurance coverage of imatinib, while there was no significant difference in the outcome of BCR-ABLIS≤1% between insured and non-insured groups (56.0% vs 51.3%) at 6 months. The long-term results at 24 months demonstrated that there was a statistically significant difference in MMR rates between the group with 3 or more PCR monitoring tests per year and the group of patients with 2 or less PCR tests per year (76.9% vs 52.2%).
  
  
  CONCLUSIONS
  The study findings suggest that CML patients benefit from insurance coverage of imatinib and higher frequency (≥3) of regularly scheduled molecular monitoring PCR in China.
authors.affiliation: a Department of Hematology , Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, The First Affiliated Hospital of Soochow University , Suzhou , PR China.
authors.forename: Guangying
authors.initials: G
authors.lastname: Sheng
authors.affiliation: a Department of Hematology , Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, The First Affiliated Hospital of Soochow University , Suzhou , PR China.
authors.forename: Suning
authors.initials: S
authors.lastname: Chen
authors.affiliation: a Department of Hematology , Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, The First Affiliated Hospital of Soochow University , Suzhou , PR China.
authors.forename: Ri
authors.initials: R
authors.lastname: Zhang
authors.affiliation: a Department of Hematology , Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, The First Affiliated Hospital of Soochow University , Suzhou , PR China.
authors.forename: Miao
authors.initials: M
authors.lastname: Miao
authors.affiliation: a Department of Hematology , Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, The First Affiliated Hospital of Soochow University , Suzhou , PR China.
authors.forename: Depei
authors.initials: D
authors.lastname: Wu
authors.affiliation: b Health Economics & Outcomes Research, IMS Health Asia Pacific , Singapore.
authors.forename: Seng Chuen
authors.initials: SC
authors.lastname: Tan
authors.affiliation: c Novartis Oncology (China) , Beijing , PR China.
authors.forename: Chao
authors.initials: C
authors.lastname: Liu
authors.affiliation: d Health Economics & Outcomes Research, IMS Health China , Shanghai , PR China.
authors.forename: Tengbin
authors.initials: T
authors.lastname: Xiong
mesh_terms: D000328:Adult; D000367:Age Factors; D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use*; D002681:China; D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000096:biosynthesis / Q000187:drug effects; D006403:Hematologic Tests; D006801:Humans; D000068877:Imatinib Mesylate / Q000191:economics* / Q000627:therapeutic use*; D019458:Insurance Coverage / Q000191:economics / Q000706:statistics & numerical data; D007348:Insurance, Health / Q000191:economics / Q000706:statistics & numerical data; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000191:economics / Q000627:therapeutic use; D012737:Sex Factors
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D000068877:Imatinib Mesylate; D016044:Fusion Proteins, bcr-abl
keywords: CML; China; Imatinib; Medical insurance coverage; Molecular monitoring; Patient level data analysis