title: Do newly marketed generic medicines expand markets using descriptive time series analysis and mixed logit models? Korea as an exemplar and its implications.
abstract: BACKGROUND
  There have been concerns in Korea that the availability of cheaper generics can appreciably increase prescribed volumes thereby negating their beneficial effects on overall pharmaceutical expenditure. Consequently, this study aimed to explore market changes after newly entered generics including market expansion and substitution effects, and to examine factors contributing to the prescribing of newly entered generics using atorvastatin as an exemplar. This is because previous studies have shown market expansion had occurred following generic atorvastatin.
  
  
  METHODS
  Explore market expansion effects by extracting all statins users from July 2008 to June 2010 from the nationally representative dataset of 2008, combined with the National Health Insurance Claims data, with atorvastatin's patent expiring in July 2008. The data consisted of medical visit episodes of patients who had been prescribed statins at least once during the observational period. Patients who had been prescribed any statin before the observation period were classified as the previously treated group and those who had not as the newly treated group. Descriptive time series analysis was conducted and the mixed logit model applied to understand factors contributing to generic atorvastatin prescriptions.
  
  
  RESULTS
  Market expansion was observed after generic atorvastatin availability with an appreciable increase in number of newly treated patients, whereas substitution effect was found among previously treated patients. Newly treated patients tended to get significantly lower daily doses (p < 0.0001). According to the mixed logistic analysis, newly treated patients were more likely to be prescribed generic atorvastatin (OR = 2.58; 95% CI, 2.05-3.26) than their counterparts. Clinicians and secondary hospitals were also key drivers of generic atorvastatin (ORs were 10.41 and 9.81, respectively).
  
  
  CONCLUSIONS
  Newly marketed generic statins in Korea resulted in an expanding market by substantially increasing the number of new patients with clinics and hospitals appreciably using newly marketed generics. However lower doses of statins were prescribed. Policy makers do recognize that generic availability can save costs so should be encouraged. However, this is a concern when generic availability appreciably expands the market, potentially increasing the financial burden. This needs to be addressed. Additionally in Korea, the quality of prescribing should be monitored, especially focusing on clinics and secondary hospitals.
authors.affiliation: Division of Biomedicine & Public Health, Mokwon University, Daejeon, 35349, South Korea.
authors.forename: Hye-Young
authors.initials: HY
authors.lastname: Kwon
authors.affiliation: Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, SE-141 86, Stockholm, Sweden. Brian.Godman@ki.se.|Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, G4 0RE, UK. Brian.Godman@ki.se.
authors.forename: Brian
authors.initials: B
authors.lastname: Godman
mesh_terms: D000368:Aged; D000069059:Atorvastatin / Q000627:therapeutic use; D003365:Costs and Cost Analysis; D016568:Drugs, Generic / Q000191:economics; D005260:Female; D005102:Health Expenditures; D006291:Health Policy; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D065186:Interrupted Time Series Analysis; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009313:National Health Programs / Q000191:economics; D056910:Republic of Korea
chemical_list: D016568:Drugs, Generic; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000069059:Atorvastatin
keywords: Generics; Health policy; Korea; Market expansion; Statins