title: Uptake and characteristics of zoledronic acid and denosumab patients and physicians in Ontario, Canada: impact of drug formulary access.
abstract: The addition of Limited Use criteria (less restrictive access) for zoledronic acid resulted in an immediate and significant increase in uptake and resulted in differences in patient/physician characteristics. In comparison, the uptake of denosumab (only listed with Limited Use) was rapid. Thus, formulary access restrictions have significant implications for prescribing.
  
  
  BACKGROUND
  We sought to describe the use of zoledronic acid and denosumab by physicians and patients over time and examine the impact of a 2012 provincial formulary modification that removed the administrative burden on physicians when prescribing zoledronic acid.
  
  
  METHODS
  We identified users of zoledronic acid and denosumab using Ontario pharmacy claims data. The number of new patients and physicians was plotted and examined over time. Interrupted time series analysis examined the impact of a formulary modification to zoledronic acid use and prescribing. Descriptive characteristics of patients and prescribers were summarized pre- and post-formulary modification for zoledronic acid and overall for denosumab.
  
  
  RESULTS
  We identified 1463 zoledronic acid patients treated by 627 physicians and 16,736 denosumab patients treated by 2904 physicians. In the first 2 months on the market, we identified a rapid uptake of denosumab (>450 physicians and >1200 patients) in contrast to zoledronic acid (<10 physicians and <10 patients). Zoledronic acid use increased significantly in the 2-month post-formulary change, yet no change in denosumab was observed. Prior to the formulary modification, more zoledronic acid patients had a history of osteoporosis therapy (41 vs. 26%) or bone density testing (30 vs. 10%). Compared to zoledronic patients (post-formulary modification), more denosumab patients had prior osteoporosis therapy (55 vs. 26%), yet fewer had a gastrointestinal diagnosis (6 vs. 11%).
  
  
  CONCLUSIONS
  We identified a rapid uptake of denosumab in only 15 months of observation. A provincial formulary modification to zoledronic acid resulted in an increase in utilization and impacted patient characteristics.
authors.affiliation: Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada, a.burden@utoronto.ca.
authors.forename: A M
authors.initials: AM
authors.lastname: Burden
authors.forename: M
authors.initials: M
authors.lastname: Tadrous
authors.forename: A
authors.initials: A
authors.lastname: Calzavara
authors.forename: S M
authors.initials: SM
authors.lastname: Cadarette
mesh_terms: D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D000069448:Denosumab / Q000627:therapeutic use*; D004164:Diphosphonates / Q000627:therapeutic use*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004363:Drug Utilization / Q000706:statistics & numerical data*; D005260:Female; D006302:Health Services Research / Q000379:methods; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D009864:Ontario; D010024:Osteoporosis / Q000188:drug therapy*; D010602:Pharmacopoeias as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000069448:Denosumab; D000077211:Zoledronic Acid