title: Impact of a prior authorization policy for montelukast on clinical outcomes for asthma and allergic rhinitis among children and adolescents in a state Medicaid program.
abstract: BACKGROUND
  Public policymakers often struggle with increased membership and limited budgets. Restrictions, commonly in the form of prior authorizations, are often placed on more costly pharmaceuticals, especially when lower cost or more effective products are available. Restrictions placed on products for difficult-to-manage disease states must be reviewed in order to ensure that unintended clinical consequences do not occur.
  
  
  OBJECTIVE
  To assess the impact of a prior authorization policy for montelukast on clinical outcomes for asthma and allergic rhinitis among children and adolescent members of Oklahoma Medicaid (MOK) from 2007 through 2010.
  
  
  METHODS
  Monthly individual-level utilization data were collected from MOK paid pharmacy and medical claims from January 1, 2007, through December 31, 2010, for members with asthma and/or allergic rhinitis. Members who were continuously eligible for the entire 48-month review period were included. The effect of a prior authorization policy for montelukast on emergency room (ER) utilization, disease-related physician office visits (DRV), and antibiotic prescription utilization (ABX) was analyzed using segmented logistic regression.
  
  
  RESULTS
  For all 3 outcomes, decreases in mean number of claims per member per month were detected when comparing the pre-implementation and post-implementation prior authorization periods for all 3 disease states of asthma, allergic rhinitis, or both. Odds of having an ER event at the point of prior authorization implementation were 0.71 (P  less than  0.001) and were 1.29 (P  less than  0.001) and 1.26 (P  less than  0.001) for DRV and ABX, respectively. Overall trend in odds was 1.02 (P  less than  0.001), 0.93 (P  less than  0.001), and 0.95 (P  less than  0.001) for ER, DRV, and ABX, but during the post-implementation period, the odds were 0.92 (P  less than  0.001) for ER and 1.03 (P  less than  0.001) for both DRV and ABX. The final result was an increasing trend prior to implementation for ER, a decrease at implementation, and a continued decrease in odds of an event in the post-implementation period. However, for DRV and ABX, there was an overall decrease in trend regardless of period, with a small increase in odds at the point of implementation.
  
  
  CONCLUSIONS
  While there was a point increase at implementation for DRV and ABX, the overall trend remained negative, indicating that no unexpected adverse clinical outcomes occurred. Additionally, no signal was found in ER use after implementation to indicate that unintended consequences occurred, particularly for those patients with asthma.
authors.affiliation: University of Oklahoma College of Pharmacy, CPB-222, P.O. Box 26901, Oklahoma City, OK 73126-0901. shellie-keast@ouhsc.edu.
authors.forename: Shellie L
authors.initials: SL
authors.lastname: Keast
authors.forename: David
authors.initials: D
authors.lastname: Thompson
authors.forename: Kevin
authors.initials: K
authors.lastname: Farmer
authors.forename: Michael
authors.initials: M
authors.lastname: Smith
authors.forename: Nancy
authors.initials: N
authors.lastname: Nesser
authors.forename: Donald
authors.initials: D
authors.lastname: Harrison
mesh_terms: D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000367:Age Factors; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D017723:Drug Utilization Review; D004632:Emergency Medical Services; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D019458:Insurance Coverage; D007356:Insurance, Pharmaceutical Services; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008484:Medicaid; D016017:Odds Ratio; D009819:Office Visits; D011050:Policy Making; D015397:Program Evaluation; D011804:Quinolines / Q000627:therapeutic use*; D012189:Retrospective Studies; D065631:Rhinitis, Allergic / Q000175:diagnosis / Q000188:drug therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000188:drug therapy*; D013221:State Health Plans; D013440:Sulfides; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000085:Acetates; D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D000900:Anti-Bacterial Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast