title: Effectiveness of step therapy policies for specialty pharmaceuticals in immune disorders.
abstract: OBJECTIVE
  To assess the effectiveness of managed care plans that limited access to infusion biologics via a step therapy policy.
  
  
  METHODS
  This was a retrospective cohort study using Symphony Health Solutions claims databases that included payer, prescription (Rx), diagnosis (Dx) and procedure (Px) information with unique anonymized patient identifiers.
  
  
  METHODS
  The percentage of patients with claims for infusion and subcutaneous (SQ) biologics were evaluated across three increasingly restrictive cohorts: (1) patients in step therapy plans versus all others in the database (population), (2) patients in step therapy plans versus patients that were members of plans that were roughly matched (matched) and (3) a subsample of patients that were members of step therapy plans that had sufficient data for a pre/post analysis (pre/post).
  
  
  RESULTS
  The population analysis comparison showed 5.1% fewer patients (p < 0.0001) with claims for infusion biologics among step therapy plans than among the overall plans. The more controlled matched and pre/post analyses showed a greater percentage of patients with claims for intravenous products in the plans with step therapy policies versus plans without step therapy policies, differences of +7.0% (p < 0.0001) and +2.8% (p = 0.0522), respectively.
  
  
  CONCLUSIONS
  Policies designed to limit utilization of infusion biologics showed equivocal results. In the near term, the intended effects of implementing step therapy policies may be limited by relatively small numbers of patients that are affected relative to the total number of users.
authors.affiliation: a a St. Helena Island , SC , USA.
authors.forename: Chris M
authors.initials: CM
authors.lastname: Kozma
authors.affiliation: b b Janssen Scientific Affairs , Horsham , PA , USA.
authors.forename: Mike
authors.initials: M
authors.lastname: Ingham
authors.affiliation: c c Vigilytics LLC , Victor , NY , USA.
authors.forename: Andy
authors.initials: A
authors.lastname: Paris
authors.affiliation: d d Health Economics and Outcomes Research, Janssen Scientific Affairs LLC , Bel Air , USA.
authors.forename: Lorie
authors.initials: L
authors.lastname: Ellis
mesh_terms: D001688:Biological Products / Q000008:administration & dosage* / Q000191:economics* / Q000627:therapeutic use; D002985:Clinical Protocols / Q000592:standards*; D004334:Drug Administration Schedule; D004363:Drug Utilization / Q000191:economics*; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D007154:Immune System Diseases / Q000188:drug therapy*; D007279:Injections, Subcutaneous; D007345:Insurance Claim Review / Q000706:statistics & numerical data; D008297:Male; D012189:Retrospective Studies
chemical_list: D001688:Biological Products
keywords: Biologics; Specialty pharmaceuticals; Step therapy