title: Adverse clinical events among medicare beneficiaries using antipsychotic drugs: linking health insurance benefits and clinical needs.
abstract: OBJECTIVE
  Medicare Part D provides formulary protections for antipsychotics but does not exempt these drugs from cost-sharing. We investigated the impact of Part D coverage on antipsychotic drug spending, adherence, and clinical outcomes among beneficiaries with varying indications for use.
  
  
  METHODS
  We conducted a historical cohort study of Medicare Advantage beneficiaries who received antipsychotic drugs, with diagnoses of schizophrenia or bipolar disorder or with no mental health diagnoses (N=10,190). Half had a coverage gap; half had no gap because of low-income subsidies. Using fixed effects regression models, we examined changes in spending and adherence as beneficiaries experienced cost-sharing increases after reaching the gap. We examined changes in hospitalizations and emergency department visits using proportional hazard models.
  
  
  RESULTS
  Across all diagnostic groups, total monthly expenditure on antipsychotic drugs decreased with cost-sharing increases in the gap compared with those with no gap (eg, schizophrenia: -$123 95% confidence interval [-$138, -$108]), and out-of-pocket spending increased (eg, schizophrenia: $104 [$98, $110]). Adherence similarly decreased, with the largest declines among those with schizophrenia (-20.6 percentage points [-22.3, -18.9] in proportion of days covered). Among beneficiaries with schizophrenia and bipolar disorder, hospitalizations and emergency department visit rates increased with cost-sharing increases (eg, schizophrenia: hazard ratio=1.32 [1.06, 1.65] for all hospitalizations), but did not among subjects without mental health diagnoses. Clinical event rates did not change among beneficiaries with low-income subsidies without gaps.
  
  
  CONCLUSIONS
  There is evidence of interruptions in antipsychotic use attributable to Part D cost-sharing. Adverse events increased among beneficiaries with approved indications for use, but not among beneficiaries without such indications.
authors.affiliation: Mid-Atlantic Permanente Research Institute, Mid-Atlantic Permanente Medical Group, Rockville, MD, USA. vfung@partners.org
authors.forename: Vicki
authors.initials: V
authors.lastname: Fung
authors.forename: Mary
authors.initials: M
authors.lastname: Price
authors.forename: Alisa B
authors.initials: AB
authors.lastname: Busch
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Landrum
authors.forename: Bruce
authors.initials: B
authors.lastname: Fireman
authors.forename: Andrew
authors.initials: A
authors.lastname: Nierenberg
authors.forename: William H
authors.initials: WH
authors.lastname: Dow
authors.forename: Rita
authors.initials: R
authors.lastname: Hui
authors.forename: Richard
authors.initials: R
authors.lastname: Frank
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Newhouse
authors.forename: John
authors.initials: J
authors.lastname: Hsu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000191:economics; D001714:Bipolar Disorder / Q000188:drug therapy; D015331:Cohort Studies; D016001:Confidence Intervals; D017047:Cost Sharing; D004637:Emergency Services, Psychiatric / Q000706:statistics & numerical data; D005260:Female; D005102:Health Expenditures; D006301:Health Services Needs and Demand; D006760:Hospitalization / Q000639:trends; D006801:Humans; D019458:Insurance Coverage / Q000191:economics*; D008297:Male; D054524:Medicare Part D; D055118:Medication Adherence; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D012559:Schizophrenia / Q000188:drug therapy; D014481:United States
chemical_list: D014150:Antipsychotic Agents