title: Positive subjective measures in abuse liability studies and real-world nonmedical use: Potential impact of abuse-deterrent opioids on rates of nonmedical use and associated healthcare costs.
abstract: OBJECTIVE
  To quantify the potential impact of reductions in positive subjective measures from human abuse liability studies on real-world rates of nonmedical use of prescription drugs and associated healthcare resource utilization and costs.
  
  
  METHODS
  Positive subjective endpoints "overall drug liking," in-the-moment "drug liking," and "drug high" Emaxs (peak effects) were recorded from published studies. Nonmedical use data were obtained from the 2010 National Survey on Drug Use and Health (NSDUH) and Drug Abuse Warning Network surveys. Multivariate regressions evaluated the association between the positive subjective endpoints and nonmedical use rates, controlling for prescription volume, whether the drug is an opioid, and controlled substance schedule. A published budget-impact model was used to assess healthcare resource utilization and cost impacts of abuse-deterrent opioid formulations.
  
  
  RESULTS
  A five-point reduction in overall drug liking/drug liking/drug high Emax was associated with a 0.25/0.10/0.05 (standard errors: 0.11/0.12/0.07) percentage point decrease in the NSDUH lifetime nonmedical use rates. Those decreases yielded a 11.3/4.2/2.1 percent reduction compared to the samples' lifetime nonmedical use rates of 2.21/2.38/2.36 percent. On the basis of a number of assumptions, these reductions were associated with private payer cost reductions for a morphine and oxycodone abuse-deterrent formulation in the ranges of $147.9-324.1 million and $230.7-958.7 million, respectively.
  
  
  CONCLUSIONS
  Reductions in overall drug liking were significantly associated with reduced real-world nonmedical use, healthcare utilization, and costs. Associations using drug high and drug liking were directionally consistent with this finding though not statistically significant. A reduction in positive subjective measures associated with an abuse-deterrent formulation has potential to reduce abuse and associated healthcare utilization and costs.
authors.affiliation: Managing Principal, Analysis Group, Inc., Boston, Massachusetts.
authors.forename: Alan G
authors.initials: AG
authors.lastname: White
authors.affiliation: Analysis Group, Inc., Boston, Massachusetts.
authors.forename: Joseph
authors.initials: J
authors.lastname: LeCates
authors.affiliation: Analysis Group, Inc., Boston, Massachusetts.
authors.forename: Howard G
authors.initials: HG
authors.lastname: Birnbaum
authors.affiliation: Analysis Group, Inc., Boston, Massachusetts.
authors.forename: Wendy
authors.initials: W
authors.lastname: Cheng
authors.affiliation: Pfizer Inc., Durham, North Carolina.
authors.forename: Carl L
authors.initials: CL
authors.lastname: Roland
authors.affiliation: Pfizer Inc., New York, New York.
authors.forename: Jack
authors.initials: J
authors.lastname: Mardekian
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects / Q000737:chemistry / Q000191:economics* / Q000627:therapeutic use*; D002017:Budgets; D002626:Chemistry, Pharmaceutical; D017046:Cost Savings; D016527:Drug Costs; D006295:Health Resources / Q000191:economics* / Q000706:statistics & numerical data; D006801:Humans; D017059:Models, Econometric; D009020:Morphine / Q000191:economics / Q000627:therapeutic use; D015999:Multivariate Analysis; D009293:Opioid-Related Disorders / Q000191:economics* / Q000517:prevention & control* / Q000523:psychology; D010098:Oxycodone / Q000191:economics / Q000627:therapeutic use; D010342:Patient Acceptance of Health Care; D055553:Prescription Drugs / Q000009:adverse effects / Q000737:chemistry / Q000191:economics* / Q000627:therapeutic use*
chemical_list: D000701:Analgesics, Opioid; D055553:Prescription Drugs; D009020:Morphine; D010098:Oxycodone