title: Clinical simulation model of long-acting opioids for treatment of chronic non-cancer pain in the United States.
abstract: OBJECTIVE
  To evaluate costs and outcomes associated with initial tapentadol ER vs oxycodone CR for the treatment of chronic non-cancer pain (CNCP) in the US.
  
  
  METHODS
  This study developed a Monte-Carlo simulation based on the scientific foundation established by published models of long-acting opioids (LAO) in patients having moderate-to-severe CNCP. It estimates costs and outcomes associated with the use of tapentadol ER vs oxycodone CR over a 1-year period from the perspective of a US payer. LAO effectiveness and treatment-emergent adverse event (TEAE) rates are derived from clinical trials of tapentadol ER vs oxycodone CR; other inputs are based on published literature supplemented sparingly with clinical opinion. Sensitivity analyses consider the impact of real-world dosing patterns for LAO on treatment costs.
  
  
  RESULTS
  Initial tapentadol ER consistently demonstrates better outcomes than initial oxycodone CR (proportion of patients achieving adequate pain relief and no GI TEAE; acute TEAE-free days; days free of chronic constipation; quality-adjusted life days; productive working hours). While total costs with initial tapentadol ER are slightly (2.2%) higher than with initial oxycodone CR, nearly twice as many modeled patients in the initial tapentadol ER arm (29% vs 15%) achieve adequate pain relief and no GI TEAE compared to initial oxycodone CR. In sensitivity analyses, tapentadol ER becomes a dominant strategy when real-world dosing patterns are considered.
  
  
  CONCLUSIONS
  The additional costs to produce better outcomes (pain relief and no GI TEAE) associated with tapentadol ER are small in the context of double the likelihood of a patient response with tapentadol ER. When daily average consumption (DACON) for oxycodone CR is factored into the analysis, initial tapentadol ER becomes a dominant strategy. Our findings are both strengthened, and limited by the use of randomized trial-centric input parameters. These results should be validated as inputs from clinical practice settings become available.
authors.affiliation: Chordata Consulting LLC, Tacoma, WA, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Neil
authors.forename: Sanjay
authors.initials: S
authors.lastname: Merchant
authors.forename: David
authors.initials: D
authors.lastname: Provenzano
authors.forename: Kristine
authors.initials: K
authors.lastname: Ogden
authors.forename: Samir H
authors.initials: SH
authors.lastname: Mody
mesh_terms: D000701:Analgesics, Opioid / Q000191:economics* / Q000627:therapeutic use; D059350:Chronic Pain / Q000188:drug therapy*; D003198:Computer Simulation; D003365:Costs and Cost Analysis; D003692:Delayed-Action Preparations / Q000191:economics / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005102:Health Expenditures; D006801:Humans; D009010:Monte Carlo Method; D017063:Outcome Assessment, Health Care; D010098:Oxycodone / Q000191:economics* / Q000627:therapeutic use; D010636:Phenols / Q000191:economics* / Q000627:therapeutic use; D000077432:Tapentadol; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010636:Phenols; D010098:Oxycodone; D000077432:Tapentadol