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.Conclusion: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.