title: Cost-effectiveness of tapentadol in severe chronic pain in Spain: a cost analysis of data from RCTs.
abstract: BACKGROUND
  Chronic pain is known to be a significant and common health problem. Tapentadol, a recently developed centrally active, oral analgesic agent is used to treat adults with severe chronic pain that can be adequately managed only with opioid analgesics. Tapentadol has been reported to provide an improved adverse-events (AE) profile compared with other potent opioid analgesics at similar levels of analgesia.
  
  
  OBJECTIVE
  The aim of this study was to compare the cost-effectiveness of tapentadol to that of opioids commonly used as first-line treatment of severe, chronic, nonmalignant pain from the perspective of the health care payer in Spain.
  
  
  METHODS
  A Markov state-transition model was developed to compare the cost-effectiveness of first-line treatment with tapentadol to that of oxycodone, morphine, and transdermal fentanyl (TDF) over a 1-year time horizon. Four health states were defined: (1) treatment discontinuation due to a severe AE; (2) treatment discontinuation due to a lack of efficacy; (3) occurrence of an AE that required medical treatment; and (4) no discontinuation and no AE. If a patient discontinued a treatment, he or she was switched to an alternative, second-line opioid. Data regarding efficacy, tolerability, and utility values (EQ-5D) were derived from randomized clinical trials. Clinical experts estimated the rates of switching to other opioids and the health care resource utilization associated with the treatment of severe chronic pain. Unit costs were derived from public price lists/tariff works and were calculated from the perspective of the National Spanish Health System. The robustness of the model results was tested in extensive sensitivity analyses in which event probabilities, costs, utilities, and treatment-switching rates were altered.
  
  
  RESULTS
  Data from 3 studies (1981 patients) were included in the model. Overall, the model predicted that initiating first-line treatment with tapentadol in patients with severe, chronic, nonmalignant pain was associated with lower costs and greater efficacy versus first-line treatment with oxycodone. Compared with morphine and TDF, tapentadol yielded incremental cost-effectiveness ratios of €2656 and €2069 per quality-adjusted life-year gained, respectively. On extensive 1-way and scenario analyses, findings on the cost-effectiveness of tapentadol were consistent. The probability that tapentadol would be cost-effective compared with each comparator at the willingness-to-pay threshold of €20,000 to €30,000/QALY gained exceeded 90%.
  
  
  CONCLUSIONS
  Based on the findings from the present model, tapentadol is likely to be a cost-effective first-line treatment in patients with severe, chronic, nonmalignant pain in Spain according to the commonly accepted willingness-to-pay thresholds. Compared with morphine and TDF, the incremental cost-effectiveness ratios were low; compared with oxycodone, tapentadol dominated, showing better quality-of-life outcomes at lower costs.
authors.affiliation: Grünenthal GmbH, Aachen, Germany.
authors.forename: Marko
authors.initials: M
authors.lastname: Obradovic
authors.forename: Robert
authors.initials: R
authors.lastname: Ikenberg
authors.forename: Nadine
authors.initials: N
authors.lastname: Hertel
authors.forename: Fernando
authors.initials: F
authors.lastname: Antoñanzas
authors.forename: Rafael
authors.initials: R
authors.lastname: Gálvez
authors.forename: Hiltrud
authors.initials: H
authors.lastname: Liedgens
mesh_terms: D000701:Analgesics, Opioid / Q000191:economics* / Q000494:pharmacology / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D006801:Humans; D010636:Phenols / Q000191:economics* / Q000494:pharmacology / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D017450:Receptors, Opioid, mu / Q000037:antagonists & inhibitors*; D013030:Spain; D000077432:Tapentadol
chemical_list: D000701:Analgesics, Opioid; D010636:Phenols; D017450:Receptors, Opioid, mu; D000077432:Tapentadol