| Sumario: | Tapentadol ER (Nucynta Extended-Release) is indicated for the management of patients with pain severe enough to require daily, continuous, long-term opioid treatment, and that is opioid responsive, and for which alternative treatment options are inadequate. Tapentadol ER tablets are available in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths. The submitted price of tapentadol ER is based on dose: 50 mg (1.04), 100 mg (1.56), 150 mg (2.09), 200 mg (2.71), and 250 mg (3.75). The recommended initial dose for opioid-naive patients is 50 mg twice daily, titrated to an optimal dose within the therapeutic range of 100 mg to 250 mg twice daily. A switch to tapentadol ER for patients currently taking another opioid analgesic should be accompanied by a 50% reduction in the calculated morphine-equivalent daily dose, followed by adjustments to an optimal dose, recommended as 100 mg to 250 mg twice daily. At the recommended dose range, the cost of tapentadol ER is 3.12 to 7.50 per patient, per day, or 1,140 to 2,738 per patient, per year. CADTH's Common Drug Review (CDR) previously reviewed tapentadol controlled-release (Nucynta CR) for the management of moderate-to-moderately-severe pain in adults who require continuous treatment for several days or more. The CADTH Canadian Drug Expert Committee recommended that tapentadol CR not be listed, based on a lack of sufficient evidence establishing the relative efficacy between tapentadol CR and oxycodone CR. The manufacturer submitted a probabilistic Markov state-transition cost-utility analysis comparing tapentadol ER with long-acting oral preparations of oxycodone, hydromorphone, and morphine in adult patients with pain severe enough to require daily, continuous, long-term opioid use that is opioid responsive and for which alternative treatment options are inadequate.
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