Clinical review report : (Paladin labs inc.). Tapentadol hydrochloride extended-release tablet (Nucynta extended-release) / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

Canadian Agency for Drugs and Technologies in Health, author, issuing body.

Language:

English

Subjects (All):

Pain--Treatment.

Pain.

Cost effectiveness.

Physical Description:

1 online resource (37 pages)

Edition:

Final.

Place of Publication:

Ottawa (ON) : Canadian Agency for Drugs and Technologies in Health, 2018.

Summary:

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.

Contents:

CADTH Canadian Drug Expert Committee final recommendation : Indication: pulmonary arterial hypertension. Selexipag (Uptravi

Actelion Pharmaceuticals Canada Inc.)Abbreviations

Executive Summary

Background

Summary of Identified Limitations and Key Results

Conclusions

Information on the Pharmacoeconomic Submission

Summary of the Manufacturer's PE Submission

Manufacturer's Base Case

Summary of Manufacturer's Sensitivity Analyses

Limitations of Manufacturer's Submission

CADTH Common Drug Review Reanalyses

Issues for Consideration

Patient Input

Appendix 1. Cost Comparison

Appendix 2. Summary of Key Outcomes

Appendix 3. Additional Information

Appendix 4. Other HTA Agencies

Appendix 5. Reviewer Worksheets

References.

Notes:

Description based on publisher supplied metadata and other sources.