Pharmacoeconomic review report : Netupitant/Palonosetron 300 mg/0.5 mg (Akynzeo) (Purdue pharma) / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

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

Series:

Common drug review clinical review report.

Common drug review clinical review report

Language:

English

Subjects (All):

Antiemetics.

Physical Description:

1 online resource (34 pages) : illustrations.

Other Title:

Pharmacoeconomic review report Netupitant/Palonosetron 300 mg/0.5 mg

Place of Publication:

Ottawa (ON) : CADTH, 2018.

Summary:

Netupitant/palonosetron (Akynzeo) is an oral fixed-dose combination of netupitant, a neurokinin-1 (NK1) receptor antagonist (RA), and palonosetron, a 5-hydroxytryptamine-3 (5-HT3) RA, available as a 300 mg/0.5 mg oral capsule. In combination with dexamethasone, netupitant/palonosetron (NEPA) is indicated for once-per-cycle treatment in adult patients for: 1. prevention of acute and delayed nausea and vomiting associated with highly emetogenic (HEC) chemotherapy, 2. prevention of acute nausea and vomiting associated with moderately emetogenic (MEC) therapy that is uncontrolled by a 5-HT3 receptor antagonist alone. Oral palonosetron was previously reviewed by CADTH Common Drug Review (CDR) in 2013 and received a "do not list" recommendation based on clinical reasons, notably the absence of direct or indirect comparisons of oral palonosetron with other oral 5-HT3RAs for the treatment of chemotherapy-induced nausea and vomiting (CINV), and because "oral palonosetron failed to demonstrate non-inferiority against intravenous palonosetron" in the delayed phase. The recommended dose for NEPA is one capsule administered orally 1 hour prior to the start of a chemotherapy cycle. The manufacturer is seeking reimbursement in line with the Health Canada indication. The manufacturer submitted a price of $135 per capsule; therefore, the cost of NEPA is $135 per chemotherapy cycle.

Contents:

Abbreviations

Executive Summary

Background

Summary of Identified Limitations and Key Results

Conclusions

Information on the Pharmacoeconomic Submission

Summary of the Manufacturer's Pharmacoeconomic 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. Summary of Other Health Technology Assessment Reviews of Drug

Appendix 5. Reviewer Worksheets

References.

Notes:

Description based on publisher supplied metadata and other sources.

Includes bibliographical references.