Amivantamab (Rybrevant) : CADTH reimbursement review / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

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

Series:

CADTH drug reimbursement review.

CADTH drug reimbursement review

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical Description:

1 online resource (178 pages) : illustrations.

Place of Publication:

Ottawa : Canadian Agency for Drugs and Technologies in Health, 2023.

Summary:

Amivantamab is indicated by Health Canada for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR exon 20 insertion mutations whose disease has progressed on, or after, platinum-based chemotherapy. The Health Canada Notice of Compliance with conditions was granted on March 30, 2022, based on the October 2020 data cut-off (DCO), through Project Orbis. Conditions for authorization are pending the results of confirmatory and other ongoing trials including the phase IIIPAPILLON trial, which aims to evaluate the efficacy of amivantamab in combination with chemotherapy in the first-line treatment of locally advanced or metastatic EGFR exon 20 insertion NSCLC, and the final report for CHRYSALIS to verify the clinical benefit of amivantamab. The sponsor is requesting that amivantamab be reimbursed as per the indication from Health Canada. Amivantamab has not been previously reviewed by CADTH. The objective of the current report is to review the beneficial and harmful effects of amivantamab (1,050mg for patients weighing less than 80 kg, and 1,400 mg for patients weighing greater than or equal to 80 kg) for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR exon 20insertion mutations whose disease has progressed on, or after, platinum-based chemotherapy.

Contents:

Clinical Review

Executive Summary

Introduction

Stakeholder Perspectives

Clinical Evidence

Discussion

Conclusions

Abbreviations

Appendix 1. Literature Search Strategy

Appendix 2. Excluded Studies

Appendix 3. Detailed Outcome Data

References

Pharmacoeconomic Review

Stakeholder Input Relevant to the Economic Review

Economic Review

Appendix 1. Cost Comparison Table

Appendix 2. Submission Quality

Appendix 3. Additional Information on the Submitted Economic Evaluation

Appendix 4. Additional Details on the CADTH Reanalyses and Sensitivity Analyses of the Economic Evaluation

Appendix 5. Submitted BIA and CADTH Appraisal

Stakeholder Input

Patient Input

Clinician Input.

Notes:

Includes bibliographical references.

Description based on publisher supplied metadata and other sources.