Neratinib (Nerlynx®). HTA ID: 19057

Assessment Status Assessment Process Complete
HTA ID 19057
Drug Neratinib
Brand Nerlynx®
Indication For the extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Assessment Process
Rapid review commissioned 18/12/2019
Rapid review completed 30/01/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of neratinib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 05/02/2020
Pre-submission consultation with Applicant 21/04/2020
Full submission received from Applicant 04/08/2020
Preliminary review sent to Applicant 17/12/2020
NCPE assessment re-commenced 26/01/2021
Factual accuracy sent to Applicant 16/04/2021
NCPE assessment re-commenced 22/04/2021
NCPE assessment completed 12/05/2021
NCPE assessment outcome The NCPE recommends that neratinib (Nerlynx®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations March 2022.