National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Neratinib (Nerlynx®) HTA ID: 19057

Neratinib is indicated 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.


NCPE Assessment Process Complete
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 the 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 check 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.