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