|Assessment Status||Assessment process complete|
|Indication||As a single agent, for the adjuvant treatment of adults with HER2-positive, early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.|
|Rapid review commissioned||20/01/2020|
|Rapid review completed||27/02/2020|
|Rapid review outcome||A full HTA is recommended to assess the clinical and cost effectiveness of trastuzumab emtansine compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||04/03/2020|
|Pre-submission consultation with Applicant||31/03/2020|
|Full submission received from Applicant||08/06/2020|
|Preliminary review sent to Applicant||29/10/2020|
|NCPE assessment re-commenced||30/11/2020|
|Factual accuracy sent to applicant||11/02/2021|
|NCPE assessment re-commenced||17/02/2021|
|NCPE assessment completed||12/03/2021|
|NCPE assessment outcome||The NCPE recommends that trastuzumab emtansine (Kadcyla®) be considered for reimbursement if 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.
The HSE has approved reimbursement following confidential price negotiations December 2021.