Pembrolizumab (Keytruda®) for neoadjuvant/adjuvant treatment of triple negative breast cancer. HTA ID: 22027

Assessment Status NCPE Assessment Process Complete
HTA ID 22027
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence.
Assessment Process
Rapid review commissioned 27/04/2022
Rapid review completed 26/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard-of-care.
Full pharmacoeconomic assessment commissioned by HSE 01/07/2022
Pre-submission consultation with Applicant 30/08/2022
Full submission received from Applicant 16/03/2023
Preliminary review sent to Applicant 11/09/2023
NCPE assessment re-commenced 09/10/2023
Factual accuracy sent to Applicant 27/11/2023
NCPE assessment re-commenced 04/12/2023
NCPE assessment completed 18/12/2023
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda®) plus chemotherapy, followed by pembrolizumab monotherapy, be considered for reimbursement if 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. June 2024