Pembrolizumab (Keytruda®) for Adjuvant melanoma

Assessment Status Assessment Process Complete
Drug Pembrolizumab
Brand Keytruda®
Indication As monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.
Assessment Process
Rapid review commissioned 19/11/2018
Rapid review completed 07/12/2018
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 19/12/2018
Pre-submission consultation with Applicant 14/01/2019
Full submission received from Applicant 16/07/2019
Preliminary review sent to Applicant 13/11/2019
NCPE assessment re-commenced 12/12/2019
Factual accuracy sent to Applicant 01/04/2020
NCPE assessment re-commenced 08/04/2020
NCPE assessment completed 15/05/2020
NCPE assessment outcome The NCPE recommends that pembrolizumab 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 May 2021.