Pembrolizumab (Keytruda®) for oesphageal carcinoma or HER-2 negative gastroesophageal junction adenocarcinoma. HTA ID: 21032

Assessment Status NCPE Assessment Process Complete
HTA ID 21032
Drug Pembrolizumab
Brand Keytruda®
Indication In combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS≥10.
Assessment Process
Rapid review commissioned 12/07/2021
Rapid review completed 05/08/2021
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 25/08/2021
Pre-submission consultation with Applicant 28/09/2021
Full submission received from Applicant 25/03/2022
Preliminary review sent to Applicant 23/09/2022
NCPE assessment re-commenced 24/10/2022
Factual accuracy sent to Applicant 08/12/2022
NCPE assessment re-commenced 15/12/2022
NCPE assessment completed 21/12/2022
NCPE assessment outcome The NCPE recommends that pembrolizumab 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.

The HSE has approved reimbursement following confidential price negotiations; June 2023