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

Assessment Status 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.