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*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.