Pembrolizumab (Keytruda), 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.
|NCPE Assessment Process||Complete|
|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 the 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 Check 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.