Pembrolizumab (Keytruda®) is indicated as monotherapy or in combination with platinum and 5-fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a combined positive score.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||25/11/2019|
|Rapid review completed||02/01/2020|
|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||07/01/2020|
|Pre-submission consultation with Applicant||24/02/2020|
|Full submission received from Applicant||28/08/2020|
|Preliminary review sent to Applicant||16/02/2021|
|NCPE assessment re-commenced||18/03/2021|
|Factual accuracy check sent to Applicant||30/04/2021|
|NCPE assessment re-commenced||10/05/2021|
|NCPE assessment completed||18/05/2021|
|NCPE assessment outcome||The NCPE recommends that pembrolizumab be considered for reimbursement if 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.