Pembrolizumab (Keytruda®) for head and neck squamous cell carcinoma. HTA ID: 19051

Assessment Status Assessment Process Complete
HTA ID 19051
Drug Pembrolizumab
Brand Keytruda®
Indication 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.
Assessment Process
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 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 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*.

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, December 2021.