Pembrolizumab (Keytruda®) for NSCLC (first line)

Assessment Status Assessment Process Complete
Drug Pembrolizumab
Brand Keytruda®
Indication For the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 (tumour proportion score [TPS] ≥ 50%) with no EGFR or ALK positive tumour mutations and no prior systemic therapy for advanced disease.
Assessment Process
Rapid review commissioned 19/12/2016
Rapid review completed 10/01/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 11/01/2017
Pre-submission consultation with Applicant 23/01/2017
Full submission received from Applicant 10/04/2017
Preliminary review sent to Applicant 04/07/2017
NCPE assessment re-commenced 02/08/2017
Factual accuracy sent to Applicant 06/10/2017
NCPE assessment re-commenced 11/10/2017
NCPE assessment completed 13/10/2017
NCPE assessment outcome Reimbursement not recommended at the submitted price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations April 2018.