National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Pembrolizumab (Keytruda®) for NSCLC (first line)

Keytruda® 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.

NCPE Assessment ProcessOngoingRapid review received19/12/2016Rapid review completed10/01/2017Rapid Review outcomeFull pharmacoeconomic assessment recommendedFull pharmacoeconomic assessment commissioned by HSE11/01/2017Pre-submission consultation with applicant23/01/2017Submission received from applicant10/04/2017Preliminary review sent to applicant04/07/2017NCPE assessment re-commenced03/08/2017Applicant Factual Accuracy Check06/10/2017NCPE assessment re-commenced11/10/2017NCPE assessment completed13/10/2017Full pharmacoeconomic assessment outcomeReimbursement not recommended at the submitted price
NCPE Assessment Process Ongoing
Rapid review received 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
Submission received from Applicant 10/04/2017
Preliminary review sent to Applicant 04/07/2017
NCPE assessment re-commenced 02/08/2017
Applicant Factual Accuracy Check 06/10/2017
NCPE assessment re-commenced 11/10/2017
NCPE assessment completed 13/10/2017
Full pharmacoeconomic assessment outcome Reimbursement not recommended at the submitted price


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