Pembrolizumab (Keytruda®) for NSCLC (second line)

Assessment Status Assessment Process Complete
Drug Pembrolizumab
Brand Keytruda®
Indication Is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab.
Assessment Process
Rapid review commissioned 03/08/2016
Rapid review completed 24/08/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 31/08/2016
Pre-submission consultation with Applicant 10/10/2016
Full submission received from Applicant 21/07/2017
Preliminary review sent to Applicant 23/10/2017
NCPE assessment re-commenced 06/03/2018
Factual accuracy sent to Applicant 17/05/2018
NCPE assessment re-commenced 25/05/2018
NCPE assessment completed 28/05/2018
NCPE assessment outcome The NCPE recommends that pembrolizumab (Keytruda) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.*

Technical 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.

Reimbursement application withdrawn (November 2018)