Cerliponase alfa (Brineura®)

Assessment Status NCPE Assessment process complete
Drug Cerliponase alfa
Brand Brineura®
Indication For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Assessment Process
Rapid review commissioned 11/10/2017
Rapid review completed 27/11/2017
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 29/11/2017
Pre-submission consultation with Applicant 13/03/2018
Full submission received from Applicant 02/08/2018
Preliminary review sent to Applicant 30/11/2018
NCPE assessment re-commenced 25/01/2019
Factual accuracy sent to Applicant 25/02/2019
NCPE assessment re-commenced 08/03/2019
NCPE assessment completed 25/03/2019
NCPE assessment outcome The NCPE recommends that cerliponase alfa (Brineura®) not be considered for reimbursement. 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; November 2020.

Technical Summary