Nusinersin (Spinraza®)

Assessment Status Assessment Process Complete
Drug Nusinersen
Brand Spinraza®
Indication Is indicated for the treatment of 5q spinal muscular atrophy (SMA)
Assessment Process
Rapid review commissioned 11/07/2017
Rapid review completed 02/08/2017
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 14/08/2017
Pre-submission consultation with Applicant 12/09/2017
Full submission received from Applicant 31/10/2017
Preliminary review sent to Applicant 28/11/2017
NCPE assessment re-commenced 06/12/2017
Factual accuracy sent to Applicant 08/12/2017
NCPE assessment re-commenced 14/12/2017
NCPE assessment completed 19/12/2017
NCPE assessment outcome Reimbursement Not Recommended at the Submitted Price.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations July 2019.