Pricing and Reimbursement Application Tracker
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nusinersen (Spinraza®)
Application Details
HSE Application ID
HSE100101
HTA Number
26016
HTA Link
https://www.ncpe.ie/nusinersen-50mg-28mg-spinraza-hta-id-26016/
Drug
nusinersen
Brand
Spinraza®
Applicant
Biogen
Indication Applied For
High dose regimen (50/28mg) for the treatment of 5q Spinal Muscular Atrophy (SMA).
Application Date
02/04/2026
Marketing Authorisation Date
09/01/2026
Application Status
Rapid Review Completed
12/05/2026
Rapid Review Commissioned
02/04/2026
Pricing and Reimbursement Application Complete
02/04/2026
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Status
Pricing and Reimbursement Application Complete
Rapid Review Commissioned
Rapid Review Completed
Applicant Meeting Held with CPU
Awaiting Proposal from Applicant
Proposal from Applicant Under Review
Full Health Technology Assessment Commissioned by HSE
NCPE Assessment Completed
HSE Drugs Group Review Pending
Reviewed by HSE Drugs Group
HSE Rare Disease Technology Review Committee - Review Requested
HSE Rare Disease Technology Review Committee - Review Received
Further Information Requested by HSE Drugs Group
Reviewed by HSE Senior Leadership Team
Managed Access Protocol (MAP) Commissioned
Proposed HSE Decision Issued to Applicant
Applicant Representations Received
HSE Decision Issued to Applicant
Application On Hold at the Request of Applicant
Application Withdrawn at the Request of Applicant
Application on Hold as Agreed by HSE and Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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