Pricing and Reimbursement Application Tracker
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onasemnogene abeparvovec (Itvisma®)
Application Details
HSE Application ID
HSE100118
HTA Number
HTA Link
Drug
onasemnogene abeparvovec
Brand
Itvisma®
Applicant
Novartis Ireland Limited
Indication Applied For
Indicated indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years of age and older.
Application Date
06/07/2026
Marketing Authorisation Date
30/06/2026
Application Status
Pricing and Reimbursement Application Complete
06/07/2026
Rapid Review Commissioned
20/05/2026
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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Application Withdrawn at the Request of Applicant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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