Pricing and Reimbursement Application Tracker
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risdiplam (Evrysdi®)
Application Details
HSE Application ID
HSE100075
HTA Number
25061
HTA Link
https://www.ncpe.ie/risdiplam-evrysdi-hta-id-25061/
Drug
risdiplam
Brand
Evrysdi®
Applicant
Roche
Indication Applied For
Indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies under 2 months of age.
Application Date
22/10/2025
Marketing Authorisation Date
16/08/2023
Application Status
Awaiting Proposal from Applicant
22/01/2026
Applicant Meeting Held with CPU
22/01/2026
Rapid Review Completed
24/11/2025
Pricing and Reimbursement Application Complete
22/10/2025
Rapid Review Commissioned
17/10/2025
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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Application Withdrawn at the Request of Applicant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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