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daridorexant (Quviviq®)
Application Details
HSE Application ID
HSE100036
HTA Number
25029
HTA Link
https://www.ncpe.ie/daridorexant-quviviq-hta-id-25029/
Drug
daridorexant
Brand
Quviviq®
Applicant
Idorsia Pharmaceuticals
Indication Applied For
Indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
Application Date
01/04/2025
Marketing Authorisation Date
29/04/2022
Application Status
Full Health Technology Assessment Commissioned by HSE
02/05/2025
Rapid Review Completed
25/04/2025
Rapid Review Commissioned
01/04/2025
Pricing and Reimbursement Application Complete
01/04/2025
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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Application Withdrawn at the Request of Applicant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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