Pricing and Reimbursement Application Tracker
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darolutamide (Nubeqa®)
Application Details
HSE Application ID
HSE100119
HTA Number
26033a
HTA Link
https://www.ncpe.ie/darolutamide-nubeqa-hta-id-26033a/
Drug
darolutamide
Brand
Nubeqa®
Applicant
Bayer Limited
Indication Applied For
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Application Date
07/07/2026
Marketing Authorisation Date
17/07/2025
Application Status
Rapid Review Completed
04/08/2026
Rapid Review Commissioned
08/07/2026
Pricing and Reimbursement Application Complete
07/07/2026
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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Application Withdrawn at the Request of Applicant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
Rapid Review Completed: On the basis of current evidence, the NCPE recommends that the product not be considered for reimbursement.
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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