Pricing and Reimbursement Application Tracker
Login
Search
darolutamide (Nubeqa®)
Application Details
HSE Application ID
HSE100120
HTA Number
26033b
HTA Link
https://www.ncpe.ie/darolutamide-nubeqa-hta-id-26033b/
Drug
darolutamide
Brand
Nubeqa®
Applicant
Bayer Limited
Indication Applied For
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (ADT).
Application Date
07/07/2026
Marketing Authorisation Date
27/02/2023
Application Status
Awaiting Proposal from Applicant
22/10/2026
Applicant Meeting Held with CPU
22/10/2026
Rapid Review Completed
04/08/2026
Rapid Review Commissioned
08/07/2026
Pricing and Reimbursement Application Complete
07/07/2026
New Search
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Application Withdrawn at the Request of Applicant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
Commercial Negotiation Postponed at the Request of 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
Delete Application
×
Are you sure you want to delete this Application?
Once it's deleted it cannot be retrieved.
Remove Status and Date
×
Are you sure you want to delete this?