Pricing and Reimbursement Application Tracker
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Trastuzumab deruxtecan (Enhertu®)
Application Details
HSE Application ID
HSE100061
HTA Number
25049
HTA Link
https://www.ncpe.ie/trastuzumab-deruxtecan-enhertu-hta-id-25049/
Drug
Trastuzumab deruxtecan
Brand
Enhertu®
Applicant
AstraZeneca
Indication Applied For
As monotherapy indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Application Date
01/08/2025
Marketing Authorisation Date
12/12/2022
Application Status
Proposal from Applicant Under Review
30/01/2026
Awaiting Proposal from Applicant
15/01/2026
Applicant Meeting Held with CPU
15/01/2026
Full Health Technology Assessment Commissioned by HSE
01/10/2025
Rapid Review Completed
03/09/2025
Rapid Review Commissioned
06/08/2025
Pricing and Reimbursement Application Complete
01/08/2025
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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Application Withdrawn at the Request of Applicant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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