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evolocumab (Repatha®)
Application Details
HSE Application ID
HSE100070
HTA Number
25055
HTA Link
https://www.ncpe.ie/evolocumab-repatha-hta-id-25055/
Drug
evolocumab
Brand
Repatha®
Applicant
Amgen Ireland Limited
Indication Applied For
Revised patient population: Indicated in adults with established atherosclerotic cardiovascular disease (i.e. confirmed diagnosis of myocardial infarction +/- revascularisation procedures, non-haemorrhagic stroke or peripheral arterial disease [i.e. secondary prevention] or in those who have undergone coronary artery bypass graft), with a LDL-C persistently ≥ 3.0 mmol/L and in adults with a confirmed diagnosis of heterozygous familial hypercholesterolaemia with a LDL-C persistently ≥ 2.5 mmol/L.
Application Date
28/08/2025
Marketing Authorisation Date
17/07/2015
Application Status
Rapid Review Completed
30/09/2025
Rapid Review Commissioned
28/08/2025
Pricing and Reimbursement Application Complete
28/08/2025
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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Application Withdrawn at the Request of Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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