HSE - PCRS

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

Awaiting Proposal from Applicant

12/02/2026

Applicant Meeting Held with CPU

12/02/2026

Rapid Review Completed

30/09/2025

Rapid Review Commissioned

28/08/2025

Pricing and Reimbursement Application Complete

28/08/2025

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