Pricing and Reimbursement Application Tracker
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acoramidis (Beyonttra®)
Application Details
HSE Application ID
HSE100022
HTA Number
25017
HTA Link
https://www.ncpe.ie/acoramidis-beyonttra-hta-id-25017/
Drug
acoramidis
Brand
Beyonttra®
Applicant
Bayer Limited
Indication Applied For
Indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Application Date
04/03/2025
Marketing Authorisation Date
10/02/2025
Application Status
Full Health Technology Assessment Commissioned by HSE
08/05/2025
Rapid Review Completed
03/04/2025
Rapid Review Commissioned
05/03/2025
Pricing and Reimbursement Application Complete
04/03/2025
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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Application Withdrawn at the Request of Applicant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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