Pricing and Reimbursement Application Tracker
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bevacizumab gamma (Lytenava®)
Application Details
HSE Application ID
HSE100056
HTA Number
25043
HTA Link
https://www.ncpe.ie/bevacizumab-gamma-lytenava-hta-id-25043/
Drug
bevacizumab gamma
Brand
Lytenava®
Applicant
Outlook Therapeutics
Indication Applied For
Indicated in adults for treatment of neovscular (wet) age-related macular degeneration (nAMD).
Application Date
03/07/2025
Marketing Authorisation Date
27/05/2024
Application Status
Application Withdrawn at the Request of Applicant
25/06/2026
Proposed HSE Decision Issued to Applicant
05/06/2026
Reviewed by HSE Senior Leadership Team
02/06/2026
Reviewed by HSE Drugs Group
12/05/2026
HSE Drugs Group Review Pending
24/02/2026
Proposal from Applicant Under Review
03/02/2026
Awaiting Proposal from Applicant
02/10/2025
Applicant Meeting Held with CPU
02/10/2025
Rapid Review Completed
30/07/2025
Rapid Review Commissioned
03/07/2025
Pricing and Reimbursement Application Complete
03/07/2025
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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Application Withdrawn at the Request of Applicant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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