Pricing and Reimbursement Application Tracker
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cabotegravir (Apretude®)
Application Details
HSE Application ID
HSE100085
HTA Number
25072
HTA Link
https://www.ncpe.ie/cabotegravir-apretude-hta-id-25072/
Drug
cabotegravir
Brand
Apretude®
Applicant
GlaxoSmithKline Limited
Indication Applied For
Apretude indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg.
Application Date
30/12/2025
Marketing Authorisation Date
15/09/2023
Application Status
Rapid Review Completed
28/01/2026
Pricing and Reimbursement Application Complete
30/12/2025
Rapid Review Commissioned
22/12/2025
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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Application Withdrawn at the Request of Applicant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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