HSE - PCRS

Application Details

HSE Application ID

HSE100062

HTA Number

25047

HTA Link

https://www.ncpe.ie/lenacapavir-sunlenca-hta-id-25047/

Drug

lenacapavir

Brand

Sunlenca®

Applicant

Gilead Sciences Ireland UC

Indication Applied For

Lenacapavir in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Application Date

22/07/2025

Marketing Authorisation Date

17/08/2022

Application Status

Managed Access Protocol (MAP) Commissioned

25/03/2026

Reviewed by HSE Senior Leadership Team

25/03/2026

Reviewed by HSE Drugs Group

10/03/2026

HSE Drugs Group Review Pending

24/02/2026

Proposal from Applicant Under Review

05/02/2026

Awaiting Proposal from Applicant

08/01/2026

Applicant Meeting Held with CPU

08/01/2026

Proposal from Applicant Under Review

12/11/2025

Awaiting Proposal from Applicant

26/09/2025

Applicant Meeting Held with CPU

26/09/2025

Rapid Review Completed

08/08/2025

Rapid Review Commissioned

25/07/2025

Pricing and Reimbursement Application Complete

22/07/2025

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