HSE - PCRS

Application Details

HSE Application ID

HSE100066

HTA Number

25050

HTA Link

https://www.ncpe.ie/guselkumab-tremfya-hta-id-25050/

Drug

Guselkumab

Brand

Tremfya®

Applicant

Johnson & Johnson Innovative Medicine (J&J IM)

Indication Applied For

Indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

Application Date

27/08/2025

Marketing Authorisation Date

02/05/2025

Application Status

Proposal from Applicant Under Review

16/02/2026

Awaiting Proposal from Applicant

04/02/2026

Proposal from Applicant Under Review

09/01/2026

Awaiting Proposal from Applicant

11/12/2025

Applicant Meeting Held with CPU

11/12/2025

Rapid Review Completed

11/09/2025

Pricing and Reimbursement Application Complete

27/08/2025

Rapid Review Commissioned

05/08/2025

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