Pricing and Reimbursement Application Tracker
Login
Search
macitentan, tadalafil (Yuvanci®)
Application Details
HSE Application ID
HSE100017
HTA Number
25009
HTA Link
https://www.ncpe.ie/macitentan-plus-tadalafil-yuvanci-hta-id-25009/
Drug
macitentan, tadalafil
Brand
Yuvanci®
Applicant
Johnson & Johnson Innovative Medicine (J&J IM)
Indication Applied For
Indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.
Application Date
17/02/2025
Marketing Authorisation Date
27/09/2024
Application Status
Awaiting Proposal from Applicant
12/09/2025
Applicant Meeting Held with CPU
12/09/2025
Proposal from Applicant Under Review
15/08/2025
Awaiting Proposal from Applicant
17/04/2025
Applicant Meeting Held with CPU
17/04/2025
Rapid Review Completed
11/03/2025
Pricing and Reimbursement Application Complete
17/02/2025
Rapid Review Commissioned
10/02/2025
New Search
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Application Withdrawn at the Request of Applicant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
Delete Application
×
Are you sure you want to delete this Application?
Once it's deleted it cannot be retrieved.
Remove Status and Date
×
Are you sure you want to delete this?