Pricing and Reimbursement Application Tracker
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avapritinib (Ayvakyt®)
Application Details
HSE Application ID
HSE100042
HTA Number
25031
HTA Link
https://www.ncpe.ie/avapritinib-ayvakyt-hta-id-25031/
Drug
avapritinib
Brand
Ayvakyt®
Applicant
Blueprint Medicines
Indication Applied For
Indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.
Application Date
14/04/2025
Marketing Authorisation Date
24/03/2022
Application Status
Full Health Technology Assessment Commissioned by HSE
30/05/2025
Rapid Review Completed
15/05/2025
Rapid Review Commissioned
14/04/2025
Pricing and Reimbursement Application Complete
14/04/2025
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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Application Withdrawn at the Request of Applicant
HSE Approval Letter Issued to Applicant
Full Health Technology Assessment Submitted to NCPE
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