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cipaglucosidase alfa in combination with miglustat (Pombiliti® in combination with Opfolda®)
Application Details
HSE Application ID
HSE100038
HTA Number
25027
HTA Link
https://www.ncpe.ie/cipaglucosidase-alfa-in-combination-with-miglustat-pombiliti-in-combination-with-opfolda-hta-id-25027/
Drug
cipaglucosidase alfa in combination with miglustat
Brand
Pombiliti® in combination with Opfolda®
Applicant
Amicus Therapeutics Europe Limited
Approved Indication
Cipaglucosidase alfa is a long-term enzyme replacement therapy, used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency).
Application Date
04/04/2025
Marketing Authorisation Date
20/03/2023
Application Status
HSE Approval Letter Issued to Applicant
05/08/2025
Proposal from Applicant Under Review
21/07/2025
Awaiting Proposal from Applicant
10/07/2025
Applicant Meeting Held with CPU
10/07/2025
Rapid Review Completed
02/05/2025
Pricing and Reimbursement Application Complete
04/04/2025
Rapid Review Commissioned
31/03/2025
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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Application Withdrawn at the Request of Applicant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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