Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved tretinoin (ATRA) with arsenic trioxide (ATO) for reimbursement as a treatment option for the treatment of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) (defined as WCC <= 10x10^9L). This regimen contains the eligibility criteria of a clinical diagnosis of APL and subsequently confirmed to have PML::RARA rearrangements by a valid test method.

This is written in the approval document as:

Treatement of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) (defined as WCC count <= 10x10^9/L)

Reimbursement

Hospital

Citation

Trentinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy, 2023, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6962/356_v4_ATRA_-Arsenic_trioxide_Induction_Therapy.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PML::RARA	Acute Promyelocytic Leukemia	Arsenic trioxide

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2018-07-09	Health Service Executive	Indication approved for reimbursement.