Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PML::RARA status confers therapeutic sensitivity to Arsenic trioxide in patients with Acute Promyelocytic Leukemia.

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 statement is based on a regulatory approval from the Health Service Executive:

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

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

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.