Advice

following a full submission assessed under the orphan equivalent process:

arsenic trioxide (Trisenox®) is not recommended for use within NHSScotland.

Indication under review: in combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.

In a Phase III study in patients with newly diagnosed, low-to-intermediate risk APL, arsenic trioxide was non-inferior to anthracycline-based chemotherapy (both in combination with tretinoin) measured by event-free survival. A significant difference in overall survival favouring arsenic trioxide was also demonstrated.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Medicine details

Medicine name:
arsenic trioxide (Trisenox)
SMC ID:
SMC2025
Indication:
In combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene
Pharmaceutical company
Teva UK Limited
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Not recommended
Date advice published:
14 January 2019