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New HTA Decisions in France
June 2020
Drug name
TRISENOX® (arsenic trioxide)
Company
Teva Health
Decision date
06/11/2019
Therapeutic area
Cancer
Therapeutic sub area
Blood and bone marrow cancers
Official notice date
18/11/2019
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
TRISENOX® is indicated for the induction of remission and consolidation in adult patients with: - newly diagnosed acute promyelocytic leukemia (APL) at low or intermediate risk (leukocyte count: ≤ 10 x 103 / μL), in combination with all trans retinoic acid (ATRA or tretinoin); - relapsed/refractory acute promyelocytic leukemia (APL) (previous therapy must have included retinoid and chemotherapy); characterised by the presence of the t(15;17) translocation and/or the presence of the PML/RARA (promyelocytic leukemia / retinoic acid receptor alpha) gene.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of TRISENOX® to be 'important' in the indications of the Marketing Authorisation. It was concluded that TRISENOX® 2 mg/ml does not provide any improvement in the medical service rendered (ASMR V) compared to the 1 mg/ml specialty already listed.