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New HTA Decisions in England
August 2020
Drug name
TRECONDI® (treosulfan)
Decision date
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Treosulfan in combination with fludarabine is recommended as an option for conditioning treatment before allogeneic haematopoietic stem cell transplant (allo-HSCT) for people with malignant diseases for whom a reduced intensity regimen, such as low-dose busulfan with fludarabine, would be suitable.
Decision Detail
Clinical evidence was provided by MC-FludT-14-L trial 2, a double-blind randomised clinical trial of treosulfan and fludarabine compared with low-dose busulfan and fludarabine in adults with acute myeloid leukaemia or myelodysplastic syndromes who were not eligible for high-intensity MAC regimens. The committee concluded that people eligible for low-dose busulfan with fludarabine have a lower mortality with treosulfan and fludarabine than with low-dose busulfan and fludarabine. The risk of disease recurrence was similar after either treatment. Not enough evidence was presented for children or for people who could tolerate a high-intensity myeloablative regimen, so it is not possible to make recommendations for these groups. Treosulfan with fludarabine dominates busulfan with fludarabine; that is, it generates more quality-adjusted life years (QALYs) at a lower cost than busulfan in both the company's base case and ERG's preferred assumptions analyses. Treosulfan with fludarabine is more effective and costs less than low-dose busulfan with fludarabine in most analyses. Therefore, treosulfan with fludarabine is recommended as an option in the NHS for conditioning treatment for people who would normally have a reduced intensity regimen.