Inclusion on the list of medicines approved for hospital use.
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Clinical Benefit
Substantial
Chronic lymphocytic leukaemia, non-Hodgkin’s lymphoma and multiple myeloma : The actual benefit is substantial.
Clinical Added Value
moderate
Chronic lymphocytic leukaemia LEVACT provides a moderate improvement in actual benefit (IAB III) compared to chlorambucil in terms of efficacy in the treatment of patients suffering from chronic lymphocytic leukaemia where combination chemotherapy including fludarabine is not suitable.
Non-Hodgkin’s lymphoma Despite the methodological limits of the non-comparative studies, but taking account of the efficacy and tolerance observed in comparison to current management, the transparency Committee considers that LEVACT provides a moderate improvement in actual benefit (IABIII) in the treatment strategy of indolent and progressive non-Hodgkin’s lymphoma following treatment with rituximab.
no clinical added value
Multiple myeloma In view of the low evidential quality of the research (study stopped prematurely, choice of irrelevant primary efficacy endpoint and lack of direct comparison with benchmark treatments), the Committee is of the opinion that LEVACT combined with prednisone provides any improvement in actual benefit (IAB V) compared to the usual first-line therapeutic management of multiple myeloma. However, as this product is not neurotoxic, the Committee considers that it does offer a useful additional treatment option for patients aged over 65 who are not eligible for autologous transplant or for treatment with thalidomide or bortezomib.
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