As no appeals against its draft recommendations were received, the National Institute for Health and Clinical Excellence (NICE) has published its guidance on the use of fludarabine monotherapy for the treatment of chronic lymphocytic leukaemia (CLL).
Andrew Dillon, chief executive, said: “This guidance applies to the use of fludarabine monotherapy only. The Appraisal Committee was aware of evidence that suggests fludarabine used in combination with cyclophosphamide conferred an enhanced treatment response compared to fludarabine alone. However, the committee was unable to make recommendations about the use of fludarabine in combination with cyclophosphamide since the drugs do not currently have a marketing authorisation for this use.
“Furthermore, the committee was unable to recommend fludarabine monotherapy since the evidence presented did not demonstrate that fludarabine, given on its own as initial treatment for people with CLL, would represent value for money when compared with chlorambucil, the treatment currently used. The committee has recommended that further research be undertaken to identify subgroups of patients who might benefit the most from fludarabine.”