Fludarabine given on its own is not recommended as an initial treatment for people with chronic lymphocytic leukaemia (CLL). Fludarabine is not licensed to be prescribed for CLL in combination with other chemotherapy medicines. This is because its 'marketing authorisation', which is normally needed before a drug can be prescribed, did not cover combination treatment. NICE was therefore unable to look at fludarabine in combination with other chemotherapy drugs for people with CLL. The process of giving a drug its marketing authorisation is not related to the NICE appraisal process and it is not carried out by NICE.
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.