NICE Technology Appraisal Guidance - No. 29: The use of
fludarabine for B-cell chronic lymphocytic leukaemia
Appraisal Guidance - No. 29: The use of fludarabine for B-cell
chronic lymphocytic leukaemia
The Health Technology Board for Scotland (HTBS) is delivering
this National Institute for Clinical Excellence (NICE) Guidance to
health professionals in NHSScotland with the following
authoritative Comment on its use in Scotland.
HTBS advises that the NICE Technology Appraisal Guidance - No. 29:
The use of fludarabine for B-cell chronic lymphocytic leukaemia is
as valid for Scotland as for England and Wales.
The NICE recommendations are shown below.
- Oral fludarabine is recommended as second line therapy for
B-cell chronic lymphocytic leukaemia (CLL) for patients who have
either failed, or are intolerant of, first line chemotherapy, and
who would otherwise have received combination chemotherapy of
- cyclophosphamide, doxorubicin, vincristine and prednisolone
- cyclophosphamide, doxorubicin and prednisolone (CAP) or
- cyclophosphamide, vincristine and prednisolone (CVP).
- The oral formulation of fludarabine is preferred to the
intravenous formulation on the basis of more favourable cost
effectiveness. Intravenous fludarabine should only be used when
oral fludarabine is contra-indicated.
HTBS anticipates that implementing this NICE Guidance in Scotland
will have the following implications for NHSScotland:
- The use of oral rather than intravenous fludarabine for second
line treatment of CLL is more likely to facilitate equity of access
to the best care for patients in remote and rural areas.
- Approximately 200 people are diagnosed with B-cell CLL each
year in Scotland. This guidance is not expected to result in a net
increase in NHSScotland expenditure as fludarabine is already in
common use. Increases in drug acquisition costs are likely to
be offset by the transfer to the oral formulation, and because the
switch from combination therapies to fludarabine should reduce the
costs of treating adverse side effects. Cost implications for
different patient scenarios are provided in section 5.2 of the NICE
HTBS’s advice represents the views of HTBS. Health professionals
are expected to take due account of this advice when exercising
their clinical judgement about the use of fludarabine for the
treatment of B-cell CLL. This advice does not, however, override or
replace the individual responsibility of health professionals to
make appropriate decisions in the circumstances of their individual
patient, in consultation with the patient and/or guardian or
This HTBS Comment is the result of a consideration of possible
contextual differences in Scotland, according to the following
- Principles and values of NHSScotland
- Epidemiology (frequency and distribution)
- Structure and provision of services in Scotland
- Other implications for the Scottish Health Service.
No important differences were identified for this NICE
Technology Appraisal Guidance. A Guide for patients and carers in
Scotland is also being distributed and is available from this
website and CancerBACUP.
HTBS would like to thank NICE for its cooperation in delivering
this Comment. HTBS is also grateful to the experts in Scotland who
provided input to this Comment and to the Cancer Network Area
Managers for their assistance in distributing this Comment
Published Date: 26 September 2001