NICE (Multiple) Technology Appraisal Guidance No 241
NICE technology appraisal guidance 70 part review: Dasatinib,
high-dose imatinib and nilotinib for the treatment of
imatinib-resistant chronic myeloid leukaemia (CML)
Dasatinib and nilotinib for people with CML for whom treatment
with imatinib has failed because of intolerance
The following NICE appraisal, published today, 13th
January 2012, has been considered by Healthcare Improvement
Scotland through its procedure of processing of NICE
appraisals:
This guidance states that:
Nilotinib is recommended for the treatment of
chronic or accelerated phase Philadelphia-chromosome-positive
chronic myeloid leukaemia (CML) in adults:
whose CML is resistant to treatment with
standard-dose imatinib
or
who have imatinib intolerance
and
if the manufacturer makes nilotinib available
with the discount agreed as part of the patient access scheme.
- Dasatinib is not recommended for the
treatment of chronic, accelerated or blast-crisis phase CML in
adults with imatinib intolerance or whose CML is resistant to
treatment with standard-dose imatinib.
- High-dose imatinib is not
recommended for the treatment of chronic, accelerated or
blast-crisis phase Philadelphia-chromosome-positive CML that is
resistant to standard-dose imatinib.
- People who are currently
receiving dasatinib or high-dose imatinib for the treatment of CML
should have the option to continue treatment until they and their
clinicians consider it appropriate to stop.
Web reference for appraisal and other related
documents: http://www.nice.org.uk/guidance/TA241
NHSScotland should note
that:
1. No important differences were identified
for this NICE appraisal and Healthcare Improvement Scotland advises
that the recommendations are as valid for Scotland as for England
and Wales. The Patient Access Scheme Advisory Group (PASAG) for
NHSScotland have approved the Patient Access Scheme as valid for
NHSScotland. PASAG Secretariat will produce a pack to
facilitate implementation of the PAS by NHS Boards. The
Implementation Packs, which are confidential to the NHS Boards,
will be circulated via the SMC Secretariat
2. The recommendations partially update the
recommendations in TA70 Guidance on the use of imatinib for
chronic myeloid leukaemia
3. The Scottish Medicines Consortium (SMC) has
previously issued guidance to NHSScotland on the use of dasatinib
and nilotinibin this indication (370/07, 440/08). There is a
material difference between the NICE and SMC advice. Dasatinib
(370/07) and nilotinib (440/08) have been accepted by SMC for
restricted use in the chronic phase of CML only. High-dose imatinib
has not been assessed by SMC for use in chronic myeloid
leukaemia.
The NICE MTA guidance supersedes the SMC
advice.
4. NHSScotland should take account of the NICE
appraisal and this Healthcare Improvement Scotland email in its
planning, funding and provision of services to ensure that
recommended drugs or treatments are made available to meet clinical
need.
5. Copies of the NICE appraisal can be
downloaded from http://www.nice.org.uk Also on the
website are tools (a costing template/statement and audit criteria)
that NICE has developed to help organisations implement this
guidance. NICE MTA costing templates now include the NHSScotland
boards. However, please note that the care pathway described in the
costing tool may not completely reflect practice in
NHSScotland.
Finally, an easy to read summary of the
appraisal, called "understanding NICE guidance" is published on the
NICE website to provide information for patients and the
public.
6. Healthcare Improvement Scotland advice
represents the evidence-based view of Healthcare Improvement
Scotland.
7. This advice does not override or replace
the individual responsibility of health professionals to make
appropriate decisions in the circumstances of their individual
patients, in consultation with the patient and/or guardian or
carer.
8. No other publications on the NICE appraisal
will be issued by Healthcare Improvement Scotland.
10. Healthcare Improvement Scotland advice is
all available on the Healthcare
Improvement Scotland website
If you need further assistance, please contact Eleanor Brownlee in the first
instance tel 0141 225 6873
Published Date: 13 January 2012
