End of life
Liposomal cytarabine–daunorubicin
qualifies as a life-extending treatment for
people with a short life expectancy.
The committee considered the advice about
life-extending treatments for people with
a short life expectancy in NICE’s guide
to the methods of technology appraisal.
It noted that the median overall survival
reported in Study 301 for the comparator
group was 5.95 months. It also noted
that the mean modelled survival was
less than 24 months in the company’s
model. Therefore the short life expectancy
criterion of less than 24 months was
met. In Study 301, overall survival in the
liposomal cytarabine–daunorubicin group
was higher than in the standard cytarabine
and daunorubicin group by a median of
3.61 months. The mean increase in overall
survival predicted by the company’s model
was over 2 years (undiscounted life years).
Even when the ERG’s least optimistic
estimate of overall survival after transplant
for liposomal cytarabine–daunorubicin
was modelled, the mean increase in overall
survival predicted by the model was more
than 3 months. Therefore liposomal
cytarabine–daunorubicin met the criterion
of extension to life of at least an additional
3 months. The committee concluded that
liposomal cytarabine–daunorubicin met
NICE’s criteria for being considered a life-
extending treatment at the end of life.
Equalities
There are no equality issues relevant to the
recommendations.
Stakeholders highlighted that liposomal
cytarabine–daunorubicin was more likely
to be used for younger people than for
older people. Because the recommendation
for liposomal cytarabine–daunorubicin is
for the whole population covered by the
marketing authorisation, the committee
concluded that its recommendations do not
have a different effect on people protected
by the equality legislation than on the
wider population. It concluded that there
are no relevant equality issues.
10 | 2019 | hospitalpharmacyeurope.com
Conclusion
Liposomal cytarabine–daunorubicin
is recommended for routine NHS use.
The committee concluded that, with
the discount agreed in the commercial
arrangement, the ICERs were within the
range that NICE usually considers an
acceptable use of NHS resources for a
life-extending treatment at the end of life.
The committee recommended liposomal
cytarabine–daunorubicin within its
marketing authorisation for treating
newly diagnosed, therapy-related acute
myeloid leukaemia and acute myeloid
leukaemia with myelodysplasia-related
changes.
Implementation
• Section 7(6) of the National Institute for
Health and Care Excellence (Constitution
and Functions) and the Health and Social
Care Information Centre (Functions)
Regulations 2013 requires clinical
commissioning groups, NHS England
and, with respect to their public health
functions, local authorities to comply with
the recommendations in this appraisal
within 3 months of its date of publication.
• The Welsh ministers have issued
directions to the NHS in Wales on
implementing NICE technology appraisal
guidance. When a NICE technology
appraisal recommends the use of a drug
or treatment, or other technology, the NHS
in Wales must usually provide funding
and resources for it within 2 months of
the first publication of the final appraisal
document.
• When NICE recommends a treatment
‘as an option’, the NHS must make sure
it is available within the period set out in
the paragraphs above. This means that, if
a patient has newly diagnosed, therapy-
related acute myeloid leukaemia or acute
myeloid leukaemia with myelodysplasia-
related changes and the doctor responsible
for their care thinks that liposomal
cytarabine–daunorubicin is the right
treatment, it should be available for use,
in line with NICE’s recommendations.