Around 6,000 people living with metastatic prostate cancer in
England will gain access to a new treatment combination from
today (Friday, 24 October), following a recommendation by
NICE.
Darolutamide, also known as Nubeqa and made by Bayer, is
recommended in final draft guidance to treat adults with
metastatic hormone-sensitive prostate cancer in combination with
androgen deprivation therapy (ADT), a hormone therapy which
lowers testosterone levels.
Taken as two tablets twice daily alongside hormone treatment,
darolutamide blocks the hormones fuelling cancer growth by
starving prostate cancer cells of the testosterone they need to
multiply and spread.
It is estimated that around 55,000 people a year are diagnosed
with prostate cancer in England. It is estimated around 6,000
people in England will be eligible for this new combination
treatment, which is available from today in the NHS.
Helen Knight, Director of Medicines Evaluation at NICE,
said: “I'm pleased we can recommend this new combination
treatment which provides another much-needed option for people
with metastatic hormone-sensitive prostate cancer.
“We are determined to ensure that effective treatments such as
darolutamide, which can help extend the length and quality of
people's lives, are made available fast to the people who need
them.”
For those with metastatic hormone-sensitive prostate cancer -
where the disease has spread to other parts of the body -
treatment options typically involve ADT, either on its own or
combined with other drugs.
Clinical trials show that adding darolutamide to standard ADT
delivers better results than ADT alone, with evidence suggesting
it is as effective as other combination treatments already
recommended by NICE and available on the NHS.
NICE used a cost comparison approach, where to get a positive
recommendation, the company needed to demonstrate the costs for
darolutamide plus ADT are similar to or lower than those for
apalutamide plus ADT, which
is recommended by NICE for this population and is already in use
in the NHS.
As a result, this final draft guidance was available five weeks
faster than would have been the case under its standard
process.
Peter Johnson, National Clinical Director for Cancer at
NHS England, said: "This decision provides another
welcome treatment option for patients living with an advanced and
aggressive form of prostate cancer. With several proven therapies
already available on the NHS, this approval gives clinicians and
their patients more flexibility to choose the approach best
suited to individual circumstances and clinical needs."
The company has a confidential commercial arrangement in place
which makes darolutamide available to the NHS with a
discount.
Read the full final draft guidance for darolutamide with androgen
deprivation therapy for treating hormone-sensitive metastatic
prostate cancer.
An embargoed copy of NICE's final draft guidance on darolutamide
with androgen deprivation therapy for treating hormone-sensitive
metastatic prostate cancer is attached.