Just under 600 people per year with a type of aggressive blood
cancer are set to benefit after NICE today recommended an
innovative cell therapy for routine NHS use, marking a
significant advance in lymphoma care. The therapy will help
people with large B-cell lymphoma - an aggressive cancer
affecting the white blood cells that normally help fight
infection - when their cancer has either not responded to initial
treatment or returned within 12 months.
In a decision that reverses its earlier draft negative
recommendation, NICE has approved CAR T-cell therapy
lisocabtagene maraleucel (also called liso-cel or Breyanzi and
made by Bristol Myers Squibb) for NHS use. Liso-cel works by
reprogramming a patient's own immune cells to fight their cancer
and is given as a one-off treatment directly into the
bloodstream.
Clinical trials showed liso-cel significantly delayed disease
progression, with patients on average living more than twice as
long without their disease worsening, compared to standard care.
The therapy involves collecting a patient's own immune cells
(T-cells) which are then modified in a laboratory to specifically
target and destroy cancer cells. These engineered cells are
reinfused into the patient as a single treatment, with the
potential to provide long-term therapeutic benefits.
The recommendation represents a significant step forward for
patients who have limited treatment options, offering new hope
for those whose lymphoma has either returned or not responded to
standard treatments. Patient experts from Blood Cancer UK and
Lymphoma Action highlighted that the treatment could be given in
an outpatient setting, minimising costly hospital stays and
potentially improving quality of life for patients and their
families.
Today's positive recommendation follows consultation after an
initial draft negative recommendation in October 2024. The
decision was reversed after Bristol Myers Squibb offered an
improved commercial arrangement to the NHS on the £297,000 list
price, per individual treatment.
In making its final recommendation, the committee also considered
additional benefits of liso-cel not captured in the economic
modelling, including the potential for outpatient administration
- reducing both hospital stays for patients and resource use for
the NHS.
Helen Knight, director of medicines evaluation at NICE,
said: "For people living with this aggressive blood
cancer, and their families, today's announcement offers real
hope. These aren't just statistics – each person who will benefit
from this treatment is someone's parent, child, partner or
friend.
"The evidence we've seen shows remarkable results. Liso-cel can
buy precious time before further treatment is needed and could
even be given as an outpatient treatment, reducing time spent in
hospital.
"We're pleased that we've been able to reverse our initial
decision and in doing so demonstrating our commitment to getting
the best care to people quickly, while ensuring value for the
taxpayer."
NHS National Director for Cancer Professor Peter Johnson
said: "It is excellent to have another CAR-T treatment
available for patients who have large B-cell lymphoma which is
not responding to treatment or where the disease returns early
on.
“This means we now have four CAR-T products across 5 clinical
indications, and more than 1,500 people have benefitted from
these treatments on the NHS at a price affordable to taxpayers.
“The NHS remains dedicated to funding the best cancer care and it
is fantastic we can offer treatments like this to hundreds more
patients with advanced blood cancers, giving them real hope of a
longer and better quality of life.”
View the full final draft guidance for lisocabtagene maraleucel for
treating relapsed or refractory large B-cell lymphoma after
first-line chemoimmunotherapy when a stem cell transplant is
suitable
[ENDS]
- About large B-cell lymphoma:
- Lymphomas are cancers of the lymphatic system, which is part
of the immune system
- Lymphomas are divided into Hodgkin lymphoma and non-Hodgkin
lymphoma
- Non-Hodgkin lymphomas (NHL) are a diverse group of conditions
categorised according to the cell type affected (B-cell or
T-cell)
- Around 4,300 people are diagnosed with diffuse large B-cell
lymphoma each year in England
- Most people diagnosed with DLBCL are 65 or over
- Although most people are cured with first-line chemotherapy,
about 10-15% have primary refractory disease and a further 20-30%
relapse
- Survival rates at 5 years for relapsed DLBCL are around 30%
- Relapsed or refractory LBCL tends to have a poorer prognosis
compared with newly diagnosed
-
About the treatment:
- Lisocabtagene maraleucel is a CAR T-cell therapy that
modifies patient's own immune cells
- Given as a one-off treatment
- Could be administered in outpatient settings
- List price is £297,000 per treatment
- Available with confidential commercial arrangement
-
Implementation:
- Treatment will be available through routine commissioning
- NHS England must make funding available within 90 days
- In the interim, funding will be available from the Cancer
Drugs Fund
