National Institute for Health and Clinical Excellence (NICE)
NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NICE
NICE has agreed a managed access agreement, via the Cancer Drugs Fund with manufacturer Kite, so more data can be collected while patients can access the treatment.
NHS patients are to be among the first in the world to be offered access to a cutting-edge cancer treatment after NICE recommended its use.
As of yesterday NHS clinicians in England are able to consider the treatment for some patients with a form of lymphoma, a cancer that attacks the immune system.
The personalised treatment, Tecartus also known as autologous anti-CD19-transduced CD3+, is a CAR-T therapy which uses the patient’s white blood cells which are then reengineered in a laboratory so they can recognise and attack cancer cells before being infused back into the patient.
New NICE guidance issued yesterday (Tuesday 19 January 2021) says the treatment can be considered for those with relapsed or refractory mantle cell lymphoma, who must previously have had a drug called Bruton’s tyrosine kinase (BTK) inhibitor, such as ibrutinib.
NICE has agreed a managed access agreement, via the Cancer Drugs Fund (CDF), with manufacturer Kite – a Gilead company – so more data can be collected while patients can access the treatment. A confidential discount for use of the therapy was agreed by NHS England and Kite.
There is no standard treatment for adults, who are usually in their 70s, with relapsed or refractory mantle cell lymphoma after a BTK inhibitor. A combination of rituximab, bendamustine and cytarabine (R BAC) is the most common treatment option.
Around 100 patients each year could be treated with this CAR-T therapy.
Evidence from a study of Tecartus, seen by NICE’s independent appraisal committee, suggests that people being treated with the CAR-T therapy may live for longer and have more time before their disease relapses.
However, there is not enough evidence to tell if lymphoma patients having the CAR-T therapy can be cured, which is why the NICE committee has asked for further data to be collected on progression-free survival, overall survival, and the age when treatment starts. This will help to reduce the uncertainty in the evidence while the treatment is used on NHS patients.
The NHS has ten providers around the country which will be able to offer this treatment option. Many parts of the country continue to experience pressures on critical care services, that are required for the administration of a CAR T therapy. With yesterday’s recommendation by NICE, clinicians can consider Tecartus as an available treatment option for eligible NHS patients at the earliest opportunity. This may require patients to travel outside their locality to receive this one-time treatment.
Meindert Boysen, deputy chief executive and director of NICE’s centre for health technology evaluation, yesterday said:
“We are pleased to be able to recommend another revolutionary CAR T-cell therapy, this time for adults with mantle cell lymphoma, which represents a step forward for personalised medicine. Clinicians will be able to consider this innovative therapy for their patients because of joint working between NICE, NHS England and NHS Improvement and the company.
“CAR T-cell therapy is expensive. The treatment is specific to each individual and could be a potential cure for some, although it is early days. Our recommendation for Tecartus, on the Cancer Drugs Fund, means people can benefit while more data is collected.”
Sir Simon Stevens, NHS chief executive, said: “It is great news that more people with lymphoma will have access to an innovative new CAR-T cancer therapy thanks to our Cancer Drugs Fund, addressing a particular need for people with mantle cell lymphoma. Despite the pressures of the pandemic, the NHS continues to place effective, innovative treatments into the hands of clinicians for the benefit of the patients we treat.”
Dick Sundh, VP, Head of ACE at Kite, a Gilead Company, yesterday said:
“This decision by NICE represents an important step towards delivering cell therapy to UK patients living with mantle cell lymphoma, who will be among the first in the world to receive this new therapy.
“Kite is the only company with two different types of cell therapies available and we will continue our strong partnership with the NHS so that eligible UK patients are able to receive treatment as soon as possible following the positive recommendation received today.”
The final draft guidance is published on nice.org.uk and consultees and commentators can appeal the recommendation of the committee until Tuesday 2 February 2021.
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