Nice update: CAR-T therapy gets green light for lymphoma treatment

What’s the guidance?

TA677: Autologous anti-CD19-transduced CD3+ cells for treating relapsed or refractory mantle cell lymphoma

Does it replace earlier guidance?

No, the appraisal is new.

What does it cover?

NHS patients will be among some of the first in the world to be offered access to a new cancer treatment after NICE recommended its use. The treatment is for patients with a form of lymphoma – a cancer that attacks the immune system.

The treatment – autologous anti-CD19-transduced CD3+ cells (KTE-X19) – is known as Tecartus and is a CAR-T therapy, using white blood cells that are ‘reengineered’ in a laboratory so they can recognise and attack cancer cells before being infused back into the patient. A small number of CAR-T therapies have been approved for use in the NHS in recent years.

According to NICE, the treatment should be considered for patients with a relapsed or refractory mantle cell lymphoma, where they have previously had a Bruton’s tyrosine kinase (BTK) inhibitor drug, such as ibrutinib.

(In a relapsed lymphoma, the disease grows again after a period of remission. Refractory cases are those where the lymphoma does not respond to treatment.)

A managed access agreement has been arranged for use within the Cancer Drugs Fund. However, there is not enough evidence to tell if lymphoma patients having the CAR-T therapy can be cured. To address this, 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 10 providers around the country that will be able to offer the treatment. Many parts of the country continue to experience pressures on critical care services, which are required for the administration of a CAR-T therapy. With the 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. 

Who is it for?

• Healthcare professionals
• Commissioners and providers of healthcare
• People with relapsed or refractory mantle cell lymphoma after a BTK inhibitor

Who is affected by the condition?

It is estimated that around 110 adults per year with relapsed or refractory mantle cell lymphoma, who have previously had a BTK inhibitor, are eligible for treatment with the technology. Around 100 are expected to receive treatment from year two onwards once uptake reaches 90%.

What are the benefits for patients?

There is currently no standard treatment for adults, who are typically 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.

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.

What are the financial implications?

The technology will be available to the NHS in line with the managed access agreement with NHS England. As part of this, NHS England and manufacturer Kite have a commercial access agreement that makes KTE-X19 available to the NHS at a reduced cost. The financial terms of the agreement are commercial in confidence.

The resource impact of the technology will be covered by the Cancer Drugs Fund budget. More evidence on KTE-X19 is being collected until the final results of the ongoing Zuma-2 study are available. After this, NICE will decide whether or not to recommend it for routine use in the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.