NICE has published final draft guidance recommending a breakthrough cancer treatment, called CAR T-cell therapy, for adults with some types of non-Hodgkin lymphoma.
Axicabtagene-ciloleucel, also known as Yescarta and manufactured by Kite, a Gilead company, is part of a new wave of personalised medicine. NICE has recommended the use of axicabtagene-ciloleucel within the Cancer Drugs Fund (CDF) giving people access to the treatment whilst more data is collected.
The therapy is for adults with relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, two aggressive subtypes of non-Hodgkin lymphoma. It will be offered to people whose disease has not responded after two or more rounds of chemotherapy or relapsed after a stem cell transplant.
CAR T-cell therapy for these lymphoma patients will be available at seven hospitals as the service is rolled out across the country.
NHS England is working closely with the sites to ensure the clinical, technical and operational requirements are in place to provide this new, complex treatment.
Meindert Boysen, director of the Centre for Health Technology Evaluation, NICE, said: “People with these aggressive subtypes of non-Hodgkin lymphoma often have very poor outcomes. NICE’s recommendation is exciting because it means that adults will have access to a CAR T-cell therapy through the Cancer Drugs Fund.”
“It is great to see that NHS England is preparing to deliver CAR T-cell therapy as quickly as possible and we hope that people can start treatment soon.”
John Stewart, NHS England’s director of specialised commissioning, said: “As we prepare to publish the NHS’s long term plan, this constructive and fast-track negotiation shows how the NHS is leading from the front by ensuring patients in England are among the first in the world to benefit from this immensely promising treatment.”
NICE’s initial draft guidance did not recommend axicabtagene-ciloleucel as the therapy was not considered cost-effective. Further negotiations between NHS England and the company led to a commercial agreement offering axicabtagene-ciloleucel at a lower price. After considering the evidence, the committee concluded that axicabtagene-ciloleucel for adults with large B-cell lymphoma or primary mediastinal large B-cell lymphoma, after two or more systemic therapies, can be offered through the CDF.
The company has a commercial access agreement. The details of the arrangement are commercial in confidence. Approximately 200 people each year in England will be eligible for the therapy. Axicabtagene-ciloleucel is given as a single intravenous infusion.
Although axicabtagene-ciloleucel is promising, there are still uncertainties around the long-term outcomes and the potential side-effects. The committee believes further data collection will reduce these uncertainties and aid a future decision about funding the therapy routinely.