CAR T-Cell Therapy Recommendation for Lymphoma Patients 

Peter Russell

February 01, 2019

The National Institute for Health and Care Excellence (NICE) said its decision to recommend the chimeric antigen receptor T-cell therapy for some people with lymphoma was 'a step forward for personalised medicine'.

Among other announcements by NICE this week was approval for a wound dressing for patients with diabetic foot ulcers that could save the NHS millions of pounds each year.

Tisagenlecleucel Included on the CDF for Lymphoma

NICE reversed an earlier decision and opted to make tisagenlecleucel (Kymriah, Novartis) available on England's Cancer Drugs Fund for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

In a final appraisal, it said the chimeric antigen receptor T-cell (CAR T-cell) therapy would be available to patients whose disease had not responded or those whose disease had relapsed after treatment with two or more courses of chemotherapy.

The list price for tisagenlecleucel is £282,000 for a single intravenous infusion. Initial draft guidance rejected tisagenlecleucel on cost grounds. However, the manufacturer agreed a confidential price discount with NHS England.

It is estimated that 200 people will be eligible for treatment each year in the UK.

NHS England said it was working closely with several hospitals across the country to deliver the complex treatment.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "Recommending another revolutionary CAR T-cell therapy for adults with lymphoma represents a step forward for personalised medicine.

"We are pleased that patients are set to benefit from such an innovative therapy so rapidly because of joint working between NICE, NHS England and the company.

"CAR T-cell therapy is expensive. However, the treatment is specific to each individual and could be a potential cure for some, although it is early days. Our recommendation for tisagenlecleucel on the Cancer Drugs Fund means people can benefit while more data is collected."

Ropinder Gill, chief executive of Lymphoma Action, commented: "This is really good news for people affected by this type of lymphoma who, until now, have faced limited treatment options. The news offers patients and their families faced with a poor prognosis a more hopeful outlook."

Dr Alasdair Rankin, director of research and patient experience at the blood cancer charity Bloodwise, said: "CAR T-cell therapy is the most promising breakthrough in blood cancer treatment of the past decade, with the potential to be used much more widely in the future.

"Ensuring access to CAR T-cell therapies gives these patients the real chance of long-term survival when all other treatments have failed."

The latest draft guidance followed two recent CAR T-cell therapy recommendations, axicabtagene ciloleucel (Yescarta, Gilead) for adults with DLBCL and tisagenlecleucel for young people with leukaemia.

Dressings for Diabetic Foot Ulcers

In final guidance, NICE recommended UrgoStart dressings (Urgo Medical) as an option for people with non-infected diabetic foot ulcers or venous leg ulcers.

An appraisal committee found that UrgoStart improved the speed and rate of wound healing in people with diabetic foot ulcers compared with standard care.

The dressings, costing around £4.28, consisted of open weave polyester mesh, impregnated with hydrocolloid polymers, within a petroleum jelly. The unique benefit of UrgoStart was a substance inhibiting the activity of protease enzymes within the wound that can lead to slower healing.

NICE said that around 70,000 people in England could be eligible for treatment with UrgoStart dressings for diabetic foot ulcers and estimated that their use could save the NHS up to £5.4 million a year if a quarter of eligible patients used them.

Percutaneous Venoplasty for MS

Interventional procedures guidance ruled out percutaneous venoplasty for chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis.

It said current evidence on the technique to improve cerebrospinal venous drainage showed the treatment was associated with serious complications and that it provided no benefit.

Laparoscopic Cerclage

Current evidence on the safety and efficacy of laparoscopic cerclage for cervical incompetence to prevent late miscarriage or preterm birth was adequate to support the use of this procedure, NICE said in interventional procedures guidance.

Its use depended on standard arrangements being in place for clinical governance, consent, and audit. Also, patient selection should be done by a multidisciplinary team experienced in the management and prevention of preterm delivery.

Electrically Stimulated Intravesical Chemotherapy

Current evidence on electrically stimulated intravesical chemotherapy for non-muscle-invasive bladder cancer showed no major safety concerns NICE said in final interventional procedures guidance.

However, evidence on efficacy was limited and the procedure should only be used in the context of research, it said.

Prostatic Urethral Temporary Implants

Final interventional procedures guidance said that current evidence on the safety and efficacy of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia was limited in quantity and quality.

It said the procedure should only be used in the context of research.

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