Gilead strikes deal with NHS England on CAR-T Yescarta

NHS England has agreed a market access deal with Gilead for its groundbreaking CAR-T therapy Yescarta, and is claiming it to be the first European deal.

The agreement follows swiftly behind a similar deal between NHS England and Novartis for its rival CAR-T treatment Kymriah in children with acute lymphoblastic leukaemia (ALL), where around 30 children in the country are year stand to benefit.

Today’s agreement will see around 200 adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma be eligible for treatment.

The cell therapy will be available to patients who have failed two or more previous therapies, and have shown spectacular results in many patients: trials show up to 40% of patients could be cured of the disease thanks to the treatment.

There is no doubt that Gilead had to make some major concessions on price, although the exact financial deal remains confidential. Yescarta has a UK list price of nearly £300,000 per patient, but the company’s commercial agreement with NHS England has now led to NICE approval via the Cancer Drugs Fund.

Simon Stevens, chief executive, NHS England said: “Thanks to investment in game-changing techniques like CAR-T, the NHS is at the forefront of providing a new wave of personalised treatments that are individually tailored to patients.

“CAR-T cell therapy is one of the most promising new treatments in a generation for lymphoma and leukaemia, and NHS patients will now be among the first in the world to benefit.

“The NHS has world leading clinicians, researchers and scientists, and today’s announcement is proof-positive that we are open to constructive and flexible partnerships with industry that rapidly bring life sciences innovation to NHS patients in a way that is also fair to British taxpayers.”

Gilead's Hilary Hutton Squire

Hilary Hutton-Squire, General Manager UK and Ireland, Gilead Sciences said: “This is an important day for patients with lymphoma who may have run out of effective treatment options leaving them just months to live. We are delighted to have been able to reach an agreement by working closely with NHS England and NICE which allows us to bring this new generation of personalised cancer treatment to patients.

“The speed of this decision shows how research-based life-sciences companies and the NHS can partner together for the benefit of patients in the UK.”

Dr Alasdair Rankin, Director of Research and Patient Experience at Bloodwise, said: “CAR-T therapies have shown huge promise in treating patients with lymphoma who have no other chance of cure. It’s admirable that the NHS has worked to make this pioneering treatment available so quickly, giving hope to hundreds of patients and their families.

“It is likely that we are only beginning to see the benefits that CAR-T therapy can bring. Treatments will continue to improve and become more effective over the coming decade and will benefit patients with other types of cancer.”

The biggest challenge of CAR-Ts is in the complex manufacturing process, which requires a patient’s own T cells to be extracted, then modified genetically in a laboratory to carry the chimeric antigen receptor (CAR), and then reinfused back into the patient to attack the cancer cells.

Integral to providing CAR-Ts is the setting up of these new procedures at specialist NHS centres around the country. The first wave of NHS hospitals now preparing to provide the cutting edge treatments are in Birmingham, Bristol, London, Manchester and Newcastle.

Not far behind Yescarta in the NICE process in DLBCL is Novartis’ Kymriah. Like its rival, it has been rejected in an initial review by NICE, but could secure a similar access deal by the end of this year if an agreement on price and access can be reached.