NICE changes its mind on BMS' lymphoma cell therapy

Hundreds of patients with a form of lymphoma will be able to access treatment with Bristol Myers Squibb's CAR-T Breyanzi after NICE backed NHS funding of the cell therapy.

Final guidance (PDF) published today recommends Breyanzi (lisocabtagene maraleucel or liso-cel) as an option for treating people with large B-cell lymphoma when their cancer has either not responded to initial treatment or returned within 12 months.

The one-shot therapy becomes the first CAR-T therapy to be recommended for this type of lymphoma, according to the health technology assessment (HTA) agency, which estimates that it will become an option for around 600 people per year in England.

The guidance covers patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma who would be suitable candidates for a bone marrow transplant – a narrower use than its approved indication.

NICE's initial guidance on Breyanzi concluded it was not a cost-effective option for patients, but the agency said this morning it changed its position after BMS "offered an improved commercial arrangement to the NHS" on the £297,000 (around $375,000) list price per individual treatment.

Patient organisation Blood Cancer UK has welcomed the change of heart, noting that for people whose lymphoma has progressed after first-line chemotherapy Breyanzi is more convenient than current NHS treatments and allows patients to avoid "multiple hospital visits and 'cycles upon cycles' of intensive chemotherapy regimens."

Josh Hill, policy officer at the charity, said: "Many of the existing treatments are extremely toxic to human cells, so we welcome this decision, which means there are more treatment options for people with blood cancer in England."

Breyanzi will be available through routine commissioning, with NHS England required to make funding available within 90 days, but in the interim funding will be available from the Cancer Drugs Fund (CDF), according to NICE.

Another patient organisation, Lymphoma Action, noted that Wales and Northern Ireland often also adopt the NICE decision. The Scottish Medicines Consortium (SMC) has not yet delivered its verdict on the CAR-T.

Commenting on the development, Professor Chris Fox, a consultant haematologist at Nottingham University Hospitals NHS Trust, said Breyanzi "delivers high rates of complete remission and offers patients improved chances of long-term survival."

He added: "Liso-cel is better tolerated by patients, with lower rates of serious side effects than current […] treatments."