By Ben Hirschler
LONDON (Reuters) - A cutting-edge CAR-T cell therapy for otherwise untreatable forms of blood cancer is too expensive to justify its use on Britain's state-funded health service, the country's healthcare cost agency NICE said on Tuesday.
The decision by the National Institute for Health and Care Excellence (NICE) is a blow to U.S. drugmaker Gilead Sciences (O:GILD), which wants to get its Yescarta product approved for use on the National Health Service (NHS).
The NICE rejection comes one day after the European Commission approved Yescarta for two aggressive forms of non-Hodgkin lymphoma. That green light cleared the way for each European country to decide on whether to fund the treatment.
Yescarta is the first CAR-T therapy to be assessed by NICE. The agency is currently appraising Novartis's (S:NOVN) rival Kymriah, which also won EU approval on Monday. NICE experts met last week to consider initial recommendations on the Swiss firm's product, a spokesman said.
Both Yescarta and Kymriah are chimeric antigen receptor T-cell therapies, or CAR-Ts, which reprogramme the body's own immune cells to attack malignant cells.
The treatments represents a brand new approach to fighting cancer, since the therapy involves extraction of infection-fighting cells from a patient. These cells are then genetically engineered to recognise cancer cells and infused back.
The process is complex and expensive but it offers hope for people with certain kinds of blood cancer who have exhausted all other treatment options.
Meindert Boysen, director of the centre for health technology evaluation at NICE, said Yescarta was "an exciting innovation in very difficult to treat cancers, with a promise of cure for some patients" but said its price was too high for it to be considered cost-effective.
The U.S. list price for Yescarta is $373,000. The UK price is confidential. NICE said Gilead had proposed a "commercial arrangement" if Yescarta was recommended. Typically, drugmakers provide price discounts in exchange for NHS access.
Gilead said it was "in ongoing discussions with NICE to identify appropriate treatment comparators which can clarify how cell therapy may be made available to patients in the UK".
Raj Chopra, head of cancer therapeutics at the Institute of Cancer Research in London, said the NICE rejection was disappointing for patients.
"If we're going to see CAR-T therapy widely available on the NHS, we need to find ways to reduce the costs," he said.
Yescarta was approved by the U.S. Food and Drug Administration in October.