Engineered cell therapy given initial ‘no’ for NHS in England
A cancer immunotherapy has been provisionally rejected as a treatment for some types of aggressive non-Hodgkin lymphoma on the NHS in England.
The draft recommendation from the National Institute for Health and Care Excellence (NICE) means axicabtagene ciloleucel (Yescarta) won’t be routinely available for patients with two aggressive types of non-Hodgkin lymphoma who have already had two or more different types of treatment.
The decision will be reviewed by NICE at the end of September.
Yescarta is one of a new line of immune-boosting treatments called CAR T cell therapies, which involve taking a patient's own immune cells and modifying them in the lab. When the engineered cells are given back to the patient they are primed to recognise and attack the cancer cells. The complexity of this process makes the drug very expensive.
In the latest clinical trial involving 111 people, 8 in 10 people responded to Yescarta and half saw their disease completely disappear six months after treatment. However, the drug also led to serious side effects in over half of patients.
Earlier in the week, both Yescarta and another CAR T therapy (Kymriah) were licensed and can now be sold for use in Europe. But before they’re available on the NHS, NICE must confirm the drugs are clinically beneficial and good value for money.
Emma Greenwood, Cancer Research UK’s director of policy, called the decision not to recommend the treatment disappointing. “CAR T cell therapies have shown great promise in some people with specific types of blood cancer, so it's disappointing Yescarta has been provisionally turned down,” she said.
More data needed
The committee said that although the clinical trial results suggest most patients given Yescarta respond to the treatment, there is no direct data to compare it with standard chemotherapy treatment. This means that the benefits of Yescarta compared with chemotherapy are unknown.
NICE also said that cost of the treatment was too high for it to be considered cost-effective on the NHS.
Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “We have been working with the companies involved, and with NHS England, with the aim of ensuring that patients in England are among the first to have access to these new treatments in Europe.”
"Although promising, there is still much more we need to know about CAR T," he added.
The drug’s manufacturer, Kite Pharma, can now submit additional data, which will be reviewed by NICE before a final decision is reached. And there will be more negotiations between the company and NHS about the price of the drug.
Greenwood urged the manufacturer to work with NICE to demonstrate the drug’s effectiveness, and to agree a deal with NHS England on a price that will allow the drug to be recommended.