Targeted drug not approved for certain lymphoma patients on the NHS
People with a certain type of lymphoma will not be able to receive a targeted cancer drug on the NHS in England.
The National Institute for Health and Care Excellence (NICE) concluded that giving brentuximab vedotin (Adcetris) to people with a type of lymphoma after they've had another treatment is not cost effective.
The decision will be reviewed in February.
This draft guidance comes after results of a phase 3 clinical trial showed that the drug was better than current treatment at stopping the lymphomas, called CD30-positive cutaneous T-cell lymphomas (CTCL), cancer getting worse. But the treatment had more severe side effects than current therapies.
NICE rejected the drug because it couldn't say for certain how much a patient's entire treatment would cost.
Rose Gray, Cancer Research UK's policy manager, said NICE has acknowledged that there is a need for new treatment options for people with this type of blood cancer, so this decision will be disappointing for those patients.
"This drug has been shown to offer some people much more time until their cancer spreads," she added.
A rare cancer
CTCL is a form of non-Hodgkin lymphoma that affects the skin. Lymphoma is a cancer that starts in certain immune cells called white blood cells. 'Cutaneous' lymphoma starts in the white blood cells in the skin.
CTCL normally develops as flat red patches on the skin's surface, which can then develop into tumours.
Currently, there is no NICE guidance on treating CTCL.
The disease can be divided into distinct types, only some of which carry a molecule on the surface of the cancer cells called CD30.
Brentuximab sticks to the CD30 molecule and delivers a drug to the cancer cell and kills it.
People usually live with the condition for many years. But according to the decision document published by NICE, patients say that being diagnosed with CTCL can severely affect physical and psychological wellbeing.
A comparison with current treatment
Standard treatment for NHS patients with this type of lymphoma is the chemotherapy drug methotrexate or another drug called bexarotene.
A clinical trial set out to see if brentuximab was more effective. It included 128 patients with CTCL. Tumour reduced in size in 36 out of 64 patients taking the targeted drug compared to 8 out of 64 taking one of the standard treatments.
More severe side effects were reported in the group taking the current treatment than the targeted drug. But brentuximab affected the nervous system in a large proportion of patients, with 44 out of 64 patients experiencing a tingling or pain sensation in the finger tips or toes, called peripheral neuropathy.
Four people died taking brentuximab and in one case the drug was thought to be the cause of death.
NICE said it rejected the drug for this group of patients because the trial only looked at how well the drug worked. Researchers did not routinely record the care patients went on to receive after they stopped receiving brentuximab.
Because of this NICE said it is uncertain how many people then go on to further treatment, such as a stem cell transplant. A stem cell transplant can cure CTLC but it is a risky and expensive procedure.
NICE also said it was unclear whether receiving brentuximab on its own, without a subsequent stem cell transplant, could extend how long patients live.
Because of these factors, NICE said it couldn't accurately judge how expensive the entire course of treatment would be per patient. This meant it couldn't be confident the drug offered value for patients and value for money.
NICE plans to review the decision in the New Year. "We urge the manufacturer, NICE and NHS England to work together before NICE reviews this decision again in February," said Gray.