Patients living with a specific type of leukaemia will not have access to a new treatment after it failed to win provisional recommendation for use on the NHS in England.
Blinatumomab (Blincyto), a drug used to treat adults with acute lymphoblastic leukaemia whose disease is in remission but who may have some cancer cells after previous treatment, has been provisionally rejected by the National Institute for Health and Care Excellence (NICE).
NICE said it needs more information from the manufacturers before it reviews the decision in April.
Cancer Research UK policy manager, Rose Gray, called the decision a disappointment for patients living with this type of leukaemia, but hopes a solution could be found before the review.
“Clinical trial evidence suggests this drug could give patients more time before their cancer returns, but NICE has asked the company to provide more information to help assess how much extra benefit the drug offers,” she said.
Harnessing the power of the immune system
Blinatumomab works by bringing leukaemia cells into close contact with immune cells, allowing the immune system to more effectively kill them.
It’s been developed for some adults with acute lymphoblastic leukaemia. It’s designed for patients whose cancer cells don’t have a particular change in their DNA (Philadelphia negative leukaemia).
The drug has been trialled for patients who may still have cancer cells in their body after treatment, but not enough to be picked up in standard tests. These remaining cancer cells can increase the risk of the cancer coming back.
In a trial involving 405 patients, blinatumomab significantly increased survival compared to standard chemotherapy. Patients taking blinatumomab lived for 7.7 months on average after treatment, compared to 4 months in patients taking chemotherapy.
Severe side effects were reported in 9 in 10 patients in both groups, with the most common being low white blood cell count and infection.
More information needed
In its provisional decision, NICE said the patients who took part in the trial did not accurately reflect those who would receive the drug on the NHS, so it couldn’t properly verify the benefits of blinatumomab.
NICE also voiced concerns that the trial didn’t reflect the current treatments available, which meant the cost effectiveness of the drug could not be measured.
“We urge NICE and the drug’s manufacturer to work together to resolve these issues before NICE reviews this decision next month,” said Gray.
NICE (2019) Blinatumomab for acute lymphoblastic leukaemia for people with minimal residual disease activity in remission [ID1036]. Appraisal Consultation Document.