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Put case for adding leukaemia drug to Cancer Drugs Fund, NICE tells company

Options currently very limited for CLL patients with 17p deletion, it says

Caroline White

Thursday, 02 June 2016

The National Institute for Health and Care Excellence (NICE) has asked pharma company Janssen to set out a case for including its leukaemia drug in the Cancer Drugs Fund, in draft guidance on ibrutinib (Imbruvica), published yesterday.

Up to 1 in 10 adults with chronic lymphocytic leukaemia (CLL) have a form of cancer with genetic changes that make their disease progress quicker and more difficult to treat. The available treatment options for CLL with these genetic changes (known as 17p deletion or TP53 mutation) are currently very limited.

NICE’s independent advisory committee felt ibrutinib could help this group of patients, particularly those who have not yet received treatment.

The committee recognised that under the current proposal, ibrutinib was not cost effective. But it was also aware that available data focused on how well ibrutinib worked as a second treatment, and was drawn mainly from people whose CLL did not have these genetic changes.

The committee felt that important further evidence could be collected on the 17p deletion group, and on the use of ibrutinib as the first treatment, before they made their final decision.

And it has set out what the case would need to look like for inclusion in the Fund. This includes details of data collection addressing uncertainties about the clinical benefits of ibrutinib and any necessary commercial access agreements to reduce the overall cost to the NHS.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE explained that the move had been prompted by NICE’s commitment to give patients faster access to promising new cancer drugs.

“The incidence of CLL has been rising since the seventies, with thousands more people being diagnosed with the condition each year. Treating [it] is complex for some, options are limited, and current treatments can have serious side effects,” she said.

“If the company puts forward a proposal that is accepted by NICE and NHS England, conditional funding will be made available while more evidence is gathered to show how well it works. This will allow us to carefully monitor and evaluate the full benefits and still ensure patients have access.”

The committee also considered ibrutinib as an option for treating CLL without the 17p and TP53 genetic changes in people who have already received another treatment. Considerable uncertainty about the survival benefits and the fact it cost substantially more than treatments currently available on the NHS meant that the committee rejected this option.

Ibrutinib works by blocking the signals which help cancerous cells multiply and survive. Taken as a once daily tablet, a year’s treatment costs more than £55,000 a patient. The company has agreed to discount the price of the drug for the NHS.

Earlier this week, the European Commission gave the go ahead to the use of ibrutinib for the treatment of adults with previously untreated CLL. The move follows a similar decision by US drugs regulator in March.

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