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NICE approves first in new class of leukaemia drugs

Published on 24/09/15 at 11:09am

NICE has issued final draft guidance which recommends that Gilead's Zydelig should be made available on the NHS for some adults with chronic lymphocytic leukaemia.

The UK watchdog has recommended Zydelig (idelalisib) when given with the monoclonal antibody rituximab, for adults with chronic lymphocytic leukaemia (CLL) who have a specific genetic change and have not received any other treatment; or for all adults with CLL whose cancer has returned less than 24 months after previous treatment.

NICE’s decision follows a preliminary ruling earlier this year, where it requested additional information from Gilead Sciences on the cost-effectiveness of the drug. Gilead submitted new economic analyses in addition to the simple discount agreement to the list price of idelalisib included in the initial submission. The new analyses prompted NICE's positive decision.  

Professor Carole Longson, NICE health technology evaluation centre director, comments: “We are delighted that Gilead Sciences responded to our consultation by providing further information for our independent appraisal committee and that they had agreed to provide idelalisib to the NHS at a reduced price in the initial submission.

“For people whose cancer has returned less than two years after their last treatment, their options are currently limited. With this new positive recommendation, the NHS will have another clinically effective option for treating adults with chronic lymphocytic leukaemia.”

CLL is the most common form of adult leukaemia in the UK, affecting approximately 28,140 people. Chemo-immunotherapy is the current standard treatment for the condition after ‘watch and wait’, but the majority of patients eventually relapse and require further treatment.

Idelalisib, however, offers a new course of action. It is the first of a new class of drug that work by blocking the signals which help cancerous cells multiply and survive, and cancer charities, as well as clinicians, responded positively to the additional option now available to CLL sufferers.

Zack Pemberton-Whiteley, head of campaigns and advocacy at Leukaemia Care, comments: “We are thrilled that eligible CLL patients in England and Wales, who previously had limited treatment options, will soon have access to idelalisib on the NHS. CLL most commonly affects people in their later years and can have a significant toll on quality of life, so the availability of tolerable treatment options that are chemotherapy-free, like idelalisib, is welcome progress in the evolution of CLL management.”

“NICE’s recommendation of idelalisib is good news for eligible CLL patients in England and Wales,” adds Dr Chris Fegan, consultant haematologist at Cardiff University School of Medicine. “I would like to thank the staff at NICE who have carried out their duties in a very open, professional and honest way for what is a new class of drug for CLL. This decision recognises the value this agent can offer patients, as idelalisib has the potential to not only allow patients to live longer, but also to improve their quality of life in a therapeutic landscape where previous options were limited.”

Idelalisib is already approved in the US for the treatment of three types of blood cancer, including in combination with rituximab for relapsed CLL. It has been available to a limited number of patients in England since January 2015 through the Cancer Drugs Fund.

Joel Levy

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