NICE approves idelalisib (Zydelig®) for the treatment of chronic lymphocytic leukaemia in England and Wales


 NICE says yes to new class of drug for adults with leukaemia

Today, the National Institute for Health and Care Excellence (NICE) has announced that idelalisib, in combination with rituximab, will be made available on the NHS in England and Wales for patients with chronic lymphocytic leukaemia (CLL). 

NICE has recommended idelalisib, when given with another cancer treatment rituximab, for adults with CLL who have a specific genetic change and have not received any other treatment or for all adults with CLL if their cancer has come back less than 24 months after previous treatment.

The decision follows a preliminary decision earlier this year where NICE asked for the company to provide further information on the cost effectiveness of the drug. Gilead Sciences responded by submitting new economic analyses alongside a simple discount agreement to the list price of idelalisib. 

You can read more and access the full FAD on the NICE website

CLLSA are very pleased NICE has recommended idelalisib as a new option to treat CLL patients in England and Wales .This is welcome news and marks a shift towards the use of targeted therapies in the management and treatment of CLL.
Idelalisib plus rituximab received European marketing authorisation a year ago and was made available to a restricted patient population in England through the Cancer Drugs Fund in January this year. Today’s positive NICE decision provides long-term availability for eligible patients in England and Wales in line with NHS Scotland who received approval to treat with idelalisib from The Scottish Medicines Consortium in March 2015 


from Gilead press statement:

Gilead’s Targeted Therapy to be Made Available on the NHS for the Treatment of Chronic Lymphocytic Leukaemia in England and Wales –

London, 24 September 2015 – Gilead Sciences’ Zydelig® (idelalisib) has today been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option in combination with rituximab for adults with chronic lymphocytic leukaemia (CLL) who have relapsed early (<24 months). This combination has also been recommended for untreated CLL patients with markers for aggressive disease (genetic abnormalities called 17p deletion and/or TP53 mutation).

As assessed by the NICE Committee, this decision indicates that idelalisib plus rituximab can offer significant health-related benefits.CLL is the most common form of adult leukaemia in the UK, affecting approximately 28,140 people. The disease can lead to life-threatening complications, such as anaemia, serious infection and bone marrow failure, and has a significant negative impact on patients’ quality of life.

This is great news for patients with CLL,” said Chris West, Spokesperson for Bloodwise, the UK’s biggest blood cancer charity. “Coinciding with National Blood Cancer Awareness Month, NICE’s recommendation of idelalisib is a very welcome development for adult patients with CLL in England and Wales, particularly when there is such uncertainty around the future availability of many blood cancer treatments.”

Chemo-immunotherapy is usually the first choice for treating CLL after ‘watch and wait’, however most patients eventually relapse and need further treatment. For patients with aggressive disease that relapses within 2 years of chemo-immunotherapy treatment options are very limited. Also five per cent of patients at diagnosis and up to 10% at treatment initiation have specific genetic abnormalities, and for these patients most conventional chemo-immunotherapy treatments are not very effective and deliver poor responses with relatively short duration.

"Idelalisib provides a much needed option for those patients with CLL in whom conventional chemotherapy-based treatment are not very effective, including when the disease relapses quickly after previous therapy and for previously untreated patients with a molecular switch (17p deletion or TP53 mutation) that prevents chemotherapy being effective," said Professor Peter Hillmen, Consultant Haematologist, NHS Leeds Teaching Hospitals. "Previously these patients have been faced with very limited, ineffective treatment, and had a much shorter survival than other patients with CLL. However NICE's decision means that these patients will soon be able to access through the NHS an effective, chemotherapy-free treatment option that directly targets the leukaemia leading to improved survival."

Read more - Full press release attached below

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