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A new treatment option for patients with chronic lymphocytic leukaemia (CLL) has today been approved by the National Institute for Health and Care Excellence (NICE). NICE are the appraisal body that decide what treatments are accessible for NHS patients in England and Wales. Ibrutinib, marketed by Janssen as Imbruvica®, will now be routinely available for CLL patients in England and Wales, offering an additional, effective treatment for patients with this chronic blood cancer.
The final appraisal determination (FAD), which is the document that sets out the details of the recommendation, indicates that ibrutinib is “recommended within its marketing authorisation as an option for treating chronic lymphocytic leukaemia in adults:
A copy of the guidance can be found here.
CLL is the most common form of leukaemia, with approximately 3,200 people diagnosed in England and Wales each year. When a patient has CLL, their bone marrow produces too many B lymphocyte cells that are not fully matured and fill up the bone marrow, preventing it from producing normal, healthy cells. Common symptoms of CLL include severe fatigue, breathlessness, anaemia, headaches, frequent infections, fever, unexplained weight loss, unexplained bleeding and bruising, night sweats and enlarged lymph nodes.
Currently available treatment options include chemotherapy, immunotherapy and stem cell transplantation. Ibrutinib, however, is an oral inhibitor of a protein known as Bruton’s Tyrosine Kinase (BTK) and works by blocking the transmission of cell signals, which helps kill cancer cells and prevents cells multiplying, slowing down the progression of the cancer.
This recommendation is particularly welcome as the positive guidance was preceded with a negative Appraisal Consultation Document (ACD), a document that outlines NICE’s preliminary recommendation of a drug or technology following an initial assessment. Disappointingly, the ACD did not recommended ibrutinib within its marketing authorisation for treating CLL patients. Following the negative ACD, a consultation process was initiated, which was an opportunity for Janssen (the drug’s manufacturer) and patient organisations like Leukaemia CARE to put forward evidence in support of ibrutinib’s clinical effectiveness and its potential to improve patient’s quality of life. Today, it has been announced that following this consultation period, and a price reduction by the manufacturer company, ibrutinib will now be available to those CLL patients who meet the criteria of the recommendation.
Ibrutinib is already available for mantle cell lymphoma (MCL) patients in Scotland and is currently being assessed by NICE for the treatment of MCL patients in England and Wales. Ibrutinib has also demonstrated itself to be clinically effective in the treatment of Waldenstrom's macroglobulinaemia (WM) and as such, is also undergoing a NICE assessment. Decisions on whether ibrutinib will be recommended for routine use for these indications are expected later this year.
Zack Pemberton-Whiteley, Leukaemia CARE’s Head of Campaigns and Advocacy, comments:
“It is fantastic news that ibrutinib will now be routinely available to chronic lymphocytic leukaemia patients in England and Wales. Leukaemia CARE has been involved throughout the ongoing NICE appraisal and we are delighted that the negative preliminary recommendation has been overturned. This decision means that CLL patients now have an additional, effective treatment option available to them should they need it. For patients, the knowledge that there are alternative treatments available should their existing one stop working relieves some of the burden that living with leukaemia causes. We hope that NICE similarly recommend ibrutinib for mantle cell lymphoma and Waldenström’s Macroglobulinaemia patients as well.”