The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document recommending Imbruvica®▼ (ibrutinib) as an option for treating relapsed or refractory mantle cell lymphoma (MCL) in adults in England and Wales, only if they have had only one previous line of therapy.
MCL is a rare type of B cell non-Hodgkin lymphoma (NHL) which grows quickly and can be difficult to treat. It is often diagnosed when it is in a later stage (not stage I or II).
Treatment can sometimes remove MCL completely but it tends to relapse fairly soon afterwards.
Around 500 patients are diagnosed with MCL each year in the UK, with a 27% chance of surviving five years after diagnosis.
Ibrutinib is already licensed for patients with relapsed and refractory MCL in 40 countries around the world, including Ireland and Scotland. Ibrutinib has remained available on the ‘old’ CDF where it has been available to patients for nearly three years for relapsed/refractory MCL treatment.
NICE has previously recommended ibrutinib for routine NHS use in patients with chronic lymphocytic leukaemia (CLL) who have had at least one prior therapy, or who have a 17p deletion or TP53 mutation and in whom chemo-immunotherapy is unsuitable; and those with Waldenström’s macroglobulinaemia (WM) in adults who have had at least one prior therapy, only if the conditions in the managed access agreement for ibrutinib are followed.
Ibrutinib is the first in a class of medicines known as Bruton’s tyrosine kinase (BTK) inhibitors, with a unique and targeted mode of action. It has been designed to specifically block the BTK protein from causing malignant B cells to multiply and spread.
Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK, said: “We are pleased that patients with this hard-to-treat cancer, who in the past had few treatment options beyond chemotherapy, can now finally access ibrutinib on the NHS in England and Wales. Though the process has been lengthy, we have remained steadfast in our commitment to ensuring access to this innovative medicine for those with MCL.”