UK’s National Institute for Health and Care Excellence (NICE) has published its final appraisal determination (FAD) recommending Janssen’s Imbruvica (ibrutinib), as a treatment option for adults with chronic lymphocytic leukaemia (CLL).

The treatment will be given for adults who have undergone at least one prior therapy or who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is not suitable.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Every year, around 3,400 people are diagnosed with CLL in the UK and the majority of them affected are above 70 years old.

Janssen UK health economics, market access and reimbursement director Jennifer Lee said: “This is very welcome news for patients with CLL, who will now be entitled to access ibrutinib via routine commissioning, and will in turn, free up much needed resources in the Cancer Drugs Fund.

“Every year, around 3,400 people are diagnosed with CLL in the UK and the majority of them affected are above 70 years old.”

“Janssen is dedicated to ensuring that patients with blood cancer have access to the most effective therapies, and we keenly await a similar positive decision by NICE for patients with mantle cell lymphoma and Waldenström macroglobulinemia, who currently have limited treatment options available to them.”

Ibrutinib is the first in a new class of medicines known as Bruton’s tyrosine kinase (BTK) inhibitors and has been designed to specifically block the BTK protein from causing malignant B-cells to multiply and spread.

The FAD recommendation made by NICE was based on the results of multiple trials, including RESONATE (PCYC- 1112) and PCYC-1102/3.5.

NICE concluded that ibrutinib represents a cost-effective treatment for patients with CLL and it works by forming a covalent bond with the BTK protein to block the transmission of cell survival signals within the malignant B-cells.