NICE backs AZ' Calquence for chronic lymphocytic leukaemia

The National Institute for Health and Care Excellence has published preliminary guidelines backing use of AstraZeneca's Calquence (acalabrutinib) as an NHS funded treatment for chronic lymphocytic leukaemia (CLL).

The Institute is proposing to allow the drug's use for untreated CLL in adults if they have a 17p deletion or TP53 mutation, and also as an option for those who have had at least one previous treatment, but only if ibrutinib is their only suitable treatment option as a further restriction.

In both settings, a further stipulation is that AstraZeneca provides Calquence according to the commercial arrangement (which remains confidential).

Unusually, NHS England is granting immediate patient access via an interim funding arrangement with AstraZeneca, which will end 30 days after the publication of positive final guidance, after which treatment will be funded by routine commissioning budgets.

“CLL is the most common type of blood cancer in the UK and this announcement is positive news for many people affected by this condition. Acalabrutinib is generally well tolerated compared to chemotherapy and is taken in tablet form rather than as an infusion, which are important considerations for people with CLL and helping them to maintain a good quality of life,” said Marc Auckland, chair of CLL Support.

However, he also expressed disappointment that the medicine was notrecommended for people with untreated non-high risk CLL, “but this is a draft decision at this point and we fervently hope that the final recommendations will include these patients too.”

Arun Krishna, head of Oncology at AstraZeneca UK, said the recommendation is “a very positive development for a selected population of people with CLL”.

“Despite this good news, we are acutely aware that many patients fall outside of today’s recommendation. We remain steadfast in our ambition to secure NHS access for these patients and will work with urgency alongside our stakeholders in NICE and NHSE to achieve this.”