Eligible patients in England with Chronic Lymphocytic Leukaemia (CLL) granted immediate access to Calquence▼ (acalabrutinib) following positive NICE recommendation

·         NICE has published a draft recommendation for acalabrutinib for routine NHS use in patients with untreated high-risk CLL or previously treated CLL¹ – the most common type of blood cancer in adults in the UK²

·         In clinical trials, acalabrutinib significantly prolonged the time patients lived without disease progression or death and was generally well tolerated compared to standard chemotherapy-based treatment, in previously treated or untreated CLL^3,4  

·         AstraZeneca has reached an agreement with NHS England to enable immediate NHS access for patents via an interim funding arrangement¹

·         Discussions continue to secure NHS access for patients with untreated, non-high risk CLL

Luton, UK, 08 December 2020 - AstraZeneca today announced that its oral targeted cancer therapy, Calquence (acalabrutinib), received a draft positive recommendation by the National Institute for Health and Care Excellence (NICE) for routine use in the NHS as a treatment for chronic lymphocytic leukaemia (CLL).¹ Specifically, acalabrutinib is recommended as an option for:¹

• Adults with untreated CLL who are considered high-risk due to certain genetic characteristics they harbour (17p deletion or TP53 mutation); and
• Adults with CLL who have had at least one previous treatment, and only if ibrutinib is their only suitable treatment option.

NHS England is granting immediate patient access via an interim funding arrangement with AstraZeneca.¹ This interim funding will end 30 days after the publication of positive final guidance, after which treatment will be funded by routine commissioning budgets.¹

NICE also considered use of acalabrutinib in a third group of patients in this appraisal – those with untreated, non-high risk CLL who are unsuitable for treatment with existing chemotherapy-based treatments. The draft guidance published today states that NICE does not recommend acalabrutinib in these patients.¹ AstraZeneca will provide additional data analyses to support continued discussions with NICE about this group of patients, with the objective of securing a positive recommendation.

Commenting on today’s announcement, Dr George Follows, Consultant Haematologist and Clinical Lead for Lymphoma and CLL at Cambridge University Hospitals NHS Foundation Trust, said: “I am delighted to see that NICE have approved acalabrutinib for use within the NHS in England to treat specific groups of chronic leukaemia patients. This is the second NICE approval of novel targeted therapies for leukaemia patients in as many weeks and marks a really ground-breaking time for the advancement of leukaemia care within the NHS. We have been lucky enough to have experience of treating patients in Cambridge with these new drugs through our clinical trials programme and have been struck by how well-tolerated and effective they are for the majority of patients. I am very pleased that we will now be able to offer these treatments to our patients in the routine clinical setting.”

Commenting on what today’s decision means for the patient community, Marc Auckland, Chair of CLL Support, said: “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. It is disappointing that the medicine has not been recommended 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: “Today’s NICE recommendation enabling immediate access to acalabrutinib 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.”

CLL is the most common type of leukaemia in adults, with an estimated 3,800-4,500 new cases in the UK each year.⁵ It is often mistakenly considered a less serious cancer due to the slower pace of disease progression, but this is not the case. The challenges of living with CLL are extremely complex and patients experience debilitating physical symptoms that can impact their ability to work^6,7 and enjoy everyday activities. Mental health is also often affected, anxiety and depression being frequently associated with the condition.⁸

Acalabrutinib was approved by the European Medicines Agency in November 2020 as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL; and as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy.⁹

Further information about the clinical trial data evaluating the efficacy and safety profile of acalabrutinib is provided below, and a full summary of product characteristics can be found here: https://www.medicines.org.uk/emc/product/11917/smpc.