Page last updated on: 20th October 2023
What is the news?
Leukaemia Care is pleased to share the decision by both NICE and the SMC to approve zanubrutinib treatment for use on the NHS in patients with chronic lymphocytic leukaemia (CLL) in all nations of the UK. Zanubrutinib has the brand name BRUKINSA® and is manufactured by the pharmaceutical company BeiGene.
Which CLL patients are eligible for this treatment?
As a first treatment:
For those who have not yet been prescribed a treatment for their CLL, zanubrutinib has has been recommended as a first treatment option for:
- any patients who have a 17p deletion or TP53 genetic mutation
- any patients who are unsuitable for the chemotherapy treatments FCR (fludarabine, cyclophosphamide and rituximab) and BR (bendamustine and rituximab).
As a subsequent treatment:
Zanubrutinib has also been recommended as a suitable option for anyone with CLL who has already tried one or more other treatments that might no longer work or are intolerable.
How was Leukaemia Care involved in the decision to approve the treatment?
For both NICE and the SMC’s treatment appraisals, Leukaemia Care provided evidence on patient experience to outline the case for this treatment to be approved.
Leukaemia Care submitted a written response to NICE and the SMC representing the views and experiences of CLL patients by drawing on sources including survey data, conversations with patients and information from patient forums.
Nick York, Leukaemia Care’s Healthcare Liaison Officer and CLL patient, also spoke to both the SMC and NICE committee about his experience of CLL and treatment and why more options for CLL patients like him are important.
Who are NICE and the SMC and what do they do?
The role of the National Institute for Health and Care Excellence (NICE) in England and the Scottish Medicines Consortium (SMC) in Scotland is to decide if a treatment is cost-effective and therefore suitable to be used on the NHS in England or Scotland. They do this by comparing the treatment’s effectiveness and price to existing treatments, if there are any. The process therefore involves looking at clinical trial data and information on the cost of delivering the new drug. NICE and the SMC also take into account comments from patient and clinical experts on the impact the drug would have on patients. NICE and the SMC then bring together a committee of people at their respective organisations to make a recommendation based on the evidence they have.
Decisions in Wales and Northern Ireland are usually based on the recommendations of either NICE or the SMC. For this appraisal, Wales have followed NICE’s recommendation. Northern Ireland has yet to make a decision on whether to approve zanubrutinib.
Why have the NICE and SMC committees made this decision and why is it important for patients?
NICE and the SMC decided to approve zanubrutinib as they understood that having more treatment options for CLL patients is beneficial and the treatment was deemed cost effective enough to meet the criteria for approval on the NHS. More treatments mean there are more options for patients up front and for those who have already been treated with other therapies but whose current treatment has become intolerable due to the side effects or has stopped working.
NICE reviewed clinical trial evidence which suggested that zanubrutinib extends the length of time CLL patients have before their condition gets worse compared with BR (in untreated population) and ibrutinib (in relapsed or refractory population). Zanubrutinib also showed an improved side effect profile in comparison to more traditional chemotherapies.
Nick York, Leukaemia Care’s Patient Advocacy and Healthcare Liaison Officer, and CLL patient himself, welcomed the approval of zanubrutinib by both NICE and the SMC:
“I have seen so much positive change in how CLL is treated in the 14 years I have lived with the disease. When I was diagnosed the only effective treatment option for CLL was chemotherapy based and if you were unsuitable for chemo there were not really any effective alternatives. Today people diagnosed with CLL have a different view ahead, as there are effective treatments available to all and these are targeted and not chemo based.
However, the population living with a diagnosis of this leukaemia is made up of many different kinds of people with varied health and disease characteristics. CLL is currently incurable and patients may require several suitable and effective treatment options at different points along our life course. I am uplifted by Today’s news that NICE and the SMC have approved zanubrutinib as an NHS treatment for CLL in England and Wales, and Scotland respectively. This decision adds another targeted treatment stepping stone option that continues to improve the quality of life and extend the path ahead for people living with CLL.”
How does the treatment work?
Zanubrutinib is a small-molecule inhibitor of a protein called Bruton’s tyrosine kinase (BTK), which stops B-cell (lymphocyte) proliferation and promotes cell death. Zanubrutinib is an oral tablet treatment that is taken for a continuous duration, i.e. for as long as it continues to work or is tolerable. If you have any questions about your own treatment plan, please speak with your doctor in the first instance.
If you have any questions about this announcement, please contact firstname.lastname@example.org.
If you want to know more about what treatments are available for you, how treatment decisions are made or have any other question related to treatment, please contact us via our helpline 08088 010 444, or send your question to WhatsApp on 07500 068 065 (services available Monday to Friday 9am – 5pm).