Venetoclax with obinutuzumab approved for a wider group of untreated CLL patients in Scotland

Charities including Leukaemia Care successfully campaigned for the Scottish Medicines Consortium (SMC) to approve venetoclax with obinutuzumab on the NHS in Scotland as a first-line treatment for a larger group of chronic lymphocytic leukaemia (CLL) patients.

What’s the news? 

Today’s news brings access to venetoclax with obinutuzmab on the NHS in Scotland in line with current access rules in England. In December 2020, venetoclax with obinutuzumab was approved for a limited number of CLL patients in Scotland, despite being approved in all CLL patients in England shortly before. We are pleased that the SMC has today announced that this wider group of all CLL patients in Scotland will have equal access to the treatment. 

How was Leukaemia Care involved? 

Leukaemia Care worked alongside charities CLL Support and Lymphoma Action to gather data, patient experience and put together a written response to the SMC before they made a decision. We focused on why having venetoclax with obinutuzumab, as an alternative option to the combination of fludarabine, cyclophosphamide and rituximab (FCR), could be beneficial to patients and have a positive impact on their quality of life. It was important to emphasise why having a choice between treatments with different side effects and different methods of administration can impact on patients’ wellbeing; survival is not the only thing that matters to patients. Additionally, two CLL patients told us what the approval of this treatment in Scotland would mean for them and we shared their views as quotes in our written submission. 

We are very pleased that CLL patients in Scotland now have equal access to venetoclax with obinutuzumab as those in England. 

Which patients are able to access now and why is this important?

Until today, venetoclax with obinutuzumab was not available as a first treatment for CLL patients in Scotland who are suitable for FCR (a combination of fludarabine, cyclophosphamide and rituximab) as an alternative treatment option. FCR is falling out of favour with both patients and clinicians as newer, non-chemotherapy treatment options increase in number and are also effective. Many patients prefer newer treatments for reasons such as being able to have them from home, or thanks to a different side effect profile they may find more tolerable. Additionally, it is thought that targeted treatments are likely to have fewer long term side effects than chemotherapy, such as the risk of secondary cancers, although this is not certain as these treatments have not been widely used for more than 5 to 10 years at present. So despite FCR being an effective treatment, we welcome an alternative option for patients.

What are the other benefits of the treatment to patients?

Not only are there more tolerable side-effects, but there is evidence from the CLL14 trial that patients are achieivng negative measurable residual disease (MRD) when being treated with venetoclax with obinutuzumab. Negative MRD means that no disease can be detected, even when you use very sensitive detection methods that can find 1 cancer cell among a million normal cells. Being MRD negative means you have a high likelihood of enduring remission. 

Venetoclax with obinutuzumab is designed to be given for 12 months, followed by a treatment free period, which patients have also told us is a positive over having treatments that must be taken until they stop working. 

How does the treatment work?

Venetoclax works by attaching to a protein called BCL-2. Large amounts of this protein are present in CLL cancer cells and it helps the cells survive for longer in the body and can make them resistant to other medicines. By attaching to and blocking Bcl-2, venetoclax causes the death of cancer cells thereby slowing down disease progression. Venetoclax is also effective against other types of leukaemia, including acute myeloid leukaemia. 

Obinutuzumab is a monoclonal antibody that targets the CD20 protein on the surface of leukaemia cells. When obinutuzumab attaches to the CD20 protein, it marks the cancer cell for destruction by the immune system.

If you have any questions about this blog, please contact our advocacy team on advocacy@leukaemiacare.org.uk.

Published: Monday 9th May 2022

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