Scotland approves two new treatments for use on the NHS

Mogamulizumab has been approved for people with rare types of relapsed or refractory skin lymphoma, and acalabrutinib has been approved as a first-line treatment for some people with chronic lymphocytic leukaemia (CLL).

SMC logo

The Scottish Medicines Consortium (SMC) has today announced that it is recommending that two new lymphoma treatments should be made available on the NHS.

The first is an antibody therapy called mogamulizumab. It has been approved for NHS use for people with advanced mycosis fungoides or Sézary syndrome who:

  • have had at least one previous course of whole body (systemic) treatment and
  • cannot have, or have not responded to, treatment with brentuximab vedotin.

Mycosis fungoides and Sézary syndrome are rare types of lymphoma that affect the skin. In clinical trials, mogamulizumab produced significant improvements in symptoms that lasted longer than other treatments.

The SMC’s decision is very welcome news for people with these debilitating conditions. It is particularly heartening because mogamulizumab was recently not approved by NICE for NHS use in England and Wales. Lymphoma Action and other organisations recently attended an appeal hearing on this decision and we are waiting to hear the outcome.

This is a hugely significant development for those living in Scotland with these rare haematological cancers. Mogamulizumab offers people with mycosis fungoides and Sézary syndrome a much-needed new treatment option for a disease where, to date, therapies have been limited. Lymphoma Action welcomes this decision by the SMC who have recognized that people with mycosis fungoides and Sézary syndrome should have access to the full range of treatment options.
Ropinder Gill, Chief Executive at Lymphoma Action

Secondly, a targeted treatment called acalabrutinib has been recommended for adults with chronic lymphocytic leukaemia (CLL) who:

  • have not been treated before and
  • have high-risk genetic changes in their CLL cells (a ‘17p deletion’ or a ‘TP53 mutation’) and
  • are not able to have standard treatment with fludarabine, cyclophosphamide and rituximab (FCR).

Acalabrutinib blocks a protein called ‘BTK’ on B cells. This disrupts the signals that help B cells to stay alive and divide. It is a capsule that you take at home every day. In clinical trials, it significantly lengthened the time until CLL progressed compared to other commonly used treatments. It is generally well tolerated. Common side effects include headache, low neutrophil count (neutropenia), diarrhoea, low red blood cell count (anaemia) and cough.

Acalabrutinib is already available on the NHS for people with CLL that has come back after at least one previous course of treatment and who are not able to have chemo-immunotherapy.

The SMC’s recommendation is narrower than the approved indication for acalabrutinib, but it is broadly consistent with NICE’s decision and brings Scotland in line with the rest of the UK.

For more information about drug development, approval and funding, visit Lymphoma TrialsLink.

7 June 2021