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Ibrutinib receives partial “yes” from SMC

written by

Leukaemia Care, Charity

  • medication

Earlier this week the Scottish Medicines Consortium (SMC) issued advice regarding the use of ibrutinib within NHS Scotland for the treatment of chronic lymphocytic leukaemia (CLL). Ibrutinib is marketed by Janssen as Imbruvica®.

Chronic lymphocytic leukaemia (CLL) is the most common form of leukaemia. However, it is still a rare condition, with approximately 185 people diagnosed in Scotland each year.

In someone with CLL, abnormal cells take over the bone marrow, meaning the bone marrow is not able to make enough normal blood cells. Due to the inability of the bone marrow to make enough healthy blood cells, CLL patients often have lower than normal numbers of red blood cells (anaemia), white blood cells (neutropenia) and/ or platelets (thrombocytopenia). These changes lead to some of the common symptoms of CLL – which include fatigue, shortness of breath, pain, enlarged lymph nodes, infections, fever, unexplained weight loss and night sweats.

Scottish Medicines Consortium Recommendation

Following an assessment under its end of life and orphan medicine (rare disease) process, the SMC recommended the use of ibrutinib within NHS Scotland for a restricted indication.

The SMC accepted the use of ibrutinib for the treatment of: “patients with 17p deletion or TP53 mutation who are unsuitable for chemoimmunotherapy.”

However, as part of the guidance, the SMC did not recommend the use of ibrutinib for CLL patients “who have received at least one prior therapy” (but without the 17p deletion or TP53 mutation).

A copy of the advice is available here.

Zack Pemberton-Whiteley, Head of Campaigns and Advocacy at Leukaemia CARE commented:

“Whilst we welcome the SMC’s decision to accept ibrutinib for patients with 17p deletion or TP53 mutation (who are unsuitable for chemo-immunotherapy), we are extremely disappointed that ibrutinib was not accepted for its full licenced indication.

"This decision means that access will be limited for Scottish patients with previously treated disease without a 17p deletion/TP53 mutation. As made clear to the SMC in their Patient and Clinician Engagement (PACE) meeting, there is a significant unmet need in both groups of patients.

“Leukaemia CARE will continue working with the SMC and Janssen to ensure access for all patients in the future.”

For further information, please contact our Campaigns and Advocacy team. They are available Monday to Friday from 9:00am – 5:30pm. If you would like to contact them, you can:

·       Call our office line on 01905 755977

·       Send them an email

·       Call the CARE line, free of charge on 08088 010 444 anytime. They will pass your enquiry onto the Campaigns and Advocacy team.