1.1 Venetoclax monotherapy is recommended, within its marketing authorisation, for treating chronic lymphocytic leukaemia (CLL) in adults:
with a 17p deletion or TP53 mutation and when a B‑cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B‑cell receptor pathway inhibitor or
without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo‑immunotherapy and a B‑cell receptor pathway inhibitor.
It is recommended only if the company provides venetoclax according to the commercial arrangement.
Why the committee made these recommendations
People with CLL for whom venetoclax monotherapy would be an option would otherwise usually have best supportive care. This includes rituximab and high-dose methylprednisolone.
The new evidence is mainly data collected from the Systemic Anti-Cancer Therapy (SACT) database from people having treatment in the NHS, while venetoclax was available in the Cancer Drugs Fund in England. The benefit of venetoclax is uncertain because the original trials did not compare it with best supportive care, and no SACT data could be collected on best supportive care.
Venetoclax meets NICE's criteria to be considered a life-extending treatment at the end of life. The cost‑effectiveness estimates are around the range that NICE considers to be an acceptable use of NHS resources for end of life treatments. Venetoclax also fulfils an unmet need and is a valued treatment option. Therefore, it is recommended.