1 Recommendations

1 Recommendations

1.1 Venetoclax with low dose cytarabine is recommended as an option for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable, only if:

  • they have over 30% bone marrow blasts

  • the company provides venetoclax according to the commercial arrangement.

1.2 This is not intended to affect treatment with venetoclax with low dose cytarabine that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

When intensive chemotherapy is unsuitable, treatment for untreated acute myeloid leukaemia is usually azacitidine or low dose cytarabine. The clinical trial evidence shows that people with untreated acute myeloid leukaemia with over 30% bone marrow blasts (from here, blasts) having venetoclax plus low dose cytarabine live longer than people having low dose cytarabine alone. The company did not submit any evidence for the 20% to 30% blast group.

Venetoclax plus low dose cytarabine meets NICE's criteria for a life-extending treatment at the end of life. The likely cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources. Therefore, for people with untreated acute myeloid leukaemia with over 30% blasts, venetoclax plus low dose cytarabine is recommended.

  • National Institute for Health and Care Excellence (NICE)