1 Recommendations

1.1 Venetoclax with azacitidine is recommended, within its marketing authorisation, as an option for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable. It is recommended only if the company provides venetoclax according to the commercial arrangement.

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 having venetoclax plus azacitidine live longer than people having azacitidine or low dose cytarabine alone.

Venetoclax with azacitidine meets NICE's criteria for a life-extending treatment at the end of life. The cost-effectiveness results are uncertain because it is not clear how many people who have venetoclax plus azacitidine might be considered cured. However, the likely cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources. Therefore, venetoclax plus azacitidine is recommended.

  • National Institute for Health and Care Excellence (NICE)