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Venetoclax with a hypomethylating agent for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable

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1 Recommendations

1.1 The committee recognised that venetoclax plus azacitidine is a promising new treatment, but was not persuaded that there is sufficient evidence of clinical and cost effectiveness to recommend it for routine commissioning for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable.

1.2 Given the uncertainties, the committee considered that venetoclax plus azacitidine may be suitable for use in the Cancer Drugs Fund. Therefore the company is invited to submit a proposal for including venetoclax plus azacitidine in the Cancer Drugs Fund for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable.

1.3 The Cancer Drugs Fund proposal should:

  • detail any commercial access arrangements

  • show plausible potential for cost effectiveness

  • explain how data collection will address the main clinical uncertainties described in section 3

  • state the likelihood that additional research will reduce uncertainty enough to support positive guidance in the future

  • state how data will be collected and what data is currently available

  • state when the results will be available.

If appropriate data is already being collected, summarise the study protocol.

Why the committee made these recommendations

When intensive chemotherapy is unsuitable, active 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 whether people who have venetoclax plus azacitidine are cured if their disease remains in remission for a certain amount of time, or what this time period might be. Also, the dose of venetoclax used to work out the cost-effectiveness estimates was different to that used in clinical practice, which makes the results more uncertain. Some of the likely cost-effectiveness estimates are higher than is normally considered a cost-effective use of NHS resources. Therefore, venetoclax plus azacitidine is not recommended for routine use in the NHS. However, it could be suitable for use in the Cancer Drugs Fund, if the company puts forward a proposal.