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    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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Draft guidance consultation

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1 Recommendations

1.1

Ivosidenib plus azacitidine is not recommended, within its marketing authorisation, for treating newly diagnosed acute myeloid leukaemia (AML) with an IDH1 R132 mutation in adults who cannot have standard intensive induction chemotherapy.

1.2

This recommendation is not intended to affect treatment with ivosidenib plus azacitidine 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

Usual treatment for newly diagnosed AML with an IDH1 R132 mutation in adults who cannot have standard intensive induction chemotherapy is venetoclax plus azacitidine.

Ivosidenib plus azacitidine has not been directly compared in a clinical trial with venetoclax plus azacitidine. It is not certain from an indirect comparison if ivosidenib plus azacitidine increases how long people live and how long they have before their condition gets worse compared with venetoclax plus azacitidine.

There are substantial uncertainties in the economic model, including around the modelling of long-term life expectancy.

Because of the uncertainties in both the economic model and the clinical evidence there is not enough evidence to determine if ivosidenib plus azacitidine is an acceptable use of NHS resources. So, it is not recommended.