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  • Question on Document

    Has all of the relevant evidence been taken into account?

  • Question on Document

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

  • Question on Document

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

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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

Draft guidance consultation

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1 Recommendations

1.1

Histamine dihydrochloride with interleukin‑2 should not be used as maintenance treatment for acute myeloid leukaemia (AML) in first remission in adults.

1.2

This recommendation is not intended to affect treatment with histamine dihydrochloride with interleukin‑2 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 healthcare professional consider it appropriate to stop.

What this means in practice

These are NICE's draft recommendations. If these recommendations become final, histamine dihydrochloride with interleukin‑2 would not be required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that histamine dihydrochloride with interleukin‑2 offers benefit in this population.

Why the committee made these recommendations

People with AML that is in first remission may have a stem cell transplant. If they cannot or do not want to have a stem cell transplant, they can have oral azacitidine. Some people might have monitoring without treatment.

Clinical trial evidence suggests that histamine dihydrochloride with interleukin‑2 increases how long people have before their AML comes back compared with monitoring without treatment. But it is unclear whether people who have histamine dihydrochloride with interleukin‑2 live longer. The relevance of the clinical trial evidence is uncertain because the trial was done more than 20 years ago and does not reflect current clinical practice or the population seen in the NHS.

Histamine dihydrochloride with interleukin‑2 has not been directly compared in a clinical trial with oral azacitidine and indirect comparisons are highly uncertain.

Because of the uncertainties with the clinical evidence there are also uncertainties with the economic model. So it is not possible to determine the most likely cost-effectiveness estimates for histamine dihydrochloride with interleukin‑2.

So, histamine dihydrochloride with interleukin‑2 should not be used.