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    Has all of the relevant evidence been taken into account?

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1 Recommendations

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1 Recommendations

1.1

Zuranolone should not be used to treat postnatal depression in adults.

1.2

This recommendation is not intended to affect treatment with zuranolone 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

Zuranolone is not 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 there is not enough evidence to determine whether zuranolone is value for money in this population.

Why the committee made these recommendations

Usual treatment foris established clinical management. This includes antidepressant medicines, high-intensity psychological interventions (such as cognitive behavioural therapy) or both.

Clinical trial evidence suggests that, compared with placebo, zuranolone decreases the number of depressive symptoms. But this is uncertain because:

  • the data was not collected over a long enough period, so the long-term benefit of zuranolone is uncertain

  • there were differences in the populations of the trials from what would be expected in NHS practice

  • established clinical management in the trials was different from what is offered in the NHS.

There is uncertainty in the economic model about:

  • how long the benefit from treatment with zuranolone lasts

  • how postnatal depression affects long-term quality of life

  • to what extent other antidepressant use affects how well zuranolone works.

Because of the uncertainties in the clinical evidence and economic model, it is not possible to determine the most likely cost-effectiveness estimates for zuranolone. So, it should not be used.