How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and resource savings reasonable interpretations of the evidence?

  • Question on Consultation

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

  • Question on Consultation

    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?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft guidance consultation

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

1.1

Sebetralstat should not be used to treat hereditary angioedema attacks in people 12 years and over.

1.2

This recommendation is not intended to affect treatment with sebetralstat 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. For young people, this decision should be made jointly by the healthcare professional, the young person and their parents or carers.

What this means in practice

Sebetralstat 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 sebetralstat is value for money in this population.

Why the committee made these recommendations

Usual treatment of acute hereditary angioedema attacks in people 12 years and over includes icatibant or a C1‑esterase inhibitor (C1‑INH) such as Berinert, Cinryze or Ruconest.

Clinical trial evidence shows that symptom relief starts sooner and attacks end faster with sebetralstat than with placebo. An indirect comparison suggests that sebetralstat may work as well as Ruconest. But these results are uncertain. This is because there are differences between the sebetralstat and Ruconest trials, and the indirect comparison only looked at time to the start of symptom relief. There is no evidence on how well sebetralstat works compared with Berinert, Cinryze or icatibant.

There are uncertainties with the economic model, including:

  • a lack of evidence on how long it takes for an attack to end with sebetralstat compared with usual treatment

  • the analyses used to estimate treatment effects for sebetralstat and usual treatment.

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