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 cost effectiveness 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 race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft guidance consultation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

Garadacimab should not be used to prevent recurrent attacks of hereditary angioedema in people 12 years and over.

1.2

This recommendation is not intended to affect treatment with garadacimab 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

Garadacimab is not required to be funded in the NHS in England to prevent recurrent attacks of hereditary angioedema in people 12 years and over. It should not be used routinely in the NHS in England.

This is because the available evidence does not suggest that garadacimab is value for money in this population.

Why the committee made these recommendations

Usual treatment for recurrent attacks of hereditary angioedema in people 12 years and over is long-term preventive treatment with berotralstat, C1-esterase inhibitors (C1‑INHs) or lanadelumab.

Clinical trial evidence shows that garadacimab reduces the number of hereditary angioedema attacks and increases the likelihood of freedom from attacks compared with placebo. Indirect comparisons suggest that garadacimab is clinically effective compared with berotralstat, C1‑INHs or lanadelumab.

There are uncertainties with some of the assumptions used in the economic model, including:

  • how usual treatment is used in NHS clinical practice, such as:

    • how well berotralstat works for people who continue treatment after 3 months

    • the timing and proportion of people switching to less-frequent lanadelumab dosing

  • how recurrent attacks of hereditary angioedema affect quality of life.

The cost-effectiveness estimates for garadacimab are also uncertain. But the most likely estimates are much higher than what NICE considers an acceptable use of NHS resources. So, garadacimab should not be used.