Garadacimab can be used as an option to prevent recurrent attacks of hereditary angioedema in people 12 years and over, only if:
they have 2 or more attacks a month, and
the company provides garadacimab according to the commercial arrangement.
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 must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Garadacimab must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that garadacimab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
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's clinical effectiveness is the same or better than berotralstat, C1‑INHs or lanadelumab.
The most likely cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources. So, garadacimab can be used as an option to prevent recurrent attacks of hereditary angioedema in people 12 years and over having 2 or more attacks a month.