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NICE(UK) positive for Dawnzera (donidalorsen) for preventing recurrent attacks of hereditary angioedema in people 12 years and over – Otsuka

Written by | 30 Aug 2026 | Allergy & Immunology

NICE(UK):
Donidalorsen can be used as an option to prevent recurrent attacks of hereditary angioedema (HAE) in people 12 years and over
, only if: i) they have 2 or more attacks a month, and ii) the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with donidalorsen that was started in the NHS before this guidance was published.

Why the committee made these recommendations: Usual treatment to prevent recurrent attacks of HAE includes berotralstat, C1‑esterase inhibitors, garadacimab and lanadelumab. Evidence from a clinical trial shows that donidalorsen reduces the rate of HAE attacks compared with placebo. It has not been directly compared with any of the usual treatments. The evidence from indirect comparisons is uncertain but suggests that donidalorsen is likely to work as well as: i) berotralstat; ii) C1‑esterase inhibitors; iii) lanadelumab taken every 4 weeks; iv) garadacimab. The results from the cost-effectiveness analyses suggest that donidalorsen is cost effective when compared with berotralstat, C1‑esterase inhibitors and lanadelumab. Garadacimab is thought to be the most relevant comparison. The results suggest that the health-related quality of life of people having donidalorsen is similar to that of people having garadacimab. Also, donidalorsen results in similar or lower lifetime costs compared to garadacimab.
So, it can be used.

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