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Lanadelumab for preventing recurrent attacks of hereditary angioedema [ID1268]

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1 Recommendations

1.1 Lanadelumab is not recommended, within its marketing authorisation, for routine prevention of recurrent attacks of hereditary angioedema in people aged 12 years and older.

1.2 This recommendation is not intended to affect treatment with lanadelumab 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 clinician consider it appropriate to stop. This decision should be made jointly by the clinician and the young person and/or the young person's parents or carers.

Why the committee made these recommendations

People with hereditary angioedema experience attacks which are often unpredictable and lead to swellings in various locations on the body. Although its marketing authorisation covers the full treatment pathway, the company positioned lanadelumab for the population currently eligible for long-term prophylactic C1-INH in the current NHS England commissioning policy. C1-INH is the most appropriate comparator for the company's proposed positioning.

Evidence from a randomised controlled trial comparing lanadelumab with placebo with short follow up suggests that people having lanadelumab have fewer hereditary angioedema attacks compared with placebo. There are no data directly comparing lanadelumab with C1-INH therefore a small cross-over trial comparing Cinryze (a C1-INH) with placebo was used to estimate the relative effectiveness of lanadelumab and C1-INH indirectly.

Lanadelumab does not meet NICE's criteria to be considered a life-extending treatment at the end of life. In line with its summary of product characteristics, a lower dosing frequency of lanadelumab (once every 4 weeks) could be used if disease is stably attack-free, but there is currently no evidence that includes switching to this lower dosing frequency and this has a large impact on the cost-effectiveness estimates. Similarly, the dose per administration, and therefore the cost, of C1-INH has a large impact on the estimates of cost effectiveness, and it is unclear what dose of Berinert (a C1-INH) is used in clinical practice. Furthermore, the discounted price of C1-INH treatments paid by the NHS is not currently included in the cost-effectiveness results. Therefore, all estimates of cost effectiveness for lanadelumab compared with C1-INH are highly uncertain. Because some cost-effectiveness estimates that were considered clinically plausible are substantially higher than what NICE normally considers an acceptable use of NHS resources, lanadelumab cannot be recommended for routine use in the NHS.