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New HTA Decisions in England
November 2019
Drug name
TAKHZYRO® (lanadelumab)
Company
Shire
Decision date
18/09/2019
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Allergies
Decision
Recommended with restrictions
Indication
Lanadelumab is recommended as an option for preventing recurrent attacks of hereditary angioedema in people aged 12 and older
Decision Detail
only if: - they are eligible for preventive C1-esterase inhibitor (C1-INH) treatment in line with NHS England's commissioning policy, that is, they are having 2 or more clinically significant attacks (as defined in the policy) per week over 8 weeks despite oral preventive therapy, or oral therapy is contraindicated or not tolerated - the lowest dosing frequency of lanadelumab is used in line with the summary of product characteristics, that is, when the condition is in a stable, attack-free phase (see section 2) and - the company provides lanadelumab according to the commercial arrangement.
Summary
The clinical evidence for lanadelumab came from HELP-03, a phase III randomised controlled trial. Results from HELP-03 showed that both the high and low lanadelumab dosing frequencies statistically significantly reduced mean monthly attack rates compared with placebo, by 87% and 73% respectively (p<0.001). The company's indirect treatment comparison produced very similar results for lanadelumab compared with placebo. It also showed that both dosing frequencies of lanadelumab had lower mean attack rates than a C1-INH (exact data are confidential so cannot be reported here). The committee concluded that lanadelumab is clinically effective compared with C1-INHs. The committee firstly considered cost-effectiveness estimates for lanadelumab compared with C1-INHs for the full HELP-03 population. It noted that most estimates from the company's plausible scenario analyses were lower than £20,000 per quality-adjusted life year (QALY) gained after including the confidential price discounts for C1-INHs (exact incremental cost-effectiveness ratios [ICERs] are confidential and cannot be reported here). Secondly, the committee considered all cost-effectiveness estimates for lanadelumab compared with C1-INHs for the subgroup from HELP-03 with at least 8 attacks in the last 4 weeks at baseline (that is, the population eligible for C1-INHs in NHS England's commissioning policy). It noted that estimates from the company's plausible scenario analyses were lower than £20,000 per QALY gained after including the confidential price discounts for C1-INHs (exact ICERs are confidential and cannot be reported here). The committee reiterated the uncertainty in all cost-effectiveness estimates.