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New HTA Decisions in England
November 2019
Drug name
XEOMIN (Botulinum neurotoxin type A)
Company
Merz
Decision date
05/09/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Cerebral palsy
Decision
Recommended
Indication
Xeomin (botulinum neurotoxin type A) is recommended, within its marketing authorisation, as an option for treating chronic sialorrhoea caused by neurological conditions in adults.
Decision Detail
It is recommended only if the company provides it according to the commercial arrangement.
Summary
The main evidence for Xeomin came from SIAXI, a randomised placebo-controlled trial. The results showed a statistically significant decrease in salivary flow rate and increase in global impression of change score at 4 weeks compared with placebo. The evidence suggests that this does not improve quality of life. However, it seems that the benefit of Xeomin on quality of life might not have been fully captured in the trial because of the way that quality of life was assessed. The EQ‑5D‑3L may not fully capture the health-related quality-of-life gain associated with sialorrhoea and the health-related quality of life of carers is not considered in SIAXI and the economic model, this would increase QALY gains and lower the ICER. The committee concluded that the most appropriate ICER for decision making was the ERG's exploratory probabilistic ICER of £45,423 per QALY gained for Xeomin compared with standard care. Taking into account the unmeasured benefits in the evidence means that the cost-effectiveness estimates are within the range that NICE usually considers a cost-effective use of NHS resources. Therefore, Xeomin is recommended.