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New HTA Decisions in Scotland
June 2020
Drug name
XEOMIN® (clostridium botulinum neurotoxin type A)
Company
Merz Pharma UK Ltd
Decision date
11/11/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Neurological conditions: general and other
Decision
Recommended
Indication
For the symptomatic treatment of chronic sialorrhoea due to neurological disorders in adults.
Decision Detail
Following a full submission, clostridium botulinum neurotoxin type A (Xeomin®) is accepted for use within NHS Scotland.
Summary
Sialorrhoea in Adults Xeomin® Investigation (SIAXI) was a randomised, double-blind, placebo-controlled, international (two countries), multicentre, parallel-group study to evaluate the efficacy and safety of clostridium botulinum neurotoxin type A for the treatment of sialorrhoea due to Parkinson’s disease, atypical parkinsonism, stroke, or traumatic brain injury. The study included adult patients with chronic troublesome sialorrhoea continuously for ≥3 months prior to screening, as assessed on the Drooling Severity and Frequency Scale (DSFS) sum score (patients required a score ≥6 points, range 2 to 9 with higher score indicating greater severity) and modified Radboud Oral Motor Inventory for Parkinson’s disease (mROMP). Clostridium botulinum neurotoxin type A improved unstimulated saliva flow rate and the Global Impression of Change Scale compared with placebo. The submitting company presented a cost-utility analysis (CUA) comparing clostridium botulinum neurotoxin type A plus standard of care (SoC) to glycopyrronium bromide plus SoC and to SoC alone for the treatment of adult patients with chronic sialorrhoea due to neurological conditions. SoC was stated to include the use of bibs alongside speech and occupational therapy. SMC clinical experts mentioned there could be some displacement of glycopyrronium bromide, but also potentially transdermal hyoscine hydrobromide patch and sublingual atropine sulphate as first line treatments. A comparison with the latter two treatments was performed as a scenario analysis. There were a number of issues in the economic analysis including a lack of evidence of relative effectiveness meaning benefit estimations were not clear, uncertainty over the health state utility estimates used in the economic analyses, and concerns that the relative long-term outcomes for clostridium botulinum neurotoxin type A versus SoC may be overestimated given the way the transition probabilities were calculated and an assumption of no treatment waning effects being used. Despite these limitations, the economic case was considered demonstrated.