National Collaborating Centre for Women's and Children's Health

Botulinum toxin
Chapter 11). The GDG agreed that assessment would be performed by a consultant. An NHS
reference cost was used for the outpatient visits for the injection as BoNT is a high-cost drug. The
reference cost for 2010–11 was £321. There is also a specialist uplift to tariffs for children of 60%;
applying this increases the cost to £514. The reference cost includes all costs related to the
procedure, the day–case admission, drug costs and staff costs. It was assumed that assessment and
follow-up would incur additional costs.
The analysis presented a baseline cost for a child or young person having two sets of injections in 1
year with only one follow-up assessment (£2,000 per child or young person). The costs would
increase if more repeat injections were given in 1 year, and with the increased likelihood of adverse
events.
It is important to consider costs alongside the benefits of treatment. The clinical evidence for this
review question was limited and there was no conclusive evidence to show BoNT would increase
function or reduce pain, which would be the most useful outcomes for developing an economic
analysis. Therefore, the analysis was presented using the NICE cost effectiveness threshold to
determine the levels of effectiveness the treatment would need to offer in terms of reduction in pain or
discomfort, improvements with self care, improvements performing their usual activities or,
conversely, prevention of deterioration in self care or usual activities. Although no cost effectiveness
results could be reported for this review question, the analysis presented a framework to allow the
GDG to decide when to recommend BoNT injections as beneficial (further details of this analysis are
presented in Chapter 11).
The GDG considered the effectiveness of casting after BoNT treatment as part of the physical therapy
review question (see Chapter 4). There was limited clinical evidence of low quality which reported a
statistically significant reduction in spasticity in children who received casting immediately after BoNT
treatment compared with those who received casting 4 weeks after BoNT treatment. However, 50% of
children who had casting immediately after injection experienced pain and required a change of cast
within 48 hours.
The clinical evidence for serial casting compared with no casting identified that there was no
statistically significant difference in walking speed between the two treatment groups. A statistically
significant improvement in PROM for ankle dorsiflexion (knee flexed) was reported, but the difference
was not significant for ankle dorsiflexion (knee extended).
It is difficult to consider the cost effectiveness of casting in addition to BoNT treatment based on the
available clinical evidence. There is considerable uncertainty around its effectiveness compared with
no casting. If casting was found to be effective, then the timing of casting would be another
consideration with resource implications, including whether or not an additional appointment would be
needed for a cast to be performed after BoNT treatment, or if casting performed immediately after
BoNT treatment might need to be replaced due to pain. Further research relating to these issues is
needed, and such research should consider resource use.
Evidence to recommendations
Relative value placed on the outcomes considered
The GDG believed that the pharmacological activity of BoNT was unlikely to extend beyond 4 months,
and for that reason the group was primarily interested in examining outcomes measured within that
time interval. However, outcomes observed after 4 months were also considered in order to examine
any potential carry-over effect.
The group also felt that AROM was more informative than PROM because AROM can be a reflection
of muscle strength (an outcome not described in the literature) and functional ability. A small but
measurable improvement in AROM (that is, a change of 5–10 degrees) may have an effect on a child
or young person’s ability to control upper limb movement and function. The GDG believed that PROM
might have a part to play in the ability of a child or young person to reach for objects effectively and in
better lower limb posture when standing and walking. However, the group’s view was that strength
remains key to improved functional ability.
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