Racecadotril is licensed for the complementary symptomatic treatment of acute diarrhoea in infants (aged over 3 months) and in children together with oral rehydration and the usual support measures (dietary advice and increased daily fluid intake [Abbott Healthcare Products Limited: personal communication January 2013]), when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible. If causal treatment is possible, racecadotril can be administered as a complementary treatment (see the summaries of product characteristics for infants and children).
Although racecadotril plus ORS solution improves recovery rate and reduces the duration of diarrhoea and the volume and frequency of stool output more than ORS solution alone or with placebo, it is unclear where it fits within current UK practice. The majority of children in the UK recover from acute diarrhoea without treatment or by using ORS solution alone and it is unclear when or whether adjunctive therapy is necessary. It is also unclear whether the benefits of racecadotril are sufficiently clinically important to warrant the additional cost.
In 2009, the Guideline Development Group for the NICE clinical guideline on diarrhoea and vomiting in children under 5 concluded there was evidence that racecadotril had an antidiarrhoeal effect but further research was needed to examine the possible clinical and health economic benefits that might be associated with its use in the UK. In 2012, a cost–utility analysis (Rautenberg et al. 2012) was published that considers the cost effectiveness of racecadotril for acute diarrhoea in children from a UK perspective. This has not been evaluated here because cost-effectiveness is excluded from the scope for Evidence Summaries: new medicines.
In December 2012, the Scottish Medicines Consortium did not recommend racecadotril for use in children in NHS Scotland. Having considered 3 studies undertaken in Europe (which were included in the meta-analysis discussed in this evidence summary) it concluded that the clinical and economic analysis presented by Abbott Healthcare Products Limited was not sufficiently robust to gain acceptance. The company has indicated their intention to resubmit.
Local decision makers will need to consider the available evidence when making decisions about using racecadotril.
It is not possible to provide estimated usage based on the available data.
Between November 2011 and October 2012, more than 60,000 items of loperamide oral solution and orodispersible tablets were prescribed in primary care in England, at a cost of over £655,000. Over the same period, almost 548,000 items of ORS solution were prescribed at a cost of almost £2.7 million (NHS Business Services Authority: personal communication January 2013).