The aim of this project, which was commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, was to review the submission of the pharmaceutical company on the evidence for the clinical and cost-effectiveness of Eluxadoline for treating irritable bowel syndrome with diarrhoea. The clinical evidence submitted by the company (Allergen) responsible for manufacturing Eluxadoline (Truberzi) consisted of one phase II and two phase III RCTs comparing Eluxadoline with placebo. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company.
After taking into consideration the company submission and the findings of the ERG’s critique, NICE released a technology appraisal guidance (TA471, August 2017). Eluxadoline is currently recommended as an option for treating irritable bowel syndrome with diarrhoea in adults only if (i) the condition has not responded to other pharmacological treatments (for example, antimotility agents, antispasmodics, tricyclic antidepressants), or (ii) pharmacological treatments are contraindicated or not tolerated, and (iii) it is started in secondary care.
Miriam Brazzelli; firstname.lastname@example.org
Cummins, E, Ayansina, D, Sharma, P, Fraser, C, Shimonovich, M, McLean, M, Brazzelli, M. Eluxadoline for treating irritable bowel syndrome with diarrhoea. Evidence Review Group report in support of NICE STA programme. University of Aberdeen: Health Services Research Unit; 2016 URL: https://www.nice.org.uk/guidance/ta471/documents/committee-papers-2
Published 30 August 2017: https://www.nice.org.uk/guidance/ta471