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Teduglutide for treating short bowel syndrome

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1 Recommendations

1.1 Teduglutide is recommended as an option for treating short bowel syndrome (SBS) only:

  • when it is started in children and young people aged 1 to 17

  • if the company provides teduglutide according to the commercial arrangement (see section 2).

People should be stable following a period of intestinal adaptation after surgery before having teduglutide.

1.2 The committee was minded not to recommend teduglutide as an option for treating SBS when it is started in people aged 18 and older. It recommends that NICE requests further clarification and analyses from the company, which should be made available for the second appraisal committee meeting, and should include:

  • an updated base case for adults that aligns dosing and administration assumptions for concomitant medications with NHS practice

  • scenario analyses considering different starting ages in the adult model, alongside justification for the starting age used

  • scenario analyses applying the placebo arm data from STEPS rather than assuming a steady state for those not on teduglutide.

1.3 These recommendations are not intended to affect treatment with teduglutide that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children and young people, this decision should be made jointly by them, their clinician and their parents or carers.

Why the committee made these recommendations

Current treatment for SBS is parenteral support (giving nutrients and fluids intravenously) with best supportive care. Best supportive care includes antimotility and antisecretory medicines, fluid restriction and diet changes.

Clinical trial evidence shows that teduglutide reduces the number of days a week people with SBS need parenteral support compared with placebo. However, how much it reduces this is uncertain because the trial design may not reflect NHS practice.

Because of the uncertainties in the clinical evidence, the cost-effectiveness estimates are uncertain. Also, none of the analyses reflect the committee's preferred assumptions. However, even when accounting for the uncertainties, the cost-effectiveness estimates when treatment is started in children are below what NICE normally considers an acceptable use of NHS resources. The cost-effectiveness estimates for treatment started in adults are likely to exceed an acceptable use of NHS resources. Therefore, teduglutide is recommended when it is started in children and young people aged 1 to 17, who can continue having it when they turn 18. The committee could not make a recommendation for teduglutide for SBS in adults, and requests further analyses from the company.