NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome

NICE Highly Specialised Technology Evaluations

Published May 22nd, 2024

Detected March 12th, 2026

Summary

The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.

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What changed

NICE has issued final guidance (HST31) recommending setmelanotide (Imcivree) for the treatment of obesity and hyperphagia in individuals aged 6 years and older diagnosed with Bardet-Biedl syndrome, provided they are between 6 and 17 years old at the start of treatment. This guidance is based on a review of available evidence and includes information on commercial arrangements and patient access schemes.

Healthcare providers are expected to consider this guidance when making treatment decisions, in consultation with patients and their carers. Commissioners and providers have a responsibility to ensure funding is available for the recommended treatment. All adverse events related to the drug should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme.

What to do next

Review NICE guidance HST31 regarding setmelanotide for Bardet-Biedl syndrome.
Consult with patients and carers regarding treatment options for obesity and hyperphagia.
Report any adverse events associated with setmelanotide use to the MHRA Yellow Card Scheme.

Source document (simplified)

Setmelanotide for treating obesity and hyperphagia in Bardet-Biedl syndrome

Highly specialised technologies guidance
HST31
Published:

22 May 2024

Download guidance (PDF)

Overview

Evidence-based recommendations on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome in people 6 years and over, only if they are between 6 and 17 years when treatment starts.

Last reviewed: 22 May 2024

Next review: This guidance will be reviewed if there is new evidence that is likely to change the recommendations.

Commercial arrangement

There is a simple discount patient access scheme for setmelanotide. NHS organisations can get details on the Commercial Access and Pricing (CAP) Portal. Non-NHS organisations can contact PatientAccessScheme@rhythmtx.com for details.

Guidance development process

How we develop NICE highly specialised technologies guidance

Your responsibility

The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.

Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.

Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.