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  • Question on Consultation

    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?
  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
  • Question on Consultation

    There is a requirement for relevant health bodies to comply with the recommendations in this evaluation within 3 months of the date final guidance is published by NICE (see section 4.1). We are aware there may be system challenges that mean an extension to this normal period may be appropriate because tirzepatide cannot be appropriately administered until:
    • training is in place
    • certain health service infrastructure requirements including goods, materials or other facilities are in place
    • other appropriate health services resources, including staff, are in place. These challenges may include:
    • commissioning arrangements for weight management services
    • how tirzepatide will fit into the current treatment pathway for weight management
    • the provision of counselling, psychological support and concomitant behavioural, dietary and physical activity advice
    • titration of tirzepatide and how a stopping rule based on treatment response at 6 months would be implemented
    • capacity in the system.
  • Question on Consultation

    Please specify any potential challenges with implementing these recommendations and the associated reasons.
  • Question on Consultation

    Please also provide any ways to overcome these potential challenges, any estimate of the time period within which the recommendation can be complied with, and any approaches to phase in funding to manage access to tirzepatide during any potential extended funding variation period.
The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1

Tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity, in adults, only if they have:

  • an initial body mass index (BMI) of at least 35 kg/m2 and

  • at least 1 weight-related comorbidity.

Use lower BMI thresholds (usually reduced by 2.5 kg/m2) for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds.

1.2

Consider stopping tirzepatide if less than 5% of the initial weight has been lost after 6 months of treatment.

1.3

These recommendations are not intended to affect treatment with tirzepatide 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 healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

Managing overweight and obesity in adults includes diet and exercise support in primary care, but the level of support available varies. Some people may also have semaglutide alongside diet and exercise support if their obesity is managed in a specialist weight management service.

Clinical trial evidence suggests that tirzepatide with diet and exercise support is more effective compared with diet and exercise support alone. Indirect comparisons suggest it is more effective compared with semaglutide alongside diet and exercise support.

The company proposed that tirzepatide could be used for people with a BMI of at least 30 kg/m2 and at least 1 weight-related comorbidity. But, the most likely cost-effectiveness estimates for this group are above the range that NICE considers an acceptable use of NHS resources. So, tirzepatide cannot be recommended for this group. The most likely cost-effectiveness estimates for people with an initial BMI of at least 35 kg/m2 and at least 1 weight-related comorbidity are within the range that NICE considers an acceptable use of NHS resources. So, tirzepatide is recommended for this group.