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Diabetes Distilled: NICE guidance on tirzepatide for weight management

Pam Brown
The NICE TA1026 Technology Appraisal Tirzepatide for managing overweight and obesity, published in December 2024, recommends tirzepatide use alongside a reduced-calorie diet and increased physical activity for adults with an initial BMI of at least 35 kg/m2 and at least one weight-related comorbidity. Reduction of the BMI threshold by 2.5 kg/m2 is recommended for those from South Asian, Chinese, other Asian, Middle Eastern, Black African or African–Caribbean ethnic backgrounds. Initiation can occur in primary care or specialist weight management settings, and treatment can continue long-term and is not limited to 2 years’ use, although a clinical decision on whether to continue treatment should be made in those who have not lost at least 5% of baseline weight after 6 months’ treatment with the highest tolerated dose. A funding variation request by NHS England has proposed a phased implementation of the guidance over as many as 12 years, due to concerns regarding budget impact and lack of services to safely and equitably implement the Technology Appraisal. NICE has tasked NHS England with developing guidance for Integrated Care Boards on initial prioritisation, taking into account clinical need, and this is expected imminently. NICE will revisit implementation after 3 years and guide on further implementation. Differences in NHS accessibility across the UK nations may occur.

NICE has previously incorporated prescribing of GLP-1 receptor agonists for people with type 2 diabetes in its guidelines, and in 2023 it published a Technology Appraisal on the use of tirzepatide for type 2 diabetes (NICE, 2023).

For obesity and weight management, at present the GLP-1 RAs liraglutide and semaglutide are only available for NHS prescribing in specialist Tier/Level 3 and 4 weight management services, where they should be provided alongside guidance on a reduced-calorie diet and increased physical activity. Not all areas of the UK have such services, and many lack capacity to manage those who meet the criteria for referral, creating inequality of access (Boyle et al, 2023). Liraglutide, semaglutide and tirzepatide for treatment of obesity are also widely available privately across the UK, with variable levels of behaviour change and lifestyle guidance and support. This means that those who can afford to purchase these drugs and services privately have had increased access to them.

In summer 2024, the SMC approved the use of all three of these drugs for weight management in primary care and other NHS settings in Scotland, with implementation based on BMI and weight-related comorbidities (see our Around the Nations article for more information). Roll-out of this guidance across Health Boards is awaited.

NICE tirzepatide technology appraisal

The long-awaited NICE Technology Appraisal, Tirzepatide for managing overweight and obesity [TA1026], was published on 23 December 2024 and recommends tirzepatide 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 BMI of at least 35 kg/m2, and:
  • at least one weight-related comorbidity.

A lower BMI threshold (usually reduced by 2.5 kg/m2) is recommended for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African–Caribbean ethnic backgrounds.

Importantly, NICE recommends that tirzepatide can be used in primary care or in specialist weight management services.

NICE accepts that obesity is a life-long, chronic condition; therefore, tirzepatide prescribing is not limited to 2 years’ use, as with previous recommendations for liraglutide and semaglutide. Clinicians should, however, decide whether to continue treatment, taking into account the risks and benefits, if less than 5% of initial weight has been lost after 6 months on the highest tolerated dose of tirzepatide.

Based on clinical trial evidence, NICE concluded that tirzepatide plus support with diet and exercise is more effective than diet and exercise support alone, and also that, based on indirect comparisons, tirzepatide is more effective for weight loss than semaglutide, both used with diet and exercise support.

Cost-effectiveness of tirzepatide for weight management

Discussions throughout the development of the guidance explored assumptions to incorporate in the models used to estimate the cost-effectiveness of tirzepatide plus diet and exercise versus other options for weight management.

Although the company manufacturing tirzepatide proposed that tirzepatide could be used for adults with a BMI of at least 30 kg/m2 and at least one weight-related comorbidity, the NICE expert advisory group identified that the likely cost-effectiveness estimates for this group are above the range that NICE considers appropriate use of NHS resources. The estimated cost-effectiveness for the group with a BMI of at least 35 kg/m2 and at least one weight-related comorbidity was deemed more acceptable, hence the current recommendations.

Time period for implementation

Normally, the time period for implementation of a NICE Technology Appraisal by ICBs, NHS England and the public health function in Local Authorities is 3 months. However, NHS England submitted a funding variation request to extend this period to up to 12 years, based on lack of availability of weight management services and clinical capacity, likely inequity of access and budget impacts.

NICE has estimated that the total population who may be eligible to receive tirzepatide for weight management is 3.4 million people; it therefore accepts the need to prioritise the implementation. It expects that at least 220 000 people in England will be eligible for NHS-funded treatment in the first 3 years.

NICE recommends mandated funding of tirzepatide for people attending NHS specialist weight management services within 3 months of publication of the final guidance, with phased introduction from 6 months of publication for other cohorts, in line with NHS England’s interim commissioning policy, since NICE accepts that it will take time to establish effective services in primary care.

NHS England originally recommended prioritisation based on BMI and the number of comorbidities (discussed previously in Around the Nations) but, following discussion, NICE recommended a modified approach to clinical prioritisation that is more closely aligned with expert opinion, and based on clinical need, such as that proposed in the joint position statement of the Society for Endocrinology and the Obesity Management Collaborative UK (Boyle et al, 2023).

Within 4 weeks of the publication of the Technology Appraisal, NHS England will therefore develop an interim commissioning policy on tirzepatide to guide implementation across England, providing guidance on prioritisation cohorts based on clinical need.

Implications for practice

There is likely to be significant differences in the roll-out of tirzepatide in primary care across the UK nations. In Scotland, tirzepatide, semaglutide and liraglutide for weight management are already approved by the SMC for use in primary and secondary care, with clinicians awaiting guidance from their individual Health Boards on how this guidance should be implemented.

In Wales, the current All-Wales Weight Management Pathway recommends that injectable weight management medications only be prescribed within a specialist service (Level 3 or 4) in combination with a behavioural lifestyle intervention including a reduced-calorie diet and increased physical activity. Tirzepatide will be available for use within these specialist services immediately, should Local Health Boards wish to use it. Further work is to be undertaken to decide whether it is appropriate for tirzepatide to be made available through other arrangements and what those arrangements will be. Welsh Ministers will make a decision on any extended use of tirzepatide and, once it has been agreed “when, how and whether” tirzepatide is to be made available outside specialist services, they will write to NICE outlining these arrangements.

After months of uncertainty and increasing demand from patients for NHS access to tirzepatide, it will be reassuring to primary care clinicians that we will not immediately be expected to act as gatekeepers or to prescribe tirzepatide at scale, but it is likely that we will continue to face many difficult and time-consuming consultations sharing this guidance and its implications. The publication of the new NICE guideline on the management of overweight and obesity has been delayed and is now expected later in January 2025.

This is an important time for primary care teams to upskill on weight management and to identify those within their practices who will be in the early cohorts qualifying for tirzepatide.

REFERENCES:

Boyle LD, Albor C, Anyiam O et al (2023) Guidance for the phased introduction of new medical therapies for weight management: A joint position statement by the Society for Endocrinology and Obesity Management Collaborative UK. Available at: https://bit.ly/3BOUPz4

NICE (2023) Tirzepatide for treating type 2 diabetes [TA924]. Available at: https://www.nice.org.uk/guidance/ta924

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