Scottish Government and NHS Scotland consensus statement on GLP-1-based therapies for obesity

A new consensus has been prepared by a multidisciplinary working group chaired by the Professional Adviser in the Diet and Healthy Weight Team of the Scottish Government and circulated to Health Board teams on 10 October 2024. The “Once for Scotland” advice is designed to inform the process of making injectable weight management drugs available and to prevent variation between Health Boards across Scotland. The consensus, available here, amends the earlier guidance on liraglutide (Saxenda®) and semaglutide (Wegovy®) use (previously in specialist weight management services only), and will also apply to tirzepatide (Mounjaro®), for which guidance was not previously in place.

The working group supports the guidance of the SMC on the clinical and cost effectiveness of injectable weight loss drugs, acknowledging that there will be challenges with delivery of this guidance for all three medications. It therefore recommends a phased introduction of these drugs across the new settings. However, it will be up to individual Health Boards across Scotland to decide how and when to implement the consensus, and which disease groups with BMI ≥38 kg/m² they will choose to prioritise.

It is understood that no Health Boards have resources and pathways in place currently; for example, Greater Glasgow & Clyde Health Board states on its website: “Prescribers are requested not to prescribe these drugs for weight management until an agreed pathway has been developed and implemented and they have been added to the NHSGGC Adult Medicines Formulary.” Diabetes & Primary Care will continue to share updates as they become available.

The consensus confirms: “Patients can be treated in any healthcare setting where evidence-based and appropriate lifestyle advice can be delivered” – including Tier 2 and Tier 3 weight management services, in primary and community care consistent with the long-term management of other associated medical conditions, and in secondary care as part of specialist treatment for associated conditions such as type 2 diabetes and chronic kidney disease.

The phased approach to implementing the guidance is as follows.

Phase 1

GLP-1 and GLP-1/GIP receptor agonists should be used as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight maintenance, in:

●  BMI ≥38 kg/m² (or ≥35 kg/m² in ethnic groups known to be at equivalent risk of obesity consequences at lower BMI than White ethnicity),

and

• one or more obesity-related clinical condition,
  or
  
• Edmonton Obesity Staging System stage 3 or 4 (see Box 1; Sharma and Kushner, 2009).

The consensus makes allowance for prescribing below this BMI level in situations where BMI is a requirement for essential treatment such as life-saving surgery or infertility treatment. This should be discussed and approved via Health Board medicines access routes for non-formulary processes.

There is an extensive list of obesity-related clinical conditions included in the consensus, as listed in Box 2.

Phases 2 and 3

No timescale has yet been set for Phase 2 or 3 implementation across Scotland, which will allow prescribing in those with BMI ≥35 kg/m² (32 kg/m² in ethnic groups) and BMI ≥30 kg/m² (27 kg/m² in ethnic groups), respectively, alongside one or more obesity-related clinical condition.

Discussion

This approach differs significantly from that in England and Wales, where, in advance of the publication of the NICE Technology Appraisal on Mounjaro for weight management (expected on 19 December 2024), the UK Government has submitted a funding variation request to amend the usual 3-month rollout of a Technology Appraisal to a staged rollout over 12 years. This proposes a 6-month implementation phase, followed by rollout over 3 years to 220 000 people, specifically those with BMI ≥40 kg/m² and three or more weight-related comorbidities, followed by those with the same BMI and two and one weight-related comorbidities, respectively. There will be a narrower range of qualifying comorbidities than in the Scottish guidance (hypertension, dyslipidaemia, obstructive sleep apnoea and cardiovascular disease, with type 2 diabetes qualifying as a comorbidity in later cohorts). The funding variation request can be found under the project documents in the NICE Guideline in Development:

• Funding variation request
• Implementation proposal

Eli Lilly, the manufacturer of tirzepatide, has entered into a partnership with the UK Government to trial “innovative approaches to treating obesity as part of a rounded package of care”, according to the company’s website. A key part of this will be the SURMOUNT-Real UK study, which will look at the effects of tirzepatide in a primary care setting on weight loss, prevention of obesity-related conditions, health-related quality of life, and changes in employment status and sick day absences, compared with usual care over 5 years. The planned study will be led by Professor Martin Rutter and run in partnership with Health Innovation Manchester and the University of Manchester, subject to relevant approvals for the study.