The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Eli Lilly’s tirzepatide (MOUNJARO ®▼) as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity, in adults with an initial Body Mass Index (BMI) of at least 35 kg/m2, and at least one weight-related comorbidity.
Lower BMI thresholds can be used for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds.i If less than 5% of the initial weight has been lost after 6 months on the highest tolerated dose, the prescriber should decide whether to continue treatment, taking into account the benefits and risks of treatment for the person.
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonistii and has previously received a NICE recommendation for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.iii
The final guidance is expected to be published on 23rd December 2024 after a period for stakeholders to appeal and to highlight factual inaccuracies.
NHS England requested a funding variation to extend the time needed to comply with NICE’s recommendations. NICE has made amendments and clarifications to NHS England’s implementation proposals, including that the funding variation must ensure tirzepatide is delivered to the estimated full eligible population of 3.4 million people within 12 years. NICE also recommends an initial implementation period of up to 3 years where it is expected that at least 220,000 people will be eligible for tirzepatide. NICE will conduct a formal review of evidence generated during the initial implementation period which could shorten the total guidance implementation timeframe of 12 years. NICE recommends mandated funding of tirzepatide within 3 months from final guidance publication for patients accessing specialist weight management services, and within 6 months of final guidance publication for a phased introduction of delivery to other eligible cohortsi.
Fernando Campo, Vice President and Head of Diabetes and Obesity, Lilly Northern Europe said: “Obesity is a public health epidemic and is a causal factor of many major chronic health conditions. We welcome the recommendation from NICE to make tirzepatide available to the estimated eligible population of 3.4 million people, and we understand that this will require a phased rollout. However the recommended timeline still means that fewer than one in 10 of these eligible patients will be able to access treatment within the first three years. We look forward to working with NHS England to ensure we can best meet the current unmet need of people living with obesity and deliver on the Government’s obesity goals.”
References
i NICE (2024). Tirzepatide for managing overweight and obesity. Final Draft Guidance. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11156 [Accessed December 2024].
ii Mounjaro (tirzepatide) KwikPen 10mg solution for injection in pre-filled pen – Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/15482/smpc [Accessed December 2024]
iii NICE (2023). Tirzepatide for treating type 2 diabetes. Available at: https://www.nice.org.uk/guidance/ta924/chapter/information-about-tirzepatide [Accessed December 2024]
