New weight loss treatment to be rolled out for people with highest clinical needs
The National Institute for Health and Care Excellence (NICE) has detailed plans for newly available treatment tirzepatide.
A new treatment to help people lose weight and reduce the risk of developing related health complications will be available over the next years.
Tirzepatide will be recommended by NICE for people with a body mass index of more than 35 and at least one weight-related illness.
The licence for tirzepatide lists examples of weight related illnesses for which the drug should be considered such as hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes.
Final draft guidance from NICE has outlined that around a quarter of a million people living with obesity will be offered the weight loss treatment over the next three years, alongside a reduced-calorie diet and increased physical activity.
NICE said that as this accounts for a very large number of people (around 3.4 million in England), the roll out of tirzepatide has to be carefully managed to ensure healthcare professionals can continue to meet the full range of health needs of all their patients.
At first, only those with the highest clinical need will be prioritised to receive the medication while the NHS tests a variety of new services to care for people living with obesity.
Following a consultation held in October on NHS England’s request to roll out the medication over 12 years, NICE has published its guidance on the way forward.
This includes prioritising people who are already receiving care in specialist weight management services who will be able to access tirzepatide within 90 days of NICE's final guidance being published if clinically eligible.
NHS England will develop a plan detailing which other groups of patients will be offered tirzepatide in the next 3 years.
NHS England plan to publish their interim commissioning guidance early next year, and those patients with the highest clinical need, outside of specialist weight management services, will start to be offered tirzepatide from 180 days after NICE final guidance is published. In total around 220,000 people are expected to benefit in this initial three year roll out period.
During this time evidence will be generated to understand the most effective forms of care, and this will inform a NICE re-evaluation of the remaining roll out period to the wider group of eligible patients.
Professor Jonathan Benger, NICE’s chief medical officer, said: “The world will look very different in three years which is why we have taken the unprecedented decision to review the way this medicine is delivered to patients then.
“Tirzepatide and other drugs like it, such as semaglutide, will help people living with obesity to lose weight, and as a result will reduce their risk of developing heart disease or having a stroke.”
He added: “But tirzepatide is not for everybody, and only those with the highest clinical need will be treated initially. This means many people will have to wait. We have had to make this difficult decision in order to protect other vital NHS services and also to test ways of delivering this new generation of weight loss medications.
“We want to help NHS England carefully manage the roll out of tirzepatide to ensure that other services are not impacted in a disproportionate way. Whilst the funding variation sets a maximum of 12 years, NICE will review the situation again within 3 years and provide further advice on how the roll out of this medicine can be managed using the learning gained from the initial phase.
“This will ensure the roll out of tirzepatide reaches everyone who is eligible in a safe and effective way.”
Tirzepatide (also known as Mounjaro and made by Eli Lilly) has been shown in clinical trials to be more effective than diet and exercise support alone, and when compared with semaglutide alongside diet and exercise support. On average patients lost 21% of their bodyweight in 36 weeks during the SURMOUNT-4 trial.
The treatment could be offered in either primary or secondary care, with appropriate support focused on diet and nutrition, behavioural and lifestyle elements, physical activity and, where appropriate, mental wellbeing. NICE highlighted that clinical assessment and support are essential.
An independent NICE committee recommended the self-administered weekly injection, costing £122 for four kwikpens at its maximum 15mg dose list price, for people living with obesity in draft guidance issued in June. It is estimated that the medicine and associated wraparound care services will cost the NHS in England around £317.2 million per year by the third year of implementation.
A NICE statement said: “Despite the considerable cost, the evidence presented to the NICE committee suggests this medicine is a cost-effective use of NHS resources for some patients. When people with obesity who already have weight-related illness lose weight, it reduces their risk of developing further health complications due to their obesity. This prevents future ill health and saves money for the NHS that can then be reinvested in other services.”
Dr Kath McCullough, NHS England’s national specialty advisor for obesity, said: “Obesity is one of the greatest public health issues facing the NHS and weight loss drugs, such as tirzepatide, are an important tool in helping people lose weight while also reducing the risk of other serious long-term conditions such as diabetes, strokes and heart attacks.
“However, on their own, weight loss drugs are not a magic bullet. They need to be prescribed by a healthcare professional alongside programmes that help people lose weight and live healthier lives by making changes to their diet and physical activity – and it is also crucial that they are prioritised for those who need them most.”
She added: “This guidance enables the NHS to implement a phased roll out of tirzepatide to patients with the highest clinical need in a safe and effective way, while also protecting access to the NHS services that all patients rely on.”
NICE is also releasing its guideline to help people living with overweight and obesity. It includes evidence-based recommendations on the prevention and management of overweight, obesity and central adiposity in children, young people and adults. It brings together and updates all of NICE's previous guidelines on overweight and obesity.
Those who aren’t eligible for tirzepatide or semaglutide but want to improve their health by losing weight are urged to seek further information via NHS Better Health.
Estimates in Frontier Economics: Estimating the full costs of obesity 2023 found that the cost of treating conditions associated with obesity puts a burden on the NHS of £11.4 billion per year.
According to the Health Survey for England 2022, around 64% of adults are either overweight or living with obesity in England. Obesity is the second most common cause of preventable death after smoking.
If no appeals are lodged during the next two weeks, NICE expects to publish final guidance on Monday, 23rd December 2024. The first NHS patients will then be able to start receiving the medicine after 90 days if they are already being looked after in specialist weight management services, or 180 days if they have the highest clinical priority. Guidance on service delivery and clinical priority is planned to be published by NHS England early next year.
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