The National Institute for Health and Care Excellence (NICE) has published guidance on the use of semaglutide for managing overweight and obesity.
Prof Tim Barrett, Professor of Paediatrics, University of Birmingham, said:
“As a children’s diabetes and obesity researcher, I welcome the new NICE guidance. It is based on high quality research evidence that shows this is an effective drug for reducing weight.
“Prescription of this drug to obese people may allow the damaging metabolic effects of obesity to be improved, while giving them a breathing space to make lifestyle changes.
“I welcome the guidance and will be investigating Semaglutide for other indications and in younger populations.”
Prof Alex Miras, Professor of Endocrinology, Ulster University, said:
“This decision made by NICE is a pivotal moment for the treatment of people living with obesity. The guidance has been based on solid data from well conducted RCTs. The difference with previous guidance in the field, is this one is much more inclusive rather than exclusive and should hopefully increase access to care for a wide range of patients living with the disease of obesity. The weight loss that can be achieved with this safe medication is substantial and likely to lead to the improvement of obesity related complications in a large number of patients.
“There are two potential limiting factors to the appropriate application of the guidance. The first one is that there are not enough services to offer the medication and the ones that exist are under resourced. This could lead to worsening of health inequalities across the country. It is therefore vital that the appropriate investment in such services becomes available, otherwise the guidance may end up becoming irrelevant to daily care. The fact that the medication can be prescribed by services that are not considered as “tier 3” is a welcome improvement to previous guidance.
“The second factor is the guidance by NICE that the medication can only be used for 2 years. Whilst this is understandable based on cost effectiveness, it makes no clinical sense as we would not stop treatment for any other chronic disease.
“Despite these limitations, this is a positive change and a valuable addition to the treatment choices of people living with obesity.”
Dr Stephen Lawrence, Associate Clinical Professor, Warwick Medical School Health Sciences, University of Warwick, said:
“Wegovy represents a class of medication called GLP receptor agonists. It has an interesting origin; it represents a laboratory copy of chemical agent found in saliva of a specific type of lizard called the Gila monster living in the US and parts of Mexico. When used in accordance with the prescribed guidelines, it promotes weight loss in a safe and effective way for most people.
“This type of drug, in its injectable form, will be familiar to many people living with diabetes who fulfil the NICE criteria to start on this class of medication. For people living with type 2 diabetes these agents are used to improve blood sugar levels as well as aiding with weight loss.
“It is important to note however, that this medication it is not a quick fix or a replacement for following a healthy lifestyle, which includes regular physical activity and healthy eating. It should therefore only be offered following assessment of the person taking the medication and as part of a program to establish a healthy lifestyle.”
Dr Simon Cork, Senior Lecturer in Physiology, Anglia Ruskin University, said:
“The news that semaglutide will be available on prescription for the treatment of obesity will be welcome news to the millions of people who struggle to lose weight and maintain that lower body weight. However many will be disappointed by the strict rules dictating who will be eligible for this drug.
“The licensing of semaglutide comes after a number of robust clinical trials demonstrating that it is effective at lowering body weight by an average of 15% in an obese population. This reduction in body weight was achieved through a once weekly injection of semaglutide in conjunction with increased exercise and reduced calorie intake, for which participants in the trial received weekly counselling sessions. Because such services are only available in specialist weight management services, this drug will only be available to individuals with a BMI over 30 who are referred to a specialist weight management centre. Such services are not available universally across the UK and therefore some patients will not be able to access this drug. Moreover waiting times for access to these services are typically long.
“The trial from which licensing recommendation was taken was conducted over a 2 year period. No data exists on the longer term impacts of taking this drug. The recommendation from NICE therefore is that prescription of this drug is limited to 2 years. This follows evidence from the clinical trial but also takes into account the level of clinical intervention required (weekly counselling meetings) needed to achieve effective weight loss, which may not be feasible long-term for the number of patients eligible. A follow up to the initial clinical trial, where participants were monitored after stopping semaglutide showed that all participants regained almost all of the weight they had lost over the course of the following year. This demonstrates the fact that obesity is a lifelong condition and that semaglutide is a treatment rather than a cure.
“Overall this is good news that this new class of anti-obesity drug has been licenced, but will likely offer only temporary weight loss for many of the patients to whom it is prescribed.”
Dr Duane Mellor, Registered Dietitian and Senior Lecturer, Aston Medical School, Aston University, said:
“The addition of semaglutide as another one of the tools that can be used to support people living with obesity along with other related health risk factors (e.g. high blood pressure) is to be welcomed. It is important to remember that living with a higher body weight or obesity is not a lifestyle choice, and people wanting to improve their health should be supported to do that, which may include losing weight, which semaglutide can help with. It is also clear that semaglutide is not intended to be a lifestyle weight loss product in the UK, it is to be used for the purpose of improving health.
“It is also important to remember that semaglutide works alongside and supports healthy lifestyle changes and when people are being offered semaglutide that they are also given ongoing support to make changes and maintain these changes with respect to diet and lifestyle. As all individuals initially being offered semaglutide via the NHS will be supported by specialist weight management services this should including support from a specialist dietitian.
“The challenge of supporting healthier diet and lifestyle long term needs to be remembered – although semaglutide can be prescribed for 24 months, the support regarding lifestyle needs to continue, and as well our society needs to change to support people to continue to make healthy choices and live healthier lives. Without changes to society and any long term support, sadly when treatment for people living with obesity stops, many can then regain weight. So, we need semaglutide to be seen as part of the toolkit that supports people to be able to improve their health, not a magic or singular solution.”
*Prof Nick Finer’s titles and affiliations were updated on Friday 10 March 2023*
Prof Nick Finer, currently expert medical consultant in obesity medicine and endocrinology; former Honorary Clinical Professor at UCL; and former Senior Principal Clinical Scientist, Global Medical Affairs Management, at Novo Nordisk, said:
“It is gratifying to see that semaglutide 2.4mg (a dose higher than used to treat people with diabetes) has been approved to help patients living with (severe) obesity improve their health.
“The efficacy of semaglutide is a true game changer for the medical treatment of obesity, a chronic disease that shortens life through its many complications. A more useful way of communicating the efficacy of semaglutide, is that in the STEP 1 trial more than half of participants lost more than 15% of their weight, and one in three lost more than 20%. These results are approaching the efficacy of bariatric surgery. There is also ever-growing clinical trial evidence of semaglutide’s efficacy now in people with diabetes, in conjunction with more intensive behavioural therapy and in different ethnic groups.
“The limitation of two years’ treatment is, of course, completely illogical since obesity is a chronic disease and is not cured by this treatment. In common with other diseases, such as hypertension and diabetes, withdrawal of a drug that is working means the benefits are likely to be lost (as has been shown in several trials by partial weight regain after semaglutide withdrawal).
“Later this year the results of a trial to see if semaglutide 2.4 mg can prevent deaths from heart disease in people with obesity (but not diabetes) are expected to be available, and if positive (as has been shown with lower doses of semaglutide in people with type 2 diabetes) NICE will have to reconsider this limitation.”
NICE Technology appraisal guidance, ‘Semaglutide for managing overweight and obesity’ was published by the National Institute for Health and Care Excellence at 00:01 UK time on Wednesday 7 March 2023.
Prof Alex Miras: “Grants/Research Support: Fractyl, Novo Nordisk, Randox.
Other Financial or Material Support/Honorarium: Novo Nordisk, GI Dynamics, AstraZeneca, Boehringer Ingelheim, Currax Pharmaceuticals.”
Dr Simon Cork: “No conflicts to declare.”
Dr Duane Mellor is a dietitian and member of British Dietetic Association.
Prof Nick Finer reports that he was an employee of Novo Nordisk until July 2022.
For all other experts, no reply to our request for DOIs was received.