In March this year, the National Institute for Health and Care Excellence (NICE) approved semaglutide (Wegovy, Novo Nordisk) for NHS use in England as an option for weight management, weight loss, and weight maintenance. Recently published clinical trial results have found that patients treated with the drug lost 15.2% of their body weight after 2 years compared with placebo. Other similar drugs are currently undergoing clinical trials.
Treatment with Wegovy was recommended by NICE for people with a BMI of 35 or more and at least one weight-related health condition, such as diabetes, high blood pressure, heart disease, and obstructive sleep apnoea. It's also a recommended treatment option for patients with a BMI between 30 and 34.9 if they meet the criteria for referral to specialist weight management services.
But what are the implications of such treatment? Treatment with Wegovy and other injectable weight management drugs could be a life-long commitment for most patients, according to some leading obesity experts.
NICE recommended that weekly injections of Wegovy should be limited to a maximum of 2 years. However, that could be an issue, according to a number of specialists, who believe patients might need treatment with these types of drugs for life, or risk putting the weight back on.
Weight Loss Often Regained
John Wilding, professor of medicine at the University of Liverpool's Department of Cardiovascular and Metabolic Medicine, was one of several experts to give an assessment on injectable weight management drugs at a recent briefing hosted by the Science Media Centre.
"We do have to think about these medicines as long-term medications," Professor Wilding said. "We know that obesity is a chronic disease, and we would never think of just giving somebody a diabetes drug, or blood pressure drug, for 2 years and then stopping it because, of course, at that point the disease will recur."
Research published last year in the journal Diabetes, Obesity and Metabolism found that patients had regained two-thirds of their weight loss a year after treatment with semaglutide was stopped.
"The minute we stop the drug, the disease relapses, so one of the most important questions we ask our patients now is, 'are you prepared to take this treatment for the rest of your life?' " said Carel Le Roux, professor of metabolic medicine at Ulster University. "Because if you're not able to do that, you should not start, because then we are probably at risk of doing more harm than we are doing good."
The 2-year treatment limit was explained by Barbara McGowen, professor of endocrinology at King's College London, as "just a cost measure". She said: "We feel that these medicines should not be stopped after 2 years," just as "you wouldn't stop a statin, you wouldn't stop a blood pressure tablet".
Professor Le Roux said he hopes as similar drugs enter the market that increased competition would persuade NICE to revise its 2-year recommendation.
Supply and Demand
Even though Wegovy has been approved for routine NHS use, issues of supply from its Danish manufacturer have led to shortages in the UK. A national patient safety alert sent to NHS trusts on 18 July by the Medicines and Healthcare products Regulatory Agency (MHRA) stated there were "very limited, intermittent supplies of all glucagon-like peptide-1 receptor agonists", and that shortages were expected to continue "until at least mid-2024".
Increased demand for Wegovy has been fuelled in part by celebrity endorsements, including one from Elon Musk, who attributed his lean appearance to using the drug, alongside fasting.
Naveed Sattar, professor of metabolic medicine at the University of Glasgow, says he doesn't think Wegovy will be available on the NHS in the UK for some time. "The demand has outstripped supply," he said, and has been "vastly underestimated".
The brand of semaglutide licensed for treating type 2 diabetes, Ozempic, is also listed as being in short supply. For that reason, the MHRA alert appealed to clinicians to refrain from off-label prescribing of GLP-1 receptor agonists for obesity management in order to conserve treatment for patients with diabetes.
When Wegovy becomes available for the NHS in England, it will have to be prescribed by a specialist. According to Professor Wilding, it will be a question of prioritising those with the most severe form of the disease. "We probably do have to start with those who are going to get the most benefit, and they tend to be those who have more severe and complex disease, with multiple complications".
GPs in England will be able to prescribe Wegovy to patients with obesity as part of a £40 million government pilot scheme designed to widen access to the treatment.
There are expectations that as new medications in this suite of drugs become available, costs will fall and availability increase.
"To have something which is safe, effective, reversible, and produces substantial and clinically meaningful levels of weight loss is really important," commented Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University, in a phone interview. "It's going to be exciting for a lot of people, but also a lot of people are going to be frustrated as they won't be able to access it as the NICE recommendation clearly sets a high BMI limit."
Private prescriptions for Wegovy are likely to be less strict than for NHS patients. High street and supermarket pharmacies have online pages where people can register their interest in Wegovy for when it becomes available. These suggest you may be eligible for a private prescription if you have a BMI of 27, together with a weight-related health condition. There are other ways of buying Wegovy online which aren't regulated, according to Professor McGowan. "There has been inappropriate use of these drugs. There's no doubt about it. It's easy to get them online."
She questioned what checks and balances are being implemented. "These drugs should not be prescribed outside of their licensing agreements, and it should definitely not be for cosmetic reasons."
Other experts pointed out that Wegovy is not a replacement for healthy diet and exercise, and stressed it should only be offered under medical supervision. Dr Cork said: "If people aren't getting that level of wraparound support, what they might find is the level of weight loss they achieve is disappointing. This drug stops you from putting weight back on. You need a belt and braces approach to modifying lifestyle and food choices to get maximum benefit from it."
Inevitably, there will be people who don't have obesity but take it because they regard it as a short cut to being slimmer. Dr Chinnadorai Rajeswaran, a consultant endocrinologist and bariatric physician from The London Obesity Clinic, told Medscape News UK: "All these weight loss medications, including Wegovy, will only be beneficial if supported by a multidisciplinary team. NICE also agrees that a specialist weight management service should provide lifestyle interventions along with prescribing semaglutide, as there is no evidence of effectiveness if semaglutide is used without these interventions."
"We are at the start of a very exciting journey," Dr Cork noted. "Semaglutide, or Wegovy, is going to be the first in a very fast moving and long line of very effective treatments for people with severe obesity."
Prof McGowan reports having received research grants and consulting fees from Novo Nordisk. Prof John Wilding has undertaken work for Novo Nordisk in the last 36 months. Prof Carel Le Roux is a member of Novo Nordisk's global advisory board and disclosed receiving payments for presentations, attending meetings, and/or travel. Prof Naveed Sattar has received payment for consultancies or talks from Novo Nordisk.
Siobhan Harris is a national and international journalist. She has been a health and medical freelance writer for WebMD and Medscape since 2009. Siobhan has worked as a radio journalist at ITN, BBC, and BFBS Forces radio. Siobhan has a law degree and NCTJ qualification in journalism.