The 30e In October, a new weight loss drug, Saxenda, became available on the NHS in England. Indicated for adult patients with obesity and additional risk factors, it is the first drug to be approved for weight management in almost a decade.
Also known as liraglutide 3 mg, the drug is manufactured by Novo Nordisk and received its European marketing authorization in 2015, before being launched in the UK two years later. It has been available privately since then – in June 2020, high street pharmacy LloydsPharmacy began offering the drug as part of a weight loss program. However, the NICE recommendation dramatically increases the number of patients who will benefit from it.
Pinder Sahota, Corporate Vice President and Managing Director of Novo Nordisk UK, said: “We are delighted that NICE has recommended Saxenda for the treatment of obesity on the NHS. This is testament to the value this treatment offers, especially in these difficult times, when policymakers and clinicians are focused on finding effective ways to tackle the prevalence of obesity in the UK.
Why the NHS took this step
Until recently, obesity patients in the UK had fairly limited options. Obesity is often still viewed as a lifestyle choice rather than a medical condition, and interventions tend to focus on the value of diet and exercise to the exclusion of medical treatments.
As of 2009, eligible patients can purchase an over-the-counter weight loss drug, Orlistat. This medicine works by interfering with the way fat is digested and has helped many people lose weight. However, it is known for its nasty side effects, including oily stools and diarrhea.
Weight loss surgery – available for very obese patients who have not responded to lifestyle changes and medications – is generally effective, but itself carries serious health risks.
There is a clear need for new treatments. Over the past 20 years, the number of people with obesity in England has nearly doubled – a problem that was tragically highlighted during the Covid-19 pandemic. Public Health England estimated that a body mass index (BMI) over 35 could increase a person’s risk of dying from Covid-19 by 40%, and a BMI over 40 could increase a person’s risk by 90 %.
In July, the government unveiled its new obesity strategy in the wake of the Covid-19 “awakening”. The plan includes limiting advertising on foods that children are likely to see, mandatory calorie labeling in restaurants and extending weight management services on the NHS. Saxenda’s launch, while not directly related to this obesity strategy, comes at a time when obesity-related health issues are a priority.
“Covid-19 has helped draw the attention of politicians to the fact that obesity is a disease,” says Professor Carel Le Roux, consultant in metabolic medicine at Imperial College London. “Some people will do very well with the diet and they should continue with this, but those who don’t respond are not morally inferior – they just don’t respond biologically and we have to use drugs and even surgery.”
He adds that the drug’s initial launch in the UK was based on one-year health data from clinical trials. However, the one-year data did not provide insight into the health economics of the drug – for that we had to wait for the three-year data.
“Data over three years has shown an 80% reduction in the risk of developing type 2 diabetes, and it is this change in risk, not the weight loss, that is driving the health economics model,” he explains. “That’s why there was a delay between the drug’s launch and the approval of NICE – NICE just didn’t have the data at their disposal to make a decision one way or the other.”
How Saxenda works
Saxenda is a once-daily injectable medicine that works by suppressing appetite. It is 97% similar to glucagon-like peptide-1 (GLP-1), a hormone released in response to food to create a feeling of fullness and fullness.
“We all make this hormone naturally, but if you have the disease of obesity, you’re not doing enough,” says Le Roux. “What Novo Nordisk did was they purified the hormone and changed an amino acid, so instead of having a half-life of two minutes, it has a half-life of 13.5 hours. . If you take the peptide, you would expect it to increase your natural level of GLP-1 and bind in the exact same place where the normal hormone would bind.
The protein binds to receptors in the pancreas, instructing the body to make insulin at the right time and in the right amounts. It binds to receptors in the part of the brain that controls hunger, ensuring that obese people suddenly feel more satisfied. It also helps regulate blood pressure and reduce inflammation.
“When you put all of these things together, the obese person is less hungry and is prevented from getting type 2 diabetes,” says Le Roux. “You reduce the complications of obesity and other diseases.”
Because it is a natural peptide, it must be administered subcutaneously to avoid being broken down by stomach acid. However, the device is simple to use and most of the potential side effects are gastrointestinal and transient. It will be used within the specialist weight management services of the NHS, alongside lifestyle-based interventions.
How the drug might help patients
The drug will be available to people with a BMI of 35 or more (or 32.5 and more in the case of certain ethnic minority groups). To be eligible for NHS treatment, patients must also have prediabetes and a high risk of cardiovascular disease, due to risk factors such as high blood pressure and cholesterol.
“It will be available not as a drug to lose weight but as a drug to gain health”, explains Le Roux. “The health gain that NICE wants to see is a reduced risk of developing type 2 diabetes, while reducing their cardiovascular risk and improving their quality of life at the same time. We will be responsible for prescribing it. We’re not going to tell patients it’s going to make them lean and happy, because it’s not true – we’re going to tell patients that it will make them healthier and more functional.
In clinical trials, people treated with Saxenda lost more weight than the placebo group and were less likely to be diagnosed with type 2 diabetes (3% vs. 11% in the control group). Although not everyone responds to the drug, those who do do tend to lose a significant proportion of their body weight.
“Patients have a one in three chance of responding biologically to this drug,” explains Le Roux. “If we look at people who respond – that is, those who are able to achieve 5% weight loss in 12 weeks, they see double-digit weight loss. If we dig a little deeper, one in three people will lose more than 10% of their weight, or about two stones, and one in seven will lose 15% of their weight, or about three stones. It really makes a difference.
He hopes this will be a step forward from the “eat less and more” model of obesity treatment, and more towards a thoughtful approach that treats obesity as a disease.
“Thirty years ago, if you suffered from depression, people would tell you to cheer up, but now we treat depression as a chronic illness and we don’t discriminate against people on that basis,” he says. “This is a good example of how we have done well before, and now we need to do the same with obesity. ”