Following last month's revelation that weight loss drug semaglutide (Wegovy, Novo Nordisk) is coming soon to a High Street pharmacist near you, the National Institute for Health and Care Excellence (NICE) has confirmed that the drug will be made available on the NHS.
"Thousands of people," NICE said, will soon be able to be prescribed the drug "as part of their treatment in an NHS specialist weight management service".
The 2019 Health Survey for England estimated that 28% of adults in England were obese and a further 36% were overweight, NICE said. Government estimates indicated that the current costs of obesity in the UK are £6.1 billion to the NHS and £27 billion to the wider society.
Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue that reduces hunger and thus overall calorie intake. Unlike rival injectables, it requires patients to give themselves a daily subcutaneous injection from a pre-filled pen only once a week.
NICE’s latest single technology appraisal guidance recommended semaglutide alongside a reduced-calorie diet and increased physical activity to adults who have at least one weight-related comorbidity – dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease – and a body mass index (BMI) of at least 35kg/m2.
The drug would also be available to people with a BMI of between 30.0 and 34.9 kg/m2, with one weight-related comorbidity, who were also eligible for referral to specialist weight management services.
For such people, NICE said, "the cost-effectiveness estimates for semaglutide are likely to be within what is normally considered a cost-effective use of NHS resources".
Lower BMI thresholds were recommended for people fromSouth Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds, whose BMI level should usually be reduced by 2.5 kg/m2.
Not Available to Everyone
NICE noted that the drug would be available to NHS patients "soon", when the manufacturer confirmed the launch of the drug in England. It said that semaglutide could help people to reduce their weight by over 10% "when used with support of a multidisciplinary team".
Helen Knight, director of medicines evaluation at NICE, said: "For some people losing weight is a real challenge, which is why a medicine like semaglutide is a welcome option.
"It won't be available to everyone. Our committee has made specific recommendations to ensure it remains value for money for the taxpayer, and it can only be used for a maximum of 2 years.
"We are pleased finally to publish our final guidance on semaglutide, which will mean some people will be able to access this much talked-about drug on the NHS."
NICE said that although it had recommended use of the drug in final draft guidance in June 2022, it had been unable to publish final guidance because the product had not been scheduled to launch in England. The latestdecision, described by one expert as a 'pivotal moment', requires the NHS in England to implement the recommendations within 3 months of the product becoming commercially available.
Clinical trial evidence showed that people lost more weight with semaglutide alongside supervised weight loss coaching than with the support alone, NICE said. Specifically, evidence from the STEP 1 randomised double-blind clinical trial showed that participants taking semaglutide lost on average 12.5% more of their body weight compared with those on placebo.
Maximum 2 Years' Treatment in Specialist Services
The decision said that semaglutide could only be prescribed "for a maximum of 2 years within a specialist weight management service providing multidisciplinary management of overweight or obesity (including but not limited to services in tiers 3 and 4)". It also recommended that clinicians consider stopping semaglutide if less than 5% of the initial weight had been lost after 6 months of treatment.
Commenting to the Science Media Centre (SMC)Alex Miras, professor of endocrinology at Ulster University, said: "This decision made by NICE is a pivotal moment for the treatment of people living with obesity." He said that the guidance was based on "solid data from well-conducted randomised trials" and should increase access to care.
"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."
Limiting factors were that there were not enough services to offer the medication, though the fact that it could now be prescribed by services that were not considered as "tier 3" was "a welcome improvement" to previous guidance.
Two-Year Limit Makes 'No Clinical Sense'
However, Prof Miras said that the guidance by NICE that semaglutide only be used for 2 years, whilst "understandable based on cost effectiveness", made "no clinical sense". We would not stop treatment for any other chronic disease, he said.
NICE noted that the recommendation mirrored the clinical and financial modelling supplied by the manufacturer that people are treated for a maximum of 2 years in specialist weight management services. Specialist weight management services, such as tier 3 services, are normally accessed for up to 2 years, NICE said. Semaglutide treatment would be limited to 2 years because of its restricted time in specialist weight management services and lack of evidence for longer use. However, it might be possible to consider long-term use in other settings "if the evidence suggests that long-term or lifetime use is clinically and cost-effective".
Also commenting to the SMC, Nick Finer, honorary clinical professor at the National Centre for Cardiovascular Prevention and Outcomes at University College London, said:"The efficacy of semaglutide is a true game changer for the medical treatment of obesity."
He noted 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."
However, he said:"The limitation of 2 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."
Withdrawal of Treatment Leads to Weight Regain
Results from an extension of the STEP 1 trial published last year showed that a year after withdrawal of treatment, participants had regained two-thirds of their prior weight loss, and cardiometabolic parameters had reverted towards baseline for most variables.
Prof Finer added: "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 single technology appraisal guidance applies to England, Wales, and Northern Ireland.