A weight-loss jab has been rejected for NHS use by England’s drugs watchdog.
The National Institute for Health and Care Excellence (Nice), which provides recommendations and guidance to health practitioners, said further evidence was needed on the clinical and cost-effectiveness of tirzepatide, which is sold under the brand name Mounjaro, before it could be recommended for NHS use.
The weekly injection, developed by the US pharmaceutical company Eli Lilly, works alongside diet and exercise to treat adults with type 2 diabetes.
The move comes after Nice approved a similar drug for NHS use, Wegovy or semaglutide, for adults with at least one obesity-related health problem, which can include type 2 diabetes. Stocks are not yet available, but the prime minister has said GPs in England may soon start offering it to some patients, as well as specialist weight management clinics.
Evidence given to the Nice committee from clinical trials showed tirzepatide at any dose resulted in better glucose control and weight loss compared with semaglutide or insulin therapy. Weight loss was more pronounced with a higher dose of the drug, although the impact on glucose levels was less dose dependent.
Nice said its independent committee “recognised the importance of new treatment options” but “more evidence is needed on the clinical and cost-effectiveness of the drug before it is recommended for NHS use”.
It has requested more data from Eli Lilly to address uncertainties in the evidence, which it said should be provided alongside further clarifications on the company’s economic model.
Nice said it was “unclear how accurately the model predicts the long-term health benefits – for example, avoiding complications of diabetes – with tirzepatide compared with [alternatives], so it is yet to be established if tirzepatide represents good value for money”.
Helen Knight, the director of medicines evaluation at Nice, added: “Type 2 diabetes is becoming more prevalent in society, so new treatment options are needed to help people with it to control their blood-glucose levels. Our committee can see the promise in tirzepatide but it requires more evidence to be able to evaluate both its clinical and cost effectiveness.”
A consultation on the Nice guidance has started and will run until 18 July.
Data published by Eli Lilly in April revealed tirzepatide helped people with type 2 diabetes who were overweight or obese lose up to 16% of their body weight, or more than 34lb (15.4kg) over nearly 17 months.
The trial evaluated 938 adults with obesity or who were overweight and had type 2 diabetes. Researchers compared the drug with a placebo as an add-on to a reduced-calorie diet and increased physical activity for those taking part.
