NICE has overturned a previous decision and recommended tirzepatide for people with difficult-to-manage diabetes.
It is thought around 180,000 people could benefit from drug developed by Eli Lilly and sold under the brand name Mounjaro.
The once-weekly injection is a dual receptor agonist that acts on both glucose-dependent insulinotropic polypeptide (GIP) receptors and glucagon-like peptide-1 (GLP-1) receptors.
It was granted marketing authorisation in October 2022 but previous draft guidance published in June this year had rejected its use as an alternative to other antidiabetic drugs such as semaglutide and liraglutide.
NICE said the manufacturer had put forward additional analyses and modelling on its clinical and cost-effectiveness which led to the final draft now recommending tirzepatide in specific circumstances.
Under the recommendations previous triple therapy with metformin and two other antidiabetic agents has to have been ineffective, not tolerated or contraindicated.
Tirzepatide is only recommended in patients who have a body mass index (BMI) of 35 kg/m2 or more and specific psychological or other medical problems associated with obesity, or who have a BMI of less than 35 kg/m2 but in whom insulin therapy would have significant occupational implications, or weight loss would benefit other significant obesity-related complications.
The expert committee said there was a need for new treatment options for type 2 diabetes as almost two in three people do not have the disease under control with current medicines, putting them at risk of complications.
NICE looked at clinical trial evidence showing tirzepatide resulted in significant reductions in blood sugar levels and body weight compared with semaglutide, insulin therapy or a placebo.
This included 81% to 97% of people reaching better glucose control and 54% to 88% reaching a 5% or greater reduction in body weight, which were significantly more than any of the comparators, the committee said.
Final guidance is scheduled to be published in October with the drug being made available to NHS patients within 90 days ‘dependent on the supply of licensed product by the manufacturer’, NICE said.
Tirzepatide is the latest in a new class of drugs in demand for weight loss, raising concerns that global shortages will mean patients with diabetes may not be able to access it.
In April, it was announced by the company that patients with type 2 diabetes and obesity or overweight achieved 15.7% weight loss at 72 weeks in a randomised controlled trial.
NICE is also assessing its role in managing overweight and obesity but recommendations are not expected until March next year.
Helen Knight, director of medicines evaluation at NICE, said: ‘Our committee recognised the potential tirzepatide has to provide an effective and good value treatment option for all those living with poorly controlled type 2 diabetes.”
‘Poorly controlled type 2 diabetes, with its associated additional health risks, is a huge challenge for those living with the condition and the NHS.’
This summer it was reported that patients with type 2 diabetes on semaglutide and other glucagon-like peptide-1 receptor agonists (GLP-1 RA) drugs are having to stop taking them, amidst ongoing shortages.
The RCGP is among those warning that unregulated use of the drugs for weight loss is ‘posing a threat to patient safety’.
Limited stocks of semaglutide, marketed as Wegovy, were made available this week for specialist weight management services as part of new NICE guidance.
Professor Azeem Majeed, professor of primary care and public health at Imperial College London said the recommendation was a positive development after the careful assessment of the evidence by NICE.
‘It offers a new treatment option for people with type 2 diabetes who have not responded well to other medications; and would be a useful alternative to drugs such as dulaglutide, liraglutide and semaglutide which are already used in the NHS.
‘One caveat is that I hope that tirzepatide does not have the supply problems we have seen with drugs such as semaglutide.’
Dr Stephen Lawrence, a GP and associate clinical professor at the University of Warwick said it had always been expected that NICE would approve tirzepatide once the company provided more data.
‘It’s good news and the most welcome aspect of this is that it is no longer a one-horse race. Having a second company producing a drug in the same class [as semaglutide] is positive and there is a pipeline of other drugs coming through.’
Douglas Twenefour, head of care at Diabetes UK, said they welcomed the decision. ‘It is very promising that the trial data showed great improvements in blood glucose management and weight loss.
‘The current GLP-1 medication shortages are causing stress and uncertainty for many people with type 2 diabetes.
‘Whilst the approval of tirzepatide is welcome, we are calling for more action to ensure ongoing and sufficient supply of these medications to people with type 2 diabetes.’