The UK’s National Institute for Health and Care Excellence (NICE) has not recommended tirzepatide (Mounjaro, developed by Eli Lilly) in draft guidance for treating type 2 diabetes in adults alongside diet and exercise, stating that it required more evidence on the clinical and cost-effectiveness before it could be recommended for NHS use.
“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,” said Helen Knight, director of medicines evaluation at NICE. “We look forward to working with the company to ensure our committee receives the evidence it has requested so at their next meeting they can fully understand the benefits and the value of this new treatment option.”
Tirzepatide is taken weekly by injection. The company has positioned tirzepatide as an option later in the treatment pathway to offer the NHS an alternative to glucagon like peptide 1 (GLP-1) receptor agonists such as dulaglutide, liraglutide and semaglutide (ozempic/rybelsus) which are already recommended for use in the NHS.
The independent NICE committee recognised the importance of new treatment options given that fewer than two-thirds of the adults with type 2 diabetes have adequate glucose control when using current treatment options.
Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy. The weight reduction was more pronounced with higher doses of tirzepatide, while the effect on glucose levels seemed less dose-dependent. Similar effects were observed against all GLP-1 receptor agonists in company’s network meta-analysis, but this was uncertain.
The committee have asked the company to provide more data to address the uncertainties in the clinical evidence, when compared to all relevant alternative treatments. This must be provided alongside further analyses and clarifications on the company’s submitted economic model.
It is also unclear how accurately the model predicts the long-term health benefits (for example avoiding complications of diabetes) with tirzepatide compared with other GPL-1 receptor agonists, so it is yet to be established if tirzepatide represents good value for money.
The committee also asked for evidence showing how the company’s model results compare with other economic models for diabetes. The price of the pre-filled disposable injection pens is commercial in confidence until final guidance is published.
A consultation on the committee’s decision has now begun via nice.org.uk and comments can be submitted until Tuesday 18 July 2023.