The National Institute for Health and Care Excellence (NICE) has recommended tirzepatide (Mounjaro; Eli Lilly) for the treatment of type 2 diabetes mellitus (T2DM), reversing its initial decision against use of the drug in June 2023.
In its final draft guidance, published on 8 September 2023, NICE said its independent committee was able to make the positive recommendation on the new treatment following “additional analyses and modelling on clinical and cost-effectiveness” provided by the manufacturer after the initial consultation.
Evidence from clinical trials showed that weekly injection of tirzepatide had significant reductions in blood sugar levels and body weight compared to semaglutide, insulin or placebo.
However, in its initial draft guidance, published on 27 June 2023, the committee concluded there were “uncertainties in the clinical evidence” and “issues with the company’s economic model”.
Following the initial draft guidance, senior diabetes pharmacists described NICE’s decision as “disheartening” and “unfortunate” owing to the potential of tirzepatide as a treatment and the shortages of glucagon-like peptide-1 receptor agonists licensed for T2DM.
The final draft guidance recommends tirzepatide for the treatment of adults with insufficiently controlled T2DM, alongside diet and exercise, when metformin (the main first-line medicine for T2DM) cannot be tolerated.
Helen Knight, director of medicines evaluation at NICE, said: “There are very few new medicines being developed to treat difficult-to-manage type 2 diabetes.
“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 recommendation will offer fresh hope for many and provide value for money for the taxpayer,” Knight added.
According to Diabetes UK, there are more than 5 million people in the UK living with diabetes, 90% of whom are estimated to have T2DM.
NICE estimate that around 180,000 people who have difficulty managing T2DM could benefit from tirzepatide, recognising the importance of new treatment as almost 2 in 3 people with T2DM do not have the disease under control with current medicines.
Commenting on NICE’s decision, Philip Newland-Jones, consultant pharmacist and clinical director of the endocrine diabetes service at Southampton General Hospital, said: “The updated positive NICE technology appraisal for tirzepatide is a welcome addition to the range of treatments for type 2 diabetes.
“There will be some practical issues to iron out with regard to availability of devices, education, local access and stable supply over the next six months, given the current pressures on the incretin marketplace; however, it is exciting to see the first dual incretin agonist be agreed as cost effective for use in type 2 diabetes in the UK market.”
The final guidance is scheduled to be published on 11 October 2023, with the drug to be made available in the NHS within 90 days from this date.