UNITED KINGDOM — In a surprising turn of events, the National Institute for Health and Care Excellence (NICE) has issued final draft guidance endorsing Eli Lilly’s Mounjaro (tirzepatide) as a treatment option for poorly controlled type 2 diabetes in adults who follow diet and exercise regimens.

This decision marks a reversal from NICE’s previous stance in June when it had called for more evidence on this once-weekly dual GIP/GLP-1 receptor agonist.

Mounjaro received approval in the UK last year, but Eli Lilly’s submission aimed at securing NICE’s backing was designed for a specific patient population: adults with type 2 diabetes who had insufficient control using three or more antidiabetic agents.

This aligns with the company’s expectation of how the drug would be utilized within the NHS.

Consequently, Mounjaro is now positioned as an alternative to other GLP-1 receptor agonists that are already recommended for NHS use.

Building confidence

In its initial assessment, NICE had acknowledged the potential of Eli Lilly’s therapy but had insisted on the need for more evidence to evaluate both its clinical effectiveness and cost-efficiency.

However, in its latest update, NICE expressed “improved confidence” in the clinical and cost-effectiveness evidence for Mounjaro, citing clinical data that showcased impressive results: 81% to 97% of patients achieved better glucose control, and 54% to 88% saw a ≥5% reduction in body weight.

These outcomes surpassed those of comparators, including Novo Nordisk’s GLP-1 receptor agonist Wegovy (semaglutide) and insulin.

Additionally, the revised cost-effectiveness ratios provided by Eli Lilly were found to be less than £20,000 (US$25,000) per quality-adjusted life year (QALY) gained for Mounjaro when compared to all other options.

NICE specified that Mounjaro can be funded through the NHS for patients in whom triple therapy with metformin and two other oral antidiabetic drugs proves ineffective, intolerable, or contraindicated.

Although Mounjaro is introduced earlier in the treatment pathway in other countries, Eli Lilly did not present any supporting evidence for this broader use in the UK. The final guidance is slated for publication on October 11.

Supply concerns persist

While Diabetes UK welcomed NICE’s decision regarding Mounjaro, it voiced concerns over supply shortages of GLP-1 medicines, especially considering their off-label use in treating obesity.

Douglas Twenefour, head of care at Diabetes UK, expressed worry that “the shortages are causing stress and uncertainty for many people with type 2 diabetes” and called for proactive measures to ensure an ongoing and adequate supply of these medications.

What lies ahead

NICE is currently evaluating Mounjaro for potential use in obesity, with an initial decision anticipated in March next year.

Meanwhile, Novo Nordisk has cautiously launched its once-weekly GLP-1 receptor agonist Wegovy (semaglutide) in the UK due to ongoing supply restrictions.

NICE recommended Wegovy’s use earlier this year for adults with at least one weight-related condition and a body mass index of at least 35, albeit suggesting that the therapy be limited to a maximum of two years.

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