England's NICE backs Mounjaro for type 2 diabetes after earlier rejection

England's National Institute for Health and Care Excellence (NICE) said on Sept. 8, 2023 that tirzepatide, sold as Mounjaro, should be covered by the National Health Service for adults with poorly controlled type 2 diabetes ^[1][2]. NICE estimates about 180,000 people could benefit from the treatment ^[1].

The recommendation is a draft version of final guidance, and it covers use of the drug alongside diet and exercise ^[2]. It follows an earlier review in which NICE did not reach the same conclusion, citing uncertainties in Eli Lilly's data, its economic model and the drug's long-term benefits ^[2]. NICE then asked Lilly for more data about the drug's benefits ^[1].

NICE said it reviewed evidence that tirzepatide can significantly reduce blood sugar and body weight compared with Novo Nordisk's semaglutide, traditional insulin therapy or a placebo ^[2]. NICE said it considers the drug a good option for patients whose type 2 diabetes is poorly controlled ^[1].

In explaining the need, NICE said about 90% of the roughly 5 million people with diabetes in the UK have type 2 diabetes, citing research from the nonprofit Diabetes UK. It also said almost 2 in 3 people with type 2 diabetes do not have the disease under control with current treatments, and that poor control can lead to complications including kidney disease, blindness and dangerous cardiovascular events ^[2].

The decision came during national shortages of Ozempic, a semaglutide product from the same drug class as tirzepatide that is approved in Britain for type 2 diabetes ^[1]. Diabetes UK told Reuters that Ozempic's increasing off-label use for weight loss has hurt people with type 2 diabetes who were prescribed the drug but struggled to fill their prescriptions ^[1].

Why it matters for patients

This is a coverage decision in England, not a change in US access or US labeling. Mounjaro has been available in the United States for type 2 diabetes since its US debut in May 2022, and Lilly has also applied for US approval for weight loss, a decision expected later in 2023 ^[1][2]. US insurers, pharmacy benefit managers and Medicare generally make their own coverage decisions, and nothing in the NICE guidance sets US policy.

The practical overlap for US readers is supply and positioning. NICE's rollout language is conditional: the drug is expected to be made available on the NHS within 90 days of final guidance, pending available supply ^[1][2]. Shortages have already affected the GLP-1 class in Britain, and Diabetes UK tied Ozempic supply problems to weight-loss prescribing outside the approved diabetes use ^[1]. Similar tension between diabetes and weight-loss demand has been reported in the US market, though the documents here do not quantify US supply.

The decision also puts a public cost-effectiveness review on record for a drug that NICE compared directly against semaglutide, insulin and placebo ^[2]. That comparison reflects how one health system weighed tirzepatide's blood sugar and weight effects; it does not establish how tirzepatide and semaglutide compare for any individual patient, and it does not address US pricing.

One detail worth noting for readers who follow brand names: in Britain, tirzepatide is reviewed and supplied under the Mounjaro name. NICE is examining a separate obesity indication for the same drug, and no decision on that use has been made ^[2].

What happens next

NICE is scheduled to publish final guidance on Oct. 11, after which the drug is to be made available in the NHS within 90 days ^[1]. Fierce Pharma reported that availability is contingent on supply ^[2].

On obesity, NICE said it expects to publish guidance in March after a January committee meeting ^[2]. In the US, a decision on tirzepatide for weight loss was expected later in 2023 ^[1].

Lilly did not immediately respond to a Reuters request for comment on the NICE recommendation ^[1].