England's NICE reverses course and backs Mounjaro for type 2 diabetes

England's National Institute for Health and Care Excellence (NICE) said on September 8, 2023, that it would recommend tirzepatide, sold as Mounjaro, alongside diet and exercise, for adults with poorly controlled type 2 diabetes ^[1][2]. The move reverses an earlier rejection: in July, NICE had "seen the promise" in the drug but declined to back it, citing uncertainties in Eli Lilly's data, its economic model, and questions about long-term benefit ^[2].

NICE estimates about 180,000 people in England could benefit from the drug ^[1]. Type 2 diabetes affects roughly 90% of the UK's 5 million diabetes patients, according to research from the nonprofit Diabetes UK cited by the agency, and nearly two in three people with type 2 diabetes do not have the disease under control with current treatments ^[2]. Uncontrolled diabetes can lead to kidney disease, blindness, and dangerous cardiovascular events ^[2]. NICE said its decision rested on evidence that tirzepatide significantly cut blood sugar and body weight compared with Novo Nordisk's semaglutide, traditional insulin therapy, or placebo ^[2].

The September 8 announcement is draft final guidance. Full guidance is scheduled for publication on October 11, 2023, after which Mounjaro is expected to become available through the NHS within 90 days, supply permitting ^[1][2]. The timing overlaps with national shortages in Britain of Novo Nordisk's Ozempic, which is in the same drug class and is approved there for type 2 diabetes ^[1]. Diabetes UK told Reuters that rising off-label use of Ozempic for weight loss has made it harder for people prescribed the drug for diabetes to fill their prescriptions ^[1].

For Eli Lilly, the reversal matters commercially. Mounjaro generated $979 million in sales in the prior quarter, and analysts at UBS have projected the drug could eventually reach $25 billion in peak annual sales, which they called potentially "the biggest drug ever" ^[2]. NICE is reviewing tirzepatide for obesity separately from this diabetes decision, with guidance expected around March 2024 following a committee meeting scheduled for January ^[2]. A US regulatory decision on tirzepatide for weight loss was expected later in 2023, according to Reuters ^[1].

Why it matters for patients

This is a UK regulatory story, not a US one, so it does not change coverage, pricing, or availability of Mounjaro or Zepbound in the United States. But it is a useful reminder for American readers about how differently the same molecule can be marketed abroad. In the US, Eli Lilly sells tirzepatide under two names: Mounjaro for type 2 diabetes and Zepbound for weight loss. Britain has no Zepbound; Mounjaro is the only brand name in use there, whether the prescription is for diabetes or, pending the separate NICE review, for obesity ^[2]. Patients who encounter British packaging, forums, or import sources should not assume Mounjaro sold in the UK is the diabetes-only product Americans might expect from the name.

The episode also shows that NICE, unlike the FDA, ties its coverage decisions explicitly to cost-effectiveness modeling, and can reverse an initial rejection once a manufacturer supplies more data, as happened here ^[2]. And the UK's Ozempic shortage, driven partly by off-label weight-loss demand, echoes a dynamic that has also strained tirzepatide and semaglutide supply in the US at various points, even though the two countries regulate and price these drugs separately ^[1].

What happens next

NICE's final guidance for tirzepatide in type 2 diabetes was scheduled for publication on October 11, 2023, with NHS availability expected within 90 days after that ^[1][2]. NICE's separate assessment of tirzepatide for obesity was expected to follow a January 2024 committee meeting, with guidance targeted for around March 2024 ^[2].