Diabetes patients in the U.K. may have to wait a bit longer to get their hands on Eli Lilly’s Mounjaro after the country’s drug value watchdog kiboshed its coverage recommendation.
England’s National Institute for Health and Care Excellence (NICE) on Tuesday said more evidence is needed on the clinical efficacy and cost-effectiveness of Eli Lilly's new diabetes therapy Mounjaro, also known as tirzepatide, before the health technology assessor can recommend the dual GIP/GLP-1 drug for use by the country’s taxpayer-funded National Health Service (NHS).
Evidence provided to NICE from Lilly’s trials showed the use of tirzepatide at any dose yielded better glucose control and lower weight versus Novo Nordisk’s injectable GLP-1 drug Ozempic (semaglutide) or insulin therapy, with weight reduction more pronounced on higher doses of the medication. The effect on glucose levels, meanwhile, appeared less dose-dependent, NICE said in draft guidance issued this week.
In fact, a Lilly meta-analysis showed similar effects against a clutch of GLP-1 receptor agonists, which also included dulaglutide and liraglutide. The problem is that comparison was “indirect” and the results “uncertain,” according to NICE.
Now, NICE is asking Lilly to fork over more data to address uncertainties around its clinical data when compared to “all relevant alternative treatments.” Likewise, Lilly must submit “further analyses and clarifications” on its provided economic model for the drug.
According to the cost watchdog, Lilly’s economic model for tirzepatide couldn’t be “fully [scrutinized]” by NICE’s external assessment group. Further, Lilly failed to provide evidence showing how the model results compare with other economic models for diabetes.
Also at issue, Lilly’s model is “unclear” when it comes to predicting long-term health benefits on Mounjaro, such as avoiding complications of diabetes versus other GLP-1 drugs. Because of those uncertainties, “it is yet to be established if tirzepatide represents good value for money,” NICE said.
“Our committee can see the promise in tirzepatide but it requires more evidence to be able to evaluate both its clinical and cost-effectiveness,” Helen Knight, director of medicines evaluation at NICE, said in a press release.This is still draft guidance, and not final, so Lilly can still convince NICE of it's drug's value.
Mounjaro snagged its type 2 diabetes nod in the U.S. back in May 2022. Stateside, the drug is homing in on a coveted obesity nod later this year, which could position tirzepatide to challenge Novo’s semaglutide newcomer Wegovy.
Analysts have pinned high hopes on Mounjaro’s potential megablockbuster trajectory. Last year, analysts at UBS opined that Lilly’s med could become one of the “biggest drug[s] ever,” with the potential to rake in some $25 billion in peak sales.
On the obesity front, Mounjaro recently aced body weight measures in the phase 3 SURMOUNT-2 trial, where the drug helped diabetic patients who are obese or overweight lose up to 15.7% of their body weight.
Still, it hasn’t all been smooth sailing for Mounjaro and its GLP-1 rivals. Earlier this month, the European Medicines Agency (EMA) ramped up scrutiny of the popular class of new drugs, raising a safety signal about the potential risk that the diabetes and obesity drugs could cause cancer.
As for Lilly’s chief rival Novo Nordisk, the Danish drugmaker’s obesity blockbuster-in-waiting, Wegovy, clinched NICE’s recommendation back in February 2022.
In early June of this year, meanwhile, the U.K. government unveiled a two-year pilot program that will allow Novo’s Wegovy to reach more overweight participants even though the treatment has yet to launch across the pond.
The pilot program will reduce waiting lists for the GLP-1 drug and relieve “huge” pressure on the NHS, U.K. Prime Minister Rishi Sunak said in a release.