Following its endorsement of Eli Lilly’s obesity medicine tirzepatide, England’s National Institute for Health and Care Excellence (NICE) has laid out plans for an unprecedented phased rollout that will limit the number eligible patients for three years.
The organization previously recommended the obesity drug, which is branded as Mounjaro in England and Zepbound in the U.S., for use alongside a reduced-calorie diet and increased exercise for people with a body mass index (BMI) of at least 35 kg/m2 and at least one weight-related health condition.
Those specifications cover a population of about 3.4 million people in England, but the NICE’s newly revealed plan calls for only about 220,000 people to receive the medicine through the National Health Service (NHS) over the next three years.
“The world will look very different in three years, which is why we’ve taken the unprecedented decision to review the way this medicine is delivered to patients then,” the NICE’s chief medical officer Jonathan Benger, M.D., explained in a press release. “Tirzepatide is not for everybody, and only those with the highest clinical need will be treated initially.”
While this means "many people will have to wait," the plan is intended to "protect other vital NHS services and also to test ways of delivering this new generation of weight loss medications," Benger added.
The NICE looks to publish its final draft guidance on the matter on Dec. 23. For 90 days after that, Mounjaro will go to only those who are already enrolled in specialized weight management services.
After 180 days, patients outside of the weight management services who have the “highest clinical need” can begin to access the drug, according to the NICE's release.
More specific guidance on clinical priorities will be posted by the NHS early next year, according to the release. The healthcare agency previously pitched the plan to NICE and proposed that those who have a BMI of at least 40 kg/m2 and at least three weight-related conditions get first dibs.
NICE will "review the situation again" in three years and use the information gained from the first phase to guide the wider rollout, Benger added.
While Eli Lilly welcomed the recommendation, Fernando Campo, the company's head of diabetes and obesity in Northern Europe, noted in a statement that it means "fewer than one in 10 of these eligible patients will be able to access treatment within the first three years."
“We look forward to working with NHS England to ensure we can best meet the current unmet need of people living with obesity and deliver on the government’s obesity goals," Campo added.
In England, four 15-mg Mounjaro pens go for 122 pounds sterling (about $155). Despite the "considerable cost" to the NHS, the NICE has determined that the medicine is cost-effective as it can cut the risk of further health complications for people with obesity.