NICE has outlined a phased three-year rollout of tirzepatide, with patients already in specialist weight management services among the first to receive the drug.

Summary: UK’s NICE has released final draft guidance for a phased three-year rollout of the weight loss drug tirzepatide, starting with patients in specialist weight management services who will be eligible to receive the drug within 90 days of the final guidance. NHS England plans to publish its interim commissioning guidance early next year, and those patients with the highest clinical need, outside of specialist weight management services, will start to be offered tirzepatide from 180 days after NICE final guidance is published.

Key Takeaways:

Phased Rollout to Begin with Specialist Services: Patients in specialist weight management services will be among the first to access tirzepatide within 90 days of NICE’s final guidance.
Recommended Patient Groups: Tirzepatide is recommended for those with obesity (BMI >35) and weight-related illnesses, including obstructive sleep apnea, hypertension, and type 2 diabetes.
Broader Access Planned Over Three Years: NHS England will prioritize high-need patients initially and develop a phased plan to expand access to approximately 220,000 eligible individuals during the initial three-year period.

Around a quarter of a million people living with obesity will be offered the weight loss drug tirzepatide, alongside a reduced-calorie diet and increased physical activity, over the next three years, final draft guidance from the United Kingdom’s National Institute for Health and Care Excellence (NICE) has outlined.

The medicine is recommended by NICE for people with a body mass index of more than 35 and at least one weight-related illness.

As this accounts for a large number of people (around 3.4 million in England), the rollout of tirzepatide has to be carefully managed to ensure healthcare professionals can continue to meet the full range of health needs of all their patients, according to NICE. Initially, only those with the highest clinical need will be prioritized to receive the medication while the National Health Service (NHS) tests new services to care for people living with obesity.

Initial Rollout Prioritizes Specialist Weight Management Services

Following a consultation held in October on NHS England’s request to roll out the medication over 12 years, NICE has published its guidance on the way forward.

This includes prioritizing people who are already receiving care in specialist weight management services who will be able to access tirzepatide within 90 days of NICE’s final guidance being published if clinically eligible.

NHS England will develop a plan detailing which other groups of patients will be offered tirzepatide in the next three years. The license for tirzepatide lists examples of weight-related illnesses for which the drug should be considered such as obstructive sleep apnea, hypertension, dyslipidaemia, cardiovascular disease, prediabetes, or type 2 diabetes.

NHS England plans to publish its interim commissioning guidance early next year, and those patients with the highest clinical need, outside of specialist weight management services, will start to be offered tirzepatide from 180 days after NICE final guidance is published. In total around 220,000 people are expected to benefit in this initial three-year rollout period.

Evidence-Based Approach for Long-Term Implementation

During this time evidence will be generated to understand the most effective forms of care, and this will inform a NICE re-evaluation of the remaining rollout period to the wider group of eligible patients.

“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. Tirzepatide and other drugs like it, such as semaglutide, will help people living with obesity to lose weight, and as a result will reduce their risk of developing heart disease or having a stroke,” says professor Jonathan Benger, CBE, MD, FRCS, FRCEM, NICE’s chief medical officer, in a release. “But tirzepatide is not for everybody, and only those with the highest clinical need will be treated initially. This means many people will have to wait. We have had to make this difficult decision in order to protect other vital NHS services and also to test ways of delivering this new generation of weight loss medications.

“We want to help NHS England carefully manage the rollout of tirzepatide to ensure that other services are not impacted in a disproportionate way. Whilst the funding variation sets a maximum of 12 years, NICE will review the situation again within 3 years and provide further advice on how the rollout of this medicine can be managed using the learning gained from the initial phase.

“This will ensure the rollout of tirzepatide reaches everyone who is eligible in a safe and effective way.”

Tirzepatide Shown to Aid Weight Loss, Deemed Cost-Effective for NHS Rollout

Tirzepatide (also known as Mounjaro and made by Eli Lilly) has been shown in clinical trials to be more effective than diet and exercise support alone and when compared with semaglutide alongside diet and exercise support. On average patients lost 21% of their body weight in 36 weeks during the SURMOUNT-4 trial.

The medicine could be offered in either primary or secondary care, with appropriate support focused on diet and nutrition, behavioral and lifestyle elements, physical activity, and where appropriate, mental well-being. Clinical assessment and support are essential.

An independent NICE committee recommended the self-administered weekly injection for people living with obesity in draft guidance issued in June. Kwik Pens are £122 each at the highest 15mg dose, and each pen contains four doses which is four weeks’ supply. It is estimated that the medicine and associated wraparound care services will cost the NHS in England around £317.2m per year by the third year of implementation.

Despite the considerable cost, the evidence presented to the NICE committee suggests this medicine is a cost-effective use of NHS resources for some patients. When people with obesity who already have weight-related illness lose weight, it reduces their risk of developing further health complications due to their obesity. This prevents future ill health and saves money for the NHS that can then be reinvested in other services, according to the committee.

“This guidance enables the NHS to implement a phased rollout of tirzepatide to patients with the highest clinical need in a safe and effective way, while also protecting access to the NHS services that all patients rely on,” says Kath McCullough, PhD, NHS England’s national specialty advisor for obesity, in a release.

NICE is also releasing its guideline to help people living with overweight and obesity. It includes evidence-based recommendations on the prevention and management of overweight, obesity, and central adiposity in children, young people, and adults. It brings together and updates all of NICE’s previous guidelines on overweight and obesity.

Those who aren’t eligible for tirzepatide or semaglutide but want to improve their health by losing weight are urged to seek further information via NHS Better Health.