NICE accepts slower rollout of tirzepatide but GP workload concerns remain

NICE has accepted a request from NHS England to slow down the roll out of weight-loss drug tirzepatide, reserving eligibility for those with the highest clinical need at first.

However its final draft guidance on use of the weekly injection, published today, still means around a quarter of a million people gaining access to the drug over the next three years.

Commenting on the announcement, the RCGP warned that a rollout at the proposed scale would have a ‘significant’ impact on primary care, with ‘serious consideration’ needed to be given to the impact on general practice as even more patients become eligible.

This is the second publication of draft guidance for tirzepatide, after NHS England warned the first set of guidance – published this summer – would have had a ‘profound impact’ on GPs with millions of patients eligible for treatment within months.

Under the recommendations, tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity, in adults, with a BMI of at least 35 kg/m2 and at least one weight-related comorbidity.

Lower BMI thresholds (usually reduced by 2.5 kg/m2) should be used for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds, NICE said.

It was found to be cost effective after data from the SURMOUNT-1 study reported that after 72 weeks 96.3% of those on tirzepatide had lost 5% or more body weight, compared with 27.9% in the placebo group who also received diet and exercise advice.

Yet NICE agreed that more time would be needed to make the drug available to all those who may benefit.

In the final draft update, NICE said it had accepted that NHS England was taking ‘considerable effort to ensure that patients for whom a delay in access to tirzepatide represents the greatest risk will have access to it under the planned interim commissioning policy’.

But it asked NHS England to come up with a more detailed plan of who exactly would be eligible in the first pilot phases based on clinical need rather than BMI alone.

This would include immediately prioritising patients already receiving care in specialist weight management services where wraparound care is available.

NICE said it wanted decisions to be based on careful consideration of highest clinical risk such as that set out in a joint position statement on phased introduction of weight loss medicines by the Society of Endocrinology and Obesity Management Collective UK.

And it said while NHS England had cited a period of 12 years to make the drug available to 3.4 million patients, NICE believes ‘there is likely to be scope to complete implementation within a significantly shorter period’.

The phased roll out will be reviewed after the first three years to look at ‘real world evidence’ of how effectively current services were operating, costs to the NHS, and whether it could be scaled up through a variety of models, including digital support for patients.

ICBs will have three months to offer the drug to those already in specialist weight management services and six months to start a phased introduction to other eligible groups.

Figures suggest 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.

In Wales, tirzepatide will be available for local health boards to prescribe through the All-Wales Weight Management Pathway but a review will be done to determine whether it should be more widely available with Welsh Ministers to make a decision.

Professor Jonathan Benger, NICE’s chief medical officer, said they wanted to help NHS England carefully manage the roll out of tirzepatide to ensure that other services are not disproportionately impacted.

‘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.

‘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.’

RCGP chair Professor Kamila Hawthorne said: ‘Expanding the rollout of tirzepatide at the scale proposed will have significant practical and resource implications for the NHS and primary care. It’s right that the proposals prioritise those patients most in need of weight loss medication – but moving forward, as more patients become eligible, serious consideration will need to be given to the impact this will have on general practice.

‘It’s vital that general practice is resourced appropriately, and that GPs have the necessary training to safely take on any additional responsibility that comes their way.’

She also said that ‘expanding the number of patients eligible for weight loss jabs, should not be seen as an alternative to properly resourcing other services designed to help patients lose weight, such as those that support patients to make lifestyle changes and weight loss clinics through to bariatric surgery’.

‘Different patients will respond to different interventions, so these services need to work alongside each other. We also don’t know how long tirzepatide should be taken for, as it appears that when it is stopped, weight gain can recur.’

Dr Kath McCullough, NHS England’s national specialty advisor for obesity, said weight loss drugs, such as tirzepatide, were an important tool in helping people lose weight while also reducing the risk of other serious long-term conditions.

‘However, on their own, weight loss drugs are not a magic bullet. They need to be prescribed by a healthcare professional alongside programmes that help people lose weight and live healthier lives by making changes to their diet and physical activity – and it’s also crucial that they are prioritised for those who need them most.

‘This guidance enables the NHS to implement a phased roll out 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.’