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However its final draft guidance on use of the weekly injection still means around a quarter of a million people gaining access to the drug over the next three years.
This is the second publication of draft guidance for tirzepatide, after NHS England warned the first set of guidance – published this summer – would have had a ‘profound impact’ with millions of patients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.
NICE: Tirzepatide for managing overweight and obesity
1.1 Tirzepatide is recommended as an option for managing overweight and obesity, alongside a reduced-calorie diet and increased physical activity, in adults, only if they have:
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- an initial body mass index (BMI) of at least 35 kg/m2 and
- at least 1 weight-related comorbidity.
Use lower BMI thresholds (usually reduced by 2.5 kg/m2) for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds.
1.2 If less than 5% of the initial weight has been lost after 6 months on the highest tolerated dose, decide whether to continue treatment, taking into account the benefits and risks of treatment for the person.
- Prioritisation of cohorts for treatment will be based on a prioritisation statement led by clinical need and produced by NHS England that considers both referral prioritisation in specialist weight management services and priority cohorts in primary care. NHS England will make available to ICBs an interim commissioning policy outlining how patient cohorts should be prioritised and the service models that are recommended.
4.12 NICE will conduct a formal review to be completed within 3 years from the date of final guidance publication. This will consider:
- characterisation and quantification of the cohorts prescribed tirzepatide, including the common comorbidities
- real-world evidence on service implementation, associated costs and service uptake
- a comparison of the different service models trialled, including their feasibility and relative clinical and cost effectiveness, and
- whether any changes to the recommendations are appropriate.
Source: NICE
A version of this article first appeared in our sister title, Pulse.
