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expert reaction to NICE’s draft guidance on tirzepatide for obesity

Scientists react to NICE publishing draft guidance on tirzepatide for obesity.

 

Dr Simon Cork, Senior Lecturer in Physiology, Anglia Ruskin University, said:

“The new guidance for tirzepatide is interesting in its marked difference in certain areas to the guidance for semaglutide.  Both drugs in theory have the same physiological basis, and would therefore be expected to have similar guidance.  However the guidance for tirzepatide around prescribing in primary and secondary care settings represents a significant shift from the guidance for semaglutide, which is for prescription only within a tier 3 service.  It is of note that tier 3 services are patchy across the UK, meaning more patients could potentially gain access to tirzepatide through their GP.  That there is no 2 year time limit (as there is with semaglutide) is also note worthy.  It’s worth noting that with semaglutide, around two-thirds of the weight lost is reversed within a year of stopping the drug.  There is no indication that this would be different with tirzepatide and indeed it is noted within the documents that they expect weight regain to occur within 2 years.  That there is no time limit on the prescribing of this drug is welcomed and will be better for patients, with the understanding that obesity is a lifelong condition requiring lifelong treatment.

“It is worth noting that the weight loss associated with tirzepatide is also greater than that observed with semaglutide with patients losing on average 22.5% body weight over 72 weeks, compared with semaglutide’s 16% body weight loss over 68 weeks.  This evidence, along with the more favourable prescribing guidelines has the potential to place tirzepatide at a competitive advantage over semaglutide.

“Ultimately there will still be a limit on the number of people who are eligible for this drug, with a requirement for patients to have a BMI over 35kg/m2 and an associated comorbidity.  This represents very few patients in the UK and so we should expect demand from alternative sources for those who do not meet the eligibility criteria to be similar to that observed for semaglutide.”

 

Dr Nerys Astbury, Associate Professor Diet & Obesity, University of Oxford, said:

“The NICE recommendation for use of tirzepatide (manufactured under the name Mounjaro by Ely Lilly) for managing overweight and obesity recommend the use of this drug for managing overweight and obesity, alongside a reduced calorie diet and increased physical activity in adults, if the individuals have a BMI >35 kg/m2 and they have at least 1 weight related co-morbidity (e.g. type 2 diabetes, sleep apnoea, osteoarthritis etc).  A lower BMI threshold of >32.5kg/m2 is recommended for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds, where there is evidence the health risks of being overweight or obese occur at lower BMI than for people from white ethnic backgrounds.

“Interestingly, whilst the recommendations for patient eligibility are the same as those for semagluatide (manufactured under the name Wegovy by Novo Nordisk), the other licenced weight management drug, there are differences in the committee’s recommendations.  Semaglutide is only recommended for use in people in combination with a specialist weight management service, with multidisciplinary input (such as a tier 2 or 3 weight management service).  The problem with this is that the provision of specialist weight management services in the UK is unequal and very limited, or completely absent in some regions.  Where these services do currently exist, they are over-subscribed or there are plans for them to be de-commissioned.

“However, unlike the recommendations on use of semaglutide, these new recommendations for the use of tirzepatide for the management of overweight and obesity do not include any caveats that it must be prescribed as part of a specialist weight management service.  This gives rise to the possibility that it could be prescribed to individuals in a range of primary and secondary care settings, where the weight management programme could use a lighter touch approach.  This is likely to widen access to treatment, particularly for individuals who cannot access a specialist weight management service in their area or are stuck on the wating list for these services.

“Whilst there may be some concerns over the credibility and variation in behavioural weight management, there are also several digital approaches either already available, or in development which could be used as a platform to the prescription of obesity pharmacotherapy.

“The introduction of more pharmacological options to help healthcare professionals outside specialist weight management settings treat people living with obesity can only be seen as a good thing.  Having more options, and brining competition to the market is likely to drive down the costs in the longer term.  What’s more these new recommendations are likely to increase the accessibility of obesity pharmacotherapy to many more people.

“However, as the numbers of people living with overweight and obesity continues to increase, there are likely to be challenges in implementing additional services to meet the increasing demand for these treatment options in the future.  This may be particularly felt in the already overstretched primary care sector, where GPs may feel that they do not have the have capacity to cope with potentially increased demand as well as the need to implement additional weight management services that these new recommendations are likely to bring.”

 

Prof Sir Stephen O’Rahilly MD FRS FMedSci, Professor of Clinical Biochemistry and Medicine, and Director, Medical Research Council Metabolic Diseases Unit, University of Cambridge, said:

“NICE have concluded that tirzepatide is a cost-effective therapy which should be available on the NHS for a subgroup of people living with very significant levels of obesity (BMI > 35) and already suffering from at least one of its adverse health consequences. Given the very positive recent results of large, randomised control trials with this drug and its beneficial effects on a range of outcomes, this decision is not surprising.  We are clearly in a new era of obesity management where, for the first time, we can have access to medicines which are effective and, though not without some side effects, largely safe.  This class of injectable drug is currently expensive, providing particular challenges to a taxpayer-funded health system like the NHS.  In the longer term, these drugs significantly reduce the risks of developing distressing and expensive complications such as Type 2 diabetes, heart attacks and kidney failure but their cost provides an immediate financial challenge at a time when NHS budgets are tight.

“The genie is out of the bottle here. Safe and effective drug treatment for obesity is not going to go away.  We must continue to work on making our environment less promoting of obesity.  But that will take political will and time.  Even if we do so, there will still be people who develop obesity because they have a very strong inherent predisposition.  Medicines such as tirzepatide will become a central plank of how we help people living with obesity to live longer and healthier lives.”

 

Prof Naveed Sattar, Professor of Cardiometabolic Medicine/Honorary Consultant, University of Glasgow, said:

“I think the guideline appears pragmatic given we have to start somewhere and that for now, helping people at greater risks of more rapidly developing other obesity related comorbidities – e.g. those with higher BMIs – seems sensible, even if many others at risk will initially be denied.  As drug costs come down and more evidence accrues on additional benefits, BMI thresholds for treatment will come down.  However, with so many already living with BMIs over 35, there will be considerable work to treat and care for this group of individuals in the NHS.”

 

 

‘NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Draft guidance consultation: Tirzepatide for managing overweight and obesity’ was published by NICE on Tuesday 4 June 2024.

https://www.nice.org.uk/guidance/indevelopment/gid-ta11156/consultation/html-content-8

https://www.nice.org.uk/guidance/GID-TA11156/documents/draft-guidance-2

 

 

Declared interests

Dr Simon Cork: “No CoI.”

Dr Nerys Astbury: “No conflicts to declare.”

Prof Sir Stephen O’Rahilly: “Professor O’Rahilly has received remuneration for advising a range of pharmaceutical and biotechnology companies developing medicines for obesity and diabetes but, at least in the last 10 years,  this has not included Lilly, the manufacturers of Tirzepatide.”

Prof Naveed Sattar: “I have consulted for several companies that make anti-obesity medicines including Eli Lilly, Novo Nordisk, AstraZeneca, Boehringer Ingelheim and Amgen, as well as other companies that market products in the cardiometabolic space.”

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