spending watchdog gives powerful new drug Mounjaro the go-ahead, a year after refusing to approve it

Emily Stearn, health reporter for Mailonline

12:14 p.m., June 4, 2024, updated 7:26 p.m., June 4, 2024.

A ‘King Kong’ weight loss injection will be available on the NHS, health chiefs announced today.

According to current guidelines, only those with type 2 diabetes who do not have their condition under control are eligible to receive Mounjaro through the health service.

But draft guidelines from Britain’s medicines watchdog now recommend its use be extended for weight loss in those who are severely obese.

It comes just a year later The National Institute for Health and Care Excellence (Nica) said ‘more evidence’ is needed before the drug is given the green light for use on the NHS for weight loss.

The move shocked diabetes and obesity experts at the time, who agreed that the treatment, given by weekly self-injections, was highly effective.

Clinics charge around £40 for a week’s supply of Mounjar or tirzepatide. Patients who take it can expect to lose up to 20 percent of their body weight, data show. Anyone with a BMI above 30 ¿ the technical classification of obesity ¿ can get a private prescription

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Mounjaro, the brand name of the drug tirzepatide, has already been approved by the leaders of the American medical institutions for weight loss.

It also became available privately in Britain in February, with clinics charging around £40 for a week’s supply.

Research has shown that the drug, produced by US pharmaceutical giant Eli Lilly, could help obese people lose more than 20 percent of their body weight in less than a year and a half.

According to the draft guidelines, Nice recommended that anyone with a BMI of at least 35 and one weight-related comorbidity should be eligible for the drug.

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Eli Lilly proposed that it be available to anyone with a BMI of 30 or more and at least one weight comorbidity.

But the ‘cost-effectiveness estimates’ were ‘above the range that Nice considers an acceptable use of NHS resources’, the watchdog added.

Mounjaro would offer an alternative to Wegovy — or semaglutide — which was also in short supply due to huge demand.

Tirzepatide works by suppressing two hormones that regulate appetite, making people feel fuller for longer while also feeling less food cravings.

The jab should come in a four-dose syringe, which provides a month’s worth of treatment if used once a week, Nice said.

It was previously only available in single doses.

Patients in the US can already get the weight loss injection ‘off-label’ from some doctors, and many are sharing their incredible transformation.

One overweight man claimed the drug helped him lose up to 100 lb (45.4 kg).

Before and after pictures show the transformation of Matthew Barlow, a 48-year-old health technology executive who lives in California.

According to the latest data, digestive problems were the most frequently reported side effects of tirzepatide, the active ingredient of Mounjara. These included about one in five participants suffering from nausea and diarrhea, and about one in 10 reporting vomiting or diarrhoea.

He started using the drug last November. At the same time, he changed his diet and lifestyle, according to the recommendations.

‘Mentally, you don’t want to eat. Now I can eat two bites of dessert and be satisfied,’ he said.

Meanwhile, a TikTok user called Emily and claimed to have lost 140lb (63.5kg) since being surprised by the weight loss injections.

‘The incredible amount of joy that is in me when I look in the mirror now is crazy,’ she said. ‘I used to cry to myself in the mirror. Now I feel like one of the cool kids.’

Professor Sir Stephen O’Rahilly, Director of the Metabolic Diseases Unit at the University of Cambridge Medical Research Council, said today: ‘Given the very positive recent results of large, randomized controlled trials with this drug and its beneficial effects across a range of outcomes, this decision is not surprisingly.

‘We are clearly in a new era of obesity management where for the first time we can have access to drugs that are effective and, although not without some side effects, mostly safe.

‘This class of injectable drugs is currently expensive, which presents particular challenges to a taxpayer-funded healthcare system such as the NHS.

‘In the long term, these drugs significantly reduce the risk of developing distressing and expensive complications such as type 2 diabetes, heart attacks and kidney failure, but their cost is an immediate financial challenge at a time when NHS budgets are tight.’

He added: ‘This is where the genie is out of the bottle. Safe and effective treatment of obesity with drugs is not going away.

‘We must continue to work to make our environment less conducive to obesity. But that will require political will and time.’

Some Americans are already using it ‘off label’. One of them is Matthew Barlow, a 48-year-old health technology executive living in California, who said he has lost more than 100 pounds since November 2022 using Mounjaro and changing his diet.

Meanwhile, Professor Naveed Sattar, honorary consultant and expert in cardiometabolic medicine at the University of Glasgow, said Nice’s updated guidelines were ‘pragmatic’.

He added: ‘I think the guideline seems pragmatic given that we have to start somewhere and for now we are helping people who are at higher risk of developing other obesity-related co-morbidities more quickly, even if many others at risk will initially be turned away. .

‘As drug costs decrease and more evidence of additional benefits accumulates, BMI thresholds for treatment will decrease.

‘However, with so many people already living with a body mass index of more than 35, there will be a lot of work to treat and care for this group of individuals in the NHS.’

But like all medicines, Mounjaro is not without side effects.

The MHRA warned that the drug could affect how well the contraceptive pill works in obese or overweight patients.

Other potential side effects include nausea, diarrhea, vomiting – which usually goes away with time – and constipation.

Low blood sugar is also ‘very common’ in patients with diabetes, the agency added.

One trial involving 900 participants also found that a fifth suffered from nausea and diarrhoea, and around one in ten reported vomiting or constipation.

Other people taking the drug outside of clinical trials have reported hair loss while taking Mounjaro.

There is also a suggested association with an increased risk of cancer from stings.

The European Medicines Agency announced this year that research in rodents showed that artificial hormones packaged in tirzepatide could increase the risk of medullary thyroid cancer.

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