Ireland stands on the cusp of a revolution in the treatment of obesity, but whether or not the State can afford it is causing concern in the health service.
New weight-loss treatments have been hailed as miracle drugs, but their first side effects are a giant cost headache for the HSE and disquiet among doctors and patients about fair access.
Heavily hyped by celebrities and influencers, the new medicines are generating phenomenal demand worldwide, leading to concerns about affordability and equity of access. Designed to treat obesity, they are being snapped up across the world, leading to massive product shortages.
Ireland is behind other countries in making these treatments available, but the HSE started reimbursing the first new-generation drug for the treatment of obesity, Saxenda, last January. Demand soared by 42 per cent per cent and it now expects to spend more on anti-obesity treatments in just one year than it had budgeted in five.
Two complaints about alleged abuse at HSE-run nursing home not investigated, Hiqa finds
Young adult mental health: ‘Stigma and embarrassment still play a significant role in reluctance to seek help’
Voluntary hospitals warn they may have to choose between paying staff and suppliers amid HSE cash limits
[ Access to groundbreaking anti-obesity drugs to be limited due to ‘unprecedented’ demand ]
The next drug, Wegovy, which was more effective in trials and needs to be injected once a week against daily injections of Saxenda, is expected to drive demand up further. A lower-dose version, known as Ozempic, is available here, but officially only for the treatment of diabetes.
Other products in development, said to be yet more effective in helping people lose weight, are on the way.
They have transformed our clinical approach to the problem, because they are the first really effective drugs for obesity
— Francis Finucane, endocrinologist and professor of medicine
The new drugs offer fresh hope to people struggling with excess weight for many years, for whom so many other options have failed. “These medicines help you lose up to 20 to 25 per cent of your excess weight. That can result in a vast improvement in quality of life,” says Susie Birney, director of the Irish Coalition for People Living with Obesity.
Francis Finucane, endocrinologist at Galway University Hospitals and professor of medicine at University of Galway, says: “These treatments are hugely important breakthroughs in the treatment of obesity and its complications.
“They have transformed our clinical approach to the problem, because they are the first really effective drugs for obesity, and they have become available when access to the only other really safe and effective option, bariatric surgery, remains very limited, especially for public patients in Ireland.”
Side effects
There are side effects, the most common of them being nausea and vomiting. And there is evidence that people who stop taking them regain the lost weight – and then some.
“Despite how good these drugs are, patient access to them is a problem,” Finucane says. “In our specialist obesity clinic, where patients are waiting up to two years for assessment, even though 70 per cent have medical cards, their obesity drugs are almost never funded by the State.”
Birney is concerned about a “blurring of the lines” between those who need these treatments and those who just want them. “Obesity medications are for the chronic disease of obesity, for the people who need treatment. That should be prioritised.”
[ Ozempic: the reality of the miracle weight-loss jabOpens in new window ]
The desperation of some people with obesity to lose weight is often driven by the stigma they feel, she says. “Having any sort of excess weight is so highly stigmatised in society, people want to do anything to get rid of weight. The problem is that many people want to use these drugs just be in a thinner body.”
The chequered history of previous anti-obesity drugs, and the aggressive role of drug companies in promoting lucrative new treatment options, gives ample ground for unease. Anti-obesity drugs are expensive, they need to be taken for life and, for now, their long-term effects are unknown.
There’s no doubt these drugs result in weight loss. Whether they’ll reduce the adverse impacts of excess weight such as cardiovascular problems has not been shown
— Prof Michael Barry, clinical director of National Centre for Pharmacoeconomics
As clinical director of the National Centre for Pharmacoeconomics, Prof Michael Barry’s job is to police the cost-effectiveness of new drugs.
“These drugs are different. They are reasonably well tolerated by patients, and they’re very effective,” he says. “There’s no doubt these drugs result in weight loss. Whether they’ll reduce the adverse impacts of excess weight such as cardiovascular problems has not been shown.”
Pharmaceutical treatments for obesity have been around for decades but there have been numerous false dawns. One drug appeared to help people lose weight but increased their risk of heart attacks. Another was linked to a rise in blood pressure, and third had to be taken off the market after it was linked to an increased risk of suicide.
Lizard’s venom
The new generation of weight-loss drugs are based on a substance first identified in a rare lizard found in US deserts, which was found to affect blood sugar levels. The substance had a short life but scientists modified it for use in humans to allow patients to produce more insulin as they needed it.
Their initial use of this synthetic hormone, known as a GLP-1 (glucagon-like peptide-1) receptor agonist, was to treat diabetes but when scientists noticed that it led to weight loss in test mice, a new research frontier opened up. In 2021, semaglutide, marketed as Wegovy and based on the lizard’s venom, won US approval.
With such a huge potential market – over 60 per cent of adults are overweight or obese – Barry’s concern is with cost. “We’re already seeing significant expenditure on this drugs group, €55 million a year, and that will increase dramatically once Wegovy is available.
“We’re going to see a huge increase in the 30,000 patients already on these drugs and an associated increase in costs. This will be amongst the biggest affordability challenges we face in the coming years.”
Haggling with the drug companies can help control costs, though at the price of delaying access for patients. Saxenda was originally priced at €3,500 per patient per year, but Barry says the price ultimately agreed was “significantly lower”.
The other way of containing costs is to limit access to drugs. To qualify for Saxenda, patients must have a body-mass index of 35 or more, be pre-diabetic and have evidence of cardiovascular disease such as high cholesterol or high blood pressure.
Half of the 2,600 applications for the drug since January have been rejected on these grounds, Barry says. A similar managed access programme is likely to be put in place for other obesity drugs.
Only “a tiny handful” of Finucane’s patients fulfil the eligibility criteria: “After engaging in a bureaucratic application process, our chances of getting funding approval for them will be 50:50 at best.” As a result, most self-fund their needs.
‘Highly genetic’
Birney says she understands the Government’s concerns over cost control, but points out that many people with obesity have tried every other option. “Many lose weight multiple times but they cannot maintain that weight loss because their body has a different genetic make-up. People don’t understand that.”
“There are psychological components, and it can be highly genetic – 40 to 70 per cent of obesity is heritable.”
I was in the gym three hours every morning for five days a week and walking eight kilometres about five days a week. I couldn’t maintain that level of intensity of exercise, but as soon as it decreased, my weight started to increase
— Susie Birney, director of the Irish Coalition for People Living with Obesity
She says she has lost significant weight on five occasions in her life but each time the weight “came back on, and more”.
“After bariatric surgery, I got to 11 stone. I never actually reached a normal BMI [body mass index], so I always felt a failure. I could be walking an hour every day and still not losing the pounds. I was in the gym three hours every morning for five days a week and walking eight kilometres about five days a week. I couldn’t maintain that level of intensity of exercise, but as soon as it decreased, my weight started to increase.”
Armed with positive trial results, drug companies behind the new treatments have been energetic in promoting them. Novo Nordisk, the Danish company behind Wegovy, Saxenda and Ozempic, was recently suspended by the UK pharmaceutical industry association over marketing breaches related to Saxenda.
The company has paid £21.7 million to health organisations and professionals in the UK over three years as part of an influence-boosting campaign.
Its separate Irish subsidiary has paid €345,000 to health professionals and organisations for consultancy and registration fees.
Many of the voices talking in the media about new obesity treatments or their organisations have received payments from the company, which it describes as being in support of medical education.
Same ingredient
Barry says he doesn’t have any problem with a drug company marketing its products but he has “a concern about people extolling the virtues of a drug in public”.
In the case of these drugs, though, he believes “they do what they say on the tin”.
In Ireland, Saxenda is available to treat obesity, Ozempic to treat diabetes and Wegovy is not yet available. Ozempic and Wegovy are the same ingredient in different doses. Doctors can prescribe approved drugs “off-label” for different indications.
Finucane says his clinic tends to prescribe Ozempic because it is in his view “probably better” than Saxenda and crucially, is cheaper – about €130 a month against €250 for Saxenda.
Novo Nordisk wrote to Irish doctors last year seeking to guide “appropriate prescribing” and making the point that Saxenda, but not Ozempic, is licensed for obesity treatment. “Given that the stronger dose of Ozempic – Wegovy – is in fact licensed for obesity in Europe, in clinic it sometimes feels like the decision not to make Ozempic available for treating obesity in Irish patients is a commercial rather than a clinical one,” Finucane says.
“Global stock shortages and supply issues have also affected Ozempic availability for Irish patients. This reflects a ‘tale of two obesities’ – one a daily struggle with a profound health problem, the other a cultural desire for thinness.
“Watching patients’ health deteriorate when they run out of Ozempic that’s been prescribed instead in beauty clinics has been difficult to stomach.”
A spokesperson for Novo Nordisk said Ozempic, Wegovy and Saxenda “are all different products with different indications, different dosages, and different titration schedules”.
Ozempic “is licenced by the European Medicines Agency for the treatment of type 2 diabetes only and therefore we can only market this medication in accordance with this licence”. Wegovy and Saxenda “are both licenced by the European Medicines Agency for the treatment of obesity”.
In Europe, the spokesperson said, Wegovy “has been launched in Denmark and Norway and we expect to launch it in a number of other countries in 2023. Once launched the EMA requires all pharmaceutical companies to ensure equitable supply across EU markets where products are available without favour for more countries with larger markets. Novo Nordisk faces the same supply challenges affecting the broader pharmaceutical sector and wider economic activity”.
