Ireland on the cusp of obesity treatment revolution but high cost of drugs causing disquiet – The Irish Times

Ireland is on the cusp of a revolution in treating obesity, but the state’s inability to cope is raising concerns about health services.

New weight-loss treatments have been hailed as miracle drugs, but their initial results have caused huge cost headaches for the HSE and concerns about equitable access among doctors and patients.

Heavily promoted by celebrities and influencers, the new drugs are generating tremendous demand worldwide, leading to concerns about affordability and access. Designed to treat obesity, they are being phased out worldwide, leading to severe product shortages.

Ireland lags behind other countries in providing these treatments, but the HSE has launched the first new generation of obesity treatment Saxenda. Demand has increased by 42 percent and is now expected to spend more on anti-obesity treatments in one year than budgeted for in five.

[ Access to groundbreaking anti-obesity drugs to be limited due to ‘unprecedented’ demand ]

The next drug, Wegovi, which is more effective in trials and requires once-a-week daily injections of Saxenda, is expected to boost demand even more. A low-dose version known as Ozempic is available here, but it is officially only for the treatment of diabetes.

Other products in development are on the way that are said to be even more effective in helping people lose weight.

They changed our clinical approach to the problem, because they were the first to be very effective for obesity.

– Francis Finucane, Endocrinologist and Professor of Medicine

The new drugs offer new hope to people who have struggled with weight for years, for whom many other options have failed. “These drugs can help you lose 20 to 25 per cent of your excess weight, which can lead to a significant improvement in quality of life,” said Susie Birney, director of the Irish Obesity Coalition.

Francis Finucane, an endocrinologist at University Hospitals Galway and professor of medicine at the University of Galway, said: “These treatments are very important breakthroughs in the treatment of obesity and its complications.

They have changed our clinical approach to the problem, because they are the first effective drugs for obesity, and the only safe and effective option is bariatric surgery, which has very limited access, especially for the general public. in Ireland.”

Side effects

There are side effects, the most common of which are nausea and vomiting. And there’s evidence that people who stop taking them regain the weight they lost — and then some.

“No matter how good these drugs are, getting them tolerable is a problem,” says Finucane. “In our specialist obesity clinic, patients are waiting up to two years for an assessment, and despite 70 per cent having a medical card, their obesity drugs are almost unfunded by the government.

Birney is concerned about the “blurring of lines” between those who need these treatments and those who need them. “Obesity drugs are for people who need treatment for severe obesity. It should be given priority,” he said.

[ Ozempic: the reality of the miracle weight-loss jab ]

Some overweight people’s desperation to lose weight is often driven by stigma, she says. “Being overweight of any kind is very despised in society, people want to do anything to get rid of weight. The problem is that many people want to use these drugs only to be in a slim body.

The history of previous anti-obesity drugs and the role of drug companies in promoting exciting new treatment options give cause for concern. Anti-obesity drugs are expensive, must be taken for life and for now, their long-term effects are unknown.

There is no doubt that these drugs cause weight loss. It has not been shown whether they reduce the negative effects of being overweight, such as cardiovascular problems.

– Professor Michael Barry, Clinical Director of the National Center for Pharmacoeconomics

As clinical director of the National Center for Drug Economics, Professor 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 are very effective,” he said. “There is no doubt that these drugs will reduce weight. Whether excess weight reduces adverse effects such as cardiovascular problems has not been shown.

Pharmaceutical treatments for obesity have been around for decades, but there have been many false dawns. A drug has been shown to help people lose weight but increases their risk of heart attack. Another was linked to high blood pressure and a third had to be withdrawn from the market due to the risk of suicide.

Lizard venom

A new generation of weight-loss drugs is based on a substance discovered for the first time in a rare lizard found in US deserts, which affects blood sugar levels. The substance was short-lived, but scientists developed it for use in humans to make patients produce more insulin when they needed it.

Known as the GLP-1 (glucagon-like peptide-1) receptor, the first use of this synthetic hormone was to treat diabetes, but when scientists discovered that it caused weight loss in test mice, a new research frontier opened up. In the year In 2021, semaglutide, marketed as Wegovy and based on lizard venom, received US approval.

In a market with such a large potential — more than 60 percent of adults are overweight — Barry’s concern is with price. “We are looking at a maximum spend of €55 million per year on this drug group, and this will increase significantly after the acquisition of Wegovi.

“We see a significant increase of 30,000 patients on these drugs and a corresponding increase in costs. This is one of the biggest pricing challenges we will face in the coming years.

Partnering with drug companies can help control costs, even at the cost of delaying access to patients. Saxenda was originally priced at €3,500 per patient per year, but Barry said the price finally agreed was “very low”.

Another way to contain costs is to limit drug availability. To be eligible for Saxenda, patients must have a body mass index of 35 or higher, have pre-diabetes 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 for those reasons, Barry said. A similar managed access program could be developed for other obesity medications.

Only a “handful” of Finucane’s patients meet the eligibility criteria: “After going through the bureaucratic application process, we have at most a 50:50 chance of getting funding for them.” As a result, most of them provide their own needs with their own money.

‘high genetics’

Birney says she understands the government’s concern over cost controls, but points out that many obese people have tried every other option. “Many people lose weight many times, but because their body has a different genetic makeup, they cannot continue to lose weight. “People don’t understand that.”

“There are psychological components, and it can be highly genetic – 40 to 70 percent of obesity is hereditary.”

Five days a week I was in the gym for three hours every morning and I walked eight kilometers five days a week. I couldn’t maintain that amount of exercise, but as soon as I lost weight, I started to gain weight.

– Susie Birney, Director of the Irish Coalition for People Living with Obesity

She says she has lost significant weight five times in her life, but each time the weight “gained back and more.”

“I gained 11 stone after bariatric surgery. I have never reached a normal BMI [body mass index], so I always felt like a failure. I used to walk for an hour every day and I still didn’t lose a kilo. Five days a week I was in the gym for three hours every morning and I walked eight kilometers five days a week. I couldn’t maintain that level of exercise, but as soon as I lost weight, I started gaining weight.”

Armed with positive trial results, the pharmaceutical companies behind the new treatments were aggressive in promoting them. Novo Nordisk, the Danish company behind Wegovi, Saxenda and Ozempic, was recently banned by the UK Pharmaceutical Industry Association for Saxenda-related marketing violations.

The company paid out £21.7 million over three years as part of a campaign to boost impact for health organizations and professionals in the UK.

Its separate Irish branch paid €345,000 in consultancy and registration fees to health professionals and organisations.

[ Business: Slimming drug Wegovy triggers significant forecast upgrade at Novo Nordisk ]

Many of the voices talking about new obesity treatments or their companies in the media have received payments from the company, which it says supports medical education.

Same substance

Barry says he has no problem with a drug company marketing its products, but “I’m concerned when people publicly extol the virtues of the drug.”

But he believes that these drugs “do what they say on the tin.”

Saxenda to treat obesity, Ozempic to treat diabetes and Wegovy are not yet available in Ireland. Ozempic and Wegovy are the same substance in different doses. Doctors can prescribe “off-label” drugs that are approved for different indications.

Finucane said that his clinic is inclined to prescribe Ozempic because in his opinion “maybe better” than Saxenda and, importantly, it is cheaper – about €130 per month to €250 Saxenda.

Novo Nordisk last year told Irish doctors it had permission to guide “appropriate prescribing” and Saxenda, but not Ozempic, to treat obesity. “The stronger Ozympic – Wegovi – is actually licensed in Europe for obesity, sometimes in the clinic the decision not to use Ozympic for treating obesity in Irish patients is commercial, not clinical,” says Finucane.

“Global stock shortages and supply problems have affected access to Ozympic for Irish patients. This reflects a ‘tale of two obesity’ – one a daily struggle with serious health problems, the other a cultural desire for thinness.

“It is hard to stomach to see patients’ health getting worse when Ozympic is prescribed instead of beauty clinics.”

“They are all different products with different indications, different doses and different titration schedules,” said a spokesperson for Novo Nordisk.

Ozympic “is only approved by the European Medicines Agency for the treatment of type 2 diabetes, so we can only market this medicine under this approval.” Wegovi and Saxenda “are both approved 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 in several other countries in 2023. After the launch, the EMA will require all pharmaceutical companies to ensure fair supply in the EU markets where the products are available. Without favoring countries with large markets. Novo Nordisk They face similar supply challenges that affect the broader pharmaceutical sector and broader economic activity.