The Health Products Regulatory Authority (HPRA) has warned of a shortage of the weight loss drug Saxenda, citing an “unexpected increase in demand”.
The state began funding the cost of Saxenda to treat people with obesity in January under the drug payment scheme, capping costs at €80 per month for some.
The shortage is linked to ongoing shortages of a related product, Ozempic, from the same manufacturer, Novo Nordisk.
Ozempic is licensed to treat diabetes in Ireland but is also prescribed for weight loss. It is cheaper and significantly more effective for weight loss than Saxenda. Saxenda is not used to treat diabetes and is the only obesity medicine reimbursed by the state.
Earlier this month, Novo Nordisk, in agreement with the HPRA, called on health professionals not to put new patients on Ozempic.
It warned that using the drug for weight management was placing supply for diabetes patients at risk. The Medical Council issued similar guidance earlier this year.
However, obesity doctors have criticised the implication that prescribing Ozempic to their patients is unethical, and have warned that such guidance is discriminatory against people with obesity.
The Irish Saxenda shortage, notified by the HPRA on Friday, will continue until 5 October. However, the European Medicine Agency warned last month that supply of Saxenda in many European countries could remain intermittent for the rest of the year.
Professor Francis Finucane, a consultant endocrinologist and obesity doctor at Galway University Hospital, said the Saxenda shortage “results from the shortage of Ozempic”.
The shortage of the drugs is “a real threat, a real concern to people with obesity and type 2 diabetes” and “signifies the challenges patients with obesity face to access treatment”.
He said there was a “huge, global shortage” of these medicines.
I don’t think anyone foresaw the demand from the non-clinical sphere, driven by the cultural desire for thinness.
“We’re in the business in clinic of providing treatment for diseases, but there has been so much demand outwith the traditional biomedical sphere that it has created this shortage.
“The awareness of these drugs has grown very significantly as people have responded well to semaglutide [Ozempic],” he said.
He described the suggestion that Ozempic should not be prescribed to people with obesity as unethical, unfounded and “biased against people with the disease of obesity”.
Jack Shanahan, a community pharmacist in Co Kerry, said demand for Saxenda had increased “dramatically” since it was added to the drug reimbursement scheme in January, and as a result of the shortage of Ozempic.
He said he did not receive any supplies of Saxenda last month and received an insufficient amount for all his Saxenda patients this month.
“It would be fair to say that the wholesalers are struggling not just in relation to this shortage but multiple. Every prescription we dispense now has a shortage issue on it – especially if there’s more than one [medicine] on it,” he said.
The Department of Health said “medicine shortages are a feature of modern health systems worldwide and a global health problem, not unique to Ireland”, adding that a “multi-stakeholder medicine shortage framework” was in place to “help prevent potential shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise”.
Novo Nordisk told The Journal it continues to receive Saxenda supply into Ireland but was “experiencing stronger than anticipated demand for the treatment which is resulting in periodic supply constraints”.
It said it was working to maximise existing production and investing in new capacity to remedy the shortfall.
A HPRA supply shortage warning also remains in place for Ozempic until 15 October, due to manufacturing delays.
The HSE has put a “managed access protocol” in place limiting who can be reimbursed for the cost of Saxenda because of the potentially high cost of funding the treatment to the state. Patients must have a body mass index of over 35, pre-diabetes and a high risk of cardiovascular disease to qualify.
Twenty-three per cent of people in Ireland over the age of 15 have obesity, according to the 2019 Healthy Ireland survey.
To embed this post, copy the code below on your site
have your say