The Swedish Medical Products Agency (MPA) has warned patients not to take a lower-than-prescribed dose of obesity drugs, following media reports of medication rationing by people intending to stretch their supply and save money.

Weight-loss medicines such as Mounjaro (tirzepatide) and Wegovy (semaglutide) have standardised doses. However, patients or doctors could set a lower dose, using an unofficial technique dubbed “the click method”, where users manually count the mechanical clicks while turning the dial of the prefilled injection pen.

Johanna Henriksnäs, Team Leader at the Efficacy and Safety department at the Swedish MPA, warns that this practice deviates from the method of use reviewed and approved by the Swedish agency and the European Medicines Agency (EMA).

“There are significant risks of incorrect dosing if the prefilled injection pen is not used as intended. Furthermore, the injection pen will be used for a longer period than intended when the ‘click method’ is used. There are no approved data showing that the medicine remains stable when used for longer than intended,” she told Euractiv.

Lowering costs

Tirzepatide and semaglutide are only reimbursed for people with type 2 diabetes in Sweden and elsewhere. France has recently become the first EU country to reimburse the cost of weight-loss drugs for patients with severe obesity.

According to the Swedish Radio report, the main reason for rationing the dosage is to save money. Swedes are paying €90 to €452 each month out of their own pocket for the medication, depending on the dosage regimen.

Henriksnäs does not believe that the agency should take action against the use of the click method at this stage.

“In Sweden, we have freedom of prescription. This means that the doctor has the right to prescribe a medicine even if the criteria set out in the summary of product characteristics are not fully met,” she explained, adding that prescriptions must be based on science and proven experience, “and the treatment is carried out under the responsibility of the prescribing doctor.”

Private sector practice

No public caregiver in Sweden is using the method, Euractiv has learned. However, it is offered by private settings like Yazen, a digital healthcare provider specialising in obesity, which has a total of 48,000 active patients. Yazen is Swedish-owned and currently operating in seven EU countries. Most of its obesity patients live in Sweden (34,500), followed by the Netherlands (11,500 patients) and Spain (600 patients).

Speaking to Euractiv about the MPA warning, David Buchebner, Yazen’s Chief Medical Officer, noted that they thoroughly inform their patients on how to manage and set the injection pens. “It’s not a case of just clicking away on your own, because it’s important to take the right dose,” he remarked, explaining that the cost of the drugs is an important factor leading some of the patients to discontinue treatment.

However, managing side effects such as nausea, vomiting, abdominal pain and diarrhoea and adjusting the medication individually are equally important, Buchebner noted.

“Costs cannot drive how we doctors organise treatments, but many of our patients are not high earners and are finding it quite difficult to make ends meet. If we can ensure that the method is safe for patients, reduce side effects and lower the cost, that is fine.”

He also pointed out that these are long-term, sometimes lifelong, courses of treatment.

An international phenomenon

David Buchebner, a specialist in endocrinology, also leads Yazen’s research projects across seven European countries. So far, they have treated around 50,000 patients and gained a great deal of clinical experience, he said.

In September, Yazen plans to present data on the outcomes of different dosages of the type 2 diabetes pills Rybelsus (semaglutide) and Wegovy (semaglutide) pen injections.

Medication rationing of modern weight-loss drugs has also been reported in other European countries, such as Great Britain.

In a survey conducted by LloydsPharmacy Online Doctor among 2,000 people taking weight-loss medication in the UK, nearly half (47%) said they had modified their dosing regimen to save money, the British Pharmaceutical Journal reported earlier this year.

[VA]