The Danish Medicines Agency (Lægemiddelstyrelsen) supports the EU’s recommendation: Ozempic should only be prescribed to diabetics. The Danish Medicines Agency (Lægemiddelstyrelsen) has expressed its support for a new recommendation from the EU, suggesting that the drug Ozempic should primarily be prescribed to diabetics and not for weight loss. To avoid drug shortages, doctors are encouraged to prescribe diabetes and weight loss medications exclusively to the patient groups for which they are approved. This call comes from the European Medicines Agency (EMA) and the EU’s task force on supply security.
Ozempic, a GLP-1 analog with the active substance semaglutide, is one of the most well-known drugs in this class. The same substance is also found in the weight loss drug Wegovy. The high demand for Ozempic has caused serious supply problems throughout 2023 and 2024, which could result in a critical shortage for the patients who need it the most.
The Danish Medicines Agency (Lægemiddelstyrelsen) emphasizes that these drugs should not be used for what they describe as “cosmetic weight loss.” The current supply situation is still unstable, which is why the recommendations from the EMA are supported. The agency specifies that doctors should prescribe GLP-1 analogs, specifically approved for diabetes, to diabetic patients, and analogs approved for the treatment of severe obesity or obesity with health problems, to the relevant patient group.
For patients who do not fall within these target groups, guidance on lifestyle changes, diet, and exercise is recommended instead. An increasing number of subsidies for Ozempic have led to a significant increase in the regions’ drug expenses, which has raised concerns about whether the drug is being prescribed to the right patient groups.
Currently, doctors have the option to prescribe Ozempic off-label to patients with severe obesity but without type 2 diabetes. However, these patients cannot receive subsidies. Off-label prescribing means that a drug is used for a purpose other than what it is officially approved for. The Danish Medicines Agency (Lægemiddelstyrelsen) warns that such a practice is likely to worsen the current supply problems and thus threaten the treatment of diabetic patients.
Recently, the Danish Society of General Medicine (Dansk Selskab for Almen Medicin – DSAM) applied to the Danish Medicines Agency (Lægemiddelstyrelsen) to introduce generic substitution between Ozempic and Wegovy in doses up to one milligram. Generic substitution would allow for replacing one drug with another that contains the same active substance. The background for the application is a recent price reduction on Ozempic, which has not been followed by a comparable reduction on Wegovy. According to Bolette Friderichsen, the chairperson of DSAM, this will ensure that patients always receive the most economically advantageous and available drug, regardless of whether Wegovy or Ozempic was originally prescribed.