Following the introduction of the procedure for off-label prescription of medicines in December 2022, the Serbian Government has now put in place the rules for reimbursements from the Health Insurance Fund (RFZO) for off-label use of medicines.
Until December 2022, the Serbian law had not regulated off-label prescription of medicines. In practice, healthcare institutions prescribed medicines for off-label use when there were no other medicines on the market approved for specific therapeutic indications.
In December 2022, the Government amended the Rulebook on Medical Prescriptions (Pravilnik o obrascu i sadržini lekarskog recepta, načinu izdavanja i propisivanja lekova) to regulate for the first time the prescription of medicines for off-label use. Off-label use means prescription of medicines for unapproved use, i.e. use not encompassed by the marketing authorisation. That may include use for an unapproved indication or in an unapproved age group, dosage, or route of administration. Certain drugs, such as drugs for paediatric use, are routinely used off-label.
The amended Rulebook provides the conditions which must be satisfied in order for the healthcare professional to be allowed to prescribe a medicine for off-label use. One of the requirements is that the ethics committee of the relevant healthcare institution has issued, based on a decision of a panel of medical doctors, an opinion confirming that the specific off-label use is necessary for the treatment of a particular patient. The healthcare professional prescribing the medicine for off-label use must obtain an informed consent form the patient (or its legal guardian), on the form which is provided in the Rulebook.
Following these developments, the Government of Serbia has amended the Rulebook on Contracting Healthcare Services with State Healthcare Fund in 2023 (Pravilnik o ugovaranju zdravstvene zaštite iz obaveznog zdravstvenog osiguranja sa davaocima zdravstvenih usluga za 2023. godinu), which entered into force on 20 May 2023. The amendments provided for the reimbursement of medicines prescribed for off-label use in hospitals and clinics (but not in primary healthcare institutions). Patients in Serbia will no longer have to pay out of pocket for the medicines prescribed for off-label use. The medicines eligible for reimbursement are included in the amended List C within the List of Medicines which are approved for prescription at the expense of state health insurance fund, applicable as of 18 May 2023. The list includes all medicines for paediatric use, malignant and rare diseases, and primary autoimmune diseases.