The medicine rituximab is used by many Norwegian health authorities to treat MS, even though it has no indication for this disease. There has been debate in the media as to whether this use is financially motivated.
Dagens Medisin 18.04.18: Utenfor godkjent bruk - er det innafor?
Dagens Medisin 13.09.18: Off-label striden: Hul bekymring for pasientens beste
Medicines are used off-label in many areas and for different reasons. The medical assessment carried out by a doctor in consultation with the patient is important, and the principle of the doctor's unrestricted right to issue prescriptions applies.
According to Norwegian legisaltion doctors are also obliged to consider the prioritisation of resource use within the health service. Healthcare personnel should ensure that healthcare does not inflict unnecessary loss of time or expense on patient, health care institution, insurance or other.
The Norwegian Medicines Agency (NoMA) is of the opinion that:
- The appropriate use of medicines off-label is the responsibility of the health service and the supervisory responsibility of the Norwegian Board of Health Supervision.
- Marketing authorisation and an approved summary of product characteristics are prerequisites for and establish the conditions for the lawful marketing of a medicine. These conditions do not instruct the prescriber.
- The authorisation process (MA process) adds value in the form of documentation and the follow-up of the quality, safety and efficacy of medicines. The health service should be willing to pay for this value.
- The Norwegian Medicines Agency realises that there is a limit to this willingness to pay.