The preapproved medicines on the reimbursement list may be prescribed directly by the physician. This is what is referred to as general reimbursement or preapproved reimbursement (blå resept). The Norwegian Medicines Agency assesses medications and determines which ones should be given under the general reimbursement scheme and conditions necessary for patients to access these reimbursed medicines.
Under certain conditions reimbursement list is still granted on the basis of individual patient applications for medications not included in the reimbursement list. Applications are sent by the physician to the Health Economics Administration (HELFO).
How does a drug get listed on the general reimbursement scheme?
The pharmaceutical company in ownership of the marketing authorization for a pharmaceutical can apply for preapproved reimbursement so that physicians can prescribe the reimbursed medicine directly to the patient. See: Application for reimbursement.
The Norwegian Medicines Agency assesses the application. In order for a reimbursement application to be granted, four criteria must be met:
- The drug is to be used in the treatment of serious diseases or risk factors with high probability of leading to, or exacerbating serious illness.
- The illness or risk of disease as mentioned above will necessitate or risk repeated treatment over a long period of time.
- The drug has a scientifically well documented and clinically relevant effect in a defined and appropriate patient population.
- Costs related to the use of the drug are reasonably related to the drug’s therapeutic value and costs associated with alternative therapies (cost-effectiveness).
The Norwegian Medicines Agency also considers the budgetary implications. If drug costs after granting reimbursement are below the so-called “bagatelle” threshold, then the Norwegian Medicines Agency evaluates and makes a decision. However, if drug costs are above this limit, the Norwegian Medicines Agency sends the case to the Ministry of Health and Care Services (HOD) who in turn forward it for political consideration and decision-making.
Reimbursement assessments are published in the news section on our website (use filter "Refusjonsbeslutninger").
Reimbursement reports from earlier periods can be found on our website under “Helseøkonomiske rapporter”.