Rapid and efficient changes of medicines

Before a completely new medicine can be introduced as a standard treatment at public hospitals, the Danish Medicines Council must first evaluate and recommend it. This also applies when a medicine with an extended indication is to be recommended as standard treatment.

When multiple medicines are available to treat a disease, Amgros can conduct a tendering procedure in which the different medicines compete against each other in a national tender. The purpose is to create competition and achieve lower prices.

For Amgros to be able to conduct a tender, the Danish Medicines Council must prepare treatment guidelines, a clinical comparative basis, and, where relevant, a cost analysis for a therapeutic area, such as multiple sclerosis. The treatment guidelines and the clinical comparative basis describe which medicines are clinically equivalent and at which doses—that is, equally effective in treating patients within the relevant therapeutic area. This applies both to the efficacy of the medicines and to any potential side effects. The cost analysis describes the treatment-related costs associated with the medicines included in the clinical comparative basis.

Once Amgros has identified the winners of the tender, the Danish Medicines Council prepares a medicine recommendation. In this recommendation, the Council ranks the clinically equivalent medicines according to which are associated with the lowest costs. In this way, hospitals can see which medicines they should choose based on the overall costs.

After we have prepared and issued the implementation memo, the Implementation Group meets. The group consists of representatives from the regions – hospital pharmacies, pharmaceutical committees, and clinical pharmacologists – as well as Amgros.

All members of the group have a direct role in practical implementation. The group discusses how implementation can be carried out in practice and the practical considerations associated with the process. For example, if it concerns a new medicine that resembles one already used by hospitals, the regions discuss how they intend to proceed. They also consider how quickly they expect to switch medicines and how they plan to do so, what resources such a change will require, whether the new medicine requires more space or different handling, and whether patients may need to visit the hospital more frequently.

When hospitals need to switch medicines, they must update their clinical guidelines. If a guideline—for example on rheumatoid arthritis—states that a specific medicine should be used in a particular situation, but another medicine is now to be used, the region will need to revise its guideline.

The same applies to information in the electronic patient record, which must also be updated to include the new medicine. In addition, the medicine must be replaced physically—both at the hospital pharmacy and in the medicine room, and possibly with the patient. Furthermore, staff may need to be trained in handling the new medicine, and patients may require instruction in its practical use.