The Danish Regions’ plan for prioritizing medicine expenditure
At a press conference on 5 February 2016, the Danish Regions presented their new model for the assessment of medicine. As part of the implementation of the new model, a new prioritization structure will be established and this will likely be named the Medicine Committee.
The Medicine Committee will be composed of the Coordination Council for Placing in Service of Hospital Medicine (also known as KRIS) and the Danish Council for the Use of Expensive Hospital Medicine (RADS), which will now amalgamate into one organisation. It is a model, which has drawn inspiration from Germany, and which will apply an economic analysis to provide a stronger bargaining position and a stronger basis for public procurement for the Regions’ Phamaceutical Organisation, Amgros. The economic analysis is to include, amongst others, the advantages of the new medicines to the patients so as to ascertain an acceptable price range for the medicine.
The aim of the Medicine Committee
The aim of the Medicine Committee will be to ensure a quick and uniform application of new hospital pharmaceuticals across hospitals and regions. Moreover, the Medicine Committee will require increased documentation that the application of both new and existing medicine in the primary and secondary sector is to the advantage of the patients. As already mentioned, the formation of the Medicine Committee is to ensure a stronger basis for Amgros’ price negotiations and procurement.
It is a prioritization structure, in which Amgros will play a pivotal role, as Amgros will pinpoint the price range acceptable in negotiations with pharmaceutical companies calculated on the basis of the assessment of the Medicine Committee.
The Medicine Committee assessment procedure
On the basis of an application from a pharmaceutical company, the Medicine Committee undertakes a professional assessment of the added value offered by a medicine compared to pre-existing treatments. The added value is assessed on the basis of three patient-related criteria:
- Life extension
- Serious/not serious symptoms and side effects
- Health-related quality of life
Moreover, on the basis of the application, the Medicine Committee is to carry out a medical and statistical assessment of the new medicine. Then, the medicine is placed in an added-value category model comprising six categories ranging from no documented added value compared to standard/other treatments to significant added value compared to standard/other treatments.
It is on the basis of this process that Amgros carries out an economical analysis, which is based on the medical category and the derived costs of the medicine, in order to ascertain an acceptable price range for use in negotiations with the pharmaceutical industry.
In the event that a medicine is recommended for standard treatment, it may be applied immediately in the departments providing health care. Its application must be monitored for a period of time until sufficient information has been gathered so as to allow the Medicine Committee to assess whether the medicine should continue to be applied in the departments providing health care.
The work of the Medicine Committee and of Amgros must be characterised by transparency. For competitive reasons, the only aspect exempt from this basic premise of transparency is the negotiation on direct prices between the pharmaceutical companies and Amgros.
The processing time required to reach the decision as to whether or not a new original medicine is to be recommended for standard treatment is expected to be approximately three months from the issue of the marketing authorisation.
The composition of the Medicine Committee
The Medicine Committee will be composed of a chairmanship appointed by the health directors of the Regions and consisting of a chairman and a deputy chairman, five medical directors, one representative of the Organization of Danish Medical Studies, three clinical pharmacologists jointly appointed by the Regions, one hospital pharmacist, two representatives appointed by Danish Patients, one representative from the Danish Health Authority, one representative from the Danish Medicines Agency, one representative appointed by the Danish Association of the Pharmaceutical Industry and two professional representatives who are to be appointed by the Medicine Committee and who will provide the Committee with special knowledge and competences.
One last step
As mentioned previously, the Medicine Committee is still merely a proposed new structure for assessing medicine. The model has been approved by the executive committee of Danish Regions, but is yet to be reviewed by the Danish Minister for Health, the Danish Parliament, patients’ associations and the pharmaceutical industry.
DELACOUR follows the development of the new model for the assessment and prioritizing medicine.