Background information on reassessment of reimbursement status
The commission report of the Reimbursement Committee
In 2003, the Minister of the Interior and Health established a committee on medicinal product reimbursement, which presented a number of proposed changes in the reimbursement area in their commission report no. 1444 of May 2004 entitled “Medicinal Product Reimbursement and proper use of medicinal products.” One of the proposals concerned the periodic reassessment of the reimbursement status of medicinal products. The Committee wrote, among other things
"that such reimbursement decisions should not be permanent decisions on the reimbursement status of these medicinal products, as the assumptions that were decisive in reaching the original decision on, for instance, general reimbursement for a medicinal product may change over time."
Against this background, the Committee recommended
"that the issue of the reimbursement status of medicinal products should be subjected to periodic reassessment with a view to evaluating whether the assumptions underlying the original decision on granting or non-granting of reimbursement remain to be valid."
The Committee emphasised
"that reassessment of the reimbursement status according to a fixed time schedule provides an opportunity to take into account experiences from the actual use of the medicinal product, including whether the current reimbursement status has contributed to a rational use of the medicinal product in practice."
The Committee indicated that there is a need to ensure the necessary openness about the background for the decisions made. Against this background, the Committee recommended
"that the Danish Medicines Agency take the initiative to define the framework for a new procedure for fixed, regular reassessments of reimbursement status, involving the relevant parties in this work."
The Government agreed with the recommendations of the Committee and presented a proposal for amendment of the Health Security Act in November 2004, according to which the Minister of the Interior and Health is authorised to determine specific rules on the reassessment of the reimbursement status of medicinal products. The bill was adopted unanimously by all the parties of the Danish Parliament, and the authorisation now appears from Section 7a(2) of Act no. 1431 of 22 December 2004 on Amendment of the Act on National Health Security etc., which entered into force on 1 April 2005.
The specific rules on reassessment of the reimbursement status of medicinal products have subsequently been defined by the Minister for the Interior and Health in Executive Order no. 180 of 17 March 2005 on Reimbursement of Medicinal Products. It appears from Section 3 that the Danish Medicines Agency is responsible for the reassessment and that the reassessment shall be carried out in accordance with the criteria for granting general reimbursement defined in the Executive Order.
Rules and guidelines
The detailed rules on the reassessment of the reimbursement status of medicines are established in the Ministry of Health's executive order no. 671 of 3 June 2016 on reimbursement (Danish title: Sundheds- og Ældreministeriets bekendtgørelse nr. 671 af 3. juni 2016 om medicintilskud). Section 3 provides that it is the Danish Medicines Agency that performs the reassessment and that the reassessment is to take place in compliance with the criteria established in the executive order on the granting of general reimbursement.
The Danish Medicines Agency's reassessment procedure is described in our guideline on the periodic reassessment of the reimbursement status of medicines (in Danish only).
Initial discussions on establishing a reassessment procedure
The Danish Medicines Agency conducted initial discussions with the Reimbursement Committee which, pursuant to Executive Order no. 167 of 14 March 2001 on the Rules of Procedure of the Reimbursement Committee, is tasked with ”advising the Danish Medicines Agency on medicinal product reimbursement matters, pursuant to Section 7f(1) of the Danish National Health Security Act.”
The discussions were held at the meetings of the Reimbursement Committee on 22 June and 17 August 2004 and concerned the establishment of the procedure for setting the framework for regular reassessments of the reimbursement status of medicinal products, including an identification of the elements that may form part of the reassessments and how the relevant parties can best be involved in the establishment of this procedure. The discussions resulted in a proposal for the elements to form part of the reassessments.
At a meeting on 4 November 2004, the Danish Medicines Agency discussed the proposal with representatives appointed by the following, invited institutions, organisations etc. interested in reimbursement:
- Danish Association of the Pharmaceutical Industry
- Danish Medical Association
- Danish Medical Society
- Danish College of General Practitioners
- Danish Council of Organisations of Disabled People
- DSI•Danish Institute for Health Services Research
- IGL – Danish Industry Association for Generic Medicines
- Institute for Rational Pharmacotherapy
- The Association of County Councils in Denmark
- The Danish Association of Parallel Importers (not present)
The members of the Reimbursement Committee also participated in the meeting.
The proposal was subsequently revised to reflect the views that were presented at the meeting or were later received from the interested parties, and which were within the framework of the intentions of the Reimbursement Committee and the Act in respect of periodic reassessment of the reimbursement status of medicinal products. The revised proposal is now described in ”Guideline on the periodic reassessment of the reimbursement status of medicines (in Danish only)".