The Medicines Council is an independent council established on January 1, 2017, by the board of Danish Regions.

The Medicines Council assesses if new medicines and existing medicines with new indications can be recommended as standard treatment and issues treatment guidelines and recommendations for the five Danish hospital regions. Without a recommendation from the Medicines Council, hospital medicines will most likely not be used in Denmark. Therefore, engaging in the Medicines Council process is critically important for market access in Denmark.

Amgros is the joint pharmaceutical procurement service for the Danish Regions. Amgros was established to create economies of scale and achieve administrative savings by centralising the procurement of pharmaceuticals. To that end, Amgros ensures the secure supply of medicines to hospitals in Denmark, and by way of tenders and bulk purchasing, Amgros ensures that the medicines are purchased at the lowest possible price.

A possible recommendation as standard treatment of new medicines and new indications is based on a medical assessment and classification of the added clinical value to patients and on an economic assessment of the effect on cost per patient and hence overall budget impact. After the assessment of the added clinical value of the medicine, price negotiations between Amgros and the pharmaceutical company are conducted.

To get a recommendation as standard treatment, pharmaceutical companies with new medicines or new indications must submit an application to the Medicines Council.

When EMA has issued a recommendation for approval (positive opinion), the applicant can submit a preliminary application including information about the medicine and indication, relevant clinical trials and expected timeline for the final application. Approximately 4 weeks after submission of the preliminary application, the Medicines Council sends a protocol to the applicant.

The protocol contains the following elements:

Based on the protocol and as soon as possible following the Commission’s approval, the applicant submits the final application to the Medicines Council. The final application must include the information requested in the protocol and a cost per patient and budget impact analysis.

After submission of the final application, the Medicines Council classifies the added clinical value of the product. The cost and budget impact analysis are assessed by Amgros, price negotiations are performed, and finally the Medicines Council makes its recommendation.

Incentive is the largest health economics consultancy in Denmark.

Since the launch of the Medicines Council, we have assisted a number of pharmaceutical companies with their applications. For some companies, we have assisted with the entire process; for other companies, we have completed the cost per patient and budget impact analysis. We join with our client companies in meetings with Amgros. Through our meetings with both the Medicines Council and Amgros, we have established good relations with all parties and we can help with informal contacts and questions.

We maintain a database (MEMO) of information about the Medicines Council’s protocols, assessments and decisions for every application. We share relevant information from the MEMO database via the LinkedIn group “Market Access in Denmark”.

We have developed considerable expertise in cost and budget impact analysis and we have developed an easy-to-use Excel model which meets the Amgros guidelines and which our clients submit to Amgros.

At Incentive, we have significant experience with and in-depth knowledge of the Medicines Council processes. We can help you with your preparations, submissions and dialogue with the Medicines Council and Amgros.