Since the Medicines Council’s creation on 1 January 2017, Incentive has assisted a large number of pharmaceutical companies with applications to the Medicines Council. We assist some companies with the whole Medicines Council application process from start to finish. In other cases, we assist with elements of the application, e.g., cost-utility and budget impact analyses, and by participating in meetings with the Medicines Council’s secretariat.

The Danish Medicines Council is an independent council that completes medicine recommendations and treatment guidelines with medicine recommendations for the five Danish regions.

The Medicines Council assesses whether new medicines and indication expansions can be recommended as standard treatment in Danish hospitals. The Council also publishes treatment guidelines and medicine recommendations for the five Danish regions. If a medicine is not recommended by the Medicines Council, it will most likely not be widely used. Therefore, it is important to engage with the Medicines Council’s processes in order to optimise the medicine’s market access.

The Medicines Council has established a process by which new medicines and indication expansions are assessed on the basis of clinical results and costs compared to relevant existing standard treatments (current Danish clinical practice).

The application process follows the six steps shown below.

It is possible to initiate the process prior to the approval from the European Medicines Agency (EMA), but the application cannot be sent to the Danish Medicines Council before a “positive opinion” from the CHMP (the Committee for Medicinal Products for Human Use).

The first step in the process is to request for the Medicines Council to complete an assessment of the new medicine and to fill out a form with the information that is indicated in the Medicines Council’s process guide. The next step is to contact the secretariat of the Medicines Council to plan an early dialogue meeting.

Once the new medicine has received a ‘positive opinion’ from the CHMP (Committee for Medicinal Products for Human Use), the applicant can send in an application with information on the medicine and its indication, results and comparative analyses from relevant clinical studies and health economic analyses.

The secretariat of the Medicines Council validates the application within 10 working days. Day 0 is when the Danish Medicines Council finds the application satisfactory. The expert committee and the secretariat assess the application and complete an assessment report. The company negotiates with Amgros 13-14 weeks after the application is accepted. Finally, the Medicines Council decides whether the medicine will be recommended as standard treatment in Danish hospitals.

For a pharmaceutical company to get a new medicine or an indication expansion recommended as a possible standard treatment, the company has to request an assessment from the Medicines Council by completing a form that specifies what information should be included in the request.

The pharmaceutical company can also request a dialogue meeting with the Medicines Council. The dialogue meeting is based on the submitted request for assessment and the specific questions that have been sent to the Medicines Council ahead of the meeting. A dialogue meeting is an important opportunity to receive guidance on the Medicines Council’s expectations to the application itself, for example, with regards to clinical questions, comparators, outcome measures, systematic literature search, indirect comparisons and the health economic analysis.

There is a method guide on the Medicines Council’s website wherein the requirements for the application are specified. Among other things, the application must contain documentation of the medicine’s clinical effect and health economic analyses.

The Medicines Council’s recommendation is based on an assessment of whether the medicine’s effect (measured in QALY) and safety are proportional to the costs of using the medicine.

The health economic analysis consists of a cost-utility analysis. This is a health economic analysis in which the health gains are measured in QALY (quality-adjusted life years), which is a standardised measurement that combines quality of life and survival. QALY can be used to compare health gains across different diseases, types of treatment and focus areas. The result of a cost-utility analysis is expressed by an incremental cost-effectiveness ratio (ICER).

If the new medicine’s health effect is equal to the relevant comparator, the company can submit a cost-minimisation analysis.

At Incentive, we have a lot of experience with and in-depth knowledge of the Medicines Council’s processes. We can help you with your preparation, submissions and dialogue with the Medicines Council.

We have developed a database, MEMO (Medicines Council, Method and Overview), which contains information about the Medicines Council’s protocols, assessments and decisions for all applications since the Medicines Council was established in January 2017. We continuously track all relevant information from the applications, which enables us to easily compare applications and decisions and delve into specific disease areas.

We have also established the LinkedIn group Market Access in Denmark, where we share news, decisions from the Medicines Council and analyses.