New medicines and new indications
The applicant must conduct a cost and budget impact analysis for new medicines and new indications assessed by the Medicine Council. Amgros assesses the validity and relevance of the submitted analyses.
Price negotiations will be based on the cost- and budget impact analysis in combination with the Medicine Council's evaluation of the added clinical value. After conclusion of the price negotiation, the Medicine Council reaches a final decision on whether to recommend using the medicine for standard treatment or not.
Process for new medicines and new indications
The figure below illustrates the assessment procedure for new medicines carried out by the Medicine Council.
DAY 150 MEETING
The objective of the Day 150 meeting is to provide the best possible basis for an appropriate assessment process for the medicine, including:
• Presentation of the medicine and a review of the expected health economic analysis
• Alignment of expectations and specification of deliverables to Amgros
• Timeline from Day 150 until decision by the Medicine Council.
When the applicant has scheduled a Day 150 meeting with the Medicine Council secretariat the applicant is advised to contact Amgros. Amgros will then invite the applicant for a meeting to discuss the health economic aspects of the medicine. The Day 150 meeting between Amgros and the applicant will always take place after the meeting between the Medicine Council secretariat and the applicant.
When submitting an application to the Medicine Council, the applicant must also submit two types of economic analyses for Amgros’ assessment: a cost analysis and budget impact analysis.
The purpose of the cost analysis is to estimate the total incremental cost to society per patient for the compared medicines.
Budget impact analysis
The purpose of the budget impact analysis is to estimate the total economic impact of using the medicine on a regional level.
The applicant must develop the economic analyses according to “Guidelines for cost analyses relating to new medicines and indications in the hospital sector”
The analyses must be of a standard that meets the requirements defined by Amgros. For this reason we recommend the applicant to use “AMGROS Estimating unit costs” The applicant should also familiarise with ”AMGROS Inspiration to presentation of cost and budget impact analyses.”
Dialogue with the applicant when needed
It is important for Amgros to maintain a good dialogue with the applicant during the process. This will provide the best possible conditions to ensure that the application follows the specifications for time horizon, methods and quality. The need for dialogue will vary on a case-by-case basis. However, applicants are encouraged to contact us to resolve any queries concerning the process or if something changes in the course of the process.
The applicant can maintain a dialogue with Amgros throughout the process, up until the Medicine Council has reached a decision. The dialogue is of particular importance in relation to the Day 150 meeting and in connection with the assessment of the submitted economic analyses.
Assessment of submitted economic analyses
Amgros will automatically receive the economic analyses when the applicant has submitted the final application to the Medicine Council secretariat. As the next step, Amgros assesses the economic analyses. Our assessment comprises of the following aspects:
• Does the applicant comply with the method guidelines?
• The quality and overall uncertainties of the cost model.
• The quality of the evidence provided.
• Relevance to Danish clinical practice.
When we have assessed the submitted analyses, the applicant may have to answer questions from Amgros. If the analyses have several shortcomings, or if the extent of our questions makes it more practical to discuss them in person, we can decide to invite the applicant for a meeting. Amgros will always be the party to invite to this meeting. The applicant can make no such request.
In addition to our questions to the applicant, Amgros will often make queries to professionals at the hospitals regarding the resource use estimated in the analyses. This way it is ensured that the estimates presented in the analysis are relevant to Danish clinical practice.
Reporting of economic analyses
After receiving the applicant’s answers to our questions and, if needed, made adjustments, the results of the analyses will be reported and published. The reporting procedure follows the description in “Template for reporting of Amgros’ evaluation of costs analyses for new medicines and new indications in the hospital sector”. The applicant is encouraged to use the same template for their reporting of the cost analyses.
Negotiation and recommendations to the Danish Medicine Council
When the Medicine Council has reached, a decision concerning the added clinical benefit of a medicine, Amgros will initiate negotiations with the applicant (only for added value categories 1-4). The purpose of the negotiations is to reach a reasonable relationship between the added clinical benefit of the medicine and the added costs of using the medicine compared with the current standard treatment.
The negotiations will be based on the conclusions on the added clinical benefit from the Medicine Council and the conclusions on the added costs of using the medicine from Amgros.
The Medicine Council then reaches a final decision as to whether to recommend using the medicine as standard treatment based on the compiled evidence and the outcome of Amgros’ negotiations.