Quantify has reviewed the new guidance on reimbursement applications for hospital pharmaceuticals in Denmark and has summarized the requirements and implications for the pharmaceutical industry. Economic analysis is now mandatory for submissions and along with medical effectiveness forms the basis for price negotiations with the authorities. The economic analysis is evaluated by Amgros, while the medical effectiveness is evaluated by the Medical Council (Medicinrådet).

To find out a bit more, we talked to Andreas Pagh Rasmussen at Amgros on the updated evaluation process for hospital pharmaceuticals in Denmark.

What is the underlying rationale for implementing this new guidance for the reimbursement for hospital pharmaceuticals?
It is important for the Danish healthcare system that patients are offered treatments based on the intervention’s added value, which also includes taking costs into account. Therefore, in addition to an evaluation of the efficacy done by Medicinrådet, Amgros will now evaluate new pharmaceuticals and indications in the hospital sector also from an economical standpoint. This means that we will evaluate the cost per patient and the total budget impact. The results of the economic analyses and the analysis on the medical effect will jointly form the basis of the reimbursement decision.

What do you mean by hospital sector drugs?
Compared to, for example, Sweden, hospital sector pharmaceuticals in Denmark include a wider range of interventions. As a rule of thumb, you could say that these are pharmaceuticals prescribed by specialists.

What do you expect to be the greatest challenge in smoothly transitioning into the new process? Are there still any uncertainties around what it will mean in practice?
Since it is a new process, both we and the pharmaceutical companies have to adapt to the changes. To ensure that this goes as smoothly as possible we want to encourage an open and friendly dialogue between the parties. One important opportunity is the initial meeting between the pharmaceutical companies and Amgros at the beginning of the application process.

Regarding the cost analysis and the budget impact analysis, do you have any advice or special wishes directed to the companies, in order to make submissions of high quality?
We have provided clear and structured guidelines which describe the required analyses. Moreover, we prepared a template of how the analysis could look like and have collected and listed the most important unit costs which can be used in the analyses. As long as submissions are prepared in line with these documents and costs are calculated in a clear and logical way, there is a good chance that the submission is of high quality.

Do you expect applicants to submit a report or separate description of the calculations?
Some description is expected i.e. underlying assumptions for the calculations, but large reports or descriptions is not expected. If calculation, inputs and assumptions are easily understandable from the calculations in the spreadsheet no further description is needed. However, when additional descriptions might be helpful, applicants are welcome to submit them separately.

How will Amgros and Medicinrådet cooperate? How are responsibilities divided and who is the applicant’s main contact?
It will be assured that the medical and economic analyses are well aligned so that they together can form the basis of the overall assessment. This means, in practice, that Medicinrådet assesses the product and indication as well as the available evidence and then publishes minutes (protokol) where the cornerstones of the medical and economic analysis are specified, such as comparator and time horizon. The final economic analysis then has to be in line with these specifications. The applicant will be in contact with both Medicinrådet and Amgros and an open dialogue is welcomed. The final submission is made to Medicinrådet and will be forwarded to Amgros.

Will it be possible to send in a reimbursement application in English?
Yes, this is possible. We are currently working on the English version of the guidelines which will soon be available for non-Danish speakers.

If you have any questions regarding the new evaluation process for hospital pharmaceuticals in Denmark, please don’t hesitate to reach out to us.