Health economics


At Amgros, we support the Danish Medicines Council in assessing financial analyses for new pharmaceuticals and extensions of indications. Together with the Danish Medicines Council's assessment of the added clinical value of the pharmaceutical, our assessment forms the basis for price negotiations between the supplier and Amgros.

Is there is a reasonable relationship between the added clinical value from a new pharmaceutical compared with the existing treatment, and the costs this entails? This is basically the question to be answered by Amgros’ assessment of the financial analyses.
THE DANISH MEDICINES COUNCIL AND AMGROS

If a supplier wants to have a new drug recommended as a possible standard treatment at Danish public hospitals, the Danish Medicines Council has to assess it first. On the basis of an application from the supplier, the Medicines Council assesses the added value from treatment with the new pharmaceutical.

While the task of the Danish Medicines Council is to assess the added clinical value, Amgros’ role is primarily to assess whether the financial analyses submitted by the applicant are valid and relevant. We then assess the total costs associated with drug.

FINANCIAL ANALYSES

Two types of financial analyses have to be submitted, and Amgros will assess these on behalf of the Danish Medicines Council; cost analyses and budget impact analyses.

Cost analyses assess the direct costs of procurement of the pharmaceutical. And any indirect costs. The purpose of the cost analyses is to determine the incremental costs (additional costs or savings) of the treatments being compared.

The purpose of the budget impact analyses is to clarify the overall economic consequences for the regions from taking the applicant's drug into use.

The health economic analyses should be prepared in accordance with the instructions in:
If the applicant applies process data, the:
The quality of analysis should meet the requirements from Amgros. We therefore recommend that the applicant uses
The applicant should also read the

Amgros automatically receives the financial analyses when the applicant has submitted an application to the Danish Medicines Council Secretariat. Immediately after this, Amgros will assess whether the financial analyses are of acceptable quality. If the analysis is not up to standard, Amgros will notify the applicant that a new or revised financial analysis has to be submitted.

At the same time, the Danish Medicines Council Secretariat will carry out a preliminary assessment of the clinical part of the application.

When both Amgros and the Medicines Council Secretariat has carried out the preliminary assessment, the Medicines Council Secretariat will inform the applicant whether receipt of the application can be considered as final.

Amgros assesses:
  • Whether the applicant complies with the method guidelines
  • The quality and general uncertainties in the cost model
  • The quality of evidence
  • Relevance in relation to Danish clinical practice

After we have reviewed the analyses submitted, the applicant has to answer a number of questions. If there are deficiencies in the analyses, or if questions are such that it would be more appropriate to clarify them at a physical meeting, we can decide to invite the applicant to a meeting. Amgros will always be the party convening this meeting. The applicant cannot request such a meeting.

In addition to the questions for the applicant, we will also often ask a number of questions to specialists at hospitals. These will be about consumption of the pharmaceuticals in the analyses. This will enable us to ensure that the estimates in the analysis are relevant in relation to clinical practice.

REPORTING FINANCIAL ANALYSES

Together with the assessment by the Medicines Council of the added clinical value, the analyses form the basis for price negotiations with the supplier.

Read more about the negotiations on new pharmaceuticals here.

Amgros reports the results of the assessments of the financial analyses to the Medicines Council.

Go to Amgros’ reports on new pharmaceuticals. (Only available in Danish).

When we have received replies to our questions and carried out any adjustments, we report the results of analyses. These reports follows the format in the:

“Template for reporting of Amgros’ evaluation of costs analyses for new medicines and new indications in the hospital sector".

Applicants can draw inspiration from the same template for their cost analyses. We publish our report after the decision on the recommendation by the Danish Medicines Council.

INDEPENDENT AND PROFESSIONAL

Amgros is independent and objective when we conduct health economic assessments.

We always focus on being professional and transparent in what we do.

We also place high demands on the validity and professional quality of our assessments. It is crucial that we have the latest and most objective knowledge in the area.

In this way, we can ensure that all suppliers receive uniform and professionally based assessment of their products.

We haven’t yet seen the full potential of the health economic evaluations. But we can ascertain that they have a positive effect on the prices we are offered for new pharmaceuticals.
Sune Lindgaard,
head of Business Intelligence and Health Economics at Amgros.

Read more

Health economics

Negotiation of prices

When the Danish Medicines Council has determined the added clinical value of a new pharmaceutical, Amgros will negotiate with the applicant

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Health economics

New pharmaceuticals

If a new drug is to be considered as a standard treatment at Danish public hospitals, the Danish Medicines Council has to assess it first.

READ MORE

Sune Lindgaard

I’m responsible for operation and development of business intelligence and health economics. I make sure that our department can proudly claim to be the partner who gets things done.