Alternative agreements


Amgros has been using alternative agreement models for several years. These ensure that patients have access to new, expensive and innovative medicines. We apply a number of principles for using alternative agreement models. Among other things, these principles ensure that all suppliers are treated equally.

Alternative agreements are agreements that use instruments other than a flat discount. They are an important tool when there is uncertainty about a medicine’s effect or financial impact—for example, when the data basis is limited at the time of approval.

These agreements can therefore help ensure that new treatments can be introduced more quickly at Danish hospitals.
OUR PRINCIPLES
We have established clear principles for alternative agreements. These are intended to ensure a simple process, fair competition, and equal treatment of suppliers. We have developed these principles by listening to our suppliers, engaging in dialogue with colleagues from other countries, and by consistently weighing the costs of new agreement models against their benefits.

When assessing an alternative agreement, we place emphasis on:
  • ensuring that the agreement is as simple as possible and can be handled in practice
  • minimising administrative burden in clinical settings
  • ensuring that the agreement can operate within existing logistics and payment systems
  • ensuring that competition is not affected—neither in the short nor the long term
Overall, there are two types of agreements:
  • financially based agreements
  • outcome-based agreements
You can read more about these here (in Danish).

We assess, on a case-by-case basis, whether an alternative agreement is relevant.

In dialogue with the supplier, Amgros will determine which type of alternative agreement model can be applied in the specific case.

In parallel, working with hospital pharmacies and the relevant clinical departments, Amgros will carry out a professional assessment of how the agreement can be designed in practice. This is to ensure that the agreement can be handled operationally.

Regardless of the agreement model, it is always the Danish Medicines Council that decides whether a new medicine or an extension of indication can be recommended as standard treatment at public hospitals.

As a general rule, Amgros prepares agreements and terms and conditions in Danish.
DIALOGE MEETING AND NEGOTIATION

Suppliers wishing to establish an alternative agreement model must complete and submit this form for both Amgros and the Danish Medicines Council: Request for alternative agreement model

The form must be submitted at the same time as the supplier sends its request for assessment to the Danish Medicines Council. The Medical Council's website contains a detailed guidance for applications with alternative agreement models (in Danish).

The form contains a section in which the supplier can request a dialogue meeting with Amgros. After we receive a request, in cooperation with the supplier, we will agree when in the Danish Medicines Council's assessment process one or more dialogue meetings with Amgros can take place. The aim of the dialogue meeting is to validate the proposed agreement model, so that it can be used in a negotiation.

The form is dynamic. In other words, the form can be changed if required after a dialogue meeting with Amgros or the Danish Medicines Council.

If the agreement involves ATMP (Advanced Therapy Medicinal Products), it is possible to have a meeting before the request for assessment is sent. This is because these products entail a large number of elements which can secure an easier implementation at Danish hospitals, if they are addressed at an early stage.

When Amgros and the supplier negotiate an alternative agreement model, prices will be negotiated for two scenarios:

  • The price based on a “flat discount”.

  • The price is based on the alternative agreement model that has been agreed may be relevant. 

We negotiate prices for both scenarios in order to support the Danish Medicines Council in their further assessment process as well as possible.
 
Read more about the negotiation process: New pharmaceuticals and negotiations

Read more about the assessment process by the Danish Medicines Council 

If you have any questions about alternative agreement models, please contact us at medicin@amgros.dk.

MODEL ALTERNATIVE AGREEMENTS

Amgros has prepared a list different models for alternative agreements. The list has some good ideas for suppliers and will help them prepare for their dialogue with Amgros.

List of models for alternative agreements (in Danish). 

STATUS ON ALTERNATIVE AGREEMENTS
In Amgros, we are open to entering into alternative agreements. We have been doing so since 2015.

Since 2021, we have compiled statistics on the number of requests received and the number of alternative agreements concluded. The data is updated once a year.


See our statistics on alternative agreements here.

READ MORE

Alternative agreements

New pharmaceuticals and negotiations

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

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Alternative agreements

Pharmaceuticals

Danes are living longer. And we can treat more diseases, because new and better drugs are entering the market all the time. This is good. But it’s expensive. Therefore, it is important that we are at the forefront of market developments.

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Marie Gerstrøm Kristiansen

Head of Consultancy and Negotiation

My job is to set the strategic direction for advice to our partners on new medicines' journey to the Danish market. We negotiate prices and agreements for new medicines and support subsequent implementation in the regions