The new guidelines aim to simplify, systematise and standardise the application process for companies applying for the assessment of a new medicinal product/extension of a therapeutic indication involving an alternative contract model. 

Among other things, the guidelines specify the conditions that must be met for the Danish Medicines Council to evaluate a medicinal product based on an alternative contract model. In addition, the guidelines also contain requirements for how the alternative contract model must be incorporated in a request and application for an assessment by the Danish Medicines Council. 

If a company wishes to use an alternative agreement model, Amgros' and the Danish Medicines Council's new form for requesting an alternative contract (in Danish) must be used

The intention is that the new guidelines will ensure that companies already incorporate their proposal for an alternative contract model in the application for a medicinal product to be recommended as standard treatment by the Danish Medicines Council, and that the alternative agreement is negotiated before the Council meeting where the Council decides on a possible recommendation. Thus, a question about the form of agreement will not delay the Danish Medicines Council's recommendation.

In relation to contract models, it should be noted that standard price contracts are typically characterised by a fixed price for a specific period. Alternative contracts differ from regular price agreements in that they can be based on economic, effect-based or conditional contract models. 

An efficacy-based alternative agreement may, for example, be relevant if there is uncertainty about the clinical efficacy of the medicine, and the final payment may therefore depend on whether the patient has benefited from the medicine. A financially conditional alternative agreement, on the other hand, may be relevant when there is uncertainty about the number of patients for a given treatment. In this case, the agreement could be that the price decreases with increasing consumption.

Want to know more?

Read The Danish Medicines Council's guidelines for applications with alternative contract models (in Danish)

Read more about alternative contract models in Amgros' overview of alternative contract models (in Danish)

If you have have any questions you are always welcome to reach out to Plesner's Life Science team.