For several years, Amgros has been using alternative agreement models when negotiating prices for new medicines. In other words, all agreements other than those based on a “flat discount”. Alternative agreements help reduce uncertainty and enhance the decision basis when the Danish Medicines Council assesses whether a new drug is to be taken into use as a possible standard treatment at Danish hospitals. For example, this could be because of scant data at the time of approval.
Following input from suppliers, the Danish Medicines Council and Amgros have now updated the form that suppliers use to request for an alternative agreement.
The aim is to help suppliers to validate an agreement proposal before submitting an application to the Danish Medicines Council.
Suppliers have to submit an updated form to Amgros and the Danish Medicines Council when they ask the Danish Medicines Council to assess a new medicine. Up to now, Amgros has not received the form until day 0 in the application process at the earliest.
If Amgros can start dialogue before the actual the application process commences, we can advise suppliers on how best to build the proposed alternative agreement into their application so that it can be used in a negotiation.
“By starting the dialogue earlier, we hope to be able to help validate suppliers’ applications to the Danish Medicines Council. This can provide a more flexible negotiation process with Amgros, and facilitate the application process at the Danish Medicines Council. In this way the new form can support our task to secure new and innovative medicines for patients at Danish hospitals,” said Flemming Sonne
Irrespective of what model Amgros and the supplier agree on, the Danish Medicines Council will always decide whether it can recommend a new medicine or extension of indication as a possible standard treatment at public hospitals.
Amgros concluded the first alternative agreement in 2015.
Amgros concluded the first effect-based agreement in 2020.
Amgros has concluded 19 alternative agreements, of which 10 are still current. The 10 current agreements are divided into four different types of alternative agreement models (price-volume model, subscription model, patient initiation model, effect-based model).
Since 1 September 2021, Amgros has received 21 proposals for alternative agreement models from 15 companies.
Of these:
- nine proposals were rejected by Amgros because the medicine was included in a tendering procedure, or for technical reasons, or because it was not possible to validate the agreement proposal
- four proposals were rejected by the Danish Medicines Council, all because the costs were not reasonable in relation to the effects, especially after taking into account the uncertainty about the effect
- three agreements were established
- two proposals were withdrawn by the supplier
- three are being assessed
Read more about the alternative agreement models here (in Danish).
Read more about Amgros’ principles for alternative agreement models here.
Read more about the Danish Medicines Council’s application process here.
Contact
Karen Torgny
Senior Specialist- Communication
I’m responsible for overall communication at Amgros, including PR. And I help to ensure that we communicate with the surrounding world in an open and engaging manner.