New pharmaceuticals and negotiations


The Danish Medicines Council assesses whether to recommend new drugs and new indications of an existing pharmaceutical as a standard treatment at Danish hospitals. Amgros negotiates prices of new pharmaceuticals.

The Danish Medicines Council applies the internationally recognised measurement unit QALY (quality-adjusted life years) to assess the effect of new medicines.

QALY is a standardised measurement that combines quality of life and survival. QALY can thus be used to compare health improvements across different diseases, treatment options and focus areas.

For more information about QALY and the application process, visit the Danish Medicines Council website

After the Danish Medicines Council has completed a clinical and health economic assessment of a new medicine, Amgros negotiates the price with the supplier. 

On the basis of the assessment by the Danish Medicines Council and price negotiated, the Danish Medicines Council will decide whether the price of the medicine is reasonable in relation to its effect. And whether the Danish Medicines Council will recommend the drug as a possible standard treatment.

PRICE NEGOTIATIONS

The purpose of the negotiations is to agree on a price level that gives a reasonable match between the effect of the medicine and costs compared with the current standard treatment.

Amgros bases its negotiations on the assessment report from the Danish Medicines Council and existing and future market conditions.

THE NEGOTIATION PROCESS
Negotiations between Amgros and the supplier can begin once the Danish Medicines Council’s draft assessment report has been sent to the supplier. At the same time, Amgros also receives the draft assessment report. Typically, the entire negotiation process lasts a maximum of 14 days. This means that the timeframe for holding a negotiation meeting between Amgros and the supplier is short.

At the negotiation meeting between Amgros and the supplier, the supplier may briefly present the medicine and provide comments on the Danish Medicines Council’s assessment report as a basis for negotiating the price. The meeting also provides an opportunity to clarify the content of the agreement between Amgros and the supplier.

Typically, two Amgros negotiators participate in the negotiation meeting. The lead negotiator will serve as the supplier’s point of contact throughout the negotiation process. Depending on the case, it may also be relevant to involve a procurement specialist or a pharmaceutical advisor.

Following the negotiations, Amgros prepares a negotiation memo for the Danish Medicines Council. The memo includes the outcome of the negotiations as well as Amgros’ assessment of current and future market conditions.

The Danish Medicines Council then makes the final decision on whether the medicine can be recommended as standard treatment in public hospitals. The negotiation memo forms part of the Council’s overall case documentation and will be published on the Council’s website once a decision has been made.
ALTERNATIVE AGREEMENTS
In some cases, alternative agreements can be used as a tool to reduce uncertainty when the Danish Medicines Council assesses new medicines and indication extensions.

Amgros defines alternative agreements as any agreements other than those based on a “simple discount”.

Amgros has established a set of principles for the use of alternative agreement models to ensure consistent and transparent treatment of all suppliers.

Read more about the principles, the negotiation process and the use of alternative agreement models.

NEW SUPPLIERS

If a new supplier has a need for dialogue with Amgros on the negotiation process or agreement conditions, we can arrange a meeting before negotiations commence. 

There is more information here - How to become an Amgros supplier.

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New pharmaceuticals and negotiations

Procurement and supply

Amgros informs the hospital pharmacies when we have set up an agreement to purchase a pharmaceutical. After this, hospital pharmacies send their purchase orders to the supplier

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New pharmaceuticals and negotiations

Efficient changes of medicines

Amgros works closely with the regions - hospital pharmacies, pharmaceutical committees and clinical pharmacologists - to ensure that new medicines get into use rapidly as standard treatment at hospitals - and thereby get to patients quickly too. Together, we also ensure that the regions can reap the savings as soon as possible because the medicine will have been through our national tendering procedure.

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New pharmaceuticals and negotiations

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.

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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