It is possible for companies to negotiate confidential prices with Amgros for selected medicines in the primary sector. Participation in the scheme is voluntary for companies and applies from 1 July 2025 to 30 June 2028. Amgros negotiates the confidential price with the original manufacturer of the medicine.
The regions assess whether an agreement should be made between the company and Amgros.
The Danish Medicines Agency will continue to make the final decision on reimbursement—now based on the negotiated confidential price.
Negotiating confidential prices within the reimbursement system will be relevant for original manufacturers of a medicine that is either:
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a new, expensive medicine
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a medicine undergoing reassessment of its reimbursement status, or
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a medicine considered for transfer from hospital treatment to the primary sector
Negotiation is possible when a medicine, due to economic considerations, has limited chances of obtaining reimbursement based on its list price. The negotiation will generally focus on the reasons for this. For example, the price may be too high relative to the medicine’s effect on individual patients, or there may be a risk that the medicine will be used for more patients than those covered by the proposed restriction.
Under current legislation, Amgros cannot negotiate with parallel importers of medicines. Therefore, the original manufacturer must cover the difference between the confidential price and the price offered by the parallel importer.
Read more about the elements companies can negotiate with Amgros, as well as the principles for price negotiations in situations where there is competition from parallel imports here.
New, expensive medicines are defined as those without substitutable generic or biosimilar competition, which have recently been launched on the Danish market and are not expected to face such competition in the near future.
For a new, expensive medicine, it is possible to request a negotiation with Amgros while the reimbursement application is being processed by the Danish Medicines Agency. The opportunity for negotiation arises when the Agency sends the Medicines Reimbursement Committee’s recommendation to the company for consultation. It is also possible to request a negotiation for a medicine that has recently been denied reimbursement.
Amgros negotiates a confidential price with companies seeking a new opportunity to obtain reimbursement based on such a price. The regions will assess whether the negotiation outcome is economically beneficial and whether an agreement can be made between Amgros and the company. If approved, the company may use the confidential price in its reimbursement application to the Danish Medicines Agency, which still makes the final decision.
Read more about the Danish Medicines Agency’s reimbursement assessment process here.
Companies wishing to negotiate with Amgros in this context must follow this guide.
The Danish Medicines Agency may decide that a group of medicines should have their reimbursement status reassessed. Under the pilot scheme, affected companies have the opportunity to negotiate a confidential price with Amgros if their medicine is proposed to lose or have its reimbursement status reduced due to its current price. The Medicines Reimbursement Committee’s draft recommendation is sent for public consultation.
Companies may then contact Amgros—typically within the first 14 days of the consultation period—to request a negotiation of a confidential price.
Amgros will negotiate with companies in parallel and within a set timeframe. The regions will then assess the negotiated agreements in the same way as for new, expensive medicines.
If the regions determine that an agreement can be made between Amgros and the company, the company subsequently submits the confidential price to the Danish Medicines Agency so it can be included in the final recommendation from the Medicines Reimbursement Committee.
Companies can contact Amgros to learn what information they should submit in advance of a confidential price negotiation.
The transfer of a treatment area from hospitals to the primary sector can occur in several ways. Under the pilot scheme, it becomes possible to negotiate a confidential price that can be included in the overall assessment of whether the transfer is economically sustainable for the regions. The process is initiated by Danish Regions, and in most cases, the Danish Medicines Council will update or prepare a treatment guideline.
Amgros will then offer all affected companies individual negotiations, which will take place during the same period as for other companies wishing to negotiate.
If the regions determine that an agreement can be made between Amgros and the company, the company or companies submit an application for general or restricted reimbursement to the Danish Medicines Agency. However, the Agency may also decide to initiate the case on its own. The Agency will make the reimbursement decision as usual—but now based on the confidential price.
If the Agency decides to grant reimbursement based on the negotiated price, Danish Regions will amend the agreement so that the Regional Wage and Tariff Board (RLTN) can enter into an agreement on a relevant service, e.g., with practicing specialists.
It is expected that the Danish Medicines Council will issue a medicine recommendation that can be used in the primary sector.
How can companies contact Amgros regarding price negotiations for the primary sector?
By sending an inquiry to: primaersektor@amgros.dk
Does the confidential pricing scheme affect the quality of treatment in the primary sector?
No, a confidential price will not negatively affect treatment quality, as the Danish Medicines Agency continues to make the professional assessment. The Agency does not grant reimbursement to a medicine that, for reasons other than price, should not be reimbursed.
Must companies always apply for reimbursement before negotiating with Amgros?
For new, expensive medicines, companies must first apply to the Danish Medicines Agency through the standard reimbursement process. This is because Amgros and the company need an indication of why the medicine cannot obtain reimbursement at the list price.
If, for example, there is a recent rejection and no new studies or changes in the competitive landscape have occurred, a previous rejection may also serve as the basis for negotiation. In that case, companies do not need to apply to the Agency before negotiating with Amgros.
For reassessments, it is the Danish Medicines Agency that initiates the process.
When confidential prices are part of the assessment of whether a therapy area can be transferred from hospitals to the primary sector, negotiations with Amgros will typically take place before the reimbursement process is initiated. In such cases, Amgros invites companies to negotiate.
The Agency (LMST) can reassess reimbursement status at any time, including for medicines covered by the pilot scheme.
Is the activity limited to 3–5 reimbursement processes per year?
The law states that 3–5 agreements on confidential prices are expected annually. This is only an estimate. Neither Amgros nor the Danish Medicines Agency can regulate the total activity under the pilot scheme. Amgros processes negotiation requests in the order they are received.
What happens when the pilot scheme ends?
Amgros and the company enter into a confidential price agreement that applies to reimbursed sales. The agreement duration is not limited.
Reimbursements granted by the Agency during the period do not expire when the scheme ends. However, agreements remain valid only if the confidential terms—including the price—are upheld.
Experiences from the pilot scheme are continuously collected and will be used for evaluation and potential adjustments. A decision will also be made in due time on whether to make the scheme permanent.
What criteria do the regions use to assess the confidential price?
The regions must make an overall assessment of the cost-effectiveness of a medicine based on a recommendation from Amgros, which is based on the outcome of the negotiated elements, as well as the financial consequences for the regions. The criteria include a specific evaluation of health economics and budget impact in a scenario where the medicine is granted general or restricted reimbursement based on a negotiated confidential price.
How is the confidential price settled?
The confidential price is settled by collecting the difference between the confidential price and the pharmacy’s purchase price for each relevant transaction at pharmacies.
Amgros collects the total confidential discounts quarterly and subsequently distributes the rebates to the relevant regions that incurred the reimbursement cost in connection with the citizen’s purchase.
Contact
Søs Nielsen
Senior Advisor
I work with cross-functional development initiatives, particularly with negotiations of confidential prices for the primary sector and follow-up on our alternative agreements.
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.