The new pilot program, applicable from 1 July 2025 to 30 June 2028, allows pharmaceutical companies to apply for reimbursement for prescription-only medicines based on a confidential price.
Key aspects of the new pilot program
The Danish Parliament recently adopted legislation introducing a three-year voluntary pilot program, applicable from 1 July 2025 to 30 June 2028, for the reimbursement eligibility of certain medicinal products. The program is based on confidential prices negotiated between Amgros and pharmaceutical companies and aims to unlock new value for industry stakeholders.
The confidential price is negotiated between Amgros and the pharmaceutical company. A group appointed by Danish Regions then assesses whether the negotiated price may be submitted for formal reimbursement evaluation. The Danish Medicines Agency ("the DMA") makes the final decision as to whether the product in question is to be granted reimbursement based on the confidential price.
The program does not result in direct savings for patients, who will continue to pay the official list price for the product in question, and the reimbursement will also be calculated based on the official list price.
However, the program aims to enable reimbursement for medicines that would not otherwise meet the applicable criteria, thereby improving patient access and supporting earlier market entry.
The confidential price of all sold packages of the relevant medicinal product, including parallel-imported and -distributed medicines, is to be reimbursed by the company that has entered into the agreement on the confidential price to the regions. However, it may be part of the negotiations between the company and Amgros that the company is only required to make partial reimbursement for packages sold by parallel importers and distributors, and reimbursement only applies to packages that are sold at the pharmacy with reimbursement.
Industry benefits at a glance
For pharmaceutical companies, the program offers a new potential, confidential pathway to reimbursement for products that would not otherwise qualify for reimbursement at list price. The program also helps protect international pricing strategies, as the offered discounts do not affect the official list price and therefore may help mitigate risks related to international reference pricing and cross-border transparency.
Scope of application
Confidential prices may be negotiated in the following situations:
- new, expensive medicines for which general or conditional reimbursement is applied;
- medicines undergoing a reassessment of their reimbursement status by the DMA; and
- medicines used for treatments that are being shifted from the hospital sector to the primary care sector.
However, confidential price agreements can generally not be used for medicines that are or have previously been subject to existing substitutable generic or biosimilar competition.
The DMA will publish a list of medicines that have been granted reimbursement based on a confidential price. The underlying terms will remain undisclosed.
Next steps
As of 1 July 2025, applications for reimbursement based on a confidentially negotiated price may be submitted to the DMA. A new executive order sets out the procedural framework for submitting such applications. Read the executive order (in Danish).
As the program remains in a trial phase until 30 June 2028, an evaluation is planned before the pilot program expires. The experience gained may inform future changes to the Danish pricing and reimbursement model.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
