Danish Medicines Council and DARE launch real-world data pilot projects for cancer medicines

The Danish Medicines Council has partnered with the Danish Alliance for Real-World Evidence (DARE) to analyze data from two pilot projects that will evaluate the performance of recommended cancer medicines in Danish clinical practice. The projects, which will begin in 2026, represent the first phase of a broader program to establish a national framework for using real-world data (RWD) to support post-launch evaluation of new medicines and inform future treatment recommendations. 

The Baseline

• The Danish Medicines Council and DARE have launched a partnership to evaluate the real-world performance of recommended cancer medicines using routinely collected healthcare data.
• The 2025–2028 program will develop and test a national framework for collecting and analyzing RWD to support post-launch evaluation, future treatment recommendations, and potential conditional reimbursement decisions.
• Two pilot studies will assess cancer medicines while establishing analytical methods and processes intended for broader use across future therapies.

The partnership was established in response to the growing challenge of assessing new medicines on the basis of limited clinical evidence at the time reimbursement recommendations are made. According to the program strategy, previous experience has shown that although the Danish Medicines Council has mechanisms for using RWD after medicines enter clinical practice, approaches such as conditional recommendations and planned reassessments have proved difficult to implement because of limitations in the infrastructure and resources needed to collect post-launch data.

Running from 2025 to 2028 and funded through Denmark's Cancer Plan V, the program aims to develop and test models for collecting and analyzing RWD to evaluate the effectiveness, safety, quality of life, and use of new cancer medicines in routine clinical practice. It will also assess the availability and quality of Danish RWD sources, develop analytical methods and process guidance for future evaluations, and establish a framework to support conditional recommendations and alternative pricing agreements. The long-term ambition is for the Danish Medicines Council to routinely use RWD to review its recommendations from 2029 onwards and generate evidence on the effectiveness of medicines in Danish clinical practice.

The first two pilot projects will evaluate pembrolizumab in combination with chemotherapy for adults with advanced non-squamous non-small cell lung cancer, and sacituzumab govitecan for adults with unresectable or metastatic triple-negative breast cancer. Beyond evaluating these medicines, the pilot projects are intended to develop and test analytical methods and processes that can be applied across future evaluations of new therapies.

Explaining the rationale for the initiative, Jannick Brennum, Chair of the steering group behind the Danish Medicines Council's partnership for RWD and Deputy Chair of the Danish Medicines Council, said:

"RWD should give us knowledge about how the medicines work in Danish patients according to the Medicines Council's recommendation. Unfortunately, we do not always know this based on the evidence available when we assess whether we can recommend a medicine."

Brennum said this reflects the fact that the treatments already used in Denmark are often more effective than the comparators used in clinical studies and that trial populations are not always representative of Danish patients. He argued that evidence generated from routine clinical practice could help determine whether treatment effects justify their costs while supporting greater use of conditional recommendations, enabling earlier patient access to promising new therapies.

Describing the collaboration with DARE, Brennum said:

"Therefore, it is a big step that we are now launching two pilot projects together with DARE, which has extensive experience and expertise within RWD and the advanced methods necessary in these projects."

DARE is a consortium comprising the Department of Clinical Epidemiology at Aarhus University Hospital and Aarhus University, Clinical Pharmacology, Pharmacy and Environmental Medicine at the University of Southern Denmark, and Phase4CPH at Bispebjerg and Frederiksberg Hospital under the Capital Region of Denmark. Espen Jimenez Solem, together with Anton Pottegård and Mette Nørgaard, will lead the analytical work on behalf of the consortium.

Solem said the pilot program addresses a longstanding gap in the systematic evaluation of high-cost hospital medicines after national decisions on their use have been made. "There has been a lack of a tool to systematically follow up on expensive hospital medicines and on national decisions on their use. This is exactly the task that the pilot projects are to solve," he said.

He added that Denmark's national health data infrastructure provides an opportunity to establish a reusable model for post-launch evidence generation:

"With the unique Danish health data, Denmark has the opportunity to become among the first countries in the world to carry out this type of analysis. The goal is to develop a model that can be reused across new treatments, so that systematic follow-up on new medicines becomes the rule rather than the exception."