Denmark: Data Crucial To Innovative Access Agreements

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Established in 2017, the Danish Medicines Council is the health technology assessment (HTA)-like body in Denmark which assesses the value for patients and costs to society of new medicines. The Medicines Council then makes recommendations to the Danish Medicines Agency (the country’s regulator) and Amgros (the national public procurement body). In a recent conversation with PharmaBoardroom, Jørgen Schøler Kristensen, the Medicines Council’s chairman and the chief medical officer at Aarhus University Hospital explains the specificities of the Danish HTA model and the importance of better utilising patient data to the Council’s work moving forward.

 

“In many ways, the Danish Medicines Council it is quite similar to The National Institute for Health and Care Excellence (NICE) in the UK, utilising very systematic HTA-like grade systems in its assessments,” outlines Schøler Kristensen. “We take pride in having the medical profession heavily involved in the decision-making process; a group of experts from all over Denmark, including patient representatives, is involved in every recommendation we make. We also have industry involvement in the Council and good collaboration with other Danish authorities like the Medicines Agency.”

 

This collaborative model is broadly appreciated by private companies. As Ida Sofie Jensen of innovative pharma industry association Lif notes, “I myself am a member of the Council, which shows the public sector’s willingness to take the concerns of private industry into account. Together with the regions, regulation for getting an application through the Medicines Council has been established, with the ultimate goal of being as transparent as possible.”

 

Expanding on the work of the Council, Schøler Kristensen highlights that “Our principles include getting more value for patients for the same spending, allowing treatment for patients even when it is not recommended as a general treatment, ensuring equal treatment across the country, making evidence-based decisions and rapid access to new well-documented treatments – when a company apply for an assessment by the Medicines Council, we only have 12-16 weeks to finish our assessment. In many instances we are one of the first institutes in the world to deal with these new medicines.”

 

In a future of individualised and often highly priced cell and gene therapies, there is a clear need for new methods of medicine pricing and performance-based contracts in Denmark, as elsewhere. Schøler Kristensen underlines the Council’s commitment to engaging in such agreements, asserting that “In collaboration with Amgros, we are beginning to strike new, innovative agreements with the industry and are exploring the possibilities of creating different models. While we have certainly not reached our destination, we are trying to find solutions to challenging questions. For example, how do we evaluate new drugs which are given once but which are potentially effective for life? Which stakeholder carries the risk of a drug not working five years into the future? Could we make a payment model so that the risk is shared? Also, given the nature of some of the new drugs coming to market, if a company wants to make a deal for a large group of patients in different areas, could we make a bigger basket of agreements?”

 

He continues, “I would like to mention that Denmark has the best collection of healthcare data in the world. The Danish Regions have built a health data authority to which we deliver a lot of data from the hospitals as well as some from GPs. Currently, we and the health data authority are co-chairing a National Hospital Medicine Registry which receives data from the hospitals on the use of expensive drugs. We are currently only using part of this data, but it is a highly promising project, and we hope to see the results of it in one or two years.”

 

Schøler Kristensen concludes, “In terms of the industry, I would love to discuss the possibility of making agreements based on post-treatment data and real-world evidence with industry associations like Lif and EFPIA. Perhaps we can find ways to collect data in new collaborative ways that will enable us to evaluate treatments and make innovative agreements.”


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