Case:
Launching companion diagnostics in the Nordics

Gastric cancer diagnostics, four distinct healthcare systems, and a labyrinth of reimbursement policies – these were the elements of a complex equation we were tasked to solve.

This case shows how we applied our knowledge of the Nordic healthcare systems and data analysis to help a global company navigate the challenges of introducing a new companion diagnostic in Sweden, Finland, Norway, and Denmark.

Challenge

A global company approached us with a significant obstacle: how to effectively navigate the market access and reimbursement dynamics for their innovative companion diagnostic across four distinct Nordic healthcare systems. Companion diagnostics, tests used to determine the most appropriate treatment for patients, are crucial in personalized medicine. However, their adoption often depends on complex factors unique to each healthcare system.

“The Nordic countries, while often viewed as a homogeneous block, each have distinct healthcare structures and reimbursement pathways,” explains Mikael Bergholdt Asmussen, our Chief Advisor for Market Access. “Our client needed to understand these nuances to tailor their approach for each market.”

The challenge had multiple facets:

1. Deciphering the clinical pathways and guidelines for gastric cancer in each country
   
   
2. Understanding the quality standards for diagnostic tests
   
   
3. Navigating the Health Technology Assessment (HTA) processes and policies
   
   
4. Unraveling the coding, coverage, and funding mechanisms for companion diagnostics

Adding to the complexity was the need to identify gaps in publicly available information, areas where primary research would be necessary to complete the picture.

Solution

Using our exclusive deep understanding of Nordic healthcare systems and our strong partnership with Nordic Pharma Insights, we embarked on a comprehensive research project, addressing over 100 specific research questions across key areas:

1. Clinical Pathways and Guidelines:
   We analyzed each country’s approach to gastric cancer screening, diagnosis, and treatment. This included identifying key decision-makers and understanding how companion diagnostics fit into existing clinical workflows.
   
   
2. Test Quality Requirements:
   We investigated the standards and regulations governing diagnostic tests in each Nordic country, ensuring our client’s product would meet or exceed local expectations.
   
   
3. HTA and Policy Landscape:
   Our team mapped out the HTA processes in each country, identifying key stakeholders, timelines, and criteria for assessment. This crucial information would help our client prepare compelling value propositions for each market.
   
   
4. Coding, Coverage, and Funding Mechanisms:
   We examined the reimbursement systems of each country, uncovering the specific codes, coverage policies, and funding pathways relevant to companion diagnostics.

“Our partnership with Nordic Pharma Insights, data providers of national pharmaceutical sales data in other Nordic countries, allowed us to complement our Danish expertise with equally deep insights across the region,” Mikael notes. “This comprehensive view is something our global client couldn’t access from their US headquarters.”

Throughout the process, we maintained a keen focus on identifying information gaps. Where public data fell short, we highlighted areas where primary research—such as key opinion leader interviews or surveys—would be necessary to complete the market access picture.

Results

Our exhaustive research yielded actionable insights that became the foundation of our client’s Nordic launch strategy.

Key outcomes included:

1. A clear understanding of the unique market access dynamics for companion diagnostics in each Nordic country, enabling tailored strategies for each market.
   
   
2. Identification of key stakeholders and decision-makers in each country’s healthcare system, allowing for targeted engagement strategies.
   
   
3. A comprehensive map of the reimbursement landscape, including specific coding and coverage pathways for companion diagnostics in gastric cancer care.
   
   
4. Insight into the varying clinical guidelines and pathways across the region, highlighting opportunities for positioning the diagnostic tool within existing treatment protocols.
   
   
5. We helped the client identify the relevant HTA pathway for companion diagnostics in each Nordic country, as there are different HTA pathways for diagnostic tests and pharmaceutical treatment in some countries.
   
   
6. Clear identification of knowledge gaps, providing a roadmap for necessary primary research to complete the market access strategy.

“The depth and breadth of insights we provided gave the client a strategic overview of the Nordic market as well as tactical, country-specific information to guide their launch plans,” remarked Mikael.

As personalized medicine and companion diagnostics play an increasingly crucial role in the life science industry, the complexities of market access dynamics grow with them. Seeing your business from the outside can uncover blind spots you never knew existed, especially in cases like this, where local experience is imperative.