Case:
Securing market access for a breakthrough vaccine

When a cutting-edge vaccine meets the intricacies of Nordic healthcare systems, even industry giants can find themselves searching for direction. Such was the case for our client, a biotech powerhouse with a promising candidate in late-stage trials.

Recognizing the complexity of the Nordic market, they sought our expertise. The result? A bespoke Nordic Market Access Blueprint, offering a clear roadmap through the diverse landscapes of Denmark, Norway, Sweden, Finland, and Iceland.

Challenge

Our client, a global biotechnology company, approached us with a clear objective: to be optimally prepared for the introduction of their phase 3 vaccine in the Nordic countries. The challenge was multifaceted, requiring a deep dive into the regulatory and market access processes of each country.

One of the primary hurdles we faced was the uncertainty surrounding the vaccine’s potential inclusion in national immunization programs (NIPs). As Mikael explains, “The market access route for a vaccine can differ significantly depending on whether it becomes part of the national immunization program or if patients have to pay out of pocket.”

Key challenges included:

1. Diverse Market Access Routes:
   Each Nordic country has unique pathways for vaccine introduction, including NIPs and private markets.
   
   
2. Varied Decision-Making Processes:
   The processes for NIP inclusion differ across countries, involving different stakeholders and timelines.
   
   
3. Funding Mechanisms:
   Understanding the funding structures for vaccines in each country, ranging from 100% public funding to various co-payment models.
   
   
4. Stakeholder Complexity:
   The stakeholder landscape varies across countries, with different entities responsible for decision-making, purchasing, and distribution.
   
   
5. Regulatory Nuances:
   While all Nordic countries follow the centralized EMA process for marketing authorization, there are country-specific requirements for subsequent steps.
   
   
6. Resource Planning:
   The client needed to understand the qualified full-time equivalent (FTE) resources required to manage the vaccine’s introduction effectively across all five countries.

Solution

To address these challenges, we tapped into Nordic Pharma Insights, data providers of national pharmaceutical sales data in other Nordic countries, to collaborate with relevant Nordic partners.

Our three-step approach combined launch experience, desk research and qualitative interviews to cover the following aspects:

1. Market Access Route Analysis:
   We conducted a detailed analysis of the market access routes in each Nordic country, focusing on both NIPs and private market opportunities.
   
   
2. Stakeholder Mapping:
   We identified and analyzed key stakeholders in each country, including health authorities, procurement bodies, and advisory groups.
   
   
3. Funding Structure Assessment:
   We provided clear insights into the funding mechanisms for vaccines in each country, highlighting the differences between public and private markets.
   
   
4. Process Mapping:
   We created detailed roadmaps outlining the regulatory and market access processes for each country, including decision-making processes and timelines.
   
   
5. Resource Assessment:
   We provided estimates of required FTE resources for managing the introduction across all five countries.

Result

The Nordic Market Access Blueprint we developed equipped the client with the knowledge and tools needed to confidently approach their vaccine introduction.

Key outcomes included:

1. Comprehensive Market Understanding:
   The client gained a deep understanding of the nuances of each Nordic market, including:
   
   
   • Denmark: The binary nature of the vaccine market (NIP or private), with 100% public funding for NIP vaccines and 100% co-payment for private market vaccines.
   • Norway: The three-tiered system including NIP, “Blå recept” vaccines, and private market vaccines, each with different funding mechanisms.
   • Sweden: The unique regional immunization program in addition to the NIP and private market, with varying co-payment structures.
   • Finland: The centralized NIP decision-making process involving the THL (National Institute for Health and Welfare) and the importance of the national budget process.
   • Iceland: The streamlined NIP process with the Directorate of Health as the key decision-maker, and the ongoing changes in tender durations.
     
     
2. Stakeholder Engagement Strategy:
   We provided a thorough analysis of key stakeholders in each country, enabling the client to develop targeted engagement strategies. For instance:
   
   
   • In Denmark, highlighting the importance of engaging with the Danish Health Authority including the Vaccination Council and Statens Serum Institute.
   • In Norway, emphasizing the role of the Norwegian Institute of Public Health (NIPH) in decision-making and procurement.
   • In Sweden, underlining the importance of both national (Public Health Agency of Sweden) and regional stakeholders.
   • In Finland, stressing the crucial role of the THL and the Ministry of Social Affairs and Health.
   • In Iceland, focusing on the Directorate of Health and the Chief Epidemiologist.
     
     
3. Resource Planning:
   Our FTE estimates allowed the client to effectively plan their resource allocation for the vaccine introduction process. We recommended 1 FTE for regulatory affairs to cover all five countries, 1 FTE for medical affairs, and 2 FTEs for public affairs/market access.
   
   
4. Risk Mitigation:
   Through our analysis, we identified potential pitfalls specific to each country, such as the lengthy tender processes in some countries and the complexities of regional decision-making in Sweden.
   
   
5. Regulatory Roadmap:
   We provided clear guidance on the regulatory steps required across the Nordic region, including the process for obtaining a Nordic Vnr (product ID number) and country-specific requirements for packaging and labelling approvals.
   

Mikael reflects on the project’s impact: “The detailed insights we provided allowed our client to anticipate challenges and capitalize on opportunities specific to each Nordic country.”