Global market access checklist

Securing market access for an innovative medical device, bio-pharmaceutical agent or diagnostic test is essential for the sustainability of life sciences companies on a global scale. Life sciences companies seeking global market access expansion must understand the vital factors that pertain to securing payer and provider coverage in foreign markets as well as the crucial evidence generation strategies needed for product acceptance. Given that market access initiatives influence every phase of the product life cycle, assessing market access strategies and identifying areas of opportunity are key factors in increasing success. 

In support of you and your life sciences company’s global market access strategy, Baker Tilly’s team of life sciences specialists have outlined steps your organization can take to aid in increasing payer and provider coverage in global markets. This checklist specially addresses the key considerations for the EU5 countries, including France, Germany, Italy, Spain and the U.K. Due to the unique strategies and priorities of pharmaceutical companies and medical device manufacturers, our whitepaper is structured into two sections customized to address the specific needs of your respective industries. 

This checklist can be used to aid in the planning of key market access initiatives including:     

• Clinical and economic evidence strategy and generation 
• Market intelligence, sizing and new indication strategy 
• Stakeholders and advocacy    
• Early access programs (EAPs)    
• Key stakeholder outreach and Health Technology Assessment submission   
• Legal considerations 
• Value-based reimbursement strategy