The EU is the second largest market in the world for pharmaceuticals, which makes it an attractive option for your next project. But that doesn’t necessarily mean it’s always commercially viable to venture outside of the US.

Europe is notorious for being more challenging than the US in terms of accessing patients and entering the market. Which, makes it more daunting for companies without any regional presence or experience. But with continually rising discount and rebate costs in the US, Europe may soon be in an improved position compared with its historically lower prices.

However this is approached, it’s more important than ever that a European and US product is carefully planned and executed.

With strategic commercialization support in the lead up to a European launch, a detailed evaluation of an asset and commercialization plan will be one of the first steps in preparing for the anticipated landscape.

To address EU challenges, a broad assessment of your strategy that covers all areas of pre-launch is critical. Are you able to synergise policy areas, research and development, and competition? Positioning your product for a successful launch in a market where there could be a number of negative opinions on its use is one battle. One that we, at Solem, have seen before. In this scenario, the outcome might not always be the one the client desires.

After a few months of working with a small hematology company, we at Solem were able to improve KOL and Payor opinion on the usefulness, efficacy and value of their product. However, the ultimate decision was to terminate non globally relevant work outside of the US after discovering a previously undisclosed COGS complication.

This demonstrates not only the importance of a tactical execution, but thorough Market Access as early as possible in your clinical development. The rationale being that any potential barriers to market can be identified early on. This means your product’s positioning can be altered to accommodate for jumping any hurdles.

Preparing for a European launch with commercialization support will look different depending on the product and its KOLs and payors. But usually, it will include the following actions:

1. Workshops
   

   A series of workshops that will enable you to ensure client alignment, establish a launch team, and define objectives, roles and responsibilities across your team.

2. Readiness Assessment
   

   A readiness assessment can identify holes in your pre-launch strategy. It will pinpoint which areas of research and work demand more focus before a tactical execution can be achieved. A readiness assessment can identify if greater focus is needed on Market Access, for example, as it pertains to the positioning of a product or therapy.

   Navigating complex environments can make costly processes all the more costly. That’s why it’s critical that trustworthy support is brought in at the early stages. A good support consultant will tell you straight whether this market is right for your product or not, as opposed to simply being focused on obtaining their next project. Sometimes, it’s not the news you want to hear, but maintaining the efficacy and value of your product comes naturally when those difficult decisions are made.

3. Landscape Assessments
   

   A Commercial Landscape Assessment ahead of a European launch might focus on Europe-G5, including Regulatory, Commercial and Pricing, Reimbursement and Market Access (PReMA) reviews and assessments. This may include input and interview with thought leaders and payors unassociated with the client’s trials to obtain KOL and payor feedback from different countries.

About Solem

Solem is a Life Science Consultancy that helps businesses launch new drugs and medical products. We partner with you across the entire development process, ensuring your products not only receive approval – but actually reach and connect with the intended market.

For more information contact us at info@solemglobal.com