Posted by Suzanna van Straaten and Theofanis Manolikas on February 25th, 2022.
At some point in its development, any growth-minded non-European biopharma company will look to Europe as a possible source of new opportunity. Europe is attractive for various reasons, including its large population, high per-capita spend on healthcare, and vast market potential.
But successfully entering Europe is a complex undertaking, and biopharma companies need to know how to safely navigate the process. The stakes are high, and there are many pitfalls to avoid. In this ongoing series of articles, we are outlining the 12 most common pitfalls that biopharma companies experience as they enter European markets:
- Not knowing what it takes to “go it alone” across Europe
- Not realizing Europe may have its own clinical endpoints in mind
- Missing the opportunity of conditional marketing authorization
- Believing EMA marketing authorization = patient access
- Thinking your list price won’t cross borders
- Missing the mark with local health technology assessment (HTA)
- Not making the right European connections
- Failing to realize that EAPs can boost…or bite
- Missing a promotable label
- Building like big pharma when you’re not
- Using individual preferences vs analysis to select HQ location
- Caring too late about your infrastructure
In this installment, we address pitfall #7.
Pitfall #7 – Not Making the Right European Connections
Why It’s Important
In several of our previous articles, we have emphasized why one should not expect that assumptions related to the US (or any other geography) will be relevant across Europe and within individual European countries. For example, in Pitfall #2, we discussed how clinical trial design and endpoints must meet EMA, HTA, and payer requirements. They can’t just be copy-pasted from the US. Here, we take a closer look at the stakeholder engagement piece of the puzzle, which is equally important for European success.
Key Opinion Leaders (KOLs) are important not just as clinical trial lead investigators, but as consultants and potential advocates for an emerging product for the healthcare regulators. Not surprisingly, each geography has its own network of KOLs, and it is important to find compliant ways of engaging with them. If you do not, it may impact approval and/or reimbursement decisions.
A particular watch-out goes to clinical trial site selection. CROs are often incentivized to select sites that will enroll most quickly. This needs to be balanced carefully towards sites located in your priority geographies with relevant KOLs.
Avoiding It
In addition to localizing clinical trial design and the overall regulatory data package, the successful manufacturer will make sure that local decision-makers are engaged early. Selecting your trial investigators within key geographies is critical for multiple reasons. For example, consider the case of a multiple sclerosis treatment that benefited from
- Local KOL advocacy towards HTA approval and
- Subsequent rapid uptake within the local market fueled in part by KOL support
Another best practice is to invest in local “expert centers” in key geographies, which can involve not only clinical trial sites but Early Access Programs to generate early market experience (see more in Pitfall #8). These centers can also generate data leading to publications that can establish a robust reputation early and provide real world evidence to the data package.
Coming Next
In the next article, we’ll address Pitfall #8: Failing to realize that Early Access Programs (EAPs) can boost…or bite. EAPs are designed to provide early access to therapies—prior to market authorization—for patients who have no other approved treatment options. Similar to Pitfall #3 regarding the opportunity and challenges of conditional marketing authorization, we will explore how EAPs can either put your best foot forward early or result in a damaged reputation.
