Who do I call when I want to talk to Europe?
Who do I call when I want to talk to Europe?
Who do I call when I want to talk to Europe?
Who do I call when I want to talk to Europe?
Building a common value & access strategy for a continent
Who do I call when I want to talk to Europe?
GAVIN OUTTERIDGE, CATHERINE CHAMOUX and RUSLAN HORBLYUK
Who do I call when I want to talk to Europe?
Who do I call when I want to talk to Europe?
“Who do I call when I want to talk to Europe?”
Famously attributed to arch-diplomatist Henry Kissinger, this question also encapsulates the pause given to any American-, Asian-, Australian- or African-headquartered biotech as they turn their minds from their home market preparations to a potential launch in Europe.
As any value & access professional knows, access is local. Any global strategy or evidence base needs tailoring for any given target market where local differences in policy, HTA methods, willingness or ability to pay and current clinical practice confront the access strategist with anxiety-inducing heterogeneity. Consequently, global pharma majors have built access capabilities country by country, with substantial teams at the local level – and have often cut out the regional layer entirely.
But what if your pockets aren’t Novartis- or Pfizer-deep? What if you’re a clinical stage biotech, developing your first product and a single Phase III is going to have to do? How then can you possibly develop an executable strategy for a continent of 40+ countries – never mind those like Spain and Italy further sub-divided into distinct provinces with their own decision-making powers?
Well, there is some good news. Here at AESARA Europe, in our work advising global clinical stage biotechs on European market access, we are increasingly looking for and finding addressable commonalities across European markets. Some recent examples just from the last year of AESARA client work alone:
Anti-infectives
Despite a wide heterogeneity of treatment approaches, not just between countries but right down to the hospital level, making identification of a standard of care comparator impossible, AESARA Europe’s stakeholder engagement surfaced an aligned policy trend, in 4 out of 5 markets studied, for novel reimbursement methods to enhance anti-microbial stewardship.
Oncology
For a product tackling a blood cancer with multiple treatment options in a complex landscape, AESARA Europe’s rigorous desk research, tested and adjusted by our physician & payer interviews, found a common, pharmacologically-similar comparator relevant in all major markets.
Neuroscience
The markedly differential safety profile & healthcare resource utilisation benefits of an oral monotherapy versus an injectable comparator combined to create an impactful, evidence-based value story with resonance across multiple markets; with HCRU savings becoming more and more relevant as Italy & Spain join UK, the Netherlands, Sweden et al. in asking for a cost-effectiveness model.
For the clinical stage biotech, Europe – just like for Kissinger – can seem too difficult to bother with.
BUT, whether you are bold enough to go it alone or are planning to share the upside and seek a European commercialisation partner, doing an evidence-based European access strategy especially before you lock in Phase III is possible, with the right expert partner helping you take an informed, pan-European perspective.