Pharmaceutical market access in Europe, by Will Dunlop

The pharmaceutical regulatory process in Europe is not a one size fits all. 

Europe’s payers share a quest for value, but differ in their approaches. Local expertise and partnering is critical.

Gaining market access in pharma across Europe has always presented challenges to pharmaceutical firms. The region has a common regulator, the European Medicines Agency, and most of its citizens receive healthcare from government-funded, often country-wide, health systems. Yet behind this top-level homogeneity lies a series of very different national and regional markets. Each of these has its own set of health policies and practices, its own culture and language, and its own tough pricing and reimbursement hurdles.

Efforts are underway to harmonize European health technology assessment methods and requirements. But they can only go so far (read more on this). Health systems reflect national health policy, clinical practices, social priorities and ultimately the wishes of voting citizens of each nation. The upshot is that clinical and economic data that is accepted in one market may not cut it in another. The standard-of-care in Germany for a particular condition may differ from that in France. Economic models that convince UK payers might not impress those in the Netherlands. The financial health of particular countries or regions will also heavily influence their willingness and ability to pay for new medicines.

What European payers all do share, however, is an aggressive quest for value. Often, they apply similar criteria (1). Because most European purchasers are tax-payer funded, that quest is more urgent than in the US market, where a far greater proportion of citizens are covered by commercial (private or employer-sponsored) insurers. Europe houses some of the most globally influential Health Technology Assessment (HTA) agencies – for example, guidance from the UK’s National Institute of Care & Health Excellence (NICE) will reach international audiences with countries also actively adopting NICE methodology.

Biosimilars – Highlight market access challenges across Europe 

Biosimilars nicely illustrate both the similarities and differences among European payers. Biosimilars are lower-priced, close-copies of specialist drugs like Herceptin® or Remicade®.  The financial pressure faced by many European governments was in large part what drove Europe to embrace these medicines in the mid 2000s, almost a decade ahead of the US. The EMA approved its first biosimilar in 2006, and around 40 more since. The US Food and Drug Administration (FDA) has approved 11. (2)

Today, amid growing competition, price discounts on biosimilar drugs in Europe range from approximately 15 to over 50%. (3).With more in the pipeline as patents on originator drugs expire, biosimilars are becoming one of the most important treatment classes for patients and health systems.

Deep local knowledge is crucial when developing market access strategies 

Of course, biosimilar uptake (like that of any other drug class) isn’t homogenous across Europe. These are complex treatments for often serious diseases, and Europe’s national payers, and clinician-prescribers don’t all share the same attitude toward them. Appropriate education, high-quality data, and a deep understanding of local concerns, practices and regulations are key to ensuring that these important medicines are safely integrated into health systems. Equally important is understanding the local purchasing or tendering system. There is substantial variation across Europe in how biosimilars are procured, with almost exclusively national tendering in some countries, and regional or local tendering in others.

Such local knowledge is key to successful market access and uptake of all medicines in Europe, biosimilar or otherwise. Partnering with experts that have their feet on the ground and a finger on the pulse in each market offers international R&D-based organisations an effective way to ensure that European patients can access their medicines.

For all its challenges, Europe is too important for any drug company to ignore. With an ageing population of over 700 million in Europe and five of the world’s top pharmaceuticals markets by value (4), Europe’s healthcare systems need, more than ever, therapies that can demonstrably improve health outcomes.

For more information on how to navigate Europe’s complex healthcare systems, contact: businessdevelopment@mundipharma.com

References:

1. Dunlop, W.C.N., Mullins, C.D., Pirk, O. et al. PharmacoEconomics (2016) 34: 1051. https://doi.org/10.1007/s40273-016-0427-

2.Cohen, J. (2018) What’s Holding Back Market Uptake of Biosimilars? Forbes, June 20, 2018. https://webcache.googleusercontent.com/search?q=cache:u_xncKPArUwJ:https://www.forbes.com/sites/joshuacohen/2018/06/20/whats-holding-back-market-uptake-of-biosimilars/+&cd=20&hl=en&ct=clnk&gl=lu&client=safar

3. Mullard, A. (2017) Bracing for the biosimilar wave. Nature Reviews Drug Discovery, March 2017. http://www.nature.com/articles/nrd.2017.36

4. https://www.worldatlas.com/articles/countries-with-the-biggest-global-pharmaceutical-markets-in-the-world.html