By Pooja Rana, Senior Consultant, and Ignacio Urdaneta, Associate Consultant
As the U.S. is the largest pharmaceutical market by revenue, many pharmaceutical manufacturers have dedicated U.S.-specific departments and teams to support new therapy launches. However, when patient populations are compared across the world, the U.S. patient population is about 100 million patients less than the EU and about 200 million less than the EU, Japan, and Canada combined. Despite this dichotomy, manufacturers may typically group all non-U.S. markets into “global” or “ex-U.S.” strategies, simplifying the global pharmaceutical market space into two archetypes.
Within this organizational structure, however, ex-U.S. markets should be viewed as unique markets with their own opportunities and challenges. Country-specific Health Technology Assessment (HTA) algorithms often do not lend themselves well to a U.S.-based collective global strategy or a “Wave 2” version of a U.S. strategy. Here’s why U.S. market access strategies may not always achieve the same results in the ex-U.S. market.
Access is Not Guaranteed in Ex-U.S. Markets
In the U.S., access is almost always guaranteed in categories such as oncology given its status as a “protected class.” The relative positioning of the product by payers, however, may be influenced by a variety of factors, which include payer-independent medical society scoring (i.e., NCCN), and in rare cases, manufacturer contracting.
Outside of the U.S., access is not guaranteed and needs to be incorporated into global strategies. There are multiple national and/or subnational payer archetypes, but overall, given the more centralized systems, there is a greater emphasis on the sustainability of medical care across patient populations based on clinical evidence and pricing.
Economic & Clinical Drivers are Intertwined Ex-U.S.
In the U.S., each new therapeutic option is assessed privately by each payer’s pharmacy & therapeutics (P&T) committee, and upon review, only a description of product coverage is published. A similar approach is taken ex-U.S., but with variable, and often more regulated, HTAs driven by central payers that generally publish extensive public reports incorporating both clinical and pharmacoeconomic experts’ evaluation.
HTA bodies across counties can differ in their conclusions on the same data package, meaning outcomes for the same therapy can vary greatly, even in neighboring markets. Even if the scientific evidence does not change, HTA bodies may differ in the portions of the data package they prioritize when conducting their assessments.
Pricing Negotiations are Based on HTA Algorithms
Within the U.S., access decisions are highly fragmented at the payer and provider level. Access can be achieved if the product’s clinical efficacy is demonstrated, and in some categories, if the price and reimbursement are received as appropriate by individual payer and provider stakeholders.
However, ex-U.S., pricing negotiations are usually centralized via an HTA incorporating clinical and economic analyses, and do not usually align to the manufacturer-led pricing or contracting. There are decision-making algorithms used by major HTA archetypes to determine what is deemed “appropriate” pricing:
- Clinical Benefit-Driven:
German (G-BA) and French (HAS) HTA bodies will assign a score to a new therapy, which is a measure of improvement compared to existing therapies. Based on the score, there are boundaries set for what could be expected in the pricing negotiations for a new therapy (i.e., premiums vs. discounts). - Cost-Effectiveness Driven:
Canadian (CDA) and UK (NICE) HTAs will model the cost-effectiveness of the new therapy against a comparator and debate the incremental cost effectiveness ratio based on the gain of quality adjusted life years (QALYs) to suggest at which price they would be willing to reimburse the therapy. - Budget Impact Driven:
In Italy (AIFA) and Spain (AEMPS), and most ex-U.S. markets outside of the G10 (e.g., Brazil), countries may delay assessments, restrict eligible populations, or choose to not reimburse based on the expected expenditure to the system, particularly if there are uncertainties with the clinical data.
After Access, Ex-U.S. Hospital Uptake is Streamlined
In the U.S., hospital uptake is one distinct component of market access, with its own challenges and requirements, while in most ex-U.S. markets, hospital uptake is much more streamlined once access is achieved.
Most ex-U.S. reference hospitals are tax-funded university hospitals that are dependent on national or sub-national governing bodies for resources. This contrasts heavily with the U.S. experience, where most hospitals prioritized for research are private academic centers responsible for managing their finances across a multitude of highly diverse payer payment schemas. The different ownership models differentially impact ease of therapy uptake and utilization, such as in financial sensitivities of care, processes to expand hospital capabilities, and overall ability to provide new therapeutics.
For example, once reimbursement and pricing are set at the national level in ex-U.S. markets, physician choice tends to play a role in product uptake and utilization only when competing therapies have similar HTA statuses. In the U.S., after NCCN positioning of products, site-level contracting and associated financial sustainability of offering product may have the largest influence on prescribing of therapies.
Tailored Ex-U.S. Market Access Strategies are Essential for Success
Access considerations vary per market and their nuances can lead to different outcomes. While the U.S. remains a pivotal player in the global pharmaceutical market, strategies developed for the U.S. do not seamlessly translate to ex-U.S. markets due to distinct regulatory, economic, and healthcare infrastructure differences. Each ex-U.S. market presents unique challenges and opportunities shaped by centralized health technology assessments, diverse pricing frameworks, and varied access mechanisms. These complexities emphasize the need for pharmaceutical companies to adopt tailored, market-specific approaches instead of relying on a one-size-fits-all U.S. vs. ex-U.S.-based model.
As companies expand globally, an understanding of the intricate landscape of ex-U.S. markets will be essential for successfully navigating access, pricing, and utilization on an international scale.
Contact us to learn how The Dedham Group can help you navigate complex global market landscapes to develop a better understanding of market dynamics.
