Over the past few years, manufacturers of different shapes and sizes expanded the role of global market access, with greater integration with other functions and affiliates.

This has been driven by two primary factors:

• Limited resources within companies have increased the focus on efficiency and knowledge-sharing between global and affiliate teams.
• Frequent launches of specialized products mean affiliates are in near-constant launch mode, relying on timely support from global teams to achieve commercial forecasts.

Manufacturers are increasingly recognizing that a positive national reimbursement decision does not guarantee commercial success. The steps after reimbursement can make or break patient access and adoption.

• Early thinking—across cross-functional alignment, evidence generation planning, and go/no-go decisions— is essential to shape downstream success and unlock real-world access.
• Success depends on understanding a wider range of external stakeholders and navigating complex healthcare system-level operational and behavioral barriers.
• Further, accelerating time to patient access is increasingly more relevant to maximize commercial potential before price erosion, competition, or patent challenges reduce exclusivity.

If minimizing the time from market access to full patient access and sales is a priority, then healthcare system value strategy would be developed before launch and executed through coordinated cross-functional efforts, in line with market compliance requirements.

Key Factors Driving Global Market Access Strategy

This Insight is the first in a series that will explore what the expanded role of global market access teams means for manufacturers, and how stakeholders can best navigate the evolving expectations and responsibilities that come with this “new normal” of patient access.

Here, we outline key terms and what they mean in practice, why these concepts are gaining prominence, and what they imply for global access teams’ strategies moving forward.

Healthcare system payers: The term “healthcare system (HCS) payer” covers multiple layers of stakeholders at regional, hospital, and local levels. Each has different degrees of budget control and decision-making power—some can restrict or delay access entirely, while others shape how reimbursement is specified in terms of formulary inclusion or budget responsibility.

HCS payers manage the tension between cost containment and fulfilling nationally determined access obligations; and at a local level the focus becomes the practicalities of implementation—from funding flows and local protocols to provider readiness.

Implications for global market access: Global market access teams should:

• Understand HCS payers’ broad business perspective and their key questions such as: Will upcoming savings here release funds elsewhere? What trade-off do I need to make to fund this product? Are the capacity savings offered by this product meaningful?
• Recognize diverse value drivers—financial levers, capacity incentives, even perverse incentives that inadvertently reward short-term cost-containment, or arise from system fragmentation where cost savings in one part of the pathway disincentivize investment in another
• Appreciate HCS payers’ decision-making is less formulaic, increasingly relying on holistic value assessment, pragmatic trade-offs, and behavioral dynamics.

Healthcare system readiness: Patient access needs to happen faster and at scale; focusing exclusively only on brand value or cost-effectiveness is not enough. Understanding and solving what the healthcare system needs is increasingly the key lever to ensure a drug can reach the right patients at the right time. The barriers to patient access are clear for many recent, high-profile products:

• Specialist weight loss services for GLP-1s
• Diagnostic infrastructure and on-treatment monitoring for amyloid inhibitors
• Genetic testing for cancer drugs and for gene therapies
• Specialist referrals in rare diseases

Healthcare system barriers affect many assets in development, including funding, referral pathways, data infrastructure, specialist availability, and system capacity. Global teams must work across functions (e.g., access, medical, commercial, policy, patient advocacy) to ensure foundational enablers are in place. These include diagnostic criteria that are defined and implemented, patients’ awareness of options, and alignment with clinical guidelines. These elements, while not all directly owned by access teams, are essential to payer decision making and real-world access, and require coordinated action across the broader cross-functional team.

Addressing healthcare system readiness requires holistic thinking that connects the “patient pathway”—as understood through medical and patient engagement perspectives—with the broader healthcare system pathway. This integrated view is important to identify real-world challenges and critically, where there are points of leverage to solve from a healthcare system payer perspective.

Implications for global market access: Stakeholders should embed this thinking early in strategic planning, ideally in the 36 months prior to marketing authorization. However, it is never too late to include this thinking for full patient access strategy optimization. As a specialist market access team, Avalere Health is often engaged because system-level challenges are directly impacting launch sales, yet our strongest impact comes when we are brought in earlier as a partner in anticipating and addressing healthcare system readiness as part of the global strategy to ensure payer hurdles are unlocked at all levels, not just nationally.

Patient access: While widely used, this term means different things in different markets:

• United Kingdon: The point a net price agreement is in place
• Asia: Access to individual subsidy mechanisms
• United States: Navigation of complex health insurance systems to secure product coverage and reimbursement.

Fundamentally, patient access means there are no barriers preventing a healthcare professional from prescribing a drug for the appropriate patient when needed in their healthcare system.

Implications for global market access: Framing true patient access as the target—and potentially a more meaningful benchmark for market access success—reflects evolving expectations globally.  We’ve been leading organizations to elevate healthcare ecosystem value into a strategic priority while operationalizing healthcare system readiness and strengthening collaboration across global to local teams to accelerate time to patient access.

Next Steps

Drawing on this developed thinking and our cross-company experience, Avalere Health  partners with global market access teams to unlock brand and system value, delivering best-in-class strategies that drive real-world patient access. Connect with us to learn more.