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Policy Brief

Beyond Healthcare Spending: The Evolving Definition of Value in Health Policy

 


The ISPOR Monthly Policy Brief provides concise insights into emerging developments shaping the global health policy landscape. Each edition highlights timely issues relevant to the health economics and outcomes research (HEOR) community and beyond, examining how evolving policy decisions influence healthcare systems, evidence generation, innovation, and patient access. View all Policy Briefs here.


 

Ana Amaris, MD, MPH, Director, Health Policy Initiatives, ISPOR

 

Overview: This September Policy Brief picks up where the August installment left off: with the question of how to evaluate the success of a pharmaceutical policy that is expected to achieve multiple objectives. This Policy Brief looks at how that question is emerging across health systems in different geographical regions, and poses a new question: What evidence is needed to support increasingly complex policy decisions?

 

Quantifying Complex Policies

The August edition of the ISPOR Policy Brief explored how the objectives of pharmaceutical policy are becoming increasingly interconnected, with policy makers seeking to balance affordability and access alongside innovation, health system sustainability, supply chain resilience, and broader economic priorities. This evolution raises a related question: As the objectives of health and pharmaceutical policy expand, how should value—and, ultimately, policy success—be defined and measured?

This question is emerging across health systems. In Canada, policy makers are considering broader approaches to assessing pharmaceutical innovation. In the United States, new drug pricing agreements combine affordability objectives with commitments related to domestic manufacturing and supply chain resilience. Discussions in South Korea illustrate potential trade-offs involving price, access, and the timing of new medicine launches, while analysis from Latin America highlights the economic and societal consequences of health and disease.

These examples illustrate a concept of value that extends beyond immediate healthcare expenditure. For HEOR, they also raise questions about evidence.

 

Expanding What Counts as Value

In Canada, the Pharmaceutical and Life Sciences Sector Task Force recommended a multidimensional framework for assessing pharmaceutical innovation that considers clinical and patient value, health system value, and societal value, including productivity. The Task Force also recommended that Canada’s Drug Agency continue evolving its health technology assessment framework to incorporate these dimensions.

A similar conversation is taking place in Latin America from a health system perspective. During the forum “Health as the Best Investment a Society Can Make” at the IX ISPOR Colombia Congress, an analysis of the socioeconomic burden of 7 diseases across 8 Latin American countries highlighted productivity losses associated with morbidity and premature mortality. Under one of the approaches used, these losses represented an estimated 3.9% of GDP on average across the countries studied in 2022.

While the contexts differ, both examples illustrate efforts to understand health and healthcare beyond immediate expenditure. Health outcomes can affect workforce participation, productivity, families, and economic and social development, while pharmaceutical innovation may generate effects across patients, health systems, and society that are not captured through a single measure of clinical benefit or healthcare spending.

 

When Policy Success Depends on What We Measure

This changing concept of value is also reflected in pharmaceutical policy design. On August 31, 2026, the US Administration announced Most-Favored-Nation (MFN) pricing agreements with 9 additional pharmaceutical manufacturers, bringing the total number of participating companies to 26. Beyond commitments related to drug prices and Medicaid access, the agreements also commit to at least $19.6 billion in US manufacturing investment and contributions of active pharmaceutical ingredients (APIs) to the Strategic Active Pharmaceutical Ingredients Reserve. The agreements combine affordability objectives with domestic manufacturing capacity and pharmaceutical supply resilience.

South Korea illustrates how these objectives can generate complex trade-offs. Concerns have emerged that the country’s relatively low medicine prices, combined with growing international price referencing, could influence the sequencing of new medicine launches. An analysis presented at the 2026 ISPOR Asia Pacific Summit found that South Korea ranked among the 3 lowest priced countries for 12 of 15 newly reimbursed medicines examined within the 19-country reference group proposed under the US MFN models. The authors concluded that South Korea’s position within these reference price distributions could delay market entry, noting that the analysis assessed potential risk rather than observed launch delays. Korea has also introduced a flexible contract system that separates publicly visible list prices from confidential negotiated prices, an approach that may help manage international pricing exposure while supporting patient access.

These examples show why the way we measure policy success matters. Lower prices or payer spending may be important outcomes, but they do not necessarily capture effects on access, innovation, or supply resilience. Understanding these trade-offs requires evidence that looks beyond a single policy objective and considers its broader effects across the health system.

 

From Expected Value to Realized Value

Identifying the potential clinical, economic, health system, or societal value of an intervention or policy is only part of the equation. An equally important question is whether that expected value is ultimately realized in practice.

This distinction is particularly relevant when policies pursue multiple objectives. An intervention may demonstrate value but face implementation barriers that limit its impact, while a policy may achieve some intended objectives but produce different outcomes across diverse populations. Evaluating value requires understanding what happens after implementation and the context in which outcomes are achieved.

The concept of realized value emerged from insights gathered and synthesized by the ISPOR Institute for Healthcare Transformation during a one-day conference in Boston, where discussions highlighted the need to strengthen the connection between evidence generation and the questions facing health policy decision makers. This includes identifying evidence gaps, determining which outcomes matter in specific decision contexts, and assessing whether policies and interventions ultimately deliver their intended value, for whom, and under what conditions.

For HEOR, realized value creates an opportunity to strengthen the connection between evidence generation, implementation, and policy evaluation. The objective is to generate evidence that helps decision makers understand not only what could create value, but what does create value in practice.

 

Looking Ahead: Policy Implications and Emerging Signals

As health and pharmaceutical policies pursue a broader range of objectives, how value is defined and evaluated will become increasingly important for evidence-informed decision making.

  • Definitions of value are broadening. Clinical outcomes and healthcare expenditures remain central, but policy makers are also considering implications for access, productivity, innovation, resilience, and societal and economic outcomes.
  • Multiple objectives create complex trade-offs. Evaluating policy success against a single outcome may overlook effects elsewhere in the health system or pharmaceutical ecosystem, reinforcing the need to consider both intended and unintended consequences.
  • Realized value is becoming an important consideration. HEOR can help bridge the gap between what policies and interventions are expected to achieve and what they ultimately deliver in practice, including for whom those outcomes are achieved, under what conditions, and across which dimensions of value.

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