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ISPOR 2026: Navigating the Interconnections Among Policy, Access, and Value

 

Ana Amaris, MD, MPH, Director, Health Policy Initiatives, ISPOR, Lawrenceville, NJ, USA

 

Overview: This June installment reflects on a broader theme that emerged at ISPOR 2026. Increasingly, policy decisions are influencing not only pricing and reimbursement, but also evidence generation, innovation incentives, launch strategies, and access pathways across health systems. Recent developments across countries and regions suggest that these issues are interconnected priorities aimed at improving healthcare worldwide and can no longer be considered in isolation.

 

Policy Developments Shaping the Landscape

 

US Pricing Reforms and Global Implications

Recent developments in the United States highlight how pharmaceutical policy conversations are extending beyond affordability alone. The continued expansion of Most-Favored-Nation (MFN) agreements has linked drug pricing discussions with broader considerations related to domestic investment, manufacturing, and competitiveness. At the same time, the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act (IRA) has shifted attention toward operational questions, including evidence requirements, negotiation processes, and long-term evaluation. These trends illustrate how pharmaceutical policy is evolving beyond pricing alone, intersecting with broader questions related to investment, competitiveness, and implementation.

Growing Attention to Competitiveness and Innovation

Across Europe, stakeholders are deeply focused on the relationships connecting affordability, competitiveness, and innovation. Concerns regarding launch sequencing and market attractiveness have prompted broader conversations about how pricing and reimbursement policies may influence investment decisions and research activity, which ultimately impacts patient access. These exchanges are taking place within a rapidly evolving global innovation landscape, including the growing role of China in pharmaceutical R&D and drug development. Policy makers around the world are therefore increasingly considering how affordability, access, innovation, and sustainability interact within broader health and economic systems.

Increasing Expectations for Evidence

Expectations regarding the evidence used to inform healthcare decision making are also evolving. Spain’s recently approved Royal Decree on Health Technology Assessment (HTA) establishes a more structured national framework while aligning with the implementation of the European Union HTA Regulation and Joint Clinical Assessments (JCAs), reflecting broader efforts to strengthen coordination and transparency in evidence assessment. More broadly, the introduction of JCAs across Europe represents an important shift toward shared clinical evidence assessments while preserving national decision making on economic, organizational, and contextual considerations.

At the same time, discussions at ISPOR 2026 highlighted growing interest in topics such as real-world evidence, AI-enabled analytics, transparency, and model validation. These developments reflect growing recognition that increasingly complex health policy decisions require robust approaches to evidence generation and assessment.

Balancing Affordability, Access, and Value

Questions regarding how value should be incorporated into healthcare decision making also are proliferating across policy dialogues. At ISPOR 2026, these themes were reflected in a plenary session on innovation under pressure, which explored how evolving pricing and trade policies may influence evidence generation, launch strategies, development decisions, and long-term incentives for innovation in drug development.

Similar questions were examined during an issue panel on value-based pricing in Medicare drug price negotiations, which explored whether negotiated prices align with conventional approaches to value assessment and discussed the practical, methodological, and policy considerations associated with integrating value into pricing decisions. Topics such as transparency, evidence requirements, feasibility, innovation, and patient access were prominently featured.

These conversations reflect growing interest in how healthcare systems define, assess, and incorporate value while pursuing broader goals related to affordability, access, innovation, and sustainability.

 

Looking Ahead

The themes highlighted throughout ISPOR 2026 underscored the growing interconnectedness of policy, access, value, innovation, and evidence generation. As policy discussions continue to evolve globally, several themes may be particularly important to monitor:

  • The evolving relationship between pricing policy and industrial policy: As governments pursue affordability objectives,  policy conversations are increasingly expanding beyond healthcare spending to include competitiveness, domestic manufacturing, supply chain resilience, and investment incentives.
  •  Evolving approaches to value assessment and evidence generation: Ongoing implementation of the EU HTA Regulation, national HTA reforms, and growing interest in real-world evidence and AI-enabled analytics may influence how value is assessed and how evidence is incorporated into healthcare decision making.
  •  The global geography of innovation: Continued growth in pharmaceutical R&D activity and investment outside traditional markets is prompting renewed dialogue about how policy environments influence innovation, research, and future product development.

 

 

 

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