Agenda for Day 2 - Tuesday December 8, 2026Tuesday, 8 December 2026 - US/Pacific

Hear from leading attorneys as they discuss the legal, regulatory, and compliance developments creating the greatest uncertainty across government pricing and contracting functions.

Discussion Topics

• MFN implementation

• CMS international reference pricing initiatives (GENEROUS/GUARD/GLOBE)

• MFP developments

• 340B litigation

• PBM reform

• State transparency requirements

• Executive Orders and regulatory uncertainty

Pricing decisions often create unintended downstream consequences. This session explores the growing relationship between gross-to-net dynamics, PBM economics, government pricing obligations, and long-term profitability.

• Discussion Topics

• Rebate inflation trends

• WAC strategy considerations

• Price protection mechanisms

• Contracting implications

• Understanding the “GTN bubble”

Artificial intelligence is beginning to move beyond experimentation and into practical use cases across pricing and contracting organizations. Hear how manufacturers are leveraging AI tools to improve efficiency, reduce manual effort, and support compliance activities.

Discussion Topics

• Contract analytics

• Rebate validation

• State transparency monitoring

• Compliance review

• Reporting workflow optimization

As policymakers scrutinize PBM practices and manufacturers face increasing rebate pressure, understanding the future of formulary management and PBM economics has become essential for pricing leaders.

Discussion Topics

• Rebate economics

• Formulary pressure

• Current administration priorities

• Pass-through models

• Bona fide service fees

This session brings together state and covered entity leaders to provide perspectives manufacturers rarely hear directly: the operational realities, constraints, and priorities shaping Medicaid program decision-making and 340B compliance.

Discussion Topics

• State rebate administration challenges

• Why states and covered entities make certain operational decisions

• Medicaid disputes and resolution approaches

• 340B program compliance and audit realities

• System modernization efforts

High-cost therapeutic categories continue to challenge traditional reimbursement, contracting, and government pricing frameworks. As manufacturers launch increasingly complex therapies with significant upfront costs, organizations must rethink how pricing, market access, government reporting, and payer engagement strategies work together.

Discussion Topics

• Contracting and reimbursement challenges across high-cost therapeutic categories
• Cell and gene therapy-specific access and affordability considerations
• Government pricing implications and reporting considerations
• Outcomes-based agreements and innovative contracting models
• Payer affordability concerns
• Lessons learned from recent launches

Gain insight into how state representatives and affordability review bodies are approaching prescription drug affordability reviews, and what manufacturers can do to engage effectively throughout the process.

Discussion Topics

• Factors states consider when evaluating drug value beyond cost
• Clinical impact, patient outcomes, affordability, and market dynamics
• Manufacturer notification, data submission, assessment, and decision-making
• Best practices for transparency and collaboration with state agencies
• Implications for pricing, contracting, access, and manufacturer engagement

A forward-looking discussion on the issues expected to shape government pricing, rebates, and contracting over the next 12 months.

Discussion Topics

• MFN
• MFP
• 340B
• PBM reform
• State transparency
• AI adoption