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Federal Trade Commission inquiry could eventually lead to overhaul of prescription drug rebate system

In June, the U.S. Federal Trade Commission (FTC) voted unanimously (5-0) to examine rising list prices of insulin, but also to probe possible anti-competitive practices by pharmacy benefit managers (PBMs) with respect to the use of rebate arrangements. Rebates are payments from drug manufacturers to PBMs in exchange for moving market share towards so-called preferred products on the formulary.

The FTC has specifically cited instances in which cheaper generics and biosimilars are excluded from PBM formularies, as this may violate competition and consumer protection laws.

The FTC inquiry into pharmacy benefit manager (PBM) practices could lead to legal action prohibiting certain rebate practices. In turn, this could induce major changes in the U.S. rebate system. Formulary management could become increasingly value- or outcomes-based, rather than simply a function of a financial power play between drug makers and PBMs. Or, rebates could fall by the wayside altogether, to be replaced by a combination of upfront discounts in lieu of rebates and value-based pricing arrangements. Partnering with Lyfegen may be the solution for manufacturers and payers alike, as its platform can put users on the right track towards successful implementation of value-based pricing arrangements.

The FTC has warned of legal action against PBMs if its inquiries find proof of anti-competitive practices. Here, the agency raised the stakes when it included terms like “commercial bribery” in its statements to describe what it perceives as anti-competitive rebates in the insulin market.

The latest FTC inquiries follow a recent investigation by Senators Grassley (R-Iowa) and Wyden (D-Oregon), which blamed rebate schemes for much of what ails the prescription drug market. Furthermore, nearly two years ago, Senator Klobuchar (D-Minnesota) and colleagues commissioned the General Accounting Office (GAO) to examine rebates. The GAO report is due out this fall.

PBMs receive rebates from drug manufacturers in exchange for preferred positioning on the formulary, which in turn drives market share. Experts have criticized rebates for the fact that payers often don’t base their decisions to include a drug on comparative clinical- and cost-effectiveness. Rather, decisions are strictly based on financial terms, namely which manufacturer offers a higher rebate payment to the PBM; a financial power play in which PBMs may threaten not to cover certain drugs if they don’t get the rebate they want. This applies to insulin as well as numerous other therapeutic categories.

What’s worse is when rebate traps or walls are involved. Branded manufacturers leverage their position as market leaders by offering financial incentives to PBMs and health insurers in the form of “all or nothing” conditional volume-based rebates, in exchange for (virtually) exclusive positioning on the formulary. This can mean keeping competitors off the formulary entirely, or severely limiting formulary access to a competing drug with drug utilization management tools like step edits. Here, a patient must use a preferred drug and fail on it (a so-called “fail-first” policy) before “stepping up” to a non-preferred drug.

Because the portion of the rebate retained by PBMs is often calculated as a percentage of a drug’s list price, PBMs can have incentives to establish formularies that favor branded drugs with higher list prices and larger rebates over lower priced biosimilars, specialty generics, or even branded competitors. Rival drugs entering the market lack sufficient sales volume to be able to offer the same level of rebates to PBMs that originator firms can provide.

Proof of the establishment of anti-competitive practices could lead to legal action being taken against PBMs. The question then becomes what would replace rebates? Payers may establish an entirely different formulary management system that is more value-based. Surely, it would be a system that’s less contingent on the role of the financial power play between drug makers and PBMs.

In areas such as immunotherapy targeting certain cancers, cell and gene therapy, and rheumatology, there are already a growing number of value-based agreements.

Girisha Fernando, CEO and Founder of Lyfegen, which offers a platform to track value-based agreements with real-world data, said that many outcomes-based deals are kept secret and therefore under the radar, so to speak. Commercial payers generally don’t share publicly what types of value-based deals they have with drug companies to maintain their competitive advantage. Yet, in an interview with Endpoints News Fernando stated that he’s observed at least a 300% increase in value-based agreements over the last five years. The Lyfegen Platform enables more efficient and transparent management of value-based drug pricing contracts by using intelligent algorithms to capture and analyze patient-level drug cost data.

Fallout from the FTC inquiry – should rebates be identified as anti-competitive - may entail further increases in value-based dealmaking.

About the author

Cohen is a health economist with more than 25 years of experience analyzing, publishing, and presenting on drug and diagnostic pricing and reimbursement, as well as healthcare policy reform initiatives. For 21 years, Cohen was an academic at Tufts University, the University of Pennsylvania, and the University of Amsterdam. Currently, and for the past five years, Cohen is an independent healthcare analyst n a variety of research, teaching, speaking, editing, and writing projects.

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For those navigating the complexities of pharma rebate management, Q1 offers unique opportunities to streamline workflows, review existing agreements, and ensure every rebate maximizes its potential. This period isn’t just about planning, it’s about implementing smarter processes to stay ahead in an increasingly dynamic healthcare landscape.

Why Rebate Management Deserves Q1 Attention

  1. Reviewing Performance

Q1 is the ideal time to evaluate rebate performance from the previous year. Were the agreements aligned with expectations? Did they deliver the promised value?

By assessing past performance, teams can identify underperforming agreements and opportunities for improvement. This ensures resources are allocated to agreements that drive measurable results.

  1. Optimizing Current Workflows

Rebate workflows are often complex, requiring significant manual effort for tracking, reconciliation, and reporting. In Q1, organizations have the opportunity to implement systems that:

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  • Provide real-time visibility into rebate performance.

Streamlining workflows early in the year creates efficiencies that save time and resources throughout the year.

  1. Negotiating Future Agreements

The first quarter is also critical for renegotiating rebate terms with manufacturers and payers. Updated contracts may include:

  • A move to outcome-based agreements, which tie rebates to specific performance metrics.
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Teams equipped with data from previous agreements are better positioned to negotiate terms that align with strategic goals.

The Role of Technology in Pharma Rebate Management

Technology is transforming how organizations approach pharma rebate management. Tools like those offered by Lyfegen enable teams to:

  • Automate workflows: Reduce manual effort in tracking and reconciliation.
  • Gain transparency: Access clear, real-time insights into rebate agreements.
  • Optimize decisions: Use data-driven analytics to evaluate and renegotiate agreements.

For example, Lyfegen’s platform simplifies rebate tracking and provides actionable insights, ensuring organizations maximize their rebate potential while minimizing inefficiencies.

Start your year smarter!

Q1 is the time to rethink and refine your approach to pharma rebate management. With smarter workflows, clearer insights, and a focus on data-driven strategies, your team can unlock measurable savings and operational excellence.

Book a demo today to discover how Lyfegen’s solutions can simplify your rebate workflows and set you up for success in 2025.

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Rising drug costs continue to challenge healthcare systems worldwide. In the UK, the proposed Voluntary Pricing Access Scheme (VPAG) and the NHS’s Accelerated Access Collaborative (AAC) are clear signals of the need for sustainable, transparent approaches to branded medicine pricing. These frameworks aim to control costs through 2028 while ensuring patient access to innovative treatments. Drug rebate management solutions are key to navigating these evolving frameworks. By automating complex workflows, providing real-time insights, and streamlining rebate tracking, these tools reduce administrative burdens, enhance transparency, and unlock significant cost savings.

Key Benefits of Modern Drug Rebate Management Solutions

  1. Automation Simplifies Operations

Traditional rebate management involves resource-heavy processes prone to delays and errors. Modern drug rebate management solutions automate tasks like reconciliation, reporting, and contract tracking, enabling healthcare providers to focus on negotiating better contracts and ensuring compliance with policies like VPAG.

  1. Transparency Reveals Opportunities

Rebate platforms provide granular visibility into contracts, helping organizations identify cost-effective therapies and maximize rebate potential. This transparency aligns with NHS AAC’s goal of improving value and ensuring public funds are spent efficiently.

  1. Real-Time Data Drives Smarter Decisions

Access to live rebate and claims data allows stakeholders to evaluate agreement performance and adjust strategies quickly. With real-time insights, healthcare providers can ensure rebates are optimized, costs are minimized, and patient access is preserved.  

This capability supports NHS AAC’s commitment to accelerating access to innovative medicines while maintaining value for taxpayers.

  1. Faster Auditing Improves Accountability

Delayed reconciliation often creates inefficiencies and compliance risks. Modern drug rebate management solutions provide real-time rebate tracking and payment reconciliation, ensuring accurate auditing and faster resolution of discrepancies. These features are critical for meeting the transparency and accountability goals of initiatives like VPAG.

Why Now?

The VPAG and AAC frameworks prioritize:

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  • Redirecting savings to high-impact therapies and improved patient care.

Modern drug rebate management solutions directly address these priorities by simplifying rebate processes, supporting compliance, and enabling healthcare providers to align with evolving regulatory frameworks.

Smarter Practices in Action

Lyfegen is an all-in-one platform designed to streamline rebate workflows, improve transparency, and deliver actionable analytics. By leveraging tools like Lyfegen, healthcare organizations can navigate regulatory changes like VPAG with confidence, ensuring efficient operations and measurable savings.

Looking ahead

As healthcare systems face rising costs and increasing complexity, adopting a modern drug rebate management solution is no longer optional, it’s essential. These tools provide the automation, transparency, and real-time insights needed to comply with frameworks like VPAG while driving cost savings and supporting innovation.

Ready to simplify your rebate workflows? Sign up for a demo today to see how smarter solutions can transform your strategy.

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