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FDA Launches a new program to speed patient access

Introduction

The FDA has launched an innovative pilot program to expedite patient access to essential therapies: the Split Real Time Application Review (STAR). Starting December 2, both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will begin accepting a limited number of marketing applications under this new initiative. By focusing on early and continuous review processes, the STAR program aims to minimize the time between final submission and the FDA’s action date, providing faster access to treatments for patients with unmet medical needs.

Key Takeaways for Pharma and Healthcare Providers

1. Accelerated Review Process for Unmet Needs

• What’s Changing: The STAR program is designed to review applications in segments, allowing FDA reviewers to assess data in real time as it becomes available. This continuous review approach differs from traditional methods, where applications are evaluated in full only after complete submission.

• Impact: For pharmaceutical companies, this streamlined process could mean faster paths to market, particularly for therapies targeting critical, unmet needs. It emphasizes the FDA’s commitment to addressing patient needs more swiftly, which could reduce financial burdens on developers facing lengthy approval processes.

2. Collaboration Between CDER and CBER

• What’s Changing: The STAR program is a collaborative effort involving both CDER and CBER, expanding its applicability to a broad range of therapies, including new drugs and biologics. This joint approach signals the FDA’s intention to standardize and extend this model across diverse therapeutic areas.

• Impact: By involving multiple FDA centers, the STAR program encourages broader participation from biotech and pharmaceutical companies developing biologics, vaccines, and innovative therapies. For patients, it represents a promising step toward quicker access to a wider array of advanced treatment options.

3. Focus on Real-Time Data and Incremental Submissions

• What’s Changing: Unlike traditional application reviews that rely on fully completed submissions, STAR’s approach allows the FDA to review segments as they are completed. This real-time data review supports a more dynamic evaluation process and could accelerate decision-making.

• Impact: For the pharma industry, this shift may lead to shorter regulatory timelines and a more predictable approval process. By providing early feedback on submitted data, the FDA enables companies to address potential issues proactively, ultimately supporting faster market access for breakthrough therapies.

Conclusion

The FDA’s STAR program represents a transformative approach to regulatory review, one that aligns with the needs of modern healthcare. By focusing on continuous, real-time reviews, the FDA is paving the way for faster patient access to treatments that address critical health needs. For pharmaceutical companies and healthcare providers, this new pathway offers a chance to bring innovations to patients more swiftly and efficiently. As the STAR program unfolds, its success could shape the future of regulatory review, setting a new standard for timely patient access in the U.S. healthcare system.

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Related blogs

Why Q1 Is Critical for Pharma Rebate Management

The first quarter of the year is a pivotal time for the pharmaceutical industry. As budgets are finalized and contracts renegotiated, Q1 sets the stage for how effectively organizations manage rebates, optimize costs, and deliver value.

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.

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Why Rebate Management Deserves Q1 Attention

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.

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:

Reduce administrative burdens.

Automate repetitive tasks.

Provide real-time visibility into rebate performance.

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

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.

Adjustments to existing terms based on market changes.

Teams equipped with data from previous agreements are better positioned to negotiate terms that align with strategic goals.
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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.

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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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Rethinking Medicine Payments with Smarter Drug Rebate Management Solutions

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

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.

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.

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.

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:

Optimizing branded medicine spending while maintaining access to innovation.

Enhancing transparency for payers, providers, and the public.

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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