Insights & Articles

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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From Zolgensma to Hemgenix, gene therapies promise one-time cures for rare and life-threatening diseases. But the financial model behind them can’t follow the traditional playbook. These treatments call for a smarter, more collaborative approach to pricing—and that’s exactly what’s taking root.

Why Payers and Pharma Need a New Playbook

Unlike conventional drugs, gene therapies frontload their cost while delivering benefits over time. That disconnect forces a fundamental rethink of how pricing, reimbursement, and risk-sharing are handled.

According to the Lyfegen 2024 Drug Contracting Trends Report, health systems worldwide are moving toward innovative agreements: outcome guarantees, installment plans, and subscription-based models. These aren’t just experiments—they’re becoming essential tools to balance patient access with financial responsibility.

For payers, it’s about managing risk while maintaining equity. For pharma, it’s about demonstrating value in a way that aligns with clinical reality. Either way, the direction is clear: shared risk, shared benefit.

Global Shifts That Are Shaping the Market

The trends are global and accelerating. In the United States, payers like Blue Cross Blue Shield and Medicaid are embracing outcome-based models for sickle cell gene therapies like Casgevy and Lyfgenia. Brazil’s Ministry of Health uses installment payments for Zolgensma, spreading risk over five years while tying reimbursement to real-world outcomes.

In Europe, countries like Spain and Italy combine restricted coverage with annual reassessments, ensuring that high-cost therapies are only reimbursed if they continue to deliver results.

The message? Pricing innovation is no longer a nice-to-have—it’s the only way forward.

How Lyfegen Bridges the Gap

At Lyfegen, we help payers and pharma move beyond the negotiation table—and into action.

• Our Agreements Library, the world’s largest digital repository of value-based contracts, helps you understand what others are doing and where the benchmarks lie.

• Our pricing simulation engine lets both sides explore scenarios before committing—making deals smarter from day one.

• And our automated platform handles everything from contract setup to rebate tracking, saving time, reducing risk, and driving transparency.

A Smarter Way to Fund the Future of Medicine

Gene therapies will continue to challenge the limits of what we think healthcare can afford. But with the right models and tools, both payers and pharma can find common ground—ensuring that innovation reaches the patients who need it most.

Curious about what’s next in drug contracting?

Download the 2024 Drug Contracting Trends Report for exclusive insights, real-world examples, and global benchmarks.

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A Bright New Chapter in UK Healthcare: How AI-Driven Reform Will Transform Drug Pricing and Access

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A Bright New Chapter in UK Healthcare: How AI-Driven Reform Will Transform Drug Pricing and Access

The UK government is taking a bold step toward modernizing public services by cutting red tape, integrating AI into operations, and bringing NHS England back under direct ministerial control. This reform signals a shift toward efficiency, innovation, and better patient care—one where AI-driven solutions like Lyfegen can play a pivotal role.

A New Dawn for NHS England

NHS England was originally established in 2012 as an arm’s-length organization to insulate the health service from political interference. Over time, however, bureaucracy accumulated, slowing decision-making and increasing costs. With Starmer’s decision to fold NHS England’s functions back into the Department of Health and Social Care (DHSC), the system is poised for a fresh start. This restructuring aims to eliminate redundant roles, reduce administrative waste, and reallocate resources to frontline care—ushering in a new era of efficient and accountable healthcare management.

What’s Changing in the UK’s Healthcare System?

A key takeaway from Starmer’s announcement is his strong push for automation. The government is aiming to cut administrative costs by 25%, ensuring that resources are directed where they matter most: patient care.

Some of the expected changes include:

  • Investing in AI & Digital Tools – Automating processes to enhance efficiency and decision-making.
  • Hiring More Digital Experts – Training 2,000 new tech apprentices by 2030, with 10% of civil servants working in tech roles.
  • Reducing Administrative Waste – Freeing up time and funds by using AI to handle repetitive tasks, allowing healthcare professionals to focus on patient outcomes.

The Impact on Drug Prices and Healthcare Access

By integrating NHS England’s functions into the DHSC, the government is positioned to strengthen and streamline negotiations with pharmaceutical companies. This shift could lead to:

  • Lower Drug Prices – Reduced bureaucracy means more direct resources for securing better pricing.
  • Stronger Negotiating Power – Direct ministerial oversight can drive sustained cost reductions rather than short-term fixes.
  • Faster Access to Medicines – Savings from automation and efficiency gains can be reinvested into reducing wait times and improving treatment availability.
  • Enhanced Value-Based Care – AI tools will optimize drug pricing strategies, ensuring maximum rebates and cost efficiency.
  • Short-Term Disruptions, Long-Term Gains – The transition may temporarily affect drug supply and pricing, but AI-driven analytics will help stabilize and reduce costs in the long run.

The AI Revolution: Powering Efficiency and Innovation

One of the most promising aspects of this reform is the government’s commitment to leveraging AI to transform operations. For an AI-powered platform like Lyfegen, this presents a significant opportunity to deliver real-world benefits in healthcare management. Here’s how Lyfegen can help:

  • Optimized Negotiations – With NHS England now under ministerial control, data-driven pricing will be crucial. Lyfegen’s Agreements Library can benchmark UK drug prices against global agreements, ensuring smarter, fairer negotiations.
  • Automated Contracting – Our AI-powered platform streamlines drug contract creation and management, reducing paperwork and making negotiations faster and more efficient.
  • Real-Time Pricing Simulations – Before finalizing agreements, Lyfegen runs real-time simulations to test different pricing scenarios, identifying the most financially and operationally beneficial outcomes.
  • Capturing Hidden Savings – By automating drug rebate management, Lyfegen detects missed savings, ensuring that every possible dollar is recovered and reinvested into patient care.

Challenges to Watch

While AI promises to revolutionize healthcare efficiency, successful implementation will require overcoming hurdles such as:

  • Data Integration – Ensuring AI systems can seamlessly access and analyze NHS data.
  • Change Management – Encouraging widespread adoption of digital tools among healthcare professionals.
  • Regulatory Compliance – Navigating evolving policies around AI-driven decision-making in healthcare.

A Bright Future for Lyfegen and the Healthcare Sector

Transforming the NHS is no small task. Beyond balancing innovation and cost, the government must manage vast amounts of healthcare data and navigate the complexities of implementing change at scale. However, Starmer’s announcement represents more than just another cycle of NHS reforms—it’s a meaningful step toward a future where efficiency and technology-driven innovation deliver real, lasting benefits to patients.

At Lyfegen, we’re ready to support this transformation by delivering AI-powered solutions that drive real savings and faster patient access. Let’s build a smarter, more efficient NHS together.

Want to see how our AI-powered solutions can support smarter drug pricing and better healthcare access? Let’s schedule a demo today.

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