Understanding the Differences in Managed Access Programs – Insights from Anton Sergienko, Director of Managed Access Program Delivery at COREX

Managed Access Programs (MAPs) are critical in expanding access to life-saving treatments before regulatory approval. However, the landscape of these programs is complex, with varying regulations, terminology, and implementation strategies across different regions. From?Named Patient Programs (NPPs)?to?Compassionate Use?and?Expanded Access, understanding the distinctions is essential for pharmaceutical companies looking to navigate this space effectively.

To clarify these complexities, we spoke with Anton Sergienko, Director of Managed Access Program Delivery at COREX, to discuss the key differences between these programs, the challenges involved, and how logistics play a vital role in ensuring seamless patient access.

Q: Anton, Managed Access Programs are often seen as highly complex. Why are they so important, and what makes them so challenging to implement?

Anton: The core objective of Managed Access Programs (MAPs) is to provide patients suffering from serious or life-threatening conditions access to investigational drugs when no approved treatment is available. These programs serve both a humanitarian and strategic purpose—not only helping patients in need but also generating real-world data (RWD) that can support regulatory approvals and market entry.

However, the challenge lies in the fact that there is no universal framework. Each country has unique regulations, approval processes, and distribution mechanisms, making these programs highly complex to implement globally. This is why companies need experienced partners like COREX—to ensure compliance, streamline logistics, and facilitate seamless market access.

Q: One of the biggest challenges is understanding the differences between various managed access programs. Can you break them down for us?

Anton: Certainly! While there are many terms associated with managed access, the three most commonly used frameworks are:

• Compassionate Use / Expanded Access Programs (EAPs) – These programs allow patients to access an investigational drug outside of clinical trials, usually when no other treatment options are available. These are often initiated at the request of a physician and must comply with strict regulatory guidelines.
• Named Patient Programs (NPPs) – Unlike traditional EAPs, which are often set up for broader groups of patients, NPPs are typically arranged on a case-by-case basis for individual patients, often through a physician’s request to the manufacturer. These programs are frequently used in countries where the drug is not yet approved but is available elsewhere.
• Early Access / Post-Trial Access Programs – These include pre-approval access programs that are designed to support patients before or after clinical trials. Pre-trial access allows patients to receive investigational drugs before formal trial enrollment. Post-trial access ensures that patients who participated in a clinical trial continue receiving treatment while regulatory approval is still pending.

Understanding which program best suits a particular market or patient population requires a deep regulatory understanding and a robust logistics network to ensure timely, compliant delivery.

Q: Logistics play a major role in ensuring these programs run smoothly. What are the key challenges from a supply chain perspective?

Anton: Delivering investigational drugs through managed access programs presents unique logistical hurdles. These include:

• Regulatory compliance: Since regulations differ by country, ensuring that shipments align with local requirements is critical. Any non-compliance could lead to delays or rejection at customs.
• Cold-chain management: Many investigational drugs require temperature-controlled transportation to maintain their efficacy. Without strict monitoring and real-time tracking, there’s a risk of product degradation.
• Last-mile delivery: Some patients live in remote or underserved regions, making it difficult to get treatments to them safely and on time. Partnering with specialized logistics providers like COREX ensures that even the most complex deliveries are handled with care.
• Data security & traceability: Since these programs involve highly sensitive patient information, secure handling of data and full traceability of drug shipments are non-negotiable.

Q: Are there any specific regulatory or financial considerations that your clients or partners often overlook when launching a Managed Access Program?

Anton: Yes, and I always advise partners to pay close attention to two critical areas:

1.???? Import Licensing & Customs Regulations

One of the biggest obstacles is securing the correct import license. Best-case scenario: One license covers the entire program. Worst-case scenario: A new license is required for each shipment, significantly delaying the process.

2.???? VAT & Duty Considerations

Customs duties and VAT can significantly increase program costs—sometimes up to 23% of the shipment value. At COREX, we pre-calculate import budgets and adjust invoices accordingly to ensure smooth customs clearance and avoid unnecessary fees.

These financial and regulatory complexities highlight why a detailed pre-launch strategy is essential for pharma companies entering managed access markets.

Q: Looking ahead, how do you see managed access programs evolving in the next five years?

Anton: The future of managed access will be shaped by greater regulatory harmonization, digital advancements, and a stronger emphasis on real-world evidence.

• More global alignment – Agencies like the FDA, EMA, and MHRA are increasingly working toward greater consistency in early access regulations, which could streamline processes for pharmaceutical companies.
• Technology-driven efficiencies – AI and blockchain could improve the way patient eligibility is determined, supply chains are tracked, and regulatory compliance is managed.
• Growing importance of real-world data – As managed access programs generate valuable insights, pharma companies will likely place a stronger emphasis on collecting and analyzing real-world data to support regulatory filings and commercialization strategies.

At COREX, we’re adapting to these trends by investing in digital solutions, strategic regulatory expertise, and end-to-end logistics capabilities to help pharmaceutical companies navigate the evolving landscape of early access.

?Final Thoughts

Managed access programs are a vital lifeline for patients who need treatments that are still on their way to full approval. However, navigating the regulatory, logistical, and operational challenges of these programs requires deep expertise.

At COREX, we’re committed to helping pharmaceutical companies design and implement compliant, patient-centric managed access programs—ensuring that innovative therapies reach those who need them most.

Looking to set up a managed access program? Our experts at COREX are here to guide you through every step—from regulatory navigation to seamless logistics.

Email us at [email protected], and let’s make patient access a reality—together.

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