pLOG

2025-10-07

From “Sustainability” to “Urgency”: The Product Lifecycle Development Mindset of PSP and EAP

The lifecycle service of a pharmaceutical product extends from pre-launch clinical trials to post-approval sales support. At its core, it focuses on addressing the critical issue of patient access to medicines. With the growing trend of accelerated drug approvals, a more strategic approach to patient support—known as *Patient Solution*—has evolved from traditional *Patient Support Programs (PSP)* to the more advanced *Expanded Access Programs (EAP)* at the forefront of the market.

At the heart of a Patient Support Program (PSP) lies a sustainable journey centered on “helping patients use their medication effectively.” It is a long-term service that spans both pre- and post-approval stages of a drug, aiming to assist patients in obtaining necessary treatments, improving medication adherence, managing side effects, and providing lifestyle and financial support. A well-designed PSP can significantly enhance clinical outcomes and ensure that the therapeutic value of a drug is both *recognized* and *sustained* in real-world settings. Moreover, the first-hand real-world data gathered through close interactions with patients and healthcare providers become invaluable, intangible assets for future drug development.

When a pharmaceutical company prepares to launch a next-generation drug or expand an existing indication, the data and insights accumulated from PSPs play a pivotal role. These findings can inform the design of new formulations or indications. Meanwhile, an Expanded Access Program (EAP)—a pre-approval mechanism authorized for urgent, compassionate use—serves as a responsive solution to address immediate patient needs. However, from a product lifecycle perspective, EAPs represent a more targeted and strategic approach within the overall development framework.

A service closed loop driven by the “Physician Treatment Plan” at its core

As a Patient Solution Provider, PatientsForce recognizes that EAPs and PSPs are not isolated service projects; their common starting point lies in the physician’s treatment plan, designed to address patient needs.

  • Starting Point of PSP: Once a physician issues a prescription, the PSP journey begins. PatientsForce steps in at this stage to provide comprehensive support—from medication education, reimbursement guidance, and financial assistance to adherence reminders—ensuring that patients can follow their physician’s treatment plan smoothly and continuously.
  • Reverse Extension of EAP: When a physician determines that a patient’s condition is critical and existing treatments are ineffective, PatientsForce leverages the patient journey data accumulated from PSPs to assist the medical team in navigating the complex EAP application process, monitoring drug safety, and ensuring a stable supply of medication, allowing physicians to focus on the most essential clinical decisions.

This physician treatment plan–driven, patient-centered service model seamlessly connects EAPs and PSPs into a strategic closed loop of “Value / Evidence / Accessibility.”

  1. Value: By continuously collecting real-world treatment outcomes through PSPs, the “therapeutic value” of a medication is made tangible.
  2. Evidence: These valuable data serve as evidence for communication with HTA bodies (health technology assessment) and payers, while also guiding the development of more precise solutions.
  3. Accessibility: Data from EAPs also serve as evidence of clinical outcomes, accelerating the approval of new drugs or indications and thereby enhancing patient access.

Value Empowerment of a Patient Solution Provider: From “Compliance” to “Verifiable Impact”

A successful PSP service professional is not only an executor of processes but also an enabler of strategy. PatientsForce internalizes the following five core modules as the foundation of its services:

  1. Unmet Needs Segmentation: Accurately identify patients with the most urgent needs and provide customized services based on their treatment journey.
  2. Evidence & Funding Pathway:Assist pharmaceutical companies in translating PSP data into language understandable to payers and participate in the design of Managed Access Agreements.
  3. Compliance & Risk:Integrate stringent Anti-Kickback, Pharmacovigilance (PV), and data protection (e.g., DPIA) processes to ensure services operate under the highest compliance standards.
  4. Service & Operations: Deliver “rapid onboarding” and “continuous support” services through multi-channel integration, using engagement rate, adherence, and treatment outcomes as key performance indicators (KPIs).
  5. Data & Insight:Establish a standardized data collection framework to quantify patient-reported outcomes (PROs) and treatment results, providing verifiable insights to support pharmaceutical companies’ commercial decisions.

PSPs ensure the sustainability of “effective use, demonstrable value, and affordability,” while EAPs build on this foundation to address the urgency of “early access.” From a business management perspective, true competitiveness lies not in optimizing individual components, but in integrating regulatory compliance, evidence generation, payer engagement, and service design into a comprehensive, patient-centered closed loop.

PatientsForce collaborates with multinational pharmaceutical companies to support physicians and patients in navigating patient support services from EAP to PSP, all within a framework of regulatory compliance.

Note:

EAP stands for Early Access Program, which provides patients with the opportunity to use a drug or therapy before it has received formal regulatory approval. It is designed for patients with serious, life-threatening conditions who have exhausted all other effective treatment options. EAP is a special humanitarian mechanism that allows patients to access investigational drugs outside of clinical trials, addressing urgent medical needs. Taiwan also has corresponding programs for managing such early-access medications.

Different countries use various names and regulations for EAPs, but the underlying principle remains the same:

  • United States (FDA):Expanded Access (also known as Compassionate Use)
  • European Union (EMA):Compassionate Use Programme
  • United Kingdom (MHRA):Early Access to Medicines Scheme (EAMS)
  • Canada (Health Canada): Special Access Programme (SAP)