Patient Support Programs 101: Why Pharma Runs PSPs in the US and EU

Pharmaceutical companies invested over $22 billion in Patient Support Programs in 2024. Yet here's the paradox: only 3-8% of eligible patients actually use these services. This massive gap reveals both the untapped potential and strategic importance of PSPs in modern pharmaceutical commercialization.

What is a Patient Support Program?

Patient Support Programs are structured initiatives that help patients access, initiate, and maintain prescribed therapies through services extending far beyond medication dispensing.

Unlike Risk Evaluation and Mitigation Strategies (REMS), which are FDA-mandated safety programs focusing on specific risks, PSPs are voluntary manufacturer-sponsored programs emphasizing patient access and adherence. They also differ from simple Patient Assistance Programs (PAPs), which primarily provide financial aid. PSPs encompass comprehensive support ecosystems including clinical case management, insurance navigation, adherence programs, and patient education.

Why Do Pharma Companies Run PSPs?

The simple answer: PSPs drive both patient benefit and commercial outcomes. They directly impact revenue while addressing genuine patient needs in increasingly complex healthcare systems.

• Commercial motivations include reducing prescription abandonment rates (which can reach 30-40% for specialty medications), extending treatment duration, and protecting market share in competitive therapeutic areas.
• Clinical motivations center on improving adherence which is critical when 50% of patients don't take medications as prescribed, leading to $100-300 billion in avoidable healthcare costs annually.

But the way PSPs are designed differs dramatically between the US and the EU due to regulatory frameworks, reimbursement systems, and data privacy requirements.

How Do PSPs Work in the US?

The US healthcare system’s complexity means PSPs focus heavily on insurance navigation and financial support.

1. Insurance Navigation and Hub Services

The US system's reliance on private insurance creates substantial administrative burden. Prior authorization requirements affect 91% of specialty medications, with approval processes taking 2-5 business days and denial rates reaching 25-30%. PSPs address this through dedicated case managers who navigate insurance verification, prior authorization submissions, and appeals processes.

Hub services or integrated platforms coordinating patient, provider, and payer interactions cut time-to-therapy by 5-6 days on average.

2. Financial Assistance

High-deductible health plans affect 42% of US workers, creating significant financial barriers even for insured patients. PSPs directly address this through copay cards, which can reduce patient out-of-pocket costs from $500-2,000 monthly to $5-25.

AbbVie's HUMIRA Complete program demonstrates measurable impact: patients enrolled in the PSP showed 69% treatment persistence at 12 months versus 55% for non-participants. After 36 months, PSP participants maintained 46% persistence compared to 34% in control groups, translating to sustained medication adherence and revenue protection.

3. Market Access & Competitive Advantage

Specialty medication launches face increasing formulary restrictions and step therapy requirements. PSPs provide competitive differentiation when clinical profiles are similar. Companies report that robust PSP offerings influence 15-25% of prescriber decisions when choosing between therapeutically equivalent options.

How Do PSPs Work in the EU?

European PSPs face tighter compliance restrictions but thrive in education and outcomes measurement.

1. Compliance and Regulation

The newly updated EFPIA Patient Solutions Guidelines (December 2024) establish clear boundaries for PSP activities across EU member states. Key requirements include:

• PSPs must not promote prescription, supply, or consumption of medicines to patients
• Programs cannot include inducements for healthcare professionals to prescribe specific products
• Patient enrollment must occur through healthcare providers, not direct patient outreach
• All activities must demonstrate documented medical need and avoid interfering with physician-patient relationships

2. Data-Driven Real-World Evidence

GDPR compliance requirements mandate explicit patient consent and data minimization, limiting commercial data collection compared to US programs. However, European PSPs excel at generating real-world evidence for health technology assessments and payer negotiations.

Programs focus on clinical outcome measurement, quality of life improvements, and healthcare utilization patterns that support value-based pricing discussions with national health services. This data becomes critical for market access in countries requiring health economic evidence for reimbursement decisions.

3. Patient Education and Care Coordination

Without the insurance navigation complexity of the US system, European PSPs emphasize disease education, self-management support, and care coordination within existing healthcare pathways. Programs often integrate with general practitioners and specialist clinics to provide supplementary patient education and adherence monitoring.

Digital platforms enable scalable patient engagement while maintaining compliance with promotional boundaries. Educational content, symptom tracking, and medication reminders delivered through smartphone applications represent growing PSP components across European markets.

Comparative Analysis: US vs EU PSP Models

The fundamental differences reflect underlying healthcare system structures and regulatory philosophies. US programs emphasize market access facilitation within complex commercial insurance frameworks. European programs focus on outcomes optimization within established public health systems.

Both aim to improve adherence and persistence but the strategy aligns with each region’s healthcare system.

Do PSPs Really Work?

Rigorous research demonstrates measurable PSP impact across clinical, economic, and commercial domains.

Adherence and Persistence Outcomes

A comprehensive systematic review of 64 studies found that 66% of adherence-focused PSP interventions reported statistically significant improvement. The most robust evidence comes from specialty medications treating chronic conditions, where PSP participants demonstrate 10-30% higher adherence rates compared to unsupported patients.

Long-term persistence data proves particularly compelling. The HUMIRA Complete analysis tracking patients over 36 months showed sustained benefits: 69% of PSP participants remained on therapy at 12 months versus 55% of controls, with differences persisting through 36-month follow-up.

Cost Savings

PSP participants generate 23-35% lower total healthcare costs despite slightly higher pharmacy expenditures, indicating that improved adherence reduces expensive downstream complications. Hospital admission rates among PSP participants show significant reductions, with one analysis estimating $438 million in potential hospital cost savings for adalimumab patients over 36 months.

ROI and Market Share

Cost-per-enrolled-patient metrics range from $500-5000 annually depending on service intensity and therapeutic area complexity. Leading programs achieve 15-40% ROI through reduced abandonment, extended treatment duration, and market share protection.

PSPs measurably impact key commercial outcomes. Time-to-first-fill improvements of 5-6 days directly influence revenue recognition and patient satisfaction. Enrollment rates in well-designed programs reach 60-80% among eligible patients, compared to 8-15% industry averages.

Risks and Constraints: Navigating the Compliance Complexity

PSPs operate within strict regulatory boundaries requiring sophisticated compliance frameworks.

US Anti-Kickback and Privacy Considerations

The US Anti-Kickback Statute prohibits payments intended to influence healthcare decision-making, requiring careful PSP design ensuring patient benefit rather than provider inducement. Safe harbor provisions protect legitimate patient assistance when programs meet specific criteria: income-based eligibility, no linking to provider decisions, and documented medical necessity.

HIPAA compliance enables comprehensive patient data collection but requires appropriate safeguards for protected health information. Companies must implement business associate agreements with PSP vendors, data encryption standards, and breach notification procedures.

EU Promotional Boundaries and GDPR

European pharmaceutical codes impose stricter limitations on company-patient interactions. The EFPIA guidelines explicitly prohibit remuneration or personal benefits for patients, while programs must demonstrate medical need documentation and avoid promotional messaging.

GDPR requirements mandate explicit consent for personal data processing, data minimization principles, and individual control over information use. European PSPs must implement transparent privacy notices, opt-out mechanisms, and data portability provisions that constrain commercial applications.

How Zelthy Supports Effective PSP Management

Zelthy offers a comprehensive platform for Patient Support Programs, helping pharmaceutical companies streamline PSP operations across regions while maintaining full compliance. Key benefits include:

• Centralized patient data management: Securely track enrollment, adherence, and outcomes in line with HIPAA and GDPR requirements.
• Automated patient engagement: Deliver reminders, educational content, and symptom tracking through digital channels, improving persistence and adherence.
• Integrated workflow for US and EU models: Support both insurance navigation and financial assistance in the US, as well as education and outcomes reporting in the EU.
• Real-time insights and analytics: Measure PSP ROI, monitor enrollment trends, and generate reports for commercial, clinical, and market access teams.

“A global pharma company used Zelthy’s PSP platform to run disease awareness campaigns and connect patients with treatments. In just 9 months, the initiative drove 500,000+ website visits, generated 80,000+ consultation requests, achieved a 30% visitor-to-appointment conversion, and doubled therapy initiations in target cities.”

Read the full story to see how Zelthy delivers measurable impact for patient engagement campaigns.

Want to explore how Zelthy can transform your PSP operations? Book a demo. Contact us at connect@zelthy.com or send us a DM on LinkedIn for more information.

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