What Makes Patient Support Programs Work, and What Doesn't

In the first installment of this two-part article, Partha Anbil, senior industry advisor, life sciences, at Coforge, and Partha Khot, life sciences practice lead, at Coforge, laid out the case for patient support programs as strategic infrastructure rather than optional add-ons — tracing the scale of medication nonadherence, the shift toward value-based care, and the four core service categories (clinical support, case management, financial assistance and technology) that make up modern hub services, along with real-world evidence tying program participation to higher adherence, longer treatment persistence and lower total cost of care.

In the second installment, the authors examine the factors that separate high performing programs from underperforming ones, the current scale and structure of the hub services industry, and the criticisms manufacturers, payers and providers continue to raise about these models, closing with strategic recommendations for manufacturers, specialty pharmacies, providers and payers and a look at where patient support programs are headed next.

Critical Success Factors: What Makes Programs Effective

Analysis of published patient support programs reveals several factors consistently associated with superior outcomes:¹

Trained Healthcare Professionals

Programs utilizing registered nurses (19 studies) or pharmacists (19 studies) as primary patient contacts demonstrated better outcomes than those relying solely on untrained customer service representatives.¹ Healthcare professionals bring clinical knowledge that enables them to provide substantive disease education, recognize symptoms concerning, and appropriately escalate issues to prescribers.

The "Nurse Ambassador" model employed in some programs exemplifies this approach. These registered nurses receive specialized training in the disease state, product characteristics, and drug access processes. They provide personalized, high-touch coordinated care that encompasses education, adherence support, and care coordination.

While healthcare professionals are more expensive resources, their clinical expertise appears to justify investment through improved outcomes. Organizations should carefully consider the balance between cost and effectiveness when determining appropriate staffing models.

Frequent, Consistent Touchpoints

Programs providing regular contact through the first 12 months of therapy show superior adherence and persistence.¹ Touchpoint frequency varies based on disease complexity and patient needs, but successful programs typically include:

• Initial intensive contact during therapy initiation (weekly to biweekly)
• Regular ongoing contact throughout the first year (monthly to quarterly)
• Proactive outreach rather than reactive response to patient-initiated calls
• Multiple communication channels (phone, email, text, video)

The first 12 months appear particularly critical, as patients are most vulnerable to non-adherence during this period. Programs concentrating support in this window while maintaining some ongoing contact beyond 12 months show best results.

Combination of Education and Practical Support

The most effective programs combine disease education with practical support addressing concrete barriers. Education alone, particularly written materials without reinforcement, shows limited impact.¹ However, when education is delivered through interactive counseling combined with financial assistance, benefits investigation, and care coordination, outcomes improve substantially.

This suggests programs should be designed around the recognition that knowledge alone is insufficient patients need both understanding and removal of practical obstacles to achieve optimal adherence.

Caregiver and Support System Engagement

Programs incorporating family members or caregivers in the education and support process demonstrate better outcomes than those focusing exclusively on patients.¹ A "buddy system" where caregivers participate in education sessions and help monitor adherence shows promise.

This finding acknowledges that chronic disease management is rarely a solitary endeavor. Family members often play crucial roles in medication administration, symptom monitoring, and providing encouragement during difficult periods. Programs that engage this broader support network leverage a valuable resource for sustained adherence.

Program Evaluation and Continuous Improvement

Successful programs incorporate systematic evaluation using a comprehensive framework encompassing inputs, activities, outputs, outcomes, and impact.¹ Regular assessment enables identification of areas for improvement and optimization of resource allocation.

Key evaluation metrics should include:

• Enrollment rates and time from prescription to enrollment
• Patient engagement levels and contact frequency.
• Medication adherence measured through proportion of days covered.
• Persistence rates and time to discontinuation
• Prior authorization success rates and time to approval
• Patient satisfaction and quality of life measures
• Healthcare utilization including hospitalizations and emergency visits
• Total cost of care including medical and pharmaceutical spending.

Organizations should establish baseline metrics before program launch, monitor performance continuously, and conduct formal evaluations at regular intervals to assess effectiveness and identify opportunities for enhancement.

Industry Landscape: Current State and Trends

Prevalence and Adoption

Patient support programs have become ubiquitous in specialty pharmaceutical commercialization. Analysis of all novel drugs approved and launched in 2019 found that 90% included some form of manufacturer-sponsored patient service. Only four of forty drugs launched without any associated patient support program, and three of those four were indicated for infectious diseases likely to see higher utilization outside the United States.

The prevalence of patient support programs across therapeutic areas demonstrates their importance:

• Rare diseases: 47.5% of programs
• Cancer and blood disorders: 12.5%
• Neurological and psychiatric disorders: 12.5%
• Infectious diseases: 7.5%
• Women's health: 7.5%

Specialty drugs (83% of novel approvals) are significantly more likely to offer comprehensive patient services compared to non-specialty drugs. This reflects both the complexity of these therapies and their prohibitive costs, which create multiple barriers requiring systematic support.

Service Mix and Program Scope

Programs vary substantially in the breadth and depth of services offered. Among 2019 launches:

• 47.5% included 1-2 service categories.
• Thirty percent included three service categories.
• Thirteen percent included all four categories (clinical support, case management, financial support, technology)

Patient-administered drugs (oral and self-injectable) are more likely to offer patient support services compared to physician-administered products. This may reflect the greater complexity patients face in managing self-administration and the opportunity for direct manufacturer-patient relationship when medications are dispensed through specialty pharmacies rather than administered in clinics.

Third-Party Service Providers

While some manufacturers operate patient support programs internally, approximately 15% contract with third-party providers including specialty pharmacies and hub service vendors. These vendors offer infrastructure, expertise, and scalability that may be difficult for individual manufacturers to develop in-house.

The specialty pharmacy industry has evolved to provide comprehensive hub services as a core competency. Large specialty pharmacy organizations operate multiple manufacturer-sponsored programs simultaneously, leveraging shared infrastructure for call centers, case management platforms, and distribution coordination. This outsourced model allows manufacturers to rapidly deploy programs without building internal capabilities.

However, outsourcing introduces challenges around brand control, data access, and consistency of patient experience across multiple products. Manufacturers must carefully evaluate build versus buy decisions and maintain rigorous oversight of third-party vendors to ensure quality and alignment with brand strategy.

Challenges and Criticisms

Despite the benefits demonstrated, patient support programs face legitimate criticisms and challenges that industry must address:

Potential Conflicts of Interest

Programs employing clinicians (nurses, pharmacists) to counsel patients on manufacturer-sponsored therapies create inherent conflicts of interest [9]. These healthcare professionals are not free to provide completely unbiased medical advice, as their primary responsibility is to the manufacturer sponsoring the program. This raises questions about whether recommendations truly serve patient best interests or are influenced by commercial considerations.

Critics argue that if patient adherence improvement is a genuine goal, support programs should extend to generic medications and competitors' products. The focus on high-margin, on-patent specialty drugs suggests commercial motivations outweigh pure patient benefit.²

Industry must address these concerns through transparency, clear disclosure of program sponsorship, and policies ensuring that patient safety and welfare take precedence over commercial objectives. Some manufacturers have established firewalls between commercial teams and patient support personnel to minimize inappropriate influence.

Administrative Burden

While programs aim to reduce prescriber burden, enrollment processes can be complex and time-consuming.³ Manual enrollment forms, inconsistent processes across different manufacturers, and lack of integration with electronic health records create administrative challenges for busy practices.

Patients on multiple specialty medications from different manufacturers may need to navigate several distinct programs, each with unique enrollment procedures, eligibility criteria, and support structures. This fragmentation can be confusing and burdensome.

Industry should prioritize simplification and standardization of enrollment processes. Digital enrollment portals, electronic prescribing integration, and adoption of common data standards could substantially reduce administrative friction.

Cost Shifting and Price Implications

Copayment assistance programs make patients less sensitive to drug prices, potentially enabling manufacturers to maintain or raise list prices knowing that patient out-of-pocket costs remain insulated.⁴ These dynamic disadvantages payers who bear the burden of high list prices while patients perceive medications as affordable.

Some argue that resources devoted to patient support programs would be better allocated to pricing medications more affordably from the outset. The tens of millions of dollars spent annually on hub services could theoretically be reflected in lower acquisition costs.

This criticism, while economically rational, overlooks the reality that even appropriately priced medications face adherence challenges unrelated to cost. Disease education, care coordination, and clinical support provide value independent of financial assistance. Nevertheless, industry must engage seriously with concerns about cost shifting and be transparent about the relationship between program costs and pricing decisions.

Lack of Transparency and Standardization

Manufacturers typically do not publicly disclose program utilization, costs, or detailed outcome data.⁵ This opacity makes it difficult for external stakeholders to evaluate program effectiveness and value. Without standardized reporting of key metrics, meaningful comparison across programs is impossible.

The absence of consistent definitions for success metrics further complicates assessment. Adherence may be measured differently across programs, and patient-reported outcomes utilize non-validated, program-specific instruments.

Industry should work collectively toward greater transparency and standardization. Publishing outcome data in peer-reviewed literature, adopting common metrics, and participating in industry-wide benchmarking would enhance credibility and facilitate identification of best practices.

Regulatory and Compliance Considerations

Patient support programs operate in a complex regulatory environment with substantial compliance risk. Anti-kickback statutes prohibit anything of value offered to induce medication prescribing or purchasing. While patient support programs generally fall within regulatory safe harbors, specific activities may raise concerns.

Manufacturers must maintain rigorous compliance programs ensuring that financial assistance is appropriately limited, that interactions with healthcare providers comply with guidelines, and that all program activities meet legal and ethical standards. Compliance failures can result in significant penalties and reputational damage.

Strategic Implications for Industry Professionals

For Pharmaceutical Manufacturers

Patient support programs should be viewed as strategic imperatives rather than tactical marketing tools. Key strategic considerations include:

Integration with Product Development: Patient support needs should be assessed during clinical development, with program design beginning well before launch. Understanding patient access barriers, insurance coverage patterns, and support requirements enables rapid program deployment at commercialization.

Resource Allocation: Manufacturers should invest in understanding which program components drive greatest value for specific patient populations and disease states. Not all services are equally impactful for all products. Rigorous evaluation and optimization enable efficient resource allocation focused on highest-impact interventions.

Build vs. Buy Decisions: The choice between internal program operation and third-party outsourcing should be made strategically rather than on cost alone. Factors to consider include therapeutic area expertise, data access requirements, brand control priorities, and long-term capability building.

Cross-Functional Alignment: Patient support programs require collaboration across multiple functions including commercial, medical affairs, market access, legal/compliance, and patient advocacy. Breaking down functional silos and establishing clear governance ensures consistent strategy execution.

Measuring Success: Manufacturers should establish comprehensive evaluation frameworks measuring not just enrollment and adherence but also patient satisfaction, provider satisfaction, cost-effectiveness, and contribution to brand positioning. Programs should be managed with the same rigor as other commercial investments, with clear ROI expectations and accountability.

For Specialty Pharmacy Organizations

Specialty pharmacies operating manufacturer-sponsored programs must balance commercial success with patient welfare:

Clinical Excellence: Employing highly trained clinical staff and maintaining clinical protocols ensures programs deliver genuine patient benefit beyond commercial objectives. Specialty pharmacies should invest in staff development, clinical training, and adherence to evidence-based practices.

Technology Investment: Digital platforms that streamline enrollment, enable care coordination, and facilitate communication enhance program efficiency and patient experience. Specialty pharmacies should prioritize technology development enabling scalability without sacrificing personalization.

Outcomes Measurement: Demonstrating value through rigorous outcomes measurement differentiates specialty pharmacy providers in a competitive market. Developing robust analytics capabilities and publishing outcome data establishes credibility and attracts manufacturer partnerships.

Patient-Centricity: While serving manufacturer clients, specialty pharmacies must maintain focus on patient needs and outcomes. Building genuine patient advocacy into organizational culture and decision-making ensures long-term success and reputation.

For Healthcare Providers and Institutions

Prescribers should strategically leverage patient support programs while maintaining independence:

Program Awareness: Understanding available programs and their services enables providers to connect patients with appropriate resources. Practices should maintain current information about programs for commonly prescribed specialty medications.

Critical Evaluation: Not all programs offer equivalent value. Providers should assess program quality, comprehensiveness, and ease of use when directing patients toward resources. Building relationships with high-quality programs benefits patients and practice efficiency.

Workflow Integration: Programs offering seamless enrollment, electronic prior authorization support, and proactive communication reduce practice burden most effectively. Providers should advocate for program features that enhance rather than complicate clinical workflows.

Independence Maintenance: While accepting support for administrative tasks, providers must maintain clinical independence and prescribing decisions free from commercial influence. Patient support programs should facilitate optimal care without compromising professional judgment.

For Payers and Health Systems

Payers face complex decisions about how to engage with manufacturer-sponsored patient support:

Policy Development: Clear policies regarding copayment assistance programs, their impact on deductible and out-of-pocket maximum calculations, and accumulator programs ensure consistent approach aligned with plan design philosophy.

Value Assessment: Payers should evaluate whether patient support programs genuinely reduce total cost of care through better outcomes and reduced medical spending or primarily shift costs while enabling higher list prices. Evidence-based assessment should inform coverage and access policies.

Collaboration Opportunities: Some health systems have developed partnerships with manufacturers to jointly support patient adherence and outcomes. These collaborations, when properly structured, can align incentives and improve system-wide efficiency.

Alternative Models: Payers should explore whether analogous support structures operated by health plans or independent organizations might deliver similar benefits without manufacturer sponsorship concerns. Some integrated delivery systems have developed internal medication therapy management programs achieving comparable outcomes.

Future Directions and Emerging Models

Personalization and Risk Stratification

As programs mature, more sophisticated patient segmentation and personalized support will likely emerge. Not all patients require the same intensity of support. Risk stratification models could identify patients at highest risk for non-adherence based on demographics, disease characteristics, prior healthcare utilization, and social determinants of health. High-risk patients receive intensive intervention while lower-risk patients receive lighter-touch support, optimizing resource allocation.

Digital Health Integration

Integration of patient support programs with digital health platforms, wearables, and remote monitoring technologies offers opportunities for more proactive, data-driven intervention. Real-time medication adherence monitoring, symptom tracking, and predictive analytics could enable anticipatory intervention before adherence lapses or disease exacerbations occur.

Value-Based Contracting Alignment

As value-based contracts between manufacturers and payers become more common, patient support programs may evolve to directly support outcome-based agreements. Programs could be designed explicitly around metrics specified in value-based contracts, with manufacturer reimbursement tied to achievement of adherence and outcome targets.

Multi-Stakeholder Collaboration

Future models may involve greater collaboration among manufacturers, payers, providers, and patients in program design and operation. Shared governance structures and aligned incentives could address current concerns about conflicts of interest while maintaining program benefits.

Expansion Beyond Specialty

While patient support programs originated in specialty pharmacy, similar models may expand to high-cost or complex treatments in traditional pharmacy. Extended-release injectables for mental health, gene therapies, and complex treatment regimens could benefit from structured support regardless of specialty designation.

Conclusion

Patient support programs represent a significant evolution in pharmaceutical commercialization, reflecting industry recognition that medication access extends far beyond the molecule itself. These programs address real patient needs, deliver measurable improvements in adherence and outcomes, and reduce overall healthcare costs when well designed and executed.

The evidence base, while still developing, demonstrates that comprehensive programs combining clinical support, care coordination, financial assistance, and practical navigation support achieve clinically meaningful improvements in medication adherence, treatment persistence, and quality of life. Programs that employ trained healthcare professionals, provide frequent proactive contact, and address multiple barriers simultaneously show greatest impact.

However, patient support programs also face legitimate criticisms regarding conflicts of interest, cost shifting, and transparency. As these programs have transitioned from novel to ubiquitous, industry must mature its approach through greater standardization, rigorous outcomes measurement, and transparency that enables external evaluation of value delivered.

For industry professionals, patient support programs are no longer optional for specialty product launches—they are essential infrastructure required for commercial success in an increasingly complex and value-focused healthcare environment. The strategic imperative is not whether to offer patient support, but how to design, implement, and optimize programs that deliver genuine value to patients while achieving commercial objectives.

Looking forward, patient support programs will likely become more sophisticated, personalized, and integrated with broader healthcare delivery and payment models. Success will require continued innovation, rigorous evaluation, transparency, and unwavering focus on patient benefit as the ultimate measure of program value.

References

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Disclaimer: The views expressed in the article are those of the authors and not of the organizations they represent.