How drug manufacturers can manage risks for patient programs

As access and treatments become more sophisticated, today’s drug manufacturers are recognizing the critical importance of Patient Support Programs (PSPs) and Patient Assistance Programs (PAPs).

PAPs and PSPs can help non-insured or underinsured patients gain better access to innovative, higher-priced specialty drugs. Patients can reduce or even eliminate their out-of-pocket costs, and many programs have the potential to improve care in chronic disease states that demand complex therapies.

However, these programs present a number of compliance risks to drug manufacturers because they position the company within the patient, provider and insurer relationship.¹ This is especially true with complicated payment arrangements involving third-party intermediaries such as hub vendors and specialty pharmacies.²

Compliance risks are also expected to increase due to greater scrutiny by the Biden administration³ and a rise in the number of specialty pharmaceutical products.⁴

Both proactive and reactive approaches are needed

Many drug manufactures have found that a combination of proactive and reactive measures can help them develop, manage, and enhance their patient programs.

A proactive approach includes:

• Program implementation and governance – Manufacturers can implement appropriate organizational structures to govern patient programs in accordance with proper guidance and leading practices.
• Procedural documentation – Documentation includes policies, procedures, work-practice documents, and communication guidelines, as well as committee charters and codes of conduct.
• Regular vendor assessments – Manufacturers should conduct routine assessments of program vendors, including hubs, specialty pharmacies, copay vendors, and outsourced field teams. Based on established methodologies, these assessments involve selecting samples and conducting detailed testing of live transactional data against business rules, as well as conducting customized analytics across applicable data sets.
• Oversight and monitoring – Some manufacturers lack the resources to monitor their patient programs on a regular or real-time basis. Businesses that design and oversee these programs should be closely monitored, along with the third-party vendors that administer them.

In the case of compliance, legal, or regulatory issues, reactive initiatives can also be applied in several ways:

• For-cause vendor audits – Organizations often become aware of potential compliance violations or concerns that may trigger an additional level of review to gather details and root causes. These audits may result in gaining an understanding of the full scope and root causes of potentially problematic issues.
• Investigations – Depending on the severity of the potential issues, companies may need to conduct investigations into patient programs, gather information and support discovery to help counsels to render informed legal opinions regarding the impacts and risks associated with potentially problematic activities and behavior.

Based on this proactive/reactive approach, drug manufacturers can develop internal governance and operational infrastructures to effectively manage and oversee patient programs and vendors. This approach can help to harmonize the management and operations of patient programs across all therapeutic areas and brands within the organization. In addition, it can help ensure that program vendors administer the program within a robust control environment to support compliance and set expectations.

Equally important, this approach can reduce financial losses due to inadequate vendor performance or noncompliance with contractual requirements.

Case in point

KPMG routinely conducts assessments of vendors administering patient support services for mature and newly launched products.

The first phase of the assessments involve gauging the vendor’s readiness and capabilities to administer contracted services. We review applicable contracts, conduct interviews of vendor personnel assigned to the programs, and review procedural documentation for the administration of each service. Based on this assessment, KPMG provides recommendations for the overall structure of the programs and compliance controls provided by the vendor. We also identify areas for improvement around expected patient experience.

The second phase of the assessments involves a review of the vendor’s operations in connection with execution of contracted services. We conduct patient-case testing to assess whether program services were administered in accordance with business rules, contract requirements, and the manufacturer’s expectations. This second phase identifies several areas of improvement and leads to further enhancements of the vendor’s controls and operations, avoiding inefficient execution of patient services and resulting in a seamless patient journey.

Takeaways

• PAPs and PSPs present a number of compliance risks to drug manufacturers, and these risks are expected to increase due to greater regulatory scrutiny and a rise in the number of specialty pharmaceutical products.
  
• Many drug manufacturers have found that a combination of proactive and reactive measures can help them develop, manage, and enhance their patient programs.
  
• Based on a proactive/reactive approach, drug manufacturers can develop internal governance and operational infrastructures to effectively manage and oversee patient programs and vendors.
  

KPMG LLP does not provide legal services.