Over 260 life sciences professionals representing 155 companies recently came to Baltimore, MD, for the 20^th Annual CBI Patient Assistance & Access Conference, which focused on themes of affordability, collaboration, and access. Bill Goodson, director, Market Access and Reimbursement Services for Eisai, Inc., kicked off the meeting by recognizing the evolution of the industry over the past 20 years and set up the day for an in-depth conversation on the state of the industry.

Discussions focused on patient challenges with access and affordability, for both uninsured and underinsured populations, leading to both opportunities and challenges for manufacturers to provide support.

Conference Themes:

• Access and affordability are a challenge for both uninsured and underinsured patients. Against the backdrop of payer consolidation and healthcare reform, we continue to see increased out-of-pocket costs for patients. Combined with the rise of Copay Accumulator Programs, where insurers are not recognizing the accrual of out-of-pocket costs for patients receiving financial assistance, accumulators have significant impact on patient out-of-pockets costs. For uninsured patients who may rely on traditional product assistance from manufacturers, common challenges arise when receiving treatment at academic centers relative to the facilities’ participation with the programs. For insured patients, we are seeing an increase in exclusions and utilization management across private payers, including requirements of a conservative treatment being tried first. Meanwhile, manufacturers struggle with challenges deciding thresholds for eligibility determinations, how to serve small patient populations, logistics around income verification, and challenges for patients transitioning to Medicare coverage.
• Patient awareness and patient centricity are key. Generally, there is low awareness of what patient-support programs are available. In terms of the hierarchy of needs for the patient, the first is financial security, then access/logistical support, medication administration, support systems, and confidence. More and more, the high-touch case manager model is the expectation for services supporting good communication, access, and a support system. It is important to keep the voice of the patient in mind when developing programs.
• Charitable giving continues to be a growing area of scrutiny in the marketplace. Against the backdrop of increased scrutiny and compliance concerns, there was considerable discussion about charitable giving, referring both to assistance for uninsured and underinsured patient populations. Uninsured assistance is typically in the form of free product; underinsured assistance is in the form of financial assistance through charitable organization or copay/coupon card programs. There were discussions about how manufacturers should manage planning for these types of giving in advance and the importance of separation between commercial and free drug programs. From a compliance perspective, it’s important for the manufacturer to document financial need, and ensure consistency in documentation and operations for their program vendors. Additionally, the Office of Inspector General has emphasized that manufacturers should not receive charity data that would correlate the donation amount with the number of subsidized treatments.

Next Steps for Manufacturers:

1. Benchmark services. Manufacturers should routinely conduct market research to garner insights into program development and performance. Patient services continue to evolve and it’s important to be aware of how those services are evolving within designated specialties.
2. Assess program design and ongoing program performance. Manufacturers should continue to be diligent about the design and ongoing performance of their patient support programs; actively work with their vendors to continually assess and improve programs to support better outcomes.
3. Compliance. Manufacturers must ensure that their patient service programs are administered in a compliant manner and be able to demonstrate appropriate monitoring.