Rethinking Reimbursement and Patient Support Following Medical Innovation

As the FDA moves to increase the speed at which it reviews and approves cell and gene therapies in the United States,¹ manufacturers need to quickly address the impact these medical innovations will have on reimbursement and coverage for patients seeking access to lifesaving therapies. Newly approved cell and gene therapies like Kymriah and Yescarta incorporate patients as a part of the supply chain, making it critical to minimize the barriers patients and providers are likely to experience and account for these hurdles in treatment workflow. As a result, manufacturers that rethink how they approach reimbursement and patient support will not only help patients navigate access and affordability, they can also mitigate their own financial risk.

Evaluating New Reimbursement Strategies

Cell and gene therapies represent a new frontier of medical innovation that can be costly for patients. The unique requirements associated with the administration of these therapies requires that innovators proactively establish coding, coverage and reimbursement strategies for these products and engage early with partners who can support their product’s needs. Because cell and gene therapies are an emerging class of therapy, the road to successful commercialization and utilization is still lined with challenges, and approval does not always equate to adoption.

As these innovations in treatment continue to develop, manufacturers must:

Coordinate with payers on how the cost for different aspects of the therapy will be covered—and when. The complexity of producing and administering a cell and gene therapy may involve multiple sites of care and multiple high-cost procedures, requiring an increased need for coordination. It will also be important to understand how a payer views a particular therapy, and how that will influence how a payer considers different coverage models. A thorough understanding of the payment logistics will be required by the therapy owner to ensure providers along the payment continuum are not financially disadvantaged when completing their part of the process.
Establish specific coding with payers to account for the unique services provided during cell and gene therapies. Cell processing codes can alleviate concerns with patients receiving care and pay providers for the services provided in a timely manner. Manufacturers should build out a coding strategy two to three years prior to a therapy launch to secure the necessary codes and collect supporting evidence that ensures payers are willing to award new and/or product-specific codes.
Collect data that supports meaningful discussions between therapy owners and payers, particularly as product portfolios change and value-based reimbursement models evolve. For example, data from a therapy’s clinical trial can highlight instances where there were higher efficacy rates in sub-populations that could impact how the payer evaluates the value of the therapy. Designing a solution that enables collection of the right data will help justify the cost effectiveness by demonstrating the therapy’s ability to lower the overall cost of the care.

"Manufacturers must ensure that patients are empowered as active participants in their own healthcare journey."

Evolving Patient Support

A manufacturer’s role does not end when a patient receives therapy. Instead, manufacturers must ensure that patients are empowered as active participants in their own healthcare journey. While some traditional specialty pharmaceuticals may need wraparound services, cell and gene therapies require additional support to address the high level of case management coordination. Patient support for cell and gene therapies must evolve beyond what is typically required for traditional therapies to anticipate and address concerns related to affordability, coverage and reimbursement that threaten to delay speed to therapy, impact adherence and, ultimately, impact product success and outcomes. Having an established patient support service program that builds upon and amplifies support services developed for traditional specialty products can help patients understand the complex clinical aspects of their care as well as what steps need to be taken throughout the therapy process.

Manufacturers must think through several considerations when developing a patient support program to address medical innovations:

Case management. Patient support systems will find the greatest success through a case management model with a dedicated point of contact assigned to each patient who is geographically aligned with field sales/educators and has the necessary expertise in regional provider and payer management. A strong patient support system will also create a wraparound service that addresses the high level of coordination required for patients undergoing new and potentially lifesaving treatments. For example, a tailored wraparound service should provide assistance with education for patients and their families, transportation to collection and treatment sites to support adherence, and personal attention required for individuals who may rely on a new therapy.
Payer coordination. A qualified patient support provider should be deployed, as well, to strategically manage and administer the cell and gene therapy program. The provider should have a deep understanding of the processes related to coverage and reimbursement related to a new medical innovation and can act as a proxy on behalf of a patient to directly coordinate with regional payers and also secure reimbursement coverage and offer financial assistance. In the event of denials for coverage, the case manager will notify the care team of the denial and determine the appropriate strategy to support the appeal of the payer’s decision.
Program capabilities. To ensure effective data and systems integration with supply chain providers, the right partner can secure a seamless transition into the commercial space by collecting data such as route-specific temperatures throughout the patient journey, which can inform risk-based contingency planning should preferred logistic options be unavailable. This will help evolve the program over time, and is critical to the rollout and ongoing development of a successful cell and gene therapy product model.

As medicine continues to innovate with more personalized treatments, manufacturers must think through the potential barriers that exist for providers, payers and patients. The stakes are high for cell and gene therapy providers. As such, careful coordination for reimbursement and patient support is paramount. It is no longer enough to merely bring a product to market; rather, patients and their providers will need support throughout the treatment process.