By Katie Moses, Associate Partner, Director of Cell and Gene Therapy Strategy
CAR-T therapy has revolutionized oncology care and paved the way for innovation. Although CAR-T therapy access has historically been confined to large academic centers and sophisticated community health systems with inpatient capabilities, a growing opportunity exists for broader adoption within community practices. CAR-T therapies have moved into earlier lines of treatment and side effect management has improved, all while hospital capacity is feeling strained and reaching eligible patients via academic centers alone continues to be a challenge. There is a need, an interest, and an opportunity for community practices, and for pharma and biotech companies to capture this opportunity, they must understand and plan for the operational, financial, and access challenges that impact community practice adoption.
Key Challenges for Community Practice Access to CAR-T Therapies
Community practices have long been leaders in delivering oncology care locally, enabling broader patient access to life-saving treatments. Given CAR-T therapy side effect profiles in late-line patients, providing these new, innovative therapies at community practices initially seemed out of reach. Over time, earlier line CAR-T approvals, such as second-line therapy for large B-cell lymphoma (LBCL) and multiple myeloma, and increasing clinical understanding of side effect risk mitigation has posed the potential for patients to have access to CAR-T treatment in the community. Currently, community practice CAR-T models — ranging from health system collaboration to independent site administration — face operational, financial, and access barriers to CAR-T adoption and utilization, so only a handful of practices have successfully operationalized CAR-T to date. Top barriers challenging community practice adoption include:
- Gaps in Infrastructure Needed to Support the Full Treatment Journey: Infrastructure required to fully support the CAR-T treatment journey includes apheresis, cell handling capabilities, product storage space, and AE management / local hospital admission protocols, as well as specialized staff to support at each step. While not all capabilities have to be internally owned and there is some precedent for external partnerships to support different steps (e.g., Provenge), these cumulative needs have challenged the ability of most community practices to adopt.
- Partnerships to Fill Infrastructure Gaps: Successful community practice operationalization of CAR-T therapy will typically require a formal or informal partnership with local, external stakeholders. Obtaining a local partner requires (1) that the partner can offer the scope of capabilities needed to support key steps in the CAR-T treatment journey (e.g., apheresis, cell processing, AE management), and (2) that there is a clear business case for supporting the CAR-T journey (i.e., viable reimbursement for the treatment journey steps they can support).Hospitalization for CAR-T therapy AE management has historically placed financial strains on the health system given high cost of care needed and under-reimbursement from government books of business based on the most closely applicable episodes of care. Community practices seeking local health system partnership will need to understand these financial risks as well as the scope of potential contracting options (e.g., practice-payer and hospital-payer vs. practice-hospital-payer) during partnership discussions.
- Investment Costs of Program Start-Up: CAR-T therapy program start-up requires up-front investments, often involving increased staffing, staff training, infrastructure expansion, remote monitoring protocols, and partnership(s) identification, as well as potential need for additional certifications for improved access (e.g., FACT accreditation). The investment needed to support a CAR-T therapy program may drive extended timelines for community practice adoption.
- Payer Coverage & Reimbursement Challenges: Payers have been evolving CAR-T therapy management approaches to minimize costs and ensure appropriate, high-quality care. As payers continue to increase site of care management, community practices are likely to face challenges. For example, payer-run CAR-T therapy center of excellence networks with participation criteria that include FACT accreditation are one mechanism that has been limiting community practice confidence with payer coverage and reimbursement. In addition, payer perceptions of community practices as a lower cost site of care coupled with the trend of decreasing hospital reimbursement for CAR-T treatment will challenge the ability for community practices to quickly recover investment costs of program build. These access challenges may be elevated at community practices with local CAR-T certified health systems that present an alternative path to cost containment for payers. To ensure there is a business case for community adoption of CAR-T, access and a financially sustainable reimbursement environment are critical.
Despite these operational, financial, and access barriers to adoption, the market is starting to see a rise in community practice interest in CAR-T therapy certification, with select sophisticated practices already paving the way to broader patient access.
How Pharma Can Support CAR-T Therapy Expansion into the Community
Pharma can provide resources, guidance, and data to aid CAR-T therapy expansion into community practices. Key tactics to help community practice adoption and utilization include:
- Infrastructure best practices sharing and training programs for involved staff (e.g., physicians, pharmacists, nursing staff, administrators)
- B2B partnership structure guidance to support optimal business arrangements for community practices to operationalize CAR-T therapy
- Targeted data generation via clinical trials to demonstrate community practice ability to offer CAR-T therapies and to support payer access
Encouraging collaboration across stakeholders and offering a pathway for establishing experience can help streamline community practice CAR-T program set-up and assist in obtaining appropriate access for commercial products.
Outlook for CAR-T Therapy in Community Practices
While limited to date, the adoption of CAR-T therapies in community practices remains promising. Oncology-focused community practices, particularly those with existing relationships with academic centers or sophisticated health systems, are well-positioned to lead this shift. Pharma companies that proactively work to address the operational, financial, and clinical barriers, as well as actively support early community practice experience via clinical trial enrollment, will play a pivotal role in accelerating adoption.
Community adoption of CAR-T therapies also creates the opportunity to activate new revenue generating centers for practices and prepare for the new age of patient care. Breaking down the barriers to CAR-T therapy being available in the community practice setting will help enable broader availability of future treatment options (e.g., cell-based therapies in immunology) with infrastructure readiness.
By investing in targeted support and fostering collaborative ecosystems, pharma companies can ensure that community practices are empowered to deliver cutting-edge therapies, improve patient access, and enhance outcomes.
Learn how The Dedham Group’s expertise can advance your CAR-T therapy network expansion strategies. Contact us.