The cell and gene therapy landscape is rapidly evolving, offering new hope but also introducing significant complexity for patients, caregivers, and healthcare providers. As more products enter the market, there is a growing need for innovative, high-touch patient support programs to guide patients throughout their complex treatment journey. UBC is proud to have supported a quarter of the gene therapy products available in the marketplace, and through our experience, we have observed how leaders in the field are addressing the unique challenges and opportunities presented in this space.
Navigating a Growing and Complex Market
Recent advances in gene delivery methods, cell manufacturing, and immune cell engineering are driving the expansion of the cell and gene therapy market. The increasing incidence of chronic and rare diseases is further fueling this growth. [1][2]However, biopharmaceutical organizations must contend with significant challenges, including high product costs and complex manufacturing requirements that demand specialized expertise and infrastructure, which can create bottlenecks in the process.
Payer Advocacy and Affordability Solutions
One of the primary challenges is navigating the intricate US payer landscape, which includes public payers, commercial insurers, and the various subsets. Addressing this requires strong advocacy and creative contracting solutions. Travel support, in alignment with OIG guidance, is becoming a crucial element to ensure that patients can access life-changing therapies without facing insurmountable logistical and financial obstacles. These challenges require advanced reimbursement services and specialized clinical travel support to be at the core of patient support program offerings.
Designing Innovative Patient Support Programs
The most effective patient support programs in the cell and gene therapy space are built with strategic alignment across patient support teams, field teams, and market access groups. Successful programs deploy tactical solutions that support patients from the initial diagnosis through long-term follow-up, involving all stakeholders—prescribing healthcare providers, product manufacturers and distributors, clinical laboratories, and treatment facilities. Coordinating communication and wrapping services around every stage of the treatment journey ensures high-touch coordination, collaboration, and support for each patient.
“Managing the patient journey for a cell and gene therapy is all about structure, communication and coordination.” Brian Campbell VP & GM, at Orchard Therapeutics – U.S.
Managing the Complex Patient Journey
The patient journey in cell and gene therapy is highly complex. Program design must account for treatment site readiness, including alignment between key opinions leaders (KOLs), administrators, and clinicians, product logistics, and ongoing follow-up—sometimes using a clinical data registry. Key strategies to ensure patients receive consistent, high-quality care throughout their treatment and that healthcare providers are educated and informed of the process include regular huddle calls with field team and patient support program to ensure milestones are met and treatment remains on track.
Key Challenges and Solutions
Organizations are learning to manage the complexity of patient services, develop effective market access strategies, and foster collaboration among stakeholders. Providing comprehensive support to both patients and caregivers is a critical factor for success in this evolving field.
Optimizing patient support in cell and gene therapy programs requires a comprehensive approach that balances operational excellence, affordability, and patient-centered care. By embracing collaboration and innovation, organizations can address the unique challenges of this complex and rapidly expanding landscape.
References:
[1] Straits Research: Cell And Gene Therapy Market Size https://www.globenewswire.com/news-release/2024/11/07/2976809/0/en/Cell-And-Gene-Therapy-Market-Size-to-Worth-USD-190-82-Billion-by-2033-Straits-Research.html
[2] Grandview Research: Cell And Gene Therapy Manufacturing Market Summary https://www.grandviewresearch.com/industry-analysis/cell-gene-therapy-manufacturing-market#
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.
About the Author
Dana Edwards, Vice President, Patient Access & Strategic Engagement
Dana Edwards serves as the Vice President, Patient Access & Strategic Engagement at UBC. She brings more than 20 years of experience in executing patient service and market access strategies to this role. Ms. Edwards is a strategic advisor to pharmaceutical and biotech leaders on the design and implementation of patient service programs that synchronize the right people, services, and technology for their unique patient population and therapy.
