By Kian Talaei, Senior Consultant

With the rapid increase in approvals for cell and gene therapy (CGT) products, a critical question emerges: does our healthcare system have the capacity to meet the growing patient demand? The CGT pipeline is continually expanding, with nearly 3,000 assets in development from preclinical through pre-registration phases, according to a report from ASGCT and our sister company, Citeline.

As more cell and gene therapies transition from clinical trials to commercially available product, there will be a need for healthcare providers to accommodate rising patient volumes. Healthcare providers will need to strategically expand capacity or develop new capabilities to address demand.

Pharmaceutical companies can play a role in ensuring adequate capacity is available to meet demand. Understanding influences on site capacity can enable development of forward-looking strategies to optimize patient reach. 

Key Factors Impacting Healthcare System’s Cell and Gene Therapy Capacity

The ability of healthcare systems to support CGT growth depends on a range of internal and external factors:

Internal Capacity Factors

  • Patient Identification, Referral, and Care Coordination: Delayed identification, referral and medical information sharing for CGT-eligible patients can contribute to provider site inefficiencies in scheduling and resource allocation. Delays are often driven by low awareness of CGT options, prioritization of alternative options available on-site, unestablished referral protocols, and mismatched or incompatible EHR systems between provider sites.
  • Infrastructure Limitations: Availability and allocation of physical infrastructure limits provider sites’ ability to treat the full CGT-eligible population. Sources of capacity bottlenecks include availability of inpatient beds, apheresis slots, surgical space, cell processing capacity and dewar/storage space, and are often exacerbated by unpredictable patient flows and referral inefficiencies.
  • Department-Level Bottlenecks: Many commercially available CGTs, particularly within the oncology space, are managed by a hospital’s bone marrow transplant (BMT) team. If BMT departments continue to be prioritized for CGT volume, the time and resources needed can exceed existing physician and supporting staff availability.
  • Availability of Skilled Staff: Specialized staff, including nurses and apheresis teams, are essential for CGT administration. However, high turnover rates, nuanced training requirements, and the need for specialized 24/7 AE monitoring may limit the number of patients that healthcare centers can support.
  • Financial Feasibility of Expansion: Many healthcare sites, especially smaller community-based hospitals and practices, face cash flow constraints due to the high upfront costs of CGT treatments (ranging from half a million to over $3 million per patient). Many smaller hospitals may not be able support higher CGT patient volumes while maintaining financial sustainability, driven by credit limit caps, risks of insufficient payer reimbursement (e.g., Medicare FFS, Medicaid), and extended times to reimbursement (e.g., 30-120+ days post-treatment).

External Capacity Factors

  • Slot Availability and Manufacturing Timelines: Slot availability and production timelines requires agile site flexibility in patient scheduling and CGT administration. This limits provider sites’ ability to operate at full capacity or results in rescheduling patients with less urgency to treat (e.g., pushing back infusion date).
  • Administrative Burden of Payer Approvals per CGT Case: Market precedent has shown that in the first year of launch, it can take several weeks to months to obtain full coverage for each CGT patient case, partly due to cost scrutiny (e.g. prior authorizations, peer-to-peer reviews, appeals, single case agreements for reimbursement). This places more administrative burden on the provider site than standard therapeutics. As CGT cases increase, provider sites will face greater administrative capacity constraints.
  • Availability of Essential Supporting Drugs: Select drugs (e.g., fludarabine, tocilizumab, etc.) are essential for supporting CGT treatment. Shortages in these drugs due to manufacturing & supply chain disruptions, regulatory barriers, and increased global demand may have downstream effects on the ability for provider sites to appropriately treat CGT patients.

Opportunities to Minimize Capacity-Driven Barriers to CGT Utilization

As CGT continues to evolve, addressing these capacity challenges is essential to ensuring patient access to life-saving treatments. Pharmaceutical manufacturers, healthcare providers, and policymakers must collaborate to build scalable, efficient, and financially sustainable models for CGT growth.

Pharmaceutical companies can help enable the availability of capacity to meet product demand with strategic planning and cross-industry engagement. While some solutions require national-level policy adjustments, such as improving reimbursement structures and expanding workforce training programs, others can be achieved with provider site mix optimization and partnership. Potential near-term solutions may include, but are not limited to:

  • Considering capacity in provider site selection for activation
  • Establishing CGT referral networks and protocols from community sites
  • Partnering with provider sites on best practices for capacity optimization (e.g., outpatient administration, scheduling coordination, staff and physical resource allocation)
  • Supporting provider sites in diversifying CGT staff from traditional oncology/BMT departments with staff training and protocol templates

By addressing these capacity influences proactively, we can enhance accessibility and ensure that more patients benefit from these transformative therapies.

 

Find out how The Dedham Group’s expertise can enhance your cell and gene therapy strategies. Contact us.