Article

CGT access: Managing risk at scale

How payer uncertainty is reshaping coverage decisions

Payers are fundamentally redefining how access, evidence, and reimbursement must be designed for cell and gene therapies (CGTs). Developing a scalable CGT payment framework is mission-critical. There are 33 CGTs currently approved in the United States, with more than 2,000 gene therapies and 900-plus cell therapies in the global development pipeline, largely focused on oncology and rare diseases.¹ GlobalData projects that the CGT market will reach $76 billion by 2030.² Pricing pressures and outcomes uncertainty are forcing payers to proceed cautiously.

Results from a 2025 Cencora survey of 19 senior payer decision-makers highlight three interrelated challenges affecting sustainable CGT coverage: gaps in durability and comparative evidence, high upfront financial exposure, and operational complexity. As coverage timelines compress and pricing headroom tightens, uncertainty about durability outcomes drives payers to narrow eligibility, strengthen prior authorization, and limit coverage to narrowly defined, trial-aligned use criteria.

These pressures are reshaping payer behavior throughout the CGT coverage life cycle. While implementation varies across plan types, geographies, and risk pools, the underlying signals shaping coverage decisions are increasingly consistent. The Cencora survey highlights payer focus on value-based contracting, long-term evidence, coding clarity, and sustainable reimbursement models as CGTs enter routine care.

Pillar 1:

Aligning early on payment and outcomes

CGT contracting has moved beyond experimentation and is increasingly being considered by payers to align financial exposure with unresolved questions around durability, outcomes, and long-term value.

Key survey findings underscore payer expectations for earlier, clearer evidence alignment:

100% of payers rate comparative effectiveness data as highly valuable before approval
95% cite durability of response as a critical consideration
84% report limited availability of clinical and value data as a barrier to early engagement
74% engage with CGT manufacturers prior to FDA approval
58% prefer engagement within six months of approval, while 42% seek engagement even earlier

Payers are receptive to multiple payment approaches, but with clear preferences and limits:

63% anticipate one-time upfront payments for single-administration CGTs
58% support access-based rebates
42% express interest in risk-sharing arrangements
32% favor value- and outcomes-based contracts

Taken together, these preferences signal openness without readiness, especially when governance, actuarial validation, and benefit-year accounting constraints limit execution.

Pillar 2:

Mitigating financial risk

Pricing pressure is no longer confined to launch negotiations. As coverage timelines compress, pricing tolerance narrows accordingly. These controls reflect a structural trust gap: payers absorb the downside risk when outcomes fall short, while manufacturers have limited ability to adjust once therapy is delivered.

Survey results also highlight how quickly pricing pressure translates into access decisions:

90% of payers make coverage determinations within six months for traditionally approved CGTs
84% involve both pharmacy and medical directors in coverage decisions
68% report that insufficient clinical efficacy evidence leads to denial or severe restriction
58% approve accelerated CGTs within three months

Faster decision-making amplifies the consequences of weak value narratives. When evidence gaps persist, price becomes the dominant risk signal, driving access controls designed to protect budgets, manage medical loss ratios, and limit downstream exposure. These mechanisms reflect payer efforts to ensure affordability over time, rather than resistance to innovation itself.

Pillar 3:

Building operational infrastructure

Digital tools are becoming foundational infrastructure for CGT access. Without scalable data capture, analytics, and reporting systems, even well-designed coverage and payment strategies struggle to function. The Cencora survey highlights payer concerns around coding complexity, miscellaneous billing pathways, and documentation requirements, which can introduce administrative friction in CGT reimbursement.

Operational barriers remain a consistent constraint for payers, with:

79% reporting difficulty translating long-term outcome assumptions into executable contracts
63% citing challenges tracking, verifying, and reconciling outcomes over time

The Cencora survey highlights payer challenges with outcomes tracking and reimbursement administration, areas that may benefit from more streamlined data and reporting capabilities.

Technology-enabled platforms support evidence exchange, outcome verification, coding workflows, and longitudinal monitoring. These operational realities do more than slow reimbursement; they influence how innovative payment models are structured, negotiated, and sustained over time.

Pillar 4:

Demonstrating value over time

Payers are planning for a future in which proven CGTs are commonplace and one-off solutions are no longer viable. A life cycle accountability paradigm is emerging that emphasizes durable outcomes supported by consistent, scalable evidence systems.

Reassessment is not a one-time checkpoint but a recurring life-cycle event, triggered as new evidence, utilization patterns, and budget impact become clearer over time. Expectations for follow-up duration are becoming more clearly defined. Two to three years of follow-up data are typically expected for reassessment. But five years or more is increasingly viewed as the threshold for long-term credibility.

While patient-reported outcomes are rarely decisive on their own, they increasingly influence reassessment decisions when linked to utilization, durability, and downstream cost impact. Payers in the Cencora survey cite risk driven by a lack of real-world evidence, uncertain applicability beyond trial populations, and manufacturer sponsorship bias.

Key survey findings include:

95% of payers want more comprehensive, long-term clinical data
68% seek detailed analytics on cost-effectiveness
53% cite enhanced real-world evidence and post-market data as unmet needs

Patient centricity becomes actionable for payers only when functional outcomes, quality-of-life measures, and patient preferences can be measured consistently and linked to long-term clinical and economic endpoints. Initial clinical success alone is insufficient; value must be reaffirmed over time to mitigate reassessment risk.

Many payers are evaluating AI-enabled outcomes monitoring platforms and digital data-capture tools to reduce operational burden. As these tools mature, actuarial modeling and real-world evidence will play an increasingly central role in defining durable value.

What durable CGT access requires

Reassessment increasingly applies not only to newly launched CGTs, but also to therapies already in use as evidence matures and budget impact becomes clearer. These dynamics have implications beyond commercial coverage, shaping expectations for how public and private payers approach evidence, affordability, and long-term accountability for high-cost therapies.

Sustainable CGT access will ultimately depend on how effectively stakeholders anticipate uncertainty before it crystallizes into financial exposure. As reassessment becomes routine, access increasingly favors strategies built for long-term accountability rather than exception handling. As CGTs scale, manufacturers that define outcomes clearly, align pricing with durability expectations, and invest early in execution-ready evidence systems will be better positioned to maintain access over time.

Learn how payers are redesigning CGT coverage and payment strategies to manage uncertainty at scale by downloading Cencora’s 2026 Payer Trends Report and registering for our upcoming webinar.

Cencora strongly encourages readers to review all available information related to the topics mentioned, including any references provided, and to rely on their own expertise and experience in making decisions related thereto.

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