Cracking the Cost-Density Code

While payer confidence in the science is growing, reimbursement complexity, data gaps and system misalignment remain barriers to broader cell and gene therapy access.

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5 minutes

Key Points

In the 2025 Cell and Gene Therapy Report published by InspiroGene by McKesson, 80% of interviewed payers said they believe cell and gene therapies are effective, yet reimbursement remains a leading barrier to broader access.
The core challenge is cost density: many cell and gene therapies are administered once but deliver benefits over many years, while the U.S. system typically evaluates costs and benefits in shorter, year-by-year windows.
In the same report, 60% of payers said innovative payment models could potentially help address these risks, though they cite the need for easy-to-measure, clinically relevant endpoints.
For biopharma, market access strategy, payer engagement, reimbursement navigation and operational coordination are becoming central to commercialization success as clinical evidence.

For much of the past decade, the prevailing assumption was that cell and gene therapy access would depend primarily on clinical proof. The data now tells a more nuanced story. According to the 2025 Cell and Gene Therapy Report: Advancing the Future of Medicine, published by InspiroGene by McKesson (InspiroGene), 80% of interviewed payers believe cell and gene therapies (CGTs) are effective, while 90% viewed them as safe. For many payers confidence in the science is no longer the primary constraint.

According to Joe DePinto, head of cell, gene and advanced therapies at InspiroGene, “cell and gene therapies are moving from novel scientific concept into one of the most important innovations in modern medicine,” but realizing their full potential depends on scale, access and collaboration.

The friction has shifted downstream into how these therapies are paid for and reimbursed. The same report found that payers remain skeptical about high upfront costs and limited long-term data, pointing to a disconnect between how the healthcare system is set up to reimburse products and how these therapies are administered. For biopharma leaders, that distinction matters: the path to broader access runs less through additional belief and more through better-aligned payment and access design.

What is the Cost-Density Problem?

Cost density describes the structural mismatch at the heart of the CGT access challenge: a large, upfront cost is concentrated into a single budget period, even though the therapy's benefit is intended to accrue over many subsequent years. As outlined in the 2025 Cell and Gene Therapy Report, many CGTs are administered once, while the U.S. healthcare system is largely structured around ongoing, predictable spending for chronic therapies.

The implication is a timing problem more than a value problem. Conventional reimbursement frameworks, designed around recurring treatments and annual evaluation cycles, are not well suited to this cost and benefit profile. The result is a system that can recognize the value of a therapy while still struggling to reconcile it within existing payment structures.

How Could Innovative Payment Models Help Unlock Access?

Sixty percent of payers say innovative payment models could potentially help address the reimbursement challenges created by high upfront costs and limited long-term data.¹ Rather than treating reimbursement friction as fixed, payers themselves are pointing toward alternative approaches.

For biopharma, that signal suggests meaningful openness among payers to outcomes-based and innovative payment arrangements that can help distribute cost and risk in ways better matched to how these therapies deliver benefit over time. For example, an outcomes-based arrangement might tie a portion of payment to whether a patient achieves a predefined clinical result over a set period. The report notes that payers cite the need for easy-to-measure, clinically relevant endpoints to make these models effective. These models are not a guaranteed solution, and their design and adoption will vary, but they represent a credible avenue for narrowing the gap between proven value and practical access.

What Does This Mean for Biopharma Commercialization Strategy?

The takeaway for commercialization teams is that market access and reimbursement navigation now sit alongside clinical development as core determinants of a therapy's reach. In practice, this means commercialization strategies must anticipate not only clinical adoption, but also how cost, risk and value will be evaluated across payer time horizons.

Engaging payers early in launch planning, anticipating the cost-density dynamic, and being prepared to discuss innovative payment frameworks with clinically relevant endpoints can help manufacturers translate payer confidence into actual patient access.

It also means planning for the operational realities that can shape access after approval, including coverage criteria, prior authorization requirements, site-of-care constraints, documentation needs and coordination across stakeholders.

This is the context in which InspiroGene is designed to help biopharma partners navigate. As part of McKesson, InspiroGene focuses on helping manufacturers, payers and providers navigate the complexities of CGT commercialization, including market access and reimbursement, so that scientific breakthroughs are better positioned to reach the patients who need them.

The signal from payers is increasingly clear. The science is largely trusted; the access model around it is the work that remains. For biopharma, closing that gap may be the difference between a therapy that is approved and one that is genuinely accessible.

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