Originally published by our sister publication Specialty Pharmacy Continuum

By Gina Shaw

Once reserved for small cohorts of patients with relapsed or refractory blood cancers, chimeric antigen receptor T-cell (CAR-T) therapy is now expanding rapidly, with multiple products approved across lymphomas, leukemias, and myeloma, and a robust pipeline targeting solid tumors. A recent review of the CAR-T landscape (Signal Transduct Target Ther 2025;10[1]:210) called it “the culmination of decades of immunology and genetic engineering research,” while cautioning that its widespread use faces “manufacturing, logistical, and economic hurdles” that must be addressed for long-term sustainability.

The market’s trajectory underscores the scale of the challenge. Analysts with Precedence Research project the global CAR-T market to reach about $12.9 billion in 2025 and to surpass $120 billion by 2034. Health systems are being asked to build the infrastructure, forecasting, and financing capacity to deliver one-time, multimillion-dollar therapies within legacy reimbursement structures.

Fran Gregory, PharmD, MBA, the vice president of emerging therapies at Cardinal Health, spoke with Pharmacy Practice News about how health systems are addressing these challenges, and what operational, contractual, and policy innovations will be required to make the next generation of cell and gene therapies sustainable.


How are health systems currently approaching the financial challenges of CAR-T, gene therapies, and other high-cost emerging therapies?

We encourage health systems, large and small, to evaluate their operational, clinical, and financial preparedness. Each of these components is equally important in ensuring a fiscally sound cell and/or gene administration facility. A cross-functional team has proven critical for an efficient financial operation, including CFOs [chief financial officers], risk management, accounting, and accounts receivable and pharmacy. We encourage health systems to prepare for and mitigate financial risk versus being afraid of it.

How do you see health systems balancing the need to be prepared for one-off patients with rare conditions versus planning for therapies that are likely to see broader uptake?

Ten or 15 years ago, when a new drug came out, we’d have to study up fast on what condition it treated, and we were often caught off guard. Health systems today are so much more sophisticated; they work with partners like Cardinal Health or have their own teams who are responsible for evaluating the clinical pipeline. Every product isn’t perfect for every hospital system. Some may decide early on that it doesn’t fit their model or area of expertise. Many sophisticated systems that are fully committed to cell and gene therapies are preparing much more diligently and intentionally for these small patient populations because they want to be centers of excellence.

We’re also working to find key areas where we can standardize and simplify, so that resources can be freed up to prepare for the next wave. One example is our Advanced Therapy Connect ordering portal, which lets providers order any advanced therapy Cardinal Health distributes in one place. That alleviates a significant administrative burden.


What are the biggest reimbursement hurdles health systems face when providing CAR-T or gene therapies, and how are they navigating them? Are payor coverage and prior authorization processes evolving quickly enough to keep pace with the pipeline of new therapies?

I think everyone is trying to do the right thing and help these products get to patients. We are doing so relatively quickly in a lot of areas, but there are definitely opportunities for improvement. We still hear about payor coverage inconsistencies between plans—commercial versus Medicare or Medicaid—in the reimbursement processes, and in what products are covered and how extensively. Providers are often required to have single-case agreements for every patient. We would like to see more trust between payors and providers, creating more of a binding contract that allows them to treat appropriate patients without going case by case.

How are health systems leveraging outcomes-based contracts or innovative payment models, and what lessons have emerged so far?

Innovative contracting and outcomes-based models are becoming more prevalent. These are happening more between the manufacturer and the payor, but recently health systems and providers are getting more involved. Pay for performance is one we hear about often; if a patient doesn’t reach a certain outcome, either a payment isn’t made or a rebate is given. Another is annuity or subscription models, allowing payment over time so that a payor doesn’t have to pay the full $500,000 or more up front if a patient should change plans.

There are also warranty or milestone payments, where payment is made at a specific clinical milestone. And the CMS [Centers for Medicare & Medicaid Services] Cell and Gene Therapy Access Model is a great example of policy-enabling innovation. It’s limited now to Medicaid and the two sickle cell products, but it could be a model for broader adoption.

Looking ahead, what changes are needed, whether in policy, contracting, or operations, to make the financial side of cell and gene therapy sustainable for health systems?

Manufacturing improvements are critical. We need to evolve into more off-the-shelf models, moving from autologous to allogeneic approaches, and develop products that are viewed as a fair price from a health economic perspective. There’s also a huge lack of health economic data.

Manufacturers could benefit by developing health economic models earlier, getting in front of payors and providers sooner to show clinical, durability, and economic value. 

Finally, healthcare policy initiatives like the Cell and Gene Therapy Access Model can influence behavior. If that model improves patient access, let’s expand it to Medicare and to commercial payors, and see how policy can drive both access and cost improvement.


Given the robust pipeline of emerging therapies, what do you anticipate will be the most pressing financial challenges for health systems in the next three to five years?

One of the things I always go back to is product advancement and scalability: how we evolve to make these therapies more affordable and accessible. The pipeline is robust, and health systems will need to prepare and partner with payors to ensure clear reimbursement practices to mitigate financial risk.

As is always the case in healthcare, collaboration is key. Health systems, payors, manufacturers, and other stakeholders can all help standardize and simplify processes. Alignment on pricing, reimbursement, and health economic data ahead of launch makes these products more sustainable and accessible for patients.

Dr. Gregory reported no relevant financial disclosures beyond her stated employment.