From Innovation to Access: Overcoming Reimbursement Challenges for Cell and Gene Therapies
In this interview, guest expert Joe DePinto, Head of Cell, Gene, and Advanced Therapies at McKesson, explores the structural, operational, and reimbursement challenges limiting access to cell and gene therapies. He highlights the importance of stakeholder collaboration, innovative payment models, real-world evidence, and streamlined approval processes to ensure that patients receive these potentially transformative treatments in a timely manner.
Joe DePinto: My name is Joe DePinto. I’m the Head of Cell, Gene, and Advanced Therapies at McKesson. I lead McKesson’s cell, gene, and advanced therapies vertical, called InspiroGene. We help our clients navigate the value chain involved in delivering complex therapeutic interventions such as cell, gene, and advanced therapies. Our clients include biopharmaceutical companies, sites of care, and other stakeholders, including payers.
I’ve been in health care for more than 30 years, with a focus on helping patients gain access to groundbreaking specialty therapies. Throughout my career, I’ve had the opportunity to work with exceptional leaders in the field, and I hope we’re making a meaningful impact by helping innovative science reach patients.
What did your panel at Asembia 2026 identify as the biggest barriers preventing cell and gene therapies from being more consistently incorporated into coverage and reimbursement frameworks today?
DePinto: We had an outstanding panel at the Asembia Specialty Pharmacy Summit this year titled, Breaking Through Reimbursement Complexities and Enabling Patient Access for Cell and Gene Therapies.
The panel included Navneet Majhail, MD, physician-in-chief of Blood Services at Sarah Cannon Cancer Institute; Michael Evans, PharmD, chief pharmacy officer at Geisinger, which serves as both a provider and a payer; and Will Schrenk, cofounder and chief executive officer of Aradigm, a company focused on risk management and reimbursement strategies for cell and gene therapies.
We spent a great deal of time discussing the progress that has been made in cell and gene therapy reimbursement, as well as the challenges that remain. Those challenges tend to be structural and process-driven rather than clinical. The clinical value of these therapies is becoming increasingly well established.
In market research conducted for our annual Cell and Gene Therapy Report, 9 of 10 payers agreed that cell and gene therapies represent an important advancement in health care. The challenge lies in navigating structural issues associated with the high upfront cost of these one-time therapies while recognizing that their value is realized over many years.
Much of our discussion focused on how to overcome these structural and operational barriers so patients can receive timely access to treatment.
From an operational standpoint, coding and documentation remain significant challenges. Sites of care must provide sufficient transparency and documentation to allow payers to confidently approve reimbursement.
From a process perspective, payers need sufficient staffing and efficient systems to ensure prior authorizations are completed quickly enough that patients do not lose their therapeutic window.
The panel focused not only on identifying these challenges but also on discussing practical, real-world solutions. One consistent theme emerged throughout the discussion: collaboration among all stakeholders will be essential to future success.
We often hear about innovative payment models, such as outcomes-based agreements or annuity payments. What do you think is actually working in practice versus what still feels theoretical for payers and employers?
DePinto: Innovative payment models have long been viewed as one potential solution.
In our annual payer research, approximately 60% of payers identify innovative payment models as one of the primary strategies for improving access to cell and gene therapies. Interestingly, providers express similar views, with approximately 60% supporting further exploration of these models.
Currently, we are seeing the greatest activity around value- and outcomes-based agreements. However, the success of these arrangements depends heavily on selecting clinical end points that are objective, measurable, and straightforward to assess over time. Without clearly defined outcomes, it becomes difficult to determine whether payments should be adjusted.
Other models—including warranties, annuity payments, and stop-loss approaches—are still largely conceptual within the cell and gene therapy space.
Whenever new cell and gene therapies enter the market, manufacturers frequently announce innovative payment strategies designed to improve patient access. At present, however, most of the practical work has centered on value- and outcomes-based agreements.
Another topic that generated significant discussion during our panel was risk sharing and risk management. Having Will Schrenk and Aerodigm represented on the panel allowed for a robust conversation about how risk can be managed more effectively across stakeholders.
Those are the areas where I believe meaningful progress is being made today, while several additional concepts are likely to evolve over the next 12 to 18 months.
How can stakeholders better align on evidence requirements, particularly through real-world evidence, to support coverage decisions and reduce uncertainty around long-term value?
DePinto: The US Food and Drug Administration require a 15-year follow-up period for every approved cell and gene therapy. This isn't solely a payer issue; regulators are also interested in understanding long-term durability of response.
The challenge is that these therapies involve a single intervention today, while much of the clinical and economic value is realized over many years.
Payers are looking for robust longitudinal data demonstrating durability of response. However, our health care system is not structurally designed to follow patients consistently over those extended periods.
Real-world evidence offers an important opportunity to demonstrate long-term value after approval. The primary challenge is maintaining longitudinal follow-up.
Several strategies are being explored, including patient tokenization, which allows patients to be followed regardless of where they live, receive care, or obtain insurance coverage.
Patients frequently change insurance plans over time—not necessarily because they change jobs, but because benefit offerings evolve. Maintaining continuity of data across those transitions remains difficult.
Currently, much of this tracking is supported through the Center for International Blood and Marrow Transplant Research (CIBMTR), and there have been ongoing discussions regarding additional registries that could further support long-term follow-up.
Real-world evidence continues to evolve as an important tool for demonstrating long-term effectiveness and durability, helping satisfy both payer requirements and regulatory expectations.
Employers are increasingly becoming part of the conversation surrounding access to high-cost therapies. What role do you see them playing in shaping reimbursement and access pathways?
DePinto: Employers—particularly self-insured employers—are becoming increasingly important participants in access and reimbursement discussions.
As therapies with prices exceeding $1 million become more common, even one or two patients receiving treatment can create significant financial pressure for an employer-sponsored health plan.
One of the most promising approaches involves risk sharing and risk pooling. Employers are increasingly exploring ways to spread financial risk while continuing to provide high-quality health care for their employees.
As science continues to advance, outcomes improve, and prices continue to increase, these approaches will become increasingly important.
Over the past several years, employers have become much more active and vocal participants in these discussions, and I expect that trend to continue.
Are there any additional insights from the panel that you think are important for our audience to know?
DePinto: One particularly interesting point discussed during the panel involved access to cell therapy.
Currently, only about 2 in 10 eligible patients ultimately receive cell therapy. There are many reasons for this, including geographic barriers, referral patterns, and the fact that many therapies are administered primarily at academic medical centers.
Dr Majhail shared that within his chimeric antigen receptor (CAR) T-cell therapy program, approximately 40% of referred patients never receive the therapy because their disease progresses before treatment can begin.
These patients often have advanced disease and are receiving later lines of therapy, making rapid disease progression common. However, lengthy prior authorization processes and reimbursement approvals can also contribute to treatment delays.
Ideally, those administrative processes could be expedited.
Payers have acknowledged this challenge and are actively exploring alternatives to traditional single-patient case agreements, which have historically been adapted from transplant reimbursement models.
Potential alternatives include standardized agreements covering multiple patients, global case rates, and reimbursement approaches that more closely resemble those used for specialty pharmaceuticals.
What encouraged me most was the degree of alignment among providers and payers. There appears to be growing momentum around practical solutions that can accelerate approvals, allowing more patients to receive these therapies before they lose their therapeutic window.
