Health systems are urged to partner with payers and plan ahead to make cell and gene therapy programs work

As cell and gene therapies move into more hospitals and cancer centers, health system leaders are learning that clinical success is only part of the equation. These treatments may offer life-changing results, but without strong financial and operational planning, patients can face delays before therapy even begins.

In the study, “From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs,” Zahra Mahmoudjafari, Pharm.D., MBA, and her coauthors present a practical framework to help institutions build safe and sustainable programs. Mahmoudjafari discussed one of the most challenging parts of that framework: working with payers and managing reimbursement, in an interview with Managed Healthcare Executive.

Cell and gene therapies are expensive and tend to require detailed prior authorization. Mahmoudjafari said health systems should prepare early and work closely with both government and commercial insurers before treating their first patient.

“I think this space in particular requires partnership, partnership with our industry colleagues but then also with our payer colleagues. And really looking to educate.” Mahmoudjafari said. “Health systems are responsible for that education piece also because our payers are looking to catch up with the innovation.”

Related: Pharmacy leadership is key to building safe and sustainable cell and gene therapy programs

She expressed that successful centers clearly define coverage pathways, sites of care expectations and appeal strategies in advance. That means understanding the differences between Medicare and commercial plans, aligning coding and billing processes and modeling best- and worst-case financial scenarios.

While payers can still be challenging, she said they are no longer a “black and white box.” Early communication, transparency and strong documentation can improve collaboration and reduce delays for patients.

Mahmoudjafari also spoke about sickle cell gene therapies, which have rolled out more slowly than many expected. She noted that innovation often comes with “bumps in the road.” Over the next few years, she expects changes in volume, more therapies moving into outpatient settings and increased competition among products. Clinical trials are also expanding into non-oncology diseases, which could bring many more patients into the system.

Due to this uncertainty, she said health systems need flexible staffing and scalable workflows. Programs should not be built around a single product. Instead, leaders should design systems that can adjust as therapies and demand change.

“I've always used the statement of ‘write everything in pencil,’ because you're going to have to re-back track and understand that this is just a space that's moving quickly but also kind of slowly in a lot of ways too,” she said.

Her advice for executives is straightforward: invest early in payer engagement, build adaptable systems and plan for change. The science may be groundbreaking, but long-term success depends on careful coordination across pharmacy, finance and operations.