The cell and gene therapy pipeline is no longer a distant possibility. It is arriving now, and health systems have a narrowing window to prepare.
With more than 35 Food and Drug Administration-approved Cell and Gene Therapies (CGT) and a pipeline that continues to expand into larger patient populations and new therapeutic areas, the CGT market has garnered rapid attention across healthcare.1 This growth is not theoretical. According to the Alliance for Regenerative Medicine, there are more than 1,700 clinical trials underway globally.2 Therapies once viewed as experimental continue to reach commercialization and clinical adoption faster than many expected, creating urgency for health systems to prepare today rather than react tomorrow. The “crystal ball” is no longer cloudy. The next generation of therapies is visible, and the time to operationalize is now.
Breakthrough CGTs now light a once-dim path to unprecedented clinical promise for a broader range of conditions spanning rare disease, cardiology, inflammatory disease, and autoimmune disorders. Health systems are tasked with building scalable, repeatable care models to deliver on that promise while managing the operational complexities that affect patient access to these novel therapeutics.
The management of CGT through a fragmented ecosystem using legacy governance structures and disconnected external relationships with payers and manufacturers is no longer sustainable. Current models were not designed for the significant resource demands of CGT. Headwinds across clinical coordination, logistics and chain-of-custody requirements, financial stewardship, quality and compliance oversight, and cross-functional accountability are pressure-testing health system infrastructure like never before.
To succeed, organizations need dedicated CGT service lines with clear governance frameworks and standardized operating procedures. Only 4 percent of health system pharmacy leaders report their organizations are fully prepared to integrate these therapies.3 This is where Cencora’s Accelerate Pharmacy Solutions plays an important role. Through its Cell and Gene Therapy Enablement solution, Accelerate Pharmacy Solutions helps health systems evaluate, build, and scale CGT programs while creating a repeatable operating model designed to withstand the evolving CGT market.
That need for a scalable model becomes even more important as sites of care evolve. As health systems face capacity limitations within acute-care settings, and manufacturers increasingly seek broader access points within community settings, the capability of a health system to efficiently and effectively diversify its CGT portfolio will be a key differentiator in the months and years ahead.
“I have sat firsthand with patients and their families discussing the promise of cell and gene therapies,” said Joe Rosano, PharmD, Managing Director, Cell and Gene Therapy, Accelerate Pharmacy Solutions. “For those patients and families, it was not a matter of how to get it done. It was a matter of when. It was on us, the health system, to figure out the how. That is what motivated me to join Accelerate Pharmacy Solutions. We have the expertise to bring care closer to home for these patients and families with an efficiency that is unmatched.”
Outpatient delivery is a critical component of advanced therapy readiness. Many therapies can potentially be delivered safely in expanded outpatient environments. These settings support improved resource utilization, potentially more favorable financial modeling, and increased patient satisfaction including reduced travel burden. Care closer to home can improve the overall patient experience, expand access to treatment, and strengthen coordination between health systems and manufacturers as they work to scale CGT delivery. Uniquely, Accelerate Pharmacy Solutions sits at the center of both players, allowing health system CGT strategies to be curated bi-directionally, instead of in a vacuum.
As health system leaders begin to evaluate their strategy, they can start by asking the following key readiness questions:
- Have we analyzed our local CGT market landscape?
- Do we have an established CGT governance council with multidisciplinary clinical, operational, financial service-line leadership?
- Have we assessed our workforce and operational capabilities against the therapies we plan to administer?
- What infrastructure do we have in place, or need to develop, in order to strengthen our reimbursement model and minimize financial exposure?
As advanced therapies move from promise to practice, the organizations investing today in governance, infrastructure, and innovative care delivery models will be best positioned to deliver the next generation of patient care.
No matter where organizations are in their CGT journey, Accelerate Pharmacy Solutions helps health systems build financial confidence, strengthen operational readiness, and establish the governance and infrastructure needed for scalable growth across therapies, sites and service lines. Learn more here.
Want to talk through your organization’s questions around CGT readiness? Connect with our team.
