Expert insights to help health systems navigate the challenges of CGT readiness

Interest in cell and gene therapies (CGTs) at health systems is growing, particularly as these therapies move into new indications that reach larger patient populations. A recent Cencora survey of 111 health systems and pharmacy stakeholders found that nearly half (49 percent) say their health systems are implementing or actively planning advance therapy implementations, while another 31 percent say they are exploring or considering these therapies. However, less than a quarter (23 percent) of these leaders are familiar with their organization’s cell and gene therapy strategy and operationsⁱ.


While there is growing health system interest in advanced therapies, these survey findings suggest a readiness gap for uptake of CGTs by health systems.  Uptake is also held back by lack of a coordinated effort across each institution to prepare, launch, and scale CGT programs. With these challenges in mind, what role can and should the manufacturer of CGTs play in helping health systems that are considering, beginning, or expanding their use of CGTs – especially in therapeutic areas beyond oncology?  

This interview with three of Cencora’s CGT and health systems thought leaders explores the issues facing manufacturers when it comes to site-of-care readiness as they look to broaden patient access and develop therapies that address conditions that affect larger patient populations.  

In a recent Cencora survey, health systems cited payer contracting and reimbursement as the top challenges to CGT implementation. Is there a role for manufacturers of advanced therapy products in helping health systems address the cost challenge? 

Louis Cicchini: It’s a good question and there aren’t easy answers. However, there are innovative payment models and other options that can be pitched that could help shift the risk. We’ve had interesting conversations with manufacturers who are eager to address this issue of a site not having the cash to manage these therapies, and who are looking at how they might be able to address the risk. If manufacturers are going to look at this, they need to think about their sites, their own programs, how the therapy will be reimbursed, and then be creative about structuring a model, whether dealing with extended payment terms, or working with sites on methods for capturing data for outcomes-based agreements. 

With that in mind, how important is it for manufacturers to expand their site network and how might they go about doing that? 

Cicchini: When expanding the site network, manufacturers will need to be realistic about where they want to go. It probably makes sense to launch first at academic medical centers (AMCs) if the AMC has the therapeutic unit relevant to the CGT, because many of them know how to manage these programs and have the governance and support in place. After that, manufacturers can look to expand to regional hospitals or community providers, but it’s important to be realistic about your network, understand the site of care, and how that dynamic is going to change with procurement practices, payers, and patients.  

Ryan Telford: The way to reach more patients closer to where they live is by activating hospitals in a community setting. As the delivery technology for advanced therapies becomes easier and less burdensome to handle, the circle of health centers implementing advanced therapies will expand.   

The other big development is the growth of advanced therapies in other therapeutic areas beyond oncology. It’s well understood that many AMCs have a lot of experience with oncology products, but as they diversify into areas such as immunology what might manufacturers do to help those sites prepare? 

Louis: For those centers, it’s about understanding who their cross-functional teams are, where the expertise currently lies, and whether that can be leveraged for another therapeutic area. If not, the center will need to plan for that and understand the channels that will need to be leveraged by the new care team and any new barriers that may emerge. The role manufacturers can play, aside from the financial factors we’ve already discussed, is in areas like training. If this new therapy isn’t just an infusion and uses a proprietary device, there will need to be significant training in how to use it.  Furthermore, they can help health systems setup their processes and make sure they’re clearly understood by addressing questions such as: Is the new care team able to bill a drug under medical benefit, or is their primary route pharmacy benefit?; Are they able to buy and bill high-cost drugs?; Is the prescribing physician the one who is procuring and administering, or is that someone else? 

Ryan: Manufacturers could provide something like an itemized list of requirements, steps, and resources when moving into a new therapeutic area. That might include building order sets, thinking about managed care, and managing patient-specific requirements. If a health center’s entire advanced therapy resourcing is around oncology, perhaps be a bit explicit with what will be needed to support patients in a different therapeutic area. Help them understand they may need to think about it differently and it’s possible what they need does not currently exist in their infrastructure. It’s not about being prescriptive, but helping them to make more educated decisions.  

Health system roles are also key to an advanced therapy program’s success, and with that in mind the Cencora survey explored the important role pharmacy plays. What can manufacturers do to help pharmacy make the case for a therapy? 

Joseph: The majority of advanced therapies are likely to be brought through some semblance of a hospital pharmacy and therapeutics (P&T) committee. These are the gatekeepers for that upfront clinical evaluation as to whether it makes clinical sense for the health system to adopt a therapy. Pharmacy leaders will likely be the ones shepherding these therapies through P&T, so manufacturers can support that process by equipping them with the data they need to present out to those committee meetings. Those pharmacy leaders need to understand the therapy in its entirety – from composition to clinical delivery, including outcomes, adverse events, and risk stratification. That information needs to include how the health system will execute on a treatment. If a patient has to be observed for  multiple hours after an intravenous infusion, what does that entail? What resources are needed? How many nurses? Which care setting is most appropriate?  

Ryan: Manufacturers can help by being pharmacy’s champion. Make sure they have the clinical value story and the cost information in a tight package that can be taken to the executive level.  

What specific recommendations would you make to manufacturers to support pharmacy engagement with P&T?  

Joseph: The first would be to equip the pharmacist to be an expert on the therapy when delivering the message to the voting body, which is usually the P&T. Second would be help them to diffuse the operations of the clinical trial bubble into real life so use of the therapy can be replicated in the real world while maintaining all safety and quality controls to maximize potential therapeutic efficacy. And the third would be that stakeholder piece that is often missing, which provides a single source that the pharmacist can get information from. Whether that person is a medical science liaison or an account manager, there needs to be one partner in the process.  

Conclusion 

Manufacturers must navigate a complex environment when working with health systems – respecting their autonomy while providing needed assistance to support the uptake of advanced therapies. “Sites are interested in adopting advance therapy programs, but it has to make sense for them. Manufacturers can look at where the burden is sitting on issues like long-term follow-up requirements and making sure that it’s feasible for sites to do this,” Louis said.  

As demand grows and as these treatments expand into therapeutic areas beyond oncology, that relationship between manufacturers and health systems will evolve. “Being able to help sites make more educated decisions is probably the order of the day,” Ryan noted. “For example, manufacturers can help by supporting pharmacy leaders with the right information to move this through to their P&T committee to make the journey easier.”  

Building those partnerships with health systems early on and providing supportive, non-promotional advice will be key to helping more patients access advanced therapies. “Unless a site has been part of the clinical trial, they lack early visibility into the data and outcomes, as well as the operational complexities and risks associated with the program. They depend on what the tertiary literature says. Having a partner to help steward pharmacy leaders at those health systems through the process could bring them up to speed with some of the larger academic sites that were part of the initial clinical trials,” Joseph added.   

Manufacturers can play an important role in helping health systems to prepare for CGT adoption or expansion. Any support, however, must prioritize the needs, capabilities, and goals of health systems and the patients they manage. Download the Cell and Gene Therapy Playbook for Site Readiness to find out more about the intentions, opportunities, and challenges facing health systems looking to implement advanced therapies and how manufacturers can provide guidance and support.  

The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.