Operational Challenges and Collaborative Solutions in Cell and Gene Therapy Implementation at UC Davis Health: Jenny Craven, PharmD, BCPS

As cell and gene therapies expand beyond rare diseases into more common conditions, health systems face mounting challenges in cost, care coordination, and timely patient access. Jenny Craven, PharmD, BCPS, the senior clinical pharmacist and pharmacy lead for emerging therapies at University of California (UC) Davis Health, explained that health systems must proactively engage with the rapidly evolving cell and gene therapy landscape. Although current approvals largely target rare diseases, she noted that more common conditions will soon follow, making early experience critical.

Craven highlighted the financial burden of these multimillion-dollar treatments, the complexity of patient care pathways, and the need for well-trained staff who can navigate both standard and nonstandard protocols. Success requires coordinated planning across eligibility, contracting, reimbursement, and patient support processes, given the high stakes and small patient populations, according to Craven.

Craven also stressed that collaboration between health systems and health plans is essential to address challenges of timeliness, cost, and appropriate patient selection. She pointed to authorization delays, inconsistent criteria, and cumbersome appeals as key barriers, advocating for alignment with real-world practice and efficient case-by-case communication. By learning from each patient experience and strengthening payer-provider partnerships, she argued, systems can ensure timely access to cell and gene therapies while balancing safety, efficacy, and financial sustainability.

This is the first interview in a 2-part series with Craven.

This transcript was lightly edited; captions were auto-generated.

Transcript

Why should health systems care about emerging therapies and cell and gene therapies?

I think today it's extremely important that health centers are taking a look at the cell and gene therapy landscape for products that they might be able to onboard at their sites, because this is such a growing and innovative space. I know that today it's mostly rare diseases or smaller disease states that are maybe having the treatments available, but tomorrow, we're probably going to be seeing things that are very commonly diagnosed items, and so having this experience now is going to only be beneficial in the future.

I think the other big caveat, or the elephant in the room, if you will, is the cost of these agents. They're millions of dollars per dose per treatment per patient, and that can definitely induce some stress, I would say, onto the system. How are we going to handle these products and make sure that they're done correctly, from the phase of eligibility, all the way through reimbursement? That's been my role in this position here.

The other big thing with them is that they are so complex. A lot of them have multiple phases of care for the patient journey. They often require nonstandard approaches. There's also that limited number of patients that they're going to be treating, so our staff need to be very well educated and prepared each time we do have a patient that comes up, even if there's a large gap of time in between that treatment. A lot of these have very nuanced things that go along with them too. I think that's also so important that we try to adopt standard procedures when at all possible but having those nonstandard approaches for those unique situations as well.

Then finally, I think health systems need to really be aware of these items because the stakeholders are very widely dispersed throughout the health care system [such] that things like needing complex contracting reviews, as well as developing those new processes, and also that complexity with each nuanced product that we need to be aware of—all the little things that go into making this program a success.

How do health systems and health plans work together to address challenges in the cell and gene therapy space, and what are some lessons learned from your work in this area?

I think health systems at academic medical centers, they definitely need to work together on these very complex, very expensive, and very timely patients’ needs for cell and gene therapies. It's important, I think, that timeliness be something that is emphasized. We need to understand that these patients are generally needing this treatment acutely and as fast as possible. A lot of times our delays in the system have been from the authorization process or the single case agreements, so improving that efficiency in that space and making sure that everybody's on the same page with that. I think the other thing is that the authorization criteria align with real-world practice a lot of times. Sometimes the criteria can be pulled from the clinical trials or from other scenarios surrounding the disease state. But I think just really emphasizing that we're using real-world practice to guide what is the appropriate patient for the best safety and efficacy outcomes, which I think the health plan is ultimately trying to accomplish.

Then also just that the denial process, the appeals process, peer to peer, all of those things that go into the authorization process are consistent and reasonable, and that ability to be able to work through those is there. I think how we partnered with our health plans is to learn from each case, understand who our contacts are and how to best communicate and really just address some of those issues as quickly and efficiently as possible.