Read Time: 6 minutes
By: Joe DePinto
We recently sat down with Joe DePinto, Head of Cell, Gene, & Advanced Therapies at McKesson, for the first in a two-part expert Q&A. Below, Joe shares important insights on operationalizing cell and gene therapy in health systems, including logistical challenges, financial considerations, patient impact, and more. You can also find the interview as an audio podcast here.
MHS: MHS Editorial Team
JDP: Joe DePinto, MBA
MHS: Thanks for joining us, Joe. Can you start by giving us a brief summary of your background and how you function in your role at McKesson today?
JDP: My name is Joe DePinto. I'm the Head of Cell, Gene, and Advanced Therapies here at McKesson. I spent much of my career in biopharma as well as in medicine and healthcare, helping to provide innovative products to patients. And in my current role as the leader of cell, gene, and advanced therapies here at McKesson, my role is to build out the strategy and the vertical in which McKesson can help biopharma companies – as well as our providers and payers – navigate the cell and gene therapy landscape and the value chain.
MHS: Can you give us a high-level overview of the relationship between cell and gene therapy and health systems?
JDP: Cell and gene therapy is an exciting space and one that many of the health systems in the United States are working with. The science and cell and gene therapy is remarkable. The scientific breakthrough and understanding of how cells and genes operate in the body have led to some really strong efficacy results for patients. With the intensity and the complex science comes the need for services and solutions to support those products - and that's where a company like McKesson helps our health care systems navigate that. So, there's a high level of awareness of cell and gene therapies. Biopharma pipelines have a significant role in the clinical trials in cell and gene therapy. There's a lot of clinical trials out there in academic treatment centers across the United States and health systems, and those clinical trials are progressing towards commercialization as they continue to be successfully completed. So, more and more activity in cell and gene is being seen in the health systems local to you on a day-to-day basis, and they're becoming not only familiar with the clinical mechanisms of cell and gene therapy, but the commercial enablement of cell and gene therapy in the marketplace.
MHS: Beyond the clinical benefits, one of the things that we hear the most about with CGT is the cost, which could be a barrier for health systems to get into the space. Can you elaborate a little bit more on that?
JDP: As these products continue to evolve in the marketplace and move from clinical to commercial, the commercialization of these products have seen them enter the market at a bit higher price point than many of the previous products. But these are not products that are made on an assembly line. Typically, they have complex manufacturing processes. They don't typically have the same cost of goods sold for the biopharmaceutical company, the same cost to manufacturer. And at times, some of these products are produced by the patient as the beginning part of the manufacturing process. So the cost of these products can range anywhere from $400,000 to $3.9 million for a course of therapy. And these products, like I said before, have unbelievable efficacy and are life-changing products for patients. So it’s not the typical product that a health system would utilize on a day-to-day basis.
MHS: What would your advice be to health systems when it comes to preparing to operationalize CGT specifically in terms of the economics?
JDP: As health systems think about cell and gene therapy, I think it's important for them to do a robust net cost recovery process – or understanding what that net cost recovery for that product is, and I think there are various components to that. One would be understanding their payer mix and outreach and education with the payer of their intent to incorporate cell and gene therapy into what they use as their armamentarium in treating patients. I think they also need to think about a standardized access to these products, whether it's ordering and purchasing these products. I think they also need to understand the appropriate billing and coding insights that will be needed to make sure that the product is appropriately paid for. And then there’s the complexity of tracking in the data of these products and making sure that they're following the appropriate SOPs and SLAs that are set forward. Remember, many of these products start at the patient side. For the first time ever, these health systems are part of the cGMP process – (current) good manufacturing process – for the product. So to broadly utilize CGT, I think a very thorough net cost recovery model is needed for each of the healthcare systems.
MHS: Let's move on to another well-known challenge for operationalizing CGT and health systems: logistical complexity. You've talked to us before about the apheresis process, the rigid handling and temperature control requirements, and the other more manual or hands-on aspects of CGT, if you will, but what about that overall journey and workflow for CGT? What are those logistical pain points that health systems are going to run into and need to plan for?
JDP: That’s an important component for each of the healthcare systems to examine before entering into an agreement to work with cell and gene therapies, first of all, because the product starts typically with the patient, especially in the cell side and the autologous patient population. Many of these patients are apheresed at the hospital. So, the patient is the product, for clarity. They typically start the manufacturing process in an apheresis unit at the hospital, and it's understanding the patient flow and the product flow that are really important. If you're a healthcare system, you want to understand all the different departments in the hospital that need to participate in the delivery of this care, so it could be anything from the apheresis center, the bone marrow transplant center, the cell therapy lab, the treatment site of the clinic, or on the unit.
A variety of different approaches can be taken in delivering care, and typically the biopharma company would ask the health system to become a qualified treatment center, which would need them to really go through a process to understand what their generally accepted manufacturing processes look like – and do it with rigor – because this all becomes part of their regulatory filings of the manufacturing process.
So, it is quite extensive, and many different parts of the organization can participate in this – everything from legal review of contracts, to technology review of ordering processes, to shipping and delivering. Many of these products are delivered in cold chain. Some of them are cryo. Some of them are fast frozen. So, understanding the product delivery mechanisms and the product – how it moves through the hospital – is really important, not only in gathering the initial cells, but also delivering the final product. The level of orchestration that goes into this is not minimal, and it takes many departments within the hospital to really work in a well-orchestrated manner to deliver these products efficiently, effectively, and safely.
MHS: If you were talking to a health system who had not yet operationalized CGT, but was looking to, what would be your top two or three pieces of advice in terms of preparing for and overcoming these logistical complexities?
JDP: I think the best advice I can give is to not reinvent the wheel. If there is a parent or child relationship with a larger academic institution that's already operationalizing these products, the ability for them to utilize their SOPs and SLAs and mildly moderate the requirements based on the available resources that that hospital has would be a huge benefit. Why reinvent the wheel? Why not use what's being used in the larger academic centers? Secondly, have a good understanding of your net cost recovery model.
MHS: The last challenge we wanted to touch on today is supply chain instability. We hear a lot about cell and gene supply chain being unstable, but these aren't traditional drugs. So does that mean something different in this space? Would it be fair and accurate to say that an unstable supply chain in the CGT world means something unique when compared to biopharma as a whole?
JDP: I don't know if unstable is the right word, but there are definitely challenges in the supply chain. Many of the early products that commercially launched in cell and gene therapy had significant challenges from a manufacturing standpoint. So – quality and enough raw materials to develop the product, whether that's viral vectors that are needed to manipulate the cells - or the ability to slot patients to get these products efficiently – all became what I call challenges in the supply chain. Now, whether that's an instability or not is up for debate.
But the reality of it is, this isn't like other products that come out of a bioreactor or come off of an assembly line. These are products that need to be manipulated – sometimes manually, sometimes in a closed environment – they need to be stored for a period of time and temperature controlled, and they need to be delivered in a fashion where the product isn't excessively shaken or the product is delivered, in a cold chain fashion where it doesn't leave a certain temperature period for a certain period of time. And then when the product's given, it can't be given in a cryo environment. It has to be warmed to a certain level. So there are a lot of requirements that cause some of the challenges in the supply chain, and a lot of it starts with manufacturing and at the biopharmaceutical companies or the CDMOs and the supply chain’s ability to coordinate with those manufacturing sites on when product will be available, when the product will get to the patient so that the patients ready to receive the product all add to that complexity that has to be navigated to deliver these groundbreaking therapies.
MHS: It sounds like it's not so much that the supply chain itself is unstable. There's just a lot of opportunity for potential hiccups along the way.
JDP: Hiccups is a good word. I think, like anything, when you have multiple steps along the way, you have risks, barriers, or challenges that can occur. And how a particular product navigates the value chain is different from one product to another. Understanding intimately all the touch points in the delivery of care and the delivery of the value chain for the product is really important. We never want to compromise patient care in cell and gene, but we also need to navigate sometimes a circuitous manner in which the product goes from the patient to the CDMO or the manufacturer, is manipulated, then comes all the way back to the health system to deliver the product. And that could have a few hiccups along the way.
MHS: What are some of the most compelling consequences of these so-called hiccups to the supply chain, both in terms of compromising patient care and also putting increased burdens on the health system?
JDP: You never want to compromise patient care, right? We want the right product to get to the right patient and the right dose at the right time. So obviously when you have a longer, more circuitous supply chain, it's really important that this is tracked from a control process and monitored. That's an important component for any product to be delivered, but especially in cell and gene, where at times with some of the products, especially autologous cell therapies, that product starts with that patient, so that patient needs to get their cells back for delivery. And it's really important that that happens and that there's a good tracking and tracing and chain of identity and that the chain of custody is quite clearly verified when the patient gets it.
The logistics and complexity of managing it for the hospitals – again, as they develop SOPs and SLAs on how this typically works, it becomes less labor intensive because it becomes systematic. They do it the first few times. They get to know how to do it. They get to know their systems. They get to see how this is optimized. that's the basis for doing it. As we look at some of the major academic centers, now they're delivering 10 to 15 products on a regular basis, so they know how to operationalize this. They know what systems and SOPs work, and they're able to manage that well, but they're also all qualified treatment centers as brought forward by each of the biopharma companies.
MHS: You’d imagine without all of those SOPs and SLAs in place, the potential consequences of those hiccups could be devastating for patient care but also increase the burden on the hospital in terms of logistics and rescheduling patients and delaying treatments and even potentially financial risks. And throughout the conversation, you mentioned several areas where McKesson may help health systems overcome some of those challenge and operationalize their CGT program in order to elevate excellence in patient care and outcomes and avoid some of these hiccups. What else does McKesson bring to the table, or what would you say are some of the primary benefits of partnering with McKesson for cell and gene therapy?
JDP: A lot of this starts with the ordering of product. Because of some of the manufacturing challenges, it's coordinating with the biopharmaceutical company availability for the product, the slot for the product and ordering the product with a great deal of confidence. Because McKesson is so well known to many of the health systems in the United States, it gives them confidence to be able to order through our specialty distribution, our 3PL, or our specialty pharmacy, and to work in coordinated fashion with the biopharma companies that are bringing McKesson into their network. So that gives them a good sense of confidence that the products are going to be ordered and the process will start off well.
Also, as we look at some of the things we're working on, we look at how do we use technology to help the health systems make some of the process challenges a little bit less? That way we can partner with different vendors along the way that engage in chain of identity and chain of custody, or partner with different couriers that deliver these products. That's all part of how McKesson sees navigating the cell and gene therapy ecosystem. We don't particularly do this all ourselves all the time. Sometimes we have offerings that are specific to McKesson, and sometimes we partner with other vendors that have expertise in the space to deliver the product for patients based on the needs of the biopharma company and the providers.
MHS: Do you have any closing thoughts you'd like to leave our readers with?
JDP: I think it's an exciting time in cell and gene therapy. When you think about the science that's evolved here… it's really complex and really necessitates complex services and solutions to be offered to providers in these healthcare systems so that they can have an industrialized standard to deliver cell and gene therapy. It's the early days. It's not there yet, but because of the unique assets McKesson has in the space, we can play a critical role in the future here. We can play a role in helping healthcare professionals industrialize the way in which cell and gene therapy is delivered to patients. But we only can do that with help from our biopharma partners, as well as the payers and the providers, all working together to deliver these really groundbreaking therapeutic interventions. I think it's an exciting time and we're only at the start. We're only at the beginning. But, the effect these products have on patients is unbelievable, and we need to be able to make sure patients have access to these products.
To learn more about partnering with McKesson to achieve more, contact us today.
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