Getting the right drug to the right patient at the right place at the right time

Q: What did you see about AmerisourceBergen that made you want to work here?
Lung-I Cheng: I look at the healthcare system as a holistic ecosystem. I'm new to distribution, having come from a biopharma background. Yet, if we think about what we're trying to achieve, getting medicines to patients who need them, I see myself as one of the partners.

AmerisourceBergen is unique in that it touches almost every segment of that ecosystem. I want to be the change agent and tap into the infrastructure, relationships, and reputation we already have. Nobody can succeed on their own when considering what's needed for cell and gene therapy moving forward. It will take a lot of system changes to make this happen.

Q: What are the top trends in the cell and gene space? How do you envision AmerisourceBergen leveraging those trends to help our partners?

Lung-I Cheng: The science keeps evolving fast, and cell therapy is no longer a proof of concept. These approved cell therapies have brought tremendous benefits to patients but in relatively small populations. However, there is a multitude of targets and disease areas that are being studied. And I think the number of approvals and positive impact on patients will pick up soon. With the promise of approvals, it will take a group effort to ensure that patient access remains top of mind. And ultimately, that's what we do as AmerisourceBergen: answer "How do you get the drug to the patient?"

Another exciting aspect of cell and gene therapy is that we see significant R&D investments globally, unlike other modalities that came before it. Right now, China has the second-highest number of clinical trials in cell and gene therapy. How we translate this momentum in R&D into patient access and commercial successes worldwide will be a focus area for many stakeholders involved. AmerisourceBergen is well-positioned because we have a global reach in many markets outside the U.S., especially through our ICS and World Courier businesses.

A third trend is the speed of platform improvements. For example, with autologous cell therapies, there's a lot of effort trying to reduce vein-to-vein time, the interval between when patients' immune cells are extracted to when the engineered cells are injected back into them. Because many of these patients have aggressive diseases, reducing this vein-to-vein time is critical. Some companies have started exploring expanding these engineered cells in vivo (in the patient). We must approach accessibility from different angles as the platforms continue improving.

Q: What should a biopharma company be looking for in a cell and gene commercialization partner?

Lung-I Cheng: Patients are at the center of everything. To that end, it is natural to ask: is this a partner that can, a hundred percent of the time, get the right drug to the right patient in the right place at the right time? AmerisourceBergen has our history, our expertise, and the right tools in place to make that happen. Furthermore, we want to innovate with biopharma partners because there will be new challenges as the field evolves. We are committed to co-creating innovative solutions to meet those challenges.

Q: What are some market access and reimbursement opportunities and challenges in the cell and gene space?

Lung-I Cheng: Regarding reimbursement, we need to consider coverage, coding, and payment levels. In the United States, achieving coverage with cell and gene therapies has gone reasonably well. What was challenging, at least in the first few years, was the lack of a specific diagnosis-related group (DRG) code for autologous cell therapies, which then created uncertainty for providers as to whether they would be reimbursed appropriately for the services provided. The Centers for Medicare & Medicaid Services have since issued a decided DRG code for those therapies.

In Europe, by contrast, the reimbursement hurdle is more about getting the coverage than the payments; however, in some countries, insufficient payment could still be an issue. The first few cell therapies in lymphoma are deemed to have "curative potential," which helped with the reimbursement negotiations in European markets. However, we are now seeing headwinds with several recently launched cell and gene therapies where the product value is not aligned with what the European payers have in mind.

The issue is even more complex for emerging markets, ranging from logistics and affordability. Some national payers have explored innovative contracting solutions to pay for cell and gene therapies with mixed success.

Q: From an equitable access perspective, a lot still needs doing to bring these innovative treatments to more patients. How can the right commercialization partner help with commercialization challenges?

Lung-I Cheng: The challenge for biopharma companies with cell and gene therapy reimbursement is you must start planning much earlier. For instance, an appropriate or inappropriate endpoint in the pivotal clinical trial could influence whether an outcomes-based contract could be implemented at commercial launch. Biopharma companies must pull commercial functions into those early R&D discussions, as the decisions have downstream implications.

What sometimes gets overlooked is also that for cell and gene therapy, unlike other modalities, the clinical trial sites will most likely become commercial sites. How a treatment is distributed for the clinical trial and how the sites of care interface with the biopharma companies to impact the commercial launch.

"We actually want to innovate with biopharma partners because there's going to be new challenges. There's going to be new solutions required to meet those challenges and we want to be part of that."

This is where AmerisourceBergen shines. We have visibility into different parts of the ecosystem that serves our biopharma partners. We are committed to being that end-to-end solution partner to ensure a seamless transition from bench to bedside.

Q: What will AmerisourceBergen's new cell and gene financial model bring to the landscape?

Lung-I Cheng: We believe that payers will be increasingly interested in participating in outcomes-based agreements for cell and gene therapy if there is a portfolio of products and that hence "the juice is worth the squeeze," recognizing the significant effort that will be required to negotiate the agreement value structure and deal with the actuarial value associated with the agreement. We designed this solution to ease the implementation of such agreements. Ultimately, that's what this is all about: making it easier for the different stakeholders to ensure the right patients get the right therapy at the right time.

Q: What advice would you share with a company on bringing their first cell and gene product to market?

Lung-I Cheng: The theme is to start thinking as early as possible to integrate your cross-functional teams and their interactions. Cell and gene therapy is a different model to develop and launch, so there will be questions you might not have uncovered.