How to Commercialize a CAR T Cell Therapy

What are the main challenges of negotiating a reimbursement scheme for a CAR T cell therapy?

For many countries, cell and gene therapies – especially CAR T cell therapies – are completely new and payers are working things out for the first time, but they invariably recognise the potential benefit these therapies bring to patients. This is why we achieved reimbursement in Europe within one-and-a-half years, which is relatively quick in oncology, never mind for a complicated and brand new therapy area. 

Innovative reimbursement schemes where discounts are applied when the therapy doesn’t have the intended effect have proved successful in working towards getting our therapy reimbursed. But we found that many countries are unfamiliar and do not have procedures in place to implement new payment plans. That isn’t to say they aren’t keen, but it’s the realities of implementation that can be tricky. This is why CAR T cell therapy is a team sport. Our job in the commercialisation team isn’t just to explain the benefits of our therapy - it also involves working collaboratively with payers to help them accommodate new payment models. 

My proudest moments at Kite have come when we finally treat a patient in a new market for the first time. It’s incredibly difficult to bring these therapies to a new market but we’re proving it can be done!

Much of what Kite is doing is completely new…

It is. Not only with payers but across the board. We’re not talking about delivering an off-the-shelf therapy. From manufacturing, to commercial, to clinical, everything is brand new and we’re only figuring things out as we go. We find that communication and collaboration – both internally and externally – is crucial to what we do. Externally, we work very closely with our network of hospitals so that we can ensure that there is an apheresis centre able to deliver the CAR T cell therapy safely, effectively and within tight deadlines. 

Internally, we have created a culture of patient centricity and one of close collaboration. When you’re doing something so new you have to learn from your challenges and share those learnings effectively.

How important are timelines for CAR T cell therapy?

Absolutely crucial. Often, the average lifespan for the patients prior to treatment is six months. And for some patients, they may only have weeks to live if they can’t get access to CAR T cell therapy treatment. There’s a chance that reducing turnaround times by even a single day could be life-changing for a patient and that is why it is central to all we do. You have to constantly innovate to figure out ways of reducing timelines; for example: how to speed up processes for qualifying new apheresis centers? How can we streamline the process for booking patients at the apheresis center? How can we reduce the amount of manual interventions in the process, which require strict oversight, through automation?

From a European perspective, was this a factor in your decision to build the new manufacturing center in Amsterdam?

Indeed. There are a number of factors that impact the speed at which you can turn around a CAR T cell therapy. Manufacturing and quality are obviously key, but so too is logistics – and the location of your manufacturing center is a key component of that. The first point is that we’re much closer to patients in Europe – we do not have to ship to another continent and back to treat and reintroduce the cells. It is also very difficult to find a spot five-to-10 minute drive from an airport with direct flights to major European cities. In fact, Amsterdam is one of, if not the only, place where we could do that. We also have a research facility in Amsterdam and the links there will be important for the delivery of these therapies.

How do you see the future of cell therapy progressing?

First of all, let’s think back to where we were two-and-a-half years ago. The consensus was that “although it looks promising, it remains to be seen whether anyone will be able to manufacture these products and successfully commercialize them.” We’ve shown that it can be done and that bodes well for the future of our industry. 

Looking ahead, we will find ways of automating autologous cell therapy manufacturing and improving the time it takes to qualify and deliver these therapies. But, ultimately, their potential is inherently limited by the need to transport, modify and deliver the therapy. I, therefore, believe that allogeneic therapy will have a huge role to play in the future and Kite has a number of initiatives in this area. On the development side, we’re also going to see big advances in solid tumors. This won’t be easy, but the potential is so vast that I believe we will find a way.

What about Kite?

We want to get our products into more countries over the next few years, especially some of the smaller ones. I also believe we will have approvals in one or two new indications and that our turnaround times will be shorter – potentially around half of the time we are able to deliver these therapies at the moment.

Do you ever feel pressure being involved in the realization of such potential for patients?

Pressure? Not exactly; rather a deep responsibility. I’ve spoken to patients that have been treated with our products and it is deeply moving to hear how it gave them another chance for life. But you do feel responsible for doing what you can to ensure that as many patients as possible also get the same opportunity. This is why we got into the industry in the first place. Though it’s common to find yourself working on a therapy that, while beneficial to patients, perhaps there’s another five similar products on the market, which limits your impact in the grand scheme of things. With cell and gene therapies, not only is your product treating patients with few (if any) options, it’s also remarkably effective – curative in many cases. You do feel responsible but also fulfilled. It’s an enjoyable area to work in!