Market access: bringing the science and clinical story together

Market access: bringing the science and clinical story together

By Maria Fontanazza | [email protected]

Market access has been and continues to be an important process, and as of late many agencies have been boosting their capabilities in this area. We recently caught up with Ellen Cappellino, the new executive director of value, access, and reimbursement at Klick Health and the agency’s chief medical officer, Holly Henry, to discuss current market access issues and its future.

Med Ad News: What are some of the challenges you see pharma companies facing related to market access today?

Ellen Cappellino: I appreciate that question and I think it really is the reason I came to Klick. One of the greatest challenges that our industry has is bringing the science and the clinical story together with the value story. From a market access perspective, it’s a balance of what’s needed for registration with the clinical evidence and data, and what’s needed for reimbursement with evidence beyond the clinical study. The science is moving very fast, and the treatment landscape is constantly changing, especially in areas like oncology. When you think about personalized medicine and rare disease, things are moving very quickly [too]. You want to get your product to market quickly for patients who need it. At the same time, you need to think about the evolving treatment landscape. What it will look like when you get there? Do you have the right endpoints to demonstrate the optimal right place in therapy relative to other treatment options?

Holly Henry: Ellen hit the nail on the head. As we are thinking about more opportunities to bring the appropriate value story to our customers with CFL [consistent with FDA-required labeling] now being a way in which we can lean into real-world evidence more to help tell the value story, it gives us the opportunity to [communicate] the true value of a molecule in a more appropriate and earlier setting.

Med Ad News: What are your goals/hopes for your new role at Klick Health?

Cappellino: Very simply, it is coming in and working with the team to build out our capabilities cross functionally. Every function in the industry touches market access because every stakeholder in the patient’s healthcare ecosystem is involved. Similarly on the agency side, all of the disciplines and different crafts touch market access. So one key thing is working together and collaborating with the team to use AI to see how it fits into market access. For example, we can use AI to do the literature search and bring forward and quickly catalog the existing  body of evidence to define the burden of illness and unmet need. This is a key piece of the value story when bringing a new product to market.

Henry: One of the things that is so important in the value story is knowing what evidence we need to generate to tell a compelling story and get that particular product to the appropriate patient. As agency partners, we talk to our clients about where those gaps are in evidence and recommend places where we need to generate new evidence. The utilization of AI helps us quickly sift through that information and make those very strategic recommendations.

Med Ad News: What trends will you be keeping your eye on in 2024?

Cappellino: From a market access perspective, we continue to hear about pricing pressure. I think we’re continuing to move from volume to value, which again goes back to the evidence. A lot of the key trends I monitor are around where is the science going and how fast it is moving. Therapeutic areas like oncology are very prolific.  The science is rapidly evolving and the pipeline is exploding.  It is becoming more challenging for HCPs to stay current.

I’m also very excited about CFL because this opens the door wider to bringing evidence beyond the clinical data into the treatment decision.

Henry: With CFL, the opportunity for us is to be able to utilize more real-world evidence. with With the tools we have and the ones that we’re going to be creating, utilizing AI, we will be able to identify WHAT evidence is needed faster. All those things together are going to help us lean into a better value story and better clinical understanding and ultimately getting the right treatment to the right patient faster. What I’m looking forward to seeing in 2024 is how the combination of those three – CFLs, real-world evidence generation, and AI will help fuel these.  I’m looking forward to how AI will help propel these things and thus help impact [areas] like rare disease and oncology, particular where we’ve had delays in getting the appropriate value story out there.

Cappellino: For me, the Holy Grail is time to treatment. If we can shorten the time between the treatment decision is made and when a patient starts therapy we provide a better chance for the best possible outcome.