Allen Lising, managing director of Xcenda’s FormularyDecisions, explains how stakeholders are using pre-approval information to make business decisions.
The Center for Biosimilars® (CFB): I'm Tony Hagen, senior editor for The Center for Biosimilars®. Today, we're talking with Allen Lising. He's the managing director of FormularyDecisions for Xcenda. Allen spoke about some interesting trends in the biosimilars community. Particularly, payers are looking much further back into the development process for biosimilars, as far back as 18 months prior to FDA approval. This additional information can help them make better formulary decisions. In addition, manufacturers are releasing much more clinical data on their biosimilars in hopes of strengthening their position in the marketplace when they do launch.
CFB: Can you describe the platform that you've created and who your intended users are?
Lising: Sure. FormularyDecisions is a secure online platform that essentially connects pharmaceutical manufacturers and health care decision makers. So, we support the exchange of information between these 2 stakeholders. As for our health care decision makers—these are our users of the platform who have access to the content— there is clinical and health economic information that can help them review and evaluate products when making value-based reimbursement decisions.
From the manufacturers' side—the pharmaceutical companies, biomedical, as well as medical devices—for them, it's a channel to not just facilitate access to their information, but also help inform their market access strategies, drive product success, and, ultimately, impact patients in a positive way. So, at a high level, that's what the platform does for these 2 stakeholders. It's free for users of the platform. And the manufacturers support the platform and make sure that information is available and there's a credible source, as well as an information exchange.
CFB: So, you'll include such information as pipeline information, what biosimilars might be under development, and dossiers. Can you explain what a dossier is for the layperson?
Lising: Sure. So, yes, to your question, we include many different sources of information and then one, which I think we'll get to later, is the Biosimilars Hub within the platform. But, in terms of your question about what a dossier is, a manufacturer has comprehensive information about a product, a compendium that they put together for payers to use when assessing a product. Under FDA compliant regulations, there's a request to access this information. So, in our platform, it's FDA compliant for secure requests. The decision makers are verified, so it's a close harbor. They're able to have this dossier, which is 300 to 400 pages, in an interactive way. So, they're able to look at it as an e-dossier, pull the information out that they use in their P&T [pharmacy and therapeutic] committees, as well as compare the information with third party content or reports such as the ICER [Institute for Clinical and Economic Review] report. The platform becomes one place. They can use the manufacturer e-dossier and look at other sources of information so they have a full picture. And specific to biosimilars, we saw a gap in the need for biosimilar information and we started to add biosimilar products to the platform. Over the past couple of years, we saw that we need to go beyond that. And working together with AmerisourceBergen colleagues, who are working on education materials and content, we were able to put that together into the platform and launch the Biosimilars Hub.
CFB: So, the e-dossier would be used by payers primarily and it will include clinical information on the products, as well?
Lising: That's correct. And we use the word "payers" in a broad sense. So, it's not just managed care organizations, but also PBMs [pharmacy benefit managers], IDNs [integrated delivery networks], hospital health systems, as well as some government bodies. But it does contain 3 types of information. One is just product information that is comprehensive.[Two, is] clinical information that includes everything from clinical trials. And then, the third grouping is the economic information from their models or from, sometimes, claims data that they've analyzed.
CFB: Tell us about the biosimilars pipeline and what you're seeing in the number of products that might be in development, and how important that development information is in influencing formulary decisions.
Lising: A few years ago, there were, obviously, no biosimilar products in the pipeline. Our platform shows that there are over 109 biosimilar products, both in the pipeline and approved. In terms of the growing interest, there was a 30% increase in activity on those products, as well as a 50% increase in requests for dossiers around biosimilar products. So, I think that shows an increase in the need for biosimilars products.
CFB: So, FormularyDecisions offers manufacturers a certain amount of information as well, is that correct? From their perspective, what are they going to learn about the health care community, payers, PBMS, and so forth?
Lising: That's a great question. Our platform offers [manufacturers] a direct channel to get their information out to payers to making sure that they have the latest information, from pre-approval to approval. At the same time, they're able to get insights into some general topics. One of your questions was whether payers are more interested in biosimilars. So, we are able to gather metrics data on increases in activity on biosimilars. [We provide] specific information that they're seeking to help inform the manufacturers from a topic perspective, like biosimilars, and at a product level. So, we provide insights, both from opinion and behavioral perspectives.
CFB: What about trends? We're seeing a lot more activity and a lot more interest in biosimilars among payers and health care clients, such as PBMs. Manufacturers are definitely entering this space in bigger numbers as they have things in development. So, what do you see unfolding here and what interesting trends should we have our radar focused on?
Lising: The trends that we see are more based on the activity within our platform. So, I can't speak for the general medium out there. Although, as you stated, there's a growing need that we've heard. But within our platform, just from the activity, we’ve seen a 30% increase, before we launched the Hub and before we promoted it to our decisionmakers, and the 50% increase in the [dossier] requests. So, there's a trend in the activity.
The other trend that we've seen that is tied to biosimilars is that payers want to see more pre-approval information. So, even within biosimilars, they're very interested in the pipeline and they're looking back [at older information]. What we're finding from our users, managed care networks, and the advisors that work with us is that it's anywhere from 12 to 18 months [prior to approval] that they're starting to look at.
And I think the third one that we're seeing is more interest in economic information and being able to model out some of these scenarios more to get a better sense, for their own plans, of what does that impact, and can they model out from different scenarios, including pre-approval products to biosimilars? So, I think those are some of the trends that we're seeing.
CFB: Going back to what you said about the 12-to-18 month look that payers are taking, do you any thoughts on why they want to start looking at a product so early in its development. They may still be in a phase 2 trial or starting phase 3, and yet the payer is interested in the product. What do you think?
Lising: Well, I think there are 2 reasons. One, from a payer perspective, they want to have less chance for surprise. I think it was the PCSK9 [proprotein convertase subtilisin kexin 9] market, where it took them not by surprise, but they weren't as prepared. Being able to have more information early on would've helped them to be more prepared. It used to be harder to find that information. If a biosimilar candidate is in phase 2 trials, how likely is that product to make it to the market and is there information on that?
As for the resources that the payers had, they didn't have teams that could go scour for this information. So, it was much tougher. Now, that there is more access to it, they become more informed and when you become more informed and understand the pipeline, you have more questions, and I think it's become part of their process. One of the payers in a presentation at AMCP [Academy of Managed Care Pharmacy] last year outlined their process and they showed how and why [they looked back] 12 to 18 months, because they were almost doing preliminary presentations to their own senior management about these products and the potential impact.
The other impact was some of the fast track. There's been some drugs that were fast tracked. So, again, I think as a payer, I want to be prepared. I want to be able to plan as much in advance. And in the past, there was also that law where you couldn't even get that information from manufacturers. Now that there are things that allow that information, payers can reach out and get it. I think the biggest thing is preparation. So, you just want to make that sure you understand that market and have an idea of the impact that pipeline products will have on that market.