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Laura Housman, MPH, MBA, DrPH: Hi, I'm Dr. Laura Housman. I am a practice director here at Avalere Health and I'm joined today by a colleague and excellent mentor on oncology, a registered pharmacist and our clinical team lead here at Avalere Health, Amy Schroeder. Amy and I work a lot on many different projects, but one in particular is Compendia, how to engage and support life sciences companies in ways of incorporating their products into Compendia, into guidelines. Recent news, hot off the press, a diagnostic company, Adaptive Biotechnologies, recently had their multiple myeloma guidelines incorporated into NCCN. And that will be a second conversation we'd love to talk about because it has material impact for all manufacturers of therapies for minimal residual disease. So we wanted to start in today and just start talking about Compendia. Amy, welcome. It's great to see you. Amy Schroeder, RPh: Thank you Laura. And good morning. Laura: One of the things we often hear is how does a clinical drug Compendia differ from other Compendia? What are the components? How do they interact with each other and with market? Amy: Sure. That's a really interesting question. We have a lot of clients that come to us and say, "We need help with Compendia." One of the first questions we ask is, "What type?" So we have pharmacopeial Compendia, which is more about the quality and the actual chemical standard for actually making the drugs. This is very important for drug manufacturers who will be later losing patent and exclusivity and generics will come to market. So it's about the quality of the product that's being made. Also, where we focus more is in the pricing and clinical drug Compendia space. And pricing Compendia are very important for all areas of healthcare to talk to each other. So it's for a physician who is billing for a drug, a payer who's paying for it, a pharmacy that is ordering it. And so it's how all of those systems talk together. And then some of the companies that make pricing Compendia also make clinical drug Compendia. And that's where our teams really focus, when we're thinking about value and evidence of products, is how do Compendia actually help in their reviews of on as well as off-label experimental information. And what's really exciting is that the clinical drug Compendia are very widely recognized by many stakeholders in healthcare. So they're very, very important. Laura: Thanks, Amy. Is there a ranking of Compendia, like the go-to book or resource? Amy: Sure. So since 1993, CMS really set the stage when they began recognizing Compendia across therapeutic areas. And since that time, oncology has sort of taken a lead in stating that Compendia need to be updated often, and also that newer Compendia that have come to market really need to be recognized. And so right now, it's like there are many Compendia that we actually consider and that we include in our conversations with clients, but the five major ones that are in oncology are really the ones that drive decisions right now. And those ones that are in oncology, some of those also have all other therapeutic areas as well. But right now we have NCCN, AHFS, drug decks, clinical pharmacology, and Lexi drugs are really the five big ones that we pay most attention to and the clients ask us to help them with. Laura: Super helpful. Are there individuals that we've been working with within client that are good partners and understand this? Or are we really the experts that are helping to shape and drive what their Compendia strategy is? Amy: Yeah. I think what's really interesting at Avalere Health is that I personally have been involved with Compendia since 1999, and so I've sort of seen just the landscape of Compendia, I actually worked at three of them, so have that insider knowledge. And then with our clinical and evidence teams, we're really able to bring together a strategy for clients and present that to them, and then really gauge whether or not a client is actually looking for us to actually do the work and conduct the research and really help guide them along the way, or if they actually just would like for us to review something that they're preparing. So that's something that we get very involved in. And it's also really interesting that Compendia work really crosses functional groups. We work mostly with medical affairs, but we also work with payer teams, we also work with provider teams. And so we try to bring everyone together to make sure that they understand what we're helping to prepare or what we are preparing for them and also what the potential impact could be to those different teams and also to the customers. Laura: I don't know many organizations that have someone that says they've worked with three of the five top ones. So I think that's just fantastic and it shows in the work that we do. Speaking of the work that we do, where you and I and our teams partner most closely is both identifying where there might be evidentiary gaps and helping to fill those in. And then also what is the best way and process for incorporating that evidence into the best Compendia for the product at hand for the client. And I think that that has meaningfully saved time, helped get product to patient faster and really has been quite beneficial. Is there one lasting comment or thought that you would share in this little snippet we have today to help folks understand the impact? Amy: Sure. Because Compendia effect on and off-label use access, what's really interesting, and we actually have a really good example of this, is we helped a client who actually had a healthcare provider who was asking about how can we support patient access in this space while we're preparing to submit information to the FDA. So where we were able to help, which was really something that impacted patients quite quickly, was getting that right information to Compendia. Compendia reviewed it, they reviewed it positively, it immediately affected health plan coverage, and we actually received feedback from the client's medical team that healthcare providers immediately noticed very quickly that patient access was supported through payer coverage. Amy: And so we actually saw that full feedback loop. But it's really important to really think in advance about not only the indications that you have coming through the FDA, but also any future evidentiary planning that you have because we can help you with each step because Compendia support is really throughout the life cycle of the product. Laura: That's the headline right there, Amy. It is so true. Thanks so much. Great to see you and looking forward to our next session. Amy: All right, thanks Laura. Laura: Thanks.