February 2, 2026
Welcome to Perspectives, a signature podcast series from The Leerink Center for Pharmacoeconomics. Hosted by Dr. Mel Whittington, a health economist and Head of the Center for Pharmacoeconomics, we will be hearing from individuals across the industry to better understand and appreciate the societal impact of healthcare innovations.
Mel Whittington: Hi everyone. You know, it’s not new news that healthcare spending has increased and is continuing to increase over time. So, payers are increasingly turning to utilization management strategies for prescription drugs. These are things like prior authorization or step therapy to manage utilization and attempt to reduce spending. So today we’re going to dig into specialty drug coverage, what it might look like in 2026, and how we should be thinking about the next wave of access challenges and opportunities. And so, to help us understand all of this, I’m joined by someone who has spent his career studying how health insurers cover specialty drugs. Dr. James Chambers is a professor of medicine at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center. He’s also one of the country’s leading experts on insurance coverage decisions and has even built a database to track all of this called the Specialty Drug Evidence and Coverage Database, also called SPEC. So, James, let’s get into it. Thanks for coming on the podcast.
James Chambers, PhD, MPharm: Great, well, thank you for having me. I’m a keen listener to your podcast. I’m very pleased to be here.
Mel Whittington: I love it. Thank you for listening. I’m glad we at least have one person. What is SPEC or the specialty drug evidence and coverage database?
James Chambers, PhD, MPharm: Okay, good place to start. So, SPEC is a research database I developed at the center here, so the Center for the Evaluation of Value and Risk in Health, at Tufts Medical Center based here in Boston. And at very high level, it’s designed to make insurer decision making more visible. And as your listeners know well, insurers play a central role in determining how and when patients actually can access specialty therapies. And coverage design is often fundamental, I believe, to a product’s commercial success. And the database is trying to, like I say, make this more visible. And the idea behind SPEC, whenever we kicked this off in 2017, was to build a data set that shows how US health plans structure access in practice. So, what they publicly require for coverage and how restrictive those requirements are, and importantly, how they vary across payers and also over time. So important to note here is that SPEC focuses on the payer imposed patient access criteria in the policy. So, we don’t track drug utilization. We don’t track pricing, although we have linked to those data sets. We’re really interested in understanding how the payer policies guide access. So today the database includes policy, some 18 of the largest US commercial health plans. I think that’s about 70% of the market or 190 million covered lives. And we track the clinical eligibility criteria, step requirements, reauthorization rules, and importantly, how those change over time. And one thing that makes us unique is that we also track the evidence the plans cite in support of those coverage decisions. So how evidence-based are these decisions? So, things like real world evidence and, I don’t know, God forbid, health technology assessments. And when do plans actually use those? My very last point about it is we include now 500 specialty therapies and more in SPEC, and we track each one for each FDA approved use separately. So Keytruda is a big problem for us because it’s approved for 20 different uses. So, it features 20 times in the data set. So that’s over 1,000 drug indication pairs at the moment.
Mel Whittington: Wow, so why specialty drugs? Why the focus on specialty drugs?
James Chambers, PhD, MPharm: That’s a very good question. And when I started SPEC, I wanted to focus on the therapies that mattered the most. And what does that mean? Well, the most from an access perspective and from a spending perspective. And those that drove a disproportionate share of health care spending. And that naturally led us to this broad, ill-defined category of specialty therapies. There’s also a practical reason in that for specialty therapies; health plans tend to publish detailed coverage policies and not really details how your access actually works. And that means that we can rely on these detailed documents of these coverage policies rather than drug formularies. And that’s important because formularies essentially are lists of drugs and the copayment tiers. What coverage policies do by contrast is really to spell out who the plan considers eligible. So what diagnostic criteria disease severity, what prior treatments they can receive, what clinical markers are required for the therapy to be considered medically necessary by the plan. So, when police plans are making decisions, they’re making a judgment on the medical necessity of that therapy. Now the FDA, of course, as you well know, judges safety and efficacy. So, this is a big difference. What we’re really tracking is the differences there. So high plans are limiting access relative to that FDA approval.
Mel Whittington: I am still hung up on the point where you said SPEC started in 2017. I can’t believe it’s been around for that long. I also can’t imagine probably like how it’s changed or evolved in that, what almost nine-year period. like what’s it been like working on this for nine years? And I imagine like, you know, the evidence and coverage evolve over time. So how do you keep it up to date and how do you deal with all of the changing landscape here?
James Chambers, PhD, MPharm: Yeah, when I say that out loud, 2017, it makes it seem like a long time, doesn’t it? I mean, it started off as a research agenda and encouraged here by my colleagues at CEVR and the Tufts to really think about where I could add value as a researcher. And I’m a long-retired pharmacist and I was really interested in the US market for these therapies. Coming from Ireland and working in Ireland and England as a pharmacist, a single payer system. I was really intrigued by how this sort of large number of individual payers making independent decisions actually played out in practice. What does that mean for patients? So, this data set really grew out of that really and understanding, I guess, specifically the variation question. So, do patients in different plans have different access to the same therapies? And if so, is that justifiable? And why is that the case? To keep it going, it very much is a team effort, and I should really give a lot of credit to, I have to say, a terrific group of researchers in the SPEC database team and without them, it wouldn’t exist, quite frankly. So, it’s been around for a long time because of the superb people that have been lucky enough to work with here at CEVR. So, you asked indeed I mean how exactly we do this well in practical terms we systematically track all publicly available coverage documentation for every therapy in the database. When a plan updates a policy, we identify what’s changed compare it to the prior version and then code those changes into the data set which allows us to track how things change over time. We currently update the database three times a year, every April, August, and December, to ensure we don’t miss any important updates. But looking ahead, we want to change to more of a real-time approach, so we can provide updates in real time about how things have changed and provide some insight into that.
Mel Whittington: Well, yeah, shout out to the SPEC team, shout out to you, shout out to the CEVR team, and excited to hear more from you all as you continually to expand SPEC and facilitate those real-time updates. You mentioned being able to look at things and how they’ve changed over time. And so, we’ve recently started a new year. Welcome to 2026. I would love to hear your predictions for 2026 as it relates to how specialty drugs will be covered. And if you could give just kind of a high-level description of your predictions, and then we can dig into each one of them separately.
James Chambers, PhD, MPharm: Okay, let’s do it. Three predictions today. All right, so number one. So, first, in oncology, we expect increased use of utilization management, particularly for subcategories of oncology. So that’s the first one. The second one, for newly approved therapies. So, these are novel therapies approved by the FDA. This year, coverage decisions, so the majority of coverage decisions, will include some form of access restriction. And to double down on this little bit, in most cases, those restrictions will closely track the pivotal trial populations for those therapies. And third, last but not least, biosimilars will be adopted more quickly as preferred options than in earlier waves of biosimilars. And I think this is important because it will accelerate these access shifts across these high spend categories. So that’s prediction number three.
Mel Whittington: Very interesting. And I’m always fascinated biosimilars and generic entry and the whole life cycle of medications. I’ve spent a lot of my career focused on thinking about drugs over the branded period or at launch. There is certainly this full life cycle and market dynamics and excited to dig into that one. Let’s start with prediction one. Remind me what prediction one is and then let’s get into it.
James Chambers, PhD, MPharm: Okay, so prediction one, in oncology we expect to see increased use of utilization management.
Mel Whittington: Okay, and so one thing I really enjoy about conversations with you is these predictions aren’t just like, you don’t just randomly come up with these predictions, but they’re data driven by all the data that you have in SPEC and, you know, so you can kind of bring the receipt. So, tell me about the data behind that prediction. Why do we think that’s gonna happen in oncology?
James Chambers, PhD, MPharm: So, in SPEC, we track these utilization management requirements and just important to note here, what we consider to be UM is some sort of coverage criterion that goes beyond the FDA label. So, when I’m talking about restrictions, I’m referring to a narrowing of the eligible patient population. So, that could be say patient eligibility criteria, so these clinical subgroup type restrictions. It could be step therapy, which of course is a requirement for a patient to feel typically a cheaper therapy before they get access to a certain product. And what we’re seeing in the data most clearly is a steady tightening of coverage in oncology. So, the share of oncology therapies with some form of utilization management increased from about 18% in 2017 to roughly 38% in 2025. And we think it’s going to increase to about 40% to put numbers on it. And I know a real strong prediction here for in 2026. And a little bit more color in that. I think what will be driving this primarily is step therapy. So, requirements for patients to feel an alternative therapy before they’ve access to a certain oncolytic care. And I think that because step requirements in oncology rose from about 6% of therapies in 2017 to roughly 26% in 2025. Now that’s driven by a lot of things. Biosimilars is a big driver of this, of course. Also, a driver of this, or small molecule oncology therapies go in generic. So, this is a good thing. But we’re seeing also steps through alternative brands within a particular indication as we’ll get to. So, I talked about these subcategories, and I think there’s three of those that I’d like to maybe touch on here. The first would be very high-cost therapies. So maybe no shock to you here. So, think about here CAR-T therapies and also combination immunotherapies. So those where budget impact is a particular concern for payers. The second, and I’ve alluded to this already, is where there’s substitutable options. So, of course, biosimilars, generics, but also these competing branded therapies. So, while this has historically been common in non-oncology categories, so, I’m sure you’re listening to very familiar, like rheumatoid arthritis, psoriasis, MS, step therapy has always been a big factor here in terms of access and variation across payors, but it’s increasingly showing up in oncology. And I think that is a very notable shift. The third, and sort of this is more like a timely thing in a way, is this IV, the subcutaneous transitions, which is, you know, a very, it’s an advancement for patients for sure, but it does provide some challenges for payors now. So, an example would be said Opdivo Qvantig, if that’s right where to pronounce it. So, where you have an IV therapy and then a newer formulation of the same therapy but it’s subcutaneous. Now this raises questions about site of care for payers and also the price for payers. These are sometimes more costly for payers but for patients they’re very important because they big advantages in terms of convenience and the word convenience maybe downplays it in fact.
Mel Whittington: Yeah, the new formulations are an interesting one as we are beginning to see Sub-Q replacing some things. And I know this specific episode of the podcast isn’t about health economics or outcomes research, but I think that is where health economics and outcomes research can be so important for innovators and investors in thinking about what are patient preferences for these different types of formulations and treatment process attributes. And there could be a little bit of a disconnect there between payors and patient preferences.
James Chambers, PhD, MPharm: It is a very important little case study, if nothing else, putting on my researcher hat. These subcutaneous therapies for patients, quicker to administer, they acquire less time in clinics and greater convenience and flexibility of where they would even go to get the therapy in the first place. And so, for patients looking at these therapies, and there’s a great New York Times article about it not so long ago, it means less disruption to daily life and a lower treatment burden. You know, this is important. But for payors who have to pay for these things, the subcutaneous formulations would raise concerns about the shifting sites where patients would receive care and like I say, those higher prices. And we’ve been tracking some of these for a long time now. So, we’ve seen this play out for Rituximab and Trastuzumab. So that’s Rituxan, Hysingla and Herceptin Hylecta. And the payors are covering those only for patients who have failed typically the IV formulation or importantly the biosimilar. So those are, yeah, it’s very interesting. So, you have examples there where there are biosimilars. Now why it’s so important to monitor going forward is because of the Keytruda and the Opdivo subcutaneous forms on the horizon where there’s no biosimilars. So, a very interesting case study where it’s not such a strong economic argument where the biosimilars do exist. So how do plans prioritize these things? I think it would be enlightening.
Mel Whittington: Sounds like a future spec research project.
James Chambers, PhD, MPharm: I can tell you all about that in 2027 when you invite me back.
Mel Whittington: You’ll have to come back. Absolutely. So, what about conditions outside of oncology? hear prediction one and uptick in utilization management within oncology. Has there been this increase in utilization management from 2017 to 2025 outside of oncology?
James Chambers, PhD, MPharm: Yes, absolutely. there’s a broader trend here across several non-oncology areas. If you think about autoimmune diseases and any high-cost therapeutic category, we are seeing an increase. We’re actually working on a project right now that’s quantifying not just the increased restrictiveness, but the increased complexity of the policies. So, we talk about administrative burden, something I haven’t mentioned. We’re seeing policies becoming much longer with many more criteria, with more baseline testing requirements. Now, often there’s multiple documents all in the form of the same decision. So, these policies have become more complex and more restrictive over time in general. A couple of things to highlight here. One area we’re watching especially closely is rare disease. So historically, just like it’s been for oncology, payors have been more cautious about imposing utilization management for rare diseases. But we are seeing a change here, an increased use of utilization management for what’s referred to as orphan products. And the core challenge for payors for orphan therapies is cost. So, while each rare disease therapy treats a small number of patients, you know roughly half of the products approved by the FDA now, just over 50% in 2025, are orphan drugs. And it’s the cumulative budget impacts of these therapies that’s the challenge. And this is again, something very important to watch because oftentimes these are extremely important therapies for patients. You’re seeing therapies approved that are the first in class or first indicated for that disease. So, this is the one and only shot the patient has. And historically, like I said, payors have not limited access to them in a meaningful way, but we’re beginning to see that. So, we hope to do some research in that this year to really quantify the trend there for rare disease. Because I think it speaks to broader challenges and exactly what payors are facing in terms of the change and the nature of innovation over time and so on.
Mel Whittington: Right. And it also speaks to the innovation that’s being approved and we’re getting is filling these unmet needs. But we need to make sure the incentives exist and patients,
James Chambers, PhD, MPharm: Yeah, and it reflects science, doesn’t it? We know much better understand genetics and the human genome and better be able to target treatments to smaller and smaller populations. We don’t really see any more a cancer therapy being approved for non-small cell lung cancer, but it’s non-small cell lung cancer with at least one mutation. So, is this greater targeting means smaller patient populations, which means higher prices, of course, has to be a higher price, of course, if you’re going to treat fewer patients. So, but hopefully more effective treatments. And I know you’ve spoken a lot about this in prior podcasts about the intersection of incentives for innovation and cost effectiveness and access, but these payor policies are almost like a revealed preference tool for these things, you know.
Mel Whittington: Right. Yes, absolutely. And that’s what I think it’s so cool is like you have real world data. This isn’t, you’re not forecasting these things, you’re using real world evidence and then making some predictions going forward. I do want to switch to prediction two and that is related to novel therapies because we’ve already been talking about these novel therapies that are being approved. John O’Brien was on the podcast last episode, and he was talking about how like the things that are being approved today would have been like science fiction when he was in pharmacy school 30 years ago. So, we have these novel therapies. And I think your prediction too was that they will have restrictions that align more closely with the clinical trial population. Can you expand on that? And again, tell us a little bit about the data from SPEC that you’ve been watching over the years.
James Chambers, PhD, MPharm: Yeah, well, consistently what we see in SPEC is that plans impose restrictions on newly approved therapies. So, whenever these therapies are first approved, plans tend to add restrictions, but over time would relax some of those restrictions. It tends to be the path. Increasingly so, those restrictions mirror the eligibility criteria used in the pivotal trials. So, things like disease severity thresholds, what treatments the patient previously received, and biomarker status, that sort of thing. And that does make sense from a payor perspective in some ways. So, for novel therapies, where’s the strongest evidence? Well, the strongest evidence comes from the trial populations so particularly for expensive therapies, plans tend to anchor coverage decisions to where the evidence is most certain. And from an access standpoint, this means that while most novel therapies are covered, real world uptake can be more limited than what that FDA approved label might suggest, especially for those patients that fall outside the trial criteria. And I think that this is something important to quantify because it does suggest increasingly that when a product manufacturer is designing the clinical trial, meeting the needs or the FDA’s needs is still a priority, of course. But let’s not forget the payors here, because the payors are increasingly scrutinizing that clinical trial population and oftentimes limiting access in a way that reflects that.
Mel Whittington: And if some of those payor coverage decisions are informed based on that population in the trial, then the population in trial, not only important for regulatory approval, but also for those payor negotiations and coverage. So how common is it for plans to restrict beyond FDA labeling? So, say we get a new drug, it comes to market, the clinical trial was in a population, and then the FDA label is a little bit different. How common is it then for plans to restrict beyond the FDA label?
James Chambers, PhD, MPharm: So, we track, it’s just over 15,000 coverage policies at any time point in SPEC at the moment. And it’s going up over time.
Mel Whittington: That’s an impressive number.
James Chambers, PhD, MPharm: I know, again, it’s one of those numbers you said I’d lied to go, my goodness. So 60, I just checked before I spoke to you. 61% of those decisions include some form of utilization management beyond the FDA approved use. That’s important is that unlike other countries that often would say, no, we’re not going to cover this drug. US payers rarely do that. They do so in certain instances, some famous examples. But typically, they provide some degree of access. But what we have found in our data is it’s often highly restricted.
Mel Whittington: It might be covered but not covered well.
James Chambers, PhD, MPharm: It’s like covered. Yeah. Do you cover? Yes, but. And it’s but that we’re really trying to really get at here.
Mel Whittington: That’s fair. So still going on this theme of restricting beyond the FDA labeling, I recently read a JAMA research letter that you wrote related to cell and gene therapy. And, you know, there’s some new news going on about cell and gene therapy. What did you find for cell and gene therapy? And what implications does this have for accessing cell and gene therapies?
James Chambers, PhD, MPharm: Yeah, you talked about science fiction technologies, I mean, like the cell and gene therapies. You know, these wonderful technologies with such great promise, but come with such a high price tag and, you know, it’s impossible to have the long-term evidence and so on. So, we felt there was a good quorum available, and we could perform this analysis. So, this was, as you said, was the JAMA research letter late last year. And we find that 52% of coverage policies for these cell and gene therapies, so all CAR-T therapies, all the cell therapies and gene therapies included some form of restriction beyond that FDA approved use, although there was wide variation across payors. So, this is an example where who your insurer is really does matter as well, I have to say. The restrictions as you would probably guess, given the lack of substitutable products for gene therapies, were primarily these clinical eligibility criteria. So, these patients subgroup restrictions rather than step therapy. And importantly, about 60% aligned closely with the pivotal trial populations.
Mel Whittington: Okay. So that’s very kind of aligned with prediction too that there could be some coverage restrictions to the clinical trial population. And I’ve seen you make this point publicly of when we’re thinking about maybe potentially increased regulatory flexibility in cell and gene therapies that’s not the only thing that matters for access but thinking about these coverage policies as well.
James Chambers, PhD, MPharm: Absolutely. I think the payers really matter here. Now, selling gene therapies, of course, have a plethora of challenges. The US system is maybe not, not really an expert in this area, but it’s not really, it’s not built for a gene therapy where patients can switch between plans and one plan pays for the therapy, but then the patient leaves to another plan. That’s not the case in a single payor system like the NHS in England, where you could see an argument for the health system to invest in cystic fibrosis gene therapy to cure the patient because the patient is guaranteed to stay in the healthcare system for the patient’s life. So, there’s lots of challenges and not to say that the payor challenge is in any way the biggest one, but what we found was the variation in decision-making criteria that I think has real implications for patients too.
Mel Whittington: Absolutely. Okay, now thinking about prediction number three, biosimilars. I love talking about biosimilars, generics, life cycle of drugs. Prediction number three, I believe, was that new biosimilars will be embraced by plans. So, tell us a little bit more about the biosimilars you have in SPEC and how this has changed over time.
James Chambers, PhD, MPharm: Yeah, it’s a really interesting area, of course. So, in SPEC, we track coverage policies for all FDA approved biosimilars and of course their originator products. And it’s been interesting to see how plans have positioned those relative to each other over time. Now what the data show is a clear shift in pair behavior. So back in 2017, biosimilars with a preferred option over the originator product only 15% of the time. So only 15% of the time did a plan say to the prescriber, you must use the biosimilar before you can prescribe the originator product. And then for the same 2017, originators were the preferred more than half the time. So today, that’s flipped. So, biosimilars are now preferred in roughly 45% of cases. And the originator products are preferred in just 6% of coverage policies. So, plans have really embraced biosimilars in terms of prioritizing patients access to the biosimilar. So, my prediction here is really twofold. One is the plans will move more quickly to designate new biosimilars as preferred options compared to what they have done in the past. So, this faster placing that biosimilar as the preferred treatment.
Mel Whittington: And so, you’re saying when a biosimilar gets approved, entered the market, there will be a kind of move to make that preferred by the payors.
James Chambers, PhD, MPharm: Yes, it’s hard to tell from the data, of course, but it’s almost as if plans are preparing for their introduction in many cases because the switch is immediate. Previously, there was a lag like you would see for maybe a brand-new product. The second part of this, think, and this is one of the purposes of biosimilars in general, that plans will expand the number of preferred choices. So, this allows patients to choose between either the originator or the biosimilar. And this is something we’ve seen with Humira. So Humira is still predominantly the preferred choice for Adalimumab, but the originator is. But almost all plans now have at least one biosimilar alongside that. So, providing patients with options. it’s not that they’re patients just towards the, so patients and providers have more choice.
Mel Whittington: They have more choice. Got it. So even when they don’t specify that either biosimilar or the originator is preferred, there is this option of we won’t state a preference, and you can choose between those.
James Chambers, PhD, MPharm: Yeah, and historically plans, at least anecdotally it seems to me that this is their preferred drug. But we’re seeing a few more options, particularly for the classes affected by biosimilars.
Mel Whittington: Moving it from originator preferred to choice. Interesting. So, what are some biosimilar launches you’re expecting in 2026?
James Chambers, PhD, MPharm: So, for those who follow this space, a few exciting ones. mean, there’ll be more Stelara biosimilars early 2026, which is important, very important therapy. And Eylea for retinal eye disease around mid-year, which is important and also a very interesting example for researchers out there, you know, with the off-label use of Bevacizumab in the retinal eye space with biosimilars and more brands. And also, products like Xolair and Denosumab later on this year. So, these are all high spend categories. And I think these will matter a lot for access and competition. And our work, as you may know, has really shown that not only are these biosimilars become preferred access, they’re driving down the price. It really does prove, at least for these categories, the competition has worked.
Mel Whittington: Competition has worked. Sometimes it takes time, but if there can be some policies in place to increase how quickly those prices drop after that patent protected period of time when we have competition, I think that’s what the biotech social contract is supposed to do.
James Chambers, PhD, MPharm: Yeah, absolutely. Yeah, we’ve seen it and I need to go back to look at the studies itself, think about after three years, biosimilars tend to have 50% market share or more. So that’s important, very important.
Mel Whittington: Very important. I think that the most exciting part about price drops, obviously the economy likes lower prices. But it’s also, then it frees up that healthcare money for those novel interventions. Going back to your prediction number two, if we have novel therapies that keep coming onto in the market, which is amazing. And we want to continue to incentivize that. And we want to have money to be able to use for those.
James Chambers, PhD, MPharm: Yeah, absolutely. I do think there’s a risk out there and again, I’m maybe not the person to talk about it specifically, but incentives in the IRA and you want to make sure that the incentives exist for biosimilar development moving forward. I think that’s key. Yeah, all these policies should complement each other and not diminish each other.
Mel Whittington: Absolutely, and that is one thing. With the certain federal health policies we’ve seen, I think we’ve started to see what impact does this have on branded drug spending, what could this have on incentives for innovation. But the piece that you’re bringing up, how does this impact biosimilar entry, small molecule generic entry? I haven’t seen a ton of research around that, so I think that’s something to keep an eye out. I did see your recent paper and team.
James Chambers, PhD, MPharm: One other thing just in biosimilar is, which I think is important is that the driving down the price of these biologics can be a very good thing for patients in not just a cost perspective. So, ICER in Boston and the clinical guidelines have both recommended that biologics be used as first line in psoriasis, say. We found in our data plans almost always impose steps before you get biologics. Your emollients, your phototherapy and so on. But now we have biosimilars driving down the price of the biologics. Maybe what happens is a real tangible shift in the stage at which patients can benefit from these therapies, which hopefully we’ll be able to quantify in the future.
Mel Whittington: Sure. It always makes me think too, if we didn’t have incentives for the originator biologic, if the incentives weren’t adequate for that originator biologic to do all of the clinical trials to enter the market, then we wouldn’t ever have the biosimilars. And so, it brings us back to incentives for innovation and the life cycle of the drug of eventually those patents are intended to expire and competition is intended to enter, and the price is intended to drop. Well, James, thank you so much for coming on the podcast. You’ve created this fascinating database that makes your production your predictions that you shared with us based on real world evidence. So, I think that’s really cool and a unique perspective that you bring. And I appreciate you coming on the podcast to provide us with these and provide insight on not only how peer decisions are made, but where they might be heading. And so related to that, can SPEC be used or has it been used to think about the access landscape for pipeline products. I know we’ve talked about products already in the market, but has it been used for pipeline products? And the only reason I ask is because I imagine it could give an idea of the forces that could impact product uptake, which is important for my world of health economics and budget impact modeling, but also models that are traditionally used on the financial services side, like discounted cash flow models or net present value models where uptake and population size is really important. So, are there any uses for that?
James Chambers, PhD, MPharm: It’s a good, very good question because when I first started doing this, I imagined that it would be used for existing products for people to understand and consistent access. But it seems that a lot of the users of the data are using it for pipeline products. And the reason is, is I think it provides a very quick way to identify analogous products and to examine coverage policies for those products have evolved over time. And those are similar clinical in market contacts and you know that includes how coverage changes when new competitors enter and clinical when clinical guidelines are updated and even when organizations like I serve issued a new technology assessment like what affects it so like you know how would the market change when this new product is approved? And so, for pipeline products, you know I think it makes SPEC particularly useful for anticipating how plans may structure access at lunch and how those requirements would relax over time and it helps translate the historical power behavior, at least I would argue, into more realistic expectations about what future access and uptake might look like.
Mel Whittington: Absolutely. Well, yeah, it seems like historical market analogs are used so commonly to make these, try to inform some assumptions around pipeline products that, you know, the nine years of data you have in SPEC could be a good resource to use.
James Chambers, PhD, MPharm: Yeah, I mean, just one deficiency that we have here is we’ve done a really good job, I would argue, to really understanding the pair criteria. We need to do a better job at understanding the impact of those criteria.
Mel Whittington: On utilization or?
James Chambers, PhD, MPharm: On health outcomes, hopefully, yeah, but first utilization. So, if there’s difference in step criteria, how did that actually impact what patients had access to it and then ultimately, outcomes, you know, did you see faster access, the better outcomes or worse access led to worse outcomes. So that is in terms of a research agenda. I think that’s a very important next step for us.
Mel Whittington: Absolutely. Well, before I let you go, how do you access SPEC? Is it something that you subscribe to or is it not available for public?
James Chambers, PhD, MPharm: Access is limited to the sponsors of a research center. So, the Center for the Evaluation of Voluntary Risk in Health here at Tufts. Sponsors can access our online platform, and they can dig around the data to their heart’s content there. We do collaborate a lot with sponsors and researchers on this. So, if anybody does have interest in the data, please feel free to reach out. We’re always interested in talking about how this data could be better used. But predominantly it’s through sponsorship of our research center which I’d love to make it publicly available. Maybe someday there’ll be a publicly available version and trying to keep this thing going. That’s how it is at the moment.
Mel Whittington: I love it. I love it. Well, thank you for coming on the podcast. The insights that you share again, I think are so neat because they’re data driven and really can be part of this roadmap for anyone trying to bring innovation to market in a system that’s becoming more demanding, more data driven, and of course, more cost conscious by the day.
James Chambers, PhD, MPharm: Great, well, thank you very much for having me.
Mel Whittington: Okay, I’ll talk to you soon.
Thank you for listening to this episode of Perspectives. If you’re interested in participating in future podcasts or would like to learn more about the Leerink Center for Pharmacoeconomics, please email cpe@medacorp.com.
