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S2.E8: Show me the Money!

38m 46s

S2.E8: Show me the Money!

Drug pricing in the pharmaceutical industry has become a central and contentious issue, driven by soaring costs and a growing number of high-priced therapies—especially in rare diseases and gene therapies. The global market, valued at over $1.6 trillion, sees spending in Canada alone at $35 billion annually, with a troubling trend of prices outpacing inflation and budget growth. Companies now initiate value assessments early in drug development, focusing on transformative rather than incremental innovations. Meanwhile, payers—both public and private—are increasingly evaluating drugs through cost-effectiveness and long-term health outcomes, though they face significant challenges in defining value due to system limitations and data gaps. Private payers often rely on public payer models, which may not reflect private sector realities such as disability avoidance or patient-specific outcomes. Despite improvements in drug efficacy and safety, the financial burden of high-cost therapies continues to expand, with projections suggesting half of all drug spending could be in the high-cost category by 2026. A deeper structural issue lies in the disconnect between the payer and the patient, where decisions are made by third parties without full alignment with patient needs. This raises urgent questions about equitable access, especially for low- and middle-income countries, where innovation may be prioritized for rare diseases at the expense of basic healthcare. Ultimately, balancing innovation with affordability requires not just better pricing models, but systemic reforms—such as improved data sharing, cross-sector collaboration, and global policy solutions—to ensure that life-saving therapies are accessible and sustainable for all.

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[MUSIC] >> From the University of Toronto's Leslie Dan Faculty of Pharmacy. This is the I'm Pharmacy Podcast. I'm Minotadros. We've explored many aspects of the drug life cycle this season. And just like any good party or meal, at the end comes the tab. So on that note, this episode we explore topic that over the last decade has received a tremendous amount of attention, drug prices. Let me set the scene. The global pharmaceutical market is expected to grow to $1.6 trillion this year. In Canada alone, we spend close to $35 billion a year on prescription drugs. This is big money, in big pharma. But there are thousands of drugs, and what is most concerning to people like me that study this sector is the fact that budgets and spending growth is outpacing inflation. Wow, before COVID inflation. Central to that is the increasing price tag of individual drugs. To set this scene, let's play my favorite game. Let's play the game name that price. Alright, so as you're listening here, I'm gonna tell you a drug, and you're gonna tell me how much you think it costs. Yeah, you're probably talking into your phone or yelling into your speakers, but let's just play along here for a second. So drug one, drug one is a generic cholesterol drug, maybe a statin. How much does that cost a year? Right, if you guessed around $100 a year, you were right. Drug two, this is a new, anti-depressant, brand name, no generic options. How much do you think it costs a year? This comes in at around $1,000 a year. Now drug three, drug three is a new biologic therapy, has no biosimilaries or any generics of any form, and it helps treat psoriasis. How much do you think it costs? Well, if you guessed 35,000 a year, you were spot on. And the last and final round, drug four, drug four is a new gene therapy for rare diseases. Well, this is where the price tags get crazy. Some of these therapies can cost anywhere from $370,000 to close to $2 million a year. And there's more and more of these drugs coming. So as you can see, prices vary. But the most alarming thing is the number of drugs coming in at these high price tags, and it's growing. According to the patented medicine prices review board, a part of the government that monitors and regulates pricing, the number of drugs that cost more than $10,000 per year, which is deemed a high cost drug, has tripled since 2006. And every year, the number of these drugs goes up and up. But these drugs are more and more for rare diseases. Some are even curative. We are getting some amazing innovations. How and what price do we pay for them? So that's what we want to explore today. How do we determine prices? What is a fair price? And lastly, what is the value of a drug? To better understand how companies price drugs, I spoke with Dr. Amin Sheet, a vice president at Santa Fe, an assistant professor at the Leslie Dan Faculty of Pharmacy. Throughout this season, we've learned about the life of a drug. So from your perspective, when they start thinking about pricing, from internally from the company, how early are your teams and your units involved? Like, are you involved at the RCT level? Is it earlier than that when they're thinking about their price and developing these strategies? And then walk us through. How does a company think about think about pricing? Yeah, today in today's world, it starts at the bench side. Yeah, because if you're, you know, for instance, let's take the example of a primary care drug, like diabetes. Let's look at insulin. Okay, that's an easy one for the pharmacy crowd, right? So if the bench side comes to me and says, oh, we have a new insulin molecule, we think it's going to be pretty interesting to develop as a new drug. Well, the first question I'm going to ask is, okay, with insulin though, with the current molecule, we stabilize, it sees pretty well, how are you going to really improve things? So if they, if they struggle to give you a story as how it's going to reduce costs to the healthcare system, you know, that molecule is probably not going to move forward. So we're really looking forward these days to sort of working on medicines where when you look at it on the bench side, there was already the potential to change the trajectory of care for a particular disease. There is less appetite for these incremental innovations, if you like, because the health systems have indicated pretty clearly that they're not looking for incremental innovation. They're looking for stepwise innovation. So when did that shift happen in your sense? Because you know, I think when I think back to like the early 2000s, late 90s, there was lots of incremental, you know, you had a new arb and a new ace and there was like 15 of them. And I just couldn't like, why did the companies must have thought it was profitable to enter these marketplaces that they kept investing? Like, but there's been a shift, right? Like now we're starting to see more and more innovation. Is that for, because we've started to, you know, as payers force them to think about value? Well, you know, it's a, it's a function of what the market, you know, companies will behave in a way that sort of caters to their customer, if you like. Here are the customers, the healthcare system. So at the beginning, like, you know, if you think about the 80s, which gave you all the drugs that you see in the late 90s. So at the time in the 80s, when you're doing assessments, you had a lot of these primary care diseases with no medical solutions. Yeah. So it was like diet and exercise and good advice back then, right? So it was, so at the time, it was kind of very fertile for, for, like, you know, and also if you think about society at the time, really in the 70s and the 80s, the regulators just for safety and efficacy was taking full hold. You know, time people telling the industry, listen, you need to cross a safety and efficacy threshold. You need to have a good risk benefit value before we can talk about you. So then we've got those regulations. So you now, you're not getting drugs, I mean, every now and then there's a safety problem with the drug, okay? And every now and then there's an extra efficacy story to a drug. But, you know, we have a pretty good regulatory system. And then the, you know, society evolves and says, okay, hold on, hold on a second. I understand that this has a positive risk benefit ratio, or you wouldn't be here. But is it really worth the money? And that sort of society's position on those points involved in this time period in the 90s, you know? And then by the, by the early 2000s, there was a tension now because there were drug decisions that were made before the system. Yeah. But like, what the hell? Why did you change everything? And it was like, okay, but now by today, I think we're not going to invest in developing a drug where we don't think it has the potential to add very good value for money on top of it being an incremental innovation. Yeah. So, so you have someone from the Ben side who proposes something. So you guys are involved that early in thinking about, you know, are you having conversations about the price and what the market can bear? Or is that more like, oh, this is worthwhile to invest in potentially? Yeah. Well, it's exactly that because, you know, you need to get some clinical data before you can have a sense of, but, you know, you need to see, and you start with the basic basic things, you know, is it going to impact the biomarker in a positive way? Once you get that phase one, two data in, that's when you start to sort of do some forecasting models. It's sort of what's an appropriate price given the size of the innovation week, the impact that this can have on health. But certainly, we're not starting something if we think the epidemiology of the disease is under control. And we're not going to invest if we think that the technology itself theoretically doesn't, you know, give a promise to changing disease trajectories. Yeah. So there's a lot of, a lot of news articles that are coming out about, you know, more on how prices keep going up. Now, I want to be clear, like, this is not, you know, this is before this whole inflation thing. It's not that this, it's like every time a new drug comes out when you take the average of new drugs, it feels like the new price benchmark is going up. Why, why do you think that that's happening? So the returns to industry on drugs are very unstable. So we end up happening is, so first of all, there's this sort of, it's a very skewed distribution of drug returns. So the first thing is that every 10 drugs you try, one will get regular to regular level. Okay. And then, but every 10 drugs that get regular to approval, almost one will make you any real money. So you have a very heavy burden on that usually one drug to sustain the whole R&D engine. Walk me through that because you have to, so like, we've talked talked about the failure rates in the clinical trial process. But now you have 10 drugs that have received regulatory approval. And you set the price. How do you lose money? Well, you lose money because, for instance, you don't get a recommendation for its utilization. The people say, I don't know. This doesn't fit very well, or it's too expensive. Or, you know, and when you're pricing, the first thing that you have to do is you have to at least recoup your cost of goods. Yeah, that's kind of like the bare minimum. But sometimes, you know, you get to market and let's say at the face to the efficacy trial, you're hoping for a treatment effect of 60% and you get 20. And then all of a sudden, you can't even price it to recoup your cost of goods. The other thing that happens is sometimes for things that do work as you start to do more indications on them, or you start to sort of look at its impact on other outcomes, you start to realize that there's more value to be had. Now, because of this dynamic that I explained, that when a drug, like think about the big drugs out there. You know, like think about the humera, or a pharmacate, or some of these anti-inflammatory drugs that sort of have spiraled into multiple indication drugs, you know? So that drug and its success almost has to carry the full innovation agenda of the firm. So that's kind of the things that people try to balance out. You need that, you need this. So if you're inside a company, you're looking at two things. First thing is, does it even cover the cost of goods? Because if it doesn't, the drug is dead, right? And then the other thing that you're looking at for your portfolio is can I generate enough money to actually pay for any, okay? And those are the two tensions that then will impact the drug pricing decision. Because if you say to me that my revenues are not gonna be big enough to, or my profit margin multiplied by my revenues, won't leave enough money on the table that I can invest in R&D, then I need to play with something. I need to change something. So then the question goes, okay, so which drugs would we have room to increase the price on? And then you'll be like, okay, this drug here is undervalued. And then there'll be a healthy discussion as can we raise the price on this drug? And then that becomes really complex discussion too. Because, okay, if I do that, am I gonna interrupt access? How would the payer react? What about competition with a competitor come in and then sweep the market? So it becomes a rich discussion around that. But it's generally driven by sort of these type of forces. - Yeah. (gentle music) - To explore how payers think about value, I spoke with Dr. Ned Zed, Boy Skitch, a vice president at Green Shield Canada, and lecturer at the Leslie Dan Faculty of Pharmacy. So let's talk about the drug comes on board, new drug, just approved by health Canada. How does that come across your desk? What's the process here? And then how do you decide what you're gonna pay for and what you're not going to? - Yeah, so I'll talk from a Green Shield perspective, though there are different models in terms of how that drug, that drug journey in the private payer space. So again, it's not different than from the public perspective. As a drug is approved, the manufacturers make submissions to private payers much like they do to Canada, much like they do to provincial government. And the submission will have all the clinical information, all the clinical trials, et cetera, safety efficacy, cost effectiveness, all those kinds of elements. And then each private payer has a slightly different pathway. So for certain private payers, they rely on what are called PBM, so pharmacy benefit managers, organizations that are specialized in this space in looking at reviewing drug therapies, managing formularies, et cetera. So the two that are most well known are tell us health and express scripts Canada, they combined cover really the majority of the private payer space. Here in Green Shield, we are both a PBM and insurer, so we do everything kind of in-house. So we have a clinical team, seven, eight pharmacists, and specific expertise we reach out to physicians and others, but the drug, yeah, as the drug is approved, the submission is made by the manufacturer, it reaches us, then we take it up from there. And we do our own standard review, our own clinical assessment. And then we make a decision around whether the drug has value for our populations, for plant sponsors and the patients that they cover. - So do you have a, is that idea of like assessing value, challenging, is there a certain lens or a line that you guys draw consistently, or do you find that it's a drug-by-drug kind of conversation? - So yeah, it's, I think that private payers have generally focused on the efficacy side of the equation historically, right? Because the question was really more, you know, that's what we were centered, that's what our mindset was around, does the drug work, as is intended to work, does it work in terms of producing a clinical outcome? How does it compare to other drugs that are already on our formulas, et cetera? I think over the last decade, private payers have gotten a little bit more sophisticated, and now we're looking at more than just, you know, what did the clinical trials show in terms of clinical safety and efficacy? Now we're looking at cost effectiveness to a much larger, than we did historically. And I think that's just because the, you know, with the sort of prevalence of high cost drugs, and the price tags and rare disease drugs, et cetera, that some of those come with, some of the decisions that have to be made now are a little bit more, you know, we have to make some harder decisions around. Can we really cover everything? Can employers continue to sustain that level of funding for drugs indefinitely? And so, you know, you get some new financial innovation models in there and new insurance models, et cetera, to help them afford that. But at the end of the day, I mean, it's still the employers who are funding, and I'm, you know, underwriting that entire cost. So, we as private payers now have to make, you know, more challenging decisions on their behalf, right, in terms of what can we cover? And that's where we started to get, you know, started to get more, a little bit more sophisticated around concepts like pharmaceutical economics, and elements around, you know, the, what is the value of the drug therapy? Beyond simply, yeah, does it achieve the clinical outcome? Is it cost effective? You know, how does it compare to other drug therapies? And then, you know, making our formulae decisions on kind of a more holistic assessment of all those factors to get at that value equation. - So, do you, do you find that like, so I guess taking a step back? So, one of the challenging things that we've picked up on about value is whose value? And so, as a payer whose, you know, you know, the employer is picking up the tab and you, you know, they're paying you, but at the same time, in the end of the day, it's the drug is for a patient. So, how do you, how do you sort of balance all of those on whose value you take into account? - And that's where I arguably, I think there's still a little bit of a dilemma, I'll say, on it from a private payer perspective, partly because a lot of the value equations are focused on the public payer, right? Avoidance of hospitalizations, you know, avoidance of physician visits, et cetera, that create the value for why you might want to pay for a particular drug. That doesn't translate very neatly in a private payer space, where we don't pay for some of those things. It's the public system that funds that. But if you narrow the value equation to purely the things that a private payer might care for, it's gonna be very challenging, quite frankly, to arrive. You would end up not listing most drugs, right? Especially high cost drugs, because how would you possibly arrive at an equation that might prove cost effectiveness purely from a private payer lens? So we do adopt, like we're, you know, we're encouraging from Silicon manufacturers to consider the elements that are important to private payers, whether it's, for example, disability avoidance or things like that. But we're very much in infancy having the data to be able to showcase, show some of those things. So we're continuing to still, I'd say to a large degree, still rely on models that have primarily have the public payer as the kind of value equation lens, right? But I think the other development that has occurred over the last decade-ish is more private payers engaging in price negotiations from Silicon manufacturers to arrive at prices that may be more reasonable than the official list price of some of these medications. - So you're in an interesting space because you get to watch as things end to the market, and you kind of have like, your part of your role sounds like having the pulse of what's going on. So it's a nice capstone to this whole, you know, season where we've been exploring the life of drugs. So where have you seen the trends going with drugs that are coming on your desk? Like where, what's the direction things are going? And maybe a specific lens on as prices have gone up, which is well documented. Are you seeing better value like as these new innovations come or is it just prices go up and the value stays the same? - No, I mean, I think that that's the part of the piece that isn't often acknowledged by public or private payers, is that we're definitely getting better efficacy, right? So, you know, the drugs coming down do have significantly better either safety profiles, better tolerability, or quite frankly, just better efficacy, right? You look at, you know, categories like treatment of psoriasis, you know, where you're now having biologics that have, you know, efficacy to clear up psoriasis. to degree, which we never even thought of possible historically, right, for second generation, third generation, biologic. So there's no question that I think we're getting, I'm just going to use more colloquially, better drugs, right? No question. Where the trend is going, unfortunately, is sort of just more and more high-cost drugs. And when I define high-cost, it's more, really, about 10,000 or more per patient per year. That's a generally agreed upon definition of high-cost, right? And that seems to be growing prevalent. So I think there's some projections that suggest that, at least in a private peer space, we will reach about 50% of all drug costs are going to be high-cost drugs by about 2026 at the current trajectory. So that's challenging, right? That means we're now literally half of all spending is in high-cost category. When that percentage was only, you know, probably about 20, low 20s, about a few years ago. So rapid, rapid growth in the high-cost segment of the market. Yeah. So as the pie gets bigger, because, you know, you're not removing things. I think this is one of the, like, are these new treatments helping reduce costs in other spaces, or is it kind of just adding up and the pie continues to get larger? You know, that, I guess that's that's what all those pharmacoeconomic models argue is avoidance of all these other healthcare system costs. You know, you do work in the space, so you know better than me, like in terms of whether that is indeed proven by looking at administrative claims data. I, you know, I think you could take some classic cases like hepatitis C and argue that that has, that does work. I mean, that any reasonable person would argue a patient getting cured of hepatitis and not having liver cirrhosis and all the subsequent complications of that should be a pretty slammed-down case for the efficacy, the value of those particular drugs, right? But I'm not sure that the hepatitis example can be extrapolated so neatly to every single drug. Having said that, I mean, you know, certainly, like, I think that the platform, the platform should develop, whether it be biologics and now gene therapies are producing some pretty incredible efficacy, right? And I think that to some degree, at least, we have to be flexible and open to the idea that drug budgets may have to grow if they are indeed, you know, reducing budgets in other parts of the healthcare system, at least notionally, right? That's something that we, I can get behind, though I'm not sure I've seen consistent data to indicate that. Well, like in the, you know, the joke I make in the public sector is that we can show that a drug is cost-effective and reduce hospitalizations, but in the end of the day, the decisions are budget-based. How big that budget's going to go, because you can't go to the hospital and say, well, I saved you three hospitalizations. Can you send me the money for that? Because the budgets are siloed. And honestly, I, you know, tongue in cheek a little bit, I think like many of healthcare's problems are accounting. I feel like it's really to save the healthcare system. We need better accounting models, and global budgets is one of those solutions that people have proposed. But yeah, I don't know, I really struggle with how we keep making these arguments and like they feel very academic, even though we're making tangible decisions on them, because we don't, we don't shift things. And healthcare's sort of notorious for, and I'm sure you see this with the drugs, we just add things on. So a new innovation comes, doesn't replace the old one, it just gets added on rather than replacing and moving along. So I think it's, it's a little bit tough to, to try to imagine a situation where the budget doesn't, you know, maybe at least plateau or something. It isn't just about prices. It's also about how we pay for things and how we budget. To explore budgets, here's Aimen again. So I mean, I understand that healthcare is a big part of national agenda, right? But here's something for people to ponder, you know, we quantify with excruciating detail what cost effectiveness, cost benefit thresholds need to be, and we limited to what, what, what, what, what music, economist jargon for you, but in a, almost in a, in a, in a bit of a shorter view. So it's like for the patient that took it today, what's the exact value today? You know, and so there are, there's, and we do it in excruciating detail. So two things that don't happen there, okay? That happen in other sectors. What's the longer term benefit of this innovation and the overall incentives to the field? Also, with the excruciating amount of specificity that you put in, do you remove sort of this kind of other social factors that get considered? So now give me contrast. Should we invest in aid to Ukraine? Should we invest in building new highways? Should we expand Pearson Airport? Should we give the University of Toronto a new faculty month? So there's a lot of decisions that govern, all these are government, right? And, and there there are not the, the dynamic is much looser in terms of decision-making on some of those things. So that's another point that I've always found intellectually very interesting, sort of the level of detail and the short-term view that's taken sometimes on drug pricing. It's not there for a lot of other purchases. Yeah, it's an interesting thing because I've thought about it too, like, you know, I think the HTA models, the health technology assessment models around drugs are leading, right? And we don't do that same screw, like if you just limit it, like I like your examples, but if you just limit it to even healthcare, we don't do that for annual visits for going, you know, like what, you know, we don't really put it through the same kind of squeezing it out for the, and I think it's because it's much easier to negotiate for a product, like a thing than it is to negotiate how much you pay an individual. Because most of healthcare is a service versus drugs is a product and it becomes an interesting dynamic. Also, you know, interest, you know, one thing I always kind of talk about is price is different when the person who's using something is not the person paying it. I always try to contrast it to like if you went out for dinner knowing that someone else is picking up the tab, do you order differently? And I think the same is true when you know someone else is picking up the tab, like it's an interesting thing, like you're negotiating with a payer, but that payer's not using that medication, right? They're giving it to beneficiaries who are patients. And so there's this weird dynamic that occurs in healthcare that's always, I think we don't talk about often enough that this price discussion is about a third party. That's not at the table, like in many ways. Yeah, it's one of the craziest moments out there. You know, it is absolutely distorted. You're right. And then every country you go to some of the distortions are different. I mean, if you just think about healthcare market in the United States, as I've studied it for a number of years, it makes Canadian health comfortable. But you're absolutely right. You're trying to do a very specific exercise with, you know, let's face it, it's only on a few variables. Healthcare, outcomes and cost of those outcomes and a drug price. But the actual bigger system that these few variables operate in this is so overwhelming. With all this talk of innovation, I wanted to know what makes our guests excited. So I asked them what makes them most excited in their fields. Here's Ned. I mean, I think it's trying to be that leading edge, you know, at least in a private peer space and hopefully even, you know, with public as well, like trying to be that leading edge case of trying new different things. And again, not just trying for the sake of trying it, but trying it with a strong evidence-based supporting it, right. Like everything we're trying to do is be like, listen, we're not inventing the wheel. Things that have been done elsewhere in the system, right? The value-based pharmacy was done in the States for a decade. Bio-similers were done in Europe before we did them. So it was sort of just, yeah, that's what's exciting. I think just trying to do things in ways that, you know, push the needle forward, hopefully for the system as a whole, right? And being nimble, you know, doing creative things in rapid fashion are all kind of things we pride ourselves on. And yeah, I hope we can continue to do that. I think there's certainly now with some of this stuff, like I said, this digital health and integration and care pathways and the ability to care for patients holistically, using analytics as the basis of that and care pathways. I think there's something that we're really excited by. So hopefully you come to fruition over the next several years. So flipping that on its head, so that was what you find most exciting. What, if you had a magic wand and there was one problem that you can solve within your piece of the healthcare system or the drug life cycle, where do you see the biggest challenge? And, you know, that if you can fix that one thing, you think you would have the greatest impact. Um, I mean, I think that I wish we had as payers, whether that be us as private or in public, more ability to be able to connect with providers. And it's not just pharmacy, like it's all of our providers dentistry, it's physiotherapist, whatever, whoever we are compensating as part of reimbursing as part of the system, say, wish we had the ability to influence, like finally, this was one example of ways in which we were trying to advance that dialogue, but it is challenging, you know, sometimes we'll publish, let's say a pharmacy update that says it might just be administrative procedure, element code, whatever using the system that will communicate it to all 10,000 pharmacies and then, but no one reads it, for example. So Well, the ability between payers and providers to connect and align is probably universal problem. I'm sure that ODB has the same issues, et cetera, right? So I wish there was better alignment there because I think if we're aligned and we're better able to serve patients, both administratively, like we're not having to call the call center or dress the issue, but also just in terms of whether it's quality of care or whatever it is, like that consistency, that ability to kind of permeate downwards will be really valuable because then we get achieved things together. And same goes for, like, let's, let's look at public system and match check, like constant disagreement around what is match check, what is the value of match, and well, that's a guiding consistency, the payer and provider that needs to be bridged, right? Yeah. It's funny with all these innovations, data, drug innovations, everything. And yet the problem seems to continue to just be communication and like improving. Yeah. Yeah. And I don't know if maybe the tech, you know, I don't know if it's just the number and complexity of the healthcare system. Maybe you just think about how many drugs you guys have on on many of your formulators? 9,000 maybe. Yeah. So you've 9,000 and each one has its own problems, issues, things that could come up. Yeah. And that pharmacy is dealing with, like, they could get a prescription for any of those 9,000 walking in, right? So you can, or that prescriber can choose to write one of them. So it's just a lot of moving parts so I can imagine. Yeah. Okay. Okay. Here's Amin's take on what excites him. As you look forward to the future and you have a crystal ball, where do you see your industry or your space going and what makes you excited, like when you think about some of the conversations we've had today, like, where do you think things are going and where does the future hold for us? I'm actually pretty excited about the future. I think from a market perspective, what excites me is that despite everything we hear, I feel that there is no more resources afforded to nations than ever before. And maybe there's a concentration of that wealth in a specific way, like, you may say, Bill Gates or Jeff Bezos or Elon Musk have all the money and, you know, but there is a remarkable appetite for philanthropy and we saw it in the pandemic. Like literally, people were throwing money at the problem beyond what the problem had. And that gives me real hope for the future. In terms of innovation, I think, you know, we sequenced the human genome in the '90s and we sat at it in the early '90s and we looked at it and we said, wow, I think only now are we getting to a place where we're able to harvest that wealth of information. And it's also driven by sort of a boom in tech where we can process lots of information. You know, so I think on top of all of that, if there are some, like, really wild fields out there, like, editing genomes and, you know, what we're seeing with some diseases replacing whole, you know, if you think about the vector editing technologies that came with the adenovirus vectors during the pandemic too, those are, those are already in use in babies that have muscle dyslexia, for instance, you know, complete irreplaceable protein. That's deficient. So these kind of genetic innovation fields really excite me, the money availability really excites me. I think where we have to work is we need some good policy solutions, okay? And the policy solutions should be, I'm not really worried about the West, to be very frank with you. I think the West already will get good service given its own systems, okay? What I am worried about is low-term middle income countries, because if we do not work on that very clearly, I think we can increase the disparities between what Western medicine needs and what the rest of the world needs. And we may get too down the path of very specialized diseases with marginal health impact and really crack them at a cost-effective price went after the other and then leave very basic needs of the low-term middle income countries completely attached. Now it would be a great injustice. So now, like I said, I think there's lots of money available. So if we can fix some policy solutions, we could have a remarkable phase of medical innovation in front of us. It could really transform the world in ways we could imagine all for it. Pricing is complicated, a combination of business decisions, systems to assess value, and even differences between countries. It depends on the eye of the beholder. What can you save the health care system, the employers, the patient, value can shift over time and from whose point of view we take it. In a time of finite budgets, are we going to have to make some very tough decisions? It has become apparent through these discussions that we need to take and make space for innovation, but at the same time, we need to continue to make sure we pay the fair price of the value of these drugs, valued as determined by helping improve health, reduce burden on the health care system, and most importantly, improving quality of life for patients. We also had some great thoughts on how value may vary around the world. The drug life is not siloed to one country, but rather a global dynamic that is very important to consider when thinking about how we pay for drugs. So how do we ensure we develop drugs that help people around the world and make sure everyone has access to these innovations? Solving these problems will be important as we aim to tap into the full potential of all innovation coming our way. Ensuring we balance access to drugs with the incentives needed for companies to invest in innovation is a tough balancing act that has been working so far, but likely needs to adapt to these new norms. A new norm of high-cost drugs and new innovations such as gene therapy and personalized medicine that are all coming our way. We will need to break the norms of how we have traditionally paid for and valued drugs in our health care system. We need to do this to make space in our budgets. I believe we can ensure that we pay a fair value, not break the bank, but at the same time make space for innovation. We're going to need our own innovation, innovation in how we value drugs, and how we do health technology assessment. I don't think we have a choice. We need to pay for these drugs that save patient lives. This episode of the I'm Pharmacy Podcast was produced by Steve Southon, Kate Richards, and me, Minotadros. It was edited by Steve Southon with musical support from Steve Southon and Diego Martinez. Special thanks to Dr. Ned Poyskitch and Dr. Amin Sheet. And well, and that's it for season two. Thank you for exploring with me the life of a drug. We'll catch you next season. Stay safe. Live from the Leslie Dan faculty of pharmacy. Check it. Ah, yeah. From targets to formulations, money, and safety investigations. The life of a drug, innovations, molecular targets, and kinetic saturations, dosage forms ready to digest, exciting science, and further intellect. We discovered, explored, and discussed. We all agree this podcast is a must, surprised by these words, but yet taken back, spoken by the host on the tenure track. Original flexes don't follow the herd, this Toronto kid, and hip hop nerd. The fresh phrase "return of the meanity" from the corner of college and university, yes, I'm sick with it, the epitome, the one and only pharmacy MC, thank you for rocking with me. Aha. I'll check y'all in season three. And that's it.

Podcast Summary

Key Points:

  1. Drug prices have surged significantly, with high-cost drugs (over $10,000 annually) tripling since 2006 and now representing a growing share of healthcare spending.
  2. Pharmaceutical companies begin pricing considerations early in drug development, especially at the bench level, focusing on whether the innovation offers real value in improving disease outcomes.
  3. The shift from incremental to stepwise innovation reflects growing pressure from healthcare systems and payers to demand higher value, not just incremental improvements.
  4. Private payers now assess drugs not only for clinical efficacy but also for cost-effectiveness, though they face challenges in defining value due to differences in cost structures and patient outcomes.
  5. High-cost drugs—especially in rare diseases and gene therapies—are increasing rapidly, with projections suggesting 50% of drug spending could be in the high-cost category by 2026.
  6. Despite improved efficacy and safety in new treatments, value assessments remain limited by budget constraints, siloed decision-making, and a lack of long-term system-wide cost savings data.
  7. A key challenge is the disconnect between the payer (who pays) and the patient (who uses), creating a distorted pricing dynamic where third-party decisions dominate.
  8. Global equity in access to innovation remains a concern, with risk of widening disparities between wealthy nations and low- and middle-income countries due to cost-driven specialization.

Summary:

Drug pricing in the pharmaceutical industry has become a central and contentious issue, driven by soaring costs and a growing number of high-priced therapies—especially in rare diseases and gene therapies. 6 trillion, sees spending in Canada alone at $35 billion annually, with a troubling trend of prices outpacing inflation and budget growth. Companies now initiate value assessments early in drug development, focusing on transformative rather than incremental innovations.

Meanwhile, payers—both public and private—are increasingly evaluating drugs through cost-effectiveness and long-term health outcomes, though they face significant challenges in defining value due to system limitations and data gaps. Private payers often rely on public payer models, which may not reflect private sector realities such as disability avoidance or patient-specific outcomes. Despite improvements in drug efficacy and safety, the financial burden of high-cost therapies continues to expand, with projections suggesting half of all drug spending could be in the high-cost category by 2026.

A deeper structural issue lies in the disconnect between the payer and the patient, where decisions are made by third parties without full alignment with patient needs. This raises urgent questions about equitable access, especially for low- and middle-income countries, where innovation may be prioritized for rare diseases at the expense of basic healthcare. Ultimately, balancing innovation with affordability requires not just better pricing models, but systemic reforms—such as improved data sharing, cross-sector collaboration, and global policy solutions—to ensure that life-saving therapies are accessible and sustainable for all.

FAQs

Drug prices have risen due to a skewed return distribution in pharmaceutical R&D, where only a few successful drugs offset the high failure rates. Companies now rely on high-cost, high-impact drugs like biologics and gene therapies to sustain innovation, and pricing strategies are increasingly driven by market dynamics and the need to recoup R&D costs.

Companies start pricing considerations early in drug development, especially after clinical data shows potential for improved health outcomes. Pricing is influenced by innovation level, disease burden, and the ability to reduce long-term healthcare costs, but must also cover R&D and manufacturing costs to remain viable.

Payers assess drug value based on clinical efficacy, cost-effectiveness, and patient outcomes. They evaluate whether a drug offers better results than existing treatments and whether it aligns with budget constraints, often using models that compare health benefits to costs.

High-cost drugs often offer superior efficacy and safety, such as in treating psoriasis or rare diseases, but their value is not always proven in cost savings. While some drugs reduce hospitalizations or complications (like in hepatitis C), the overall healthcare cost impact remains debated due to budget limitations.

Private payers focus more on individual patient outcomes like disability avoidance and cost-effectiveness, while public payers often measure value through hospitalization avoidance and system-wide savings. This creates a gap in how value is defined and evaluated across systems.

The future will involve more high-cost drugs, especially in rare diseases, and a growing need for better value assessment models. Pricing may shift toward value-based models that consider long-term health outcomes, not just upfront costs, to ensure fair access and sustainable innovation.

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