EP426: Cost Containment Versus Value-based Drug Purchasing, With Nina Lathia, RPh, MSc, PhD
February 08, 2024
426
33:26

EP426: Cost Containment Versus Value-based Drug Purchasing, With Nina Lathia, RPh, MSc, PhD

For a full transcript of this episode, click here.

Here’s something Randy Vogenberg, PhD, wrote the other day; and I made some light edits: Research has documented the unintended impacts of poor pharmacy benefit strategy. Examples include increasing costs of care, bankruptcies, and member satisfaction declines.

And, yeah … agreed. Also, probably health problems if we’re talking about a member unable to access a drug they really need. I heard the other day about how so many patients who have had organ transplants have a hard time getting their transplant rejection meds. What?! I just can’t even with that one. On the other hand, you could have a plan that pays for all manner of drugs, cost-effective or not, appropriate or not.

And now we have premiums that no one can afford, and everybody loses for the exact opposite reason. These are the downsides that happen when pharmacy purchasing gets itself into a suboptimal place. And this can happen for many reasons, but one of them is when there is not a concerted effort to buy pharmaceuticals in a value-based way.

Now, here’s some reasons why employers may have a rough time paying for value (ie, paying a fair price for drugs that work).

Here’s one reason: Most employers do not have the power to influence the price of a medication. So, any given employer could decide, based on some cost-effectiveness analysis, that the price of a drug is too high. But it’s not like they can march into Pharma HQ and haggle. It’s more of a take-it-or-leave-it kind of thing.

Here’s a number two reason why value-based pharmacy purchasing can be tough: Pharmacy spend is siloed a lot of times from medical spend. So, the pharmacy vendor is only concerned about cost and denies access to even drugs that are proven to reduce medical spend.

Why wouldn’t they do that? The PBM (pharmacy benefit manager) was hired to reduce pharmacy spend. The end. Who cares how many ER visits or disease exacerbations transpired? That’s the medical director’s problem, not theirs.

Here’s the number three reason why value-based purchasing is rough: The time horizon an employee is with an employer, which is not one day—and it’s not a lifetime. Why did I say one day? I have heard more than once that the actuarial time horizon that some pharmacy plans use to determine if a drug is cost-effective is one day. If the drug doesn’t accrue any benefits in one day, well then, it’s a cost. It’s not effective.

On the other hand (and also problematic in the real world), sometimes cost-effectiveness analyses are done with a timeframe of the patient’s lifetime. And, yeah … there aren’t many employers who have employees for a lifetime—like, they’re 85 years old and still on the employer’s dime—so the time horizon can’t be too short.

But if it’s a really expensive med that will, at most, prevent something that’s not gonna happen anytime soon (heart failure, kidney failure, a stroke), these are things that an employer may pay for but likely is never gonna see the cost benefit of because that benefit will happen 30 years from now when the patient is on Medicare.

And here’s a fourth reason why value-based purchasing is tough: The FDA is approving drugs based on evidence from one study (ie, not a ton of evidence). And these drugs are also really expensive.

So, some of the above issues are solvable; some are less solvable. With this in mind, let’s tick through some advice that my guest today, Nina Lathia, suggests if you want to offer members a value-based formulary.

1. Have a stated goal. And maybe that stated goal is to meaningfully improve health of plan members while maintaining access, satisfaction, and affordability for said plan members and the plan.

2. Think holistically about healthcare spend, not just pharmacy spend.

3. Know what the value-based price of a drug has been calculated to be. I talked about this at length in the show with Anna Kaltenboeck (EP303). Also, Bryce Platt, PharmD, has written about this a lot.

4. Look into risk-based deals with Pharma and/or installment payments and/or some of these other interesting payment models that are emerging. Luke Prettol linked to one of them the other day.

5. Set good decision-making precedents that include shared decision-making with members/patients. This means communicating with employees and plan members about what you are doing to make good drug purchasing decisions and evaluate the clinical pros and cons of expensive drugs for any given patient. There are genetic tests now that can be done to determine if a drug is ever going to work for a patient, were these tests even done.

I mean, from a patient standpoint, some of these drugs have horrible side effects; and they might be being prescribed by a doc who’s not an expert in that condition. If I’m a patient and there’s a genetic test I could take before I pay a ton of my own money and subject myself to what might be some pretty nasty side effects (you know, all the things that you hear about at the ends of those pharma ads on TV, right?), this could be, in the right hands, a patient benefit. This feels very different from prior auths administered by a vendor doing all kinds of stuff, where it’s hard to make any connections to clinical value or patient upside, even if you squint at it sideways and use your imagination.

And, yeah … this is easy to say and really hard to do.

One definition I want to chuck in here for you: If we’re talking about a cost-effectiveness analysis, cost-effectiveness analyses calculate how effective is the drug, minus side effects at diminishing the so-called burden of illness—burden of illness meaning the financial and health costs of the disease itself or its exacerbations.

Nina Lathia, my guest today, is a pharmacist by training who has worked in hospital pharmacies. She earned a PhD in health economics. Currently she’s doing consulting work, helping purchasers make value-based decisions about pharmacy spend and managing formularies.

Specialty Pharmacy Playlist: https://lnns.co/uNZ3moCaQMb

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You can learn more by emailing Nina at nina.lathia@healthcaredecisionmaking.com.

You can also connect with her on LinkedIn.

 

Nina Lathia, RPh, MSc, PhD, has spent over 15 years helping healthcare payers achieve value on their drug spend.

As the chief executive officer of Healthcare Decision Making, Nina works with public and private healthcare payers, helping them to make evidence-based decisions about their pharmaceutical benefits that lead to improved health outcomes and long-term financial sustainability of their health plans. Her focus is on providing independent, actionable advice for healthcare payers on reimbursement decisions related to expensive new drug therapies.

Nina is a frequent public speaker and commentator on employer-sponsored pharmacy benefits design, value-based healthcare decision-making, and evidence-based medicine.

Nina honed her skills in value-based assessment of drug therapies when she was a senior technical advisor at the National Institute for Health and Care Excellence (NICE) in the United Kingdom from 2014 to 2017. She has also worked as a clinical lecturer at the University of Toronto. Her work has been published in a number of high-impact peer-reviewed journals.

Nina holds a master’s degree and doctorate in health economics from the University of Toronto.

 

06:34 What does cost containment mean?

07:43 Why is it important to consider health outcomes?

10:00 What does value-based purchasing mean in Pharma?

11:09 What are the principles of cost-effectiveness analysis?

12:50 Pharmacy plan time horizons versus employer time horizons.

14:42 Why is it increasingly important for payers to take a more global look at health and cost outcomes?

16:14 Why is the first step establishing a value-based price for drugs?

16:43 Why is the second step thinking about risk-sharing agreements with manufacturers?

18:57 LinkedIn article by Bryce Platt, PharmD.

19:20 What should an employer do if there’s only one drug option and the price is too high?

21:20 What’s a specialty carve-out solution?

21:26 EP352 and EP353 with Pramod John, PhD, of VIVIO.

22:10 Why should employers get more comfortable with saying “no” to certain drugs?

25:36 Why is patient engagement key?

28:23 What does “good” look like for employers implementing drug-spend changes?

29:51 EP337 with Olivia Webb.

 

You can learn more by emailing Nina at nina.lathia@healthcaredecisionmaking.com.

You can also connect with her on LinkedIn.

 

Recent past interviews:

Click a guest’s name for their latest RHV episode!

Marshall Allen, Stacey Richter (INBW39), Peter Hayes, Joey Dizenhouse, Benjamin Jolley, Emily Kagan Trenchard (Encore! EP392), Cora Opsahl (Encore! EP372), Jodilyn Owen, Ge Bai, Andreas Mang

 

[00:00.000 --> 00:11.000] Episode 426, Cost Containment, Versus Value-Based Drug Purchasing. Today I speak with Nina Lafayette. [00:19.000 --> 00:23.000] American healthcare entrepreneurs and executives you want to know, talking. [00:25.000 --> 00:27.000] We're relentlessly seeking value. [00:27.000 --> 00:32.000] Here's something Randy Vogenberg wrote the other day, and I made some late edits. [00:32.000 --> 00:38.000] Research has documented the unintended impacts of poor pharmacy benefit strategy. [00:38.000 --> 00:44.000] Examples include increasing costs of care, bankruptcies, and member satisfaction declines. [00:44.000 --> 00:52.000] And yeah, agreed. Also probably health problems. If we're talking about a member unable to access a drug they really need, [00:52.000 --> 01:01.000] I heard the other day about how so many patients who have had organ transplants have a hard time getting their transplant rejection meds. [01:01.000 --> 01:07.000] What? I just can't even with that one. On the other hand, you could have a plan that pays for all men or of drugs, [01:07.000 --> 01:15.000] cost-effective or not, appropriate or not. And now we have premiums that no one can afford and everybody loses for the exact opposite reason. [01:16.000 --> 01:22.000] These are the downsides that happen when pharmacy purchasing gets itself into a suboptimal place. [01:22.000 --> 01:31.000] And this can happen for many reasons, but one of them is when there is not a concerted effort to buy pharmaceuticals in a value-based way. [01:31.000 --> 01:39.000] Now, here's some reasons why employers may have a rough time paying for value, i.e. paying a fair price for drugs that work. [01:39.000 --> 01:44.000] Here's one reason. Most employers do not have the power to influence the price of a medication. [01:44.000 --> 01:51.000] So any given employer could decide based on some cost-effectiveness analysis that the price of a drug is too high. [01:51.000 --> 01:57.000] But it's not like they can march in the pharma HQ and haggle. It's more of a take it or leave it kind of thing. [01:57.000 --> 02:01.000] Here's the number two reason why value-based pharmacy purchasing can be tough. [02:01.000 --> 02:04.000] Pharmacy spend is siloed a lot of times for medical spend. [02:04.000 --> 02:12.000] So the pharmacy vendor is only concerned about costs and denies access to even drugs that are proven to reduce medical spend. [02:12.000 --> 02:16.000] Why wouldn't they do that? The PBM was hired to reduce pharmacy spend. [02:16.000 --> 02:22.000] The end. Who cares how many ER visits or disease exacerbations transpired? That's the medical director's problem. [02:22.000 --> 02:26.000] Not theirs. Here's the number three reason why value-based purchasing is rough. [02:26.000 --> 02:33.000] The time horizon and employee is with an employer, which is not one day, and it's not a lifetime. [02:33.000 --> 02:35.000] Why did I say one day? [02:35.000 --> 02:44.000] I have heard more than once that the actuarial time horizon that some pharmacy plans use to determine if a drug is cost-effective is one day. [02:44.000 --> 02:50.000] If the drug doesn't occur any benefits in one day, well then, it's a cost. It's not effective. [02:50.000 --> 03:00.000] On the other hand, and also problematic in the real world, sometimes cost-effectiveness analyses are done with a time frame of the patient's lifetime. [03:00.000 --> 03:08.000] And yeah, there aren't many employers who have employees for a lifetime, like they're 85 years old and still in the employer's dime. [03:08.000 --> 03:19.000] So the time horizon can't be too short, but if it's some really expensive med that will at most prevent something that's not going to happen anytime soon, heart failure, kidney failure, a stroke. [03:19.000 --> 03:29.000] These are things that an employer may pay for, but likely is never going to see the cost benefit of because that benefit will happen 30 years from now when the patient is on Medicare. [03:29.000 --> 03:32.000] And here's a fourth reason why value-based purchasing is tough. [03:32.000 --> 03:38.000] The FDA is approving drugs based on evidence from one study, i.e., not a ton of evidence. [03:38.000 --> 03:40.000] And these drugs are also really expensive. [03:40.000 --> 03:44.000] So some of the above issues are solvable, some are less solvable. [03:44.000 --> 03:52.000] With this in mind, let's take through some advice that my guest today, Nina Latvia, suggests if you want to offer members a value-based formulary. [03:52.000 --> 03:54.000] Number one, have a stated goal. [03:54.000 --> 04:04.000] And maybe that stated goal is to meaningfully improve health of plan members while maintaining access, satisfaction and affordability for said plan members and the plan. [04:04.000 --> 04:08.000] Number two, think holistically about health care spend, not just pharmacy spend. [04:08.000 --> 04:10.000] Number three, piece of advice. [04:10.000 --> 04:16.000] Know what the value-based price of a drug has been calculated to be. [04:16.000 --> 04:18.000] I talked about this at length in the show with Anna. [04:18.000 --> 04:25.000] Colton Bach, that's episode 303, also Bryce Platt has written about this a lot, links in the show notes. [04:25.000 --> 04:27.000] Number four, piece of advice. [04:27.000 --> 04:34.000] Look into risk-based deals with pharma and or installment payments and or some of these other interesting payment models that are emerging. [04:34.000 --> 04:37.000] Luke Petrol linked to one of them the other day. [04:37.000 --> 04:39.000] Again, link in the show notes. [04:39.000 --> 04:40.000] Piece of advice. [04:40.000 --> 04:46.000] Five, set good decision-making precedence that include shared decision-making with members slash patients. [04:46.000 --> 04:58.000] This means communicating with employees and plan members about what you are doing to make good drug purchasing decisions and evaluate the clinical pros and cons of expensive drugs for any given patient. [04:58.000 --> 05:05.000] Like, there are genetic tests now that can be done to determine if a drug is ever going to work for a patient where these tests even done. [05:05.000 --> 05:08.000] I mean, from a patient standpoint, some of these drugs have horrible side effects. [05:08.000 --> 05:14.000] And they might be being prescribed by a doc who's not an expert in that condition. [05:14.000 --> 05:26.000] If I'm a patient and there's a genetic test I could take before I pay a ton of my own money and subject myself to what might be some pretty nasty side effects, you know, all the things that you hear about at the ends of those form ads on TV. [05:26.000 --> 05:27.000] Right? [05:27.000 --> 05:30.000] Like, this could be in the right hands, a patient benefit. [05:30.000 --> 05:42.000] This feels very different from prior-oss administered by a vendor doing all kinds of stuff where it's hard to make any connections to clinical value or patient upside, even if you have to squint at it sideways and use your imagination. [05:42.000 --> 05:45.000] And, yeah, this is easy to say and really hard to do. [05:45.000 --> 05:52.000] Nina Lathia, my guest today, is a pharmacist by training who has worked in hospital pharmacies. [05:52.000 --> 05:54.000] She earned a PhD in health economics. [05:54.000 --> 06:02.000] Currently, she's doing consulting work, helping purchasers make value-based decisions about pharmacy spend and managing formularies. [06:02.000 --> 06:03.000] My name is Stacey Richter. [06:03.000 --> 06:06.000] This podcast is sponsored by a Ventria Health Group. [06:06.000 --> 06:09.000] Nina Lathia, welcome to Relentless Health Value. [06:09.000 --> 06:10.000] Thank you very much for having me, Stacey. [06:10.000 --> 06:23.000] So if we're thinking about managing formularies and buying drugs, there's two ways that often get put on a counterpoint for how one goes about doing that. [06:23.000 --> 06:26.000] One of the ends of that continuum is cost containment. [06:26.000 --> 06:32.000] The other end is often purported to be value-based purchasing. [06:32.000 --> 06:34.000] So let's just start on the first side. [06:34.000 --> 06:46.000] If I'm a purchaser, I am a self-insured employer and I am thinking to myself, all right, I got to come up with my philosophical underpinning for how I'm going to choose to construct my formula here. [06:46.000 --> 06:48.000] And I'm going to go with cost containment. [06:48.000 --> 06:49.000] What does that mean? [06:49.000 --> 06:58.000] Cost containment refers to measures or strategies that are designed to reduce or manage the cost of drugs. [06:58.000 --> 07:10.000] So with these strategies, you're only looking, as the name suggests, at the cost of the drug and you're not in any way considering the health outcomes that result from these strategies or measures. [07:11.000 --> 07:20.000] So examples of these strategies could be things like only reimbursing the lowest cost drug, implementing step therapy protocols that are based on cost alone. [07:20.000 --> 07:35.000] So, for example, requiring plan members to try the lowest cost drug, even though it may not be the most appropriate drug for their condition, cost containment can even include things like cost shifting from payers to plan members. [07:35.000 --> 07:41.000] So they're bearing more of the cost of the drug in an effort to reduce the payers' cost. [07:41.000 --> 07:50.000] The problem with this is when we're not thinking about health outcomes, we often make what could be described as suboptimal decisions. [07:50.000 --> 08:04.000] When we're thinking about cost alone, we may be inappropriately steering a plan member to a lower cost drug that's not appropriate, or we may be denying them access to a higher cost drug that would actually improve their health outcomes. [08:04.000 --> 08:17.000] So in the short term, while we may be reducing or containing costs with these measures, in the long run, we're often not doing ourselves a favor by failing to consider health outcomes and the costs associated with those health outcomes. [08:17.000 --> 08:22.000] As you were talking, what I was thinking of is that there's all kinds of different situations. [08:22.000 --> 08:32.000] In certain situations, there actually is a comparable generic, for example, which is way cheaper than the brands, or some combination of generics. [08:32.000 --> 08:37.000] You can take these two generics and it'll cost 20 bucks, or you can take this brand and it will cost 2,000. [08:37.000 --> 08:46.000] In those situations, if the patient chooses to take the brand, it's costing everybody a whole lot of money very unnecessarily. [08:47.000 --> 08:53.000] So in that case, those extra thousands that the brand cost is, you know, a waste, really. [08:53.000 --> 09:00.000] So in those cases, thinking about the cost is actually making the whole plan more affordable for everybody. [09:00.000 --> 09:05.000] On the other hand, there are situations where there's only a brand, right? [09:05.000 --> 09:15.000] Like there is no generics, or the brand for certain patients, maybe the two generics in certain cases are fine, but in other cases, you're going to have a patient where, who's past the point, [09:15.000 --> 09:18.000] like the brand actually is clinically differentiated. [09:18.000 --> 09:29.000] And if that patient doesn't take the right med for their condition, or the only med for their condition, then they're going to wind up with some acute medical issues either sooner or later. [09:29.000 --> 09:32.000] And in those cases, it's very short-sighted. [09:32.000 --> 09:34.000] That's exactly getting to the heart of the matter Stacy. [09:34.000 --> 09:43.000] In some cases, like when we're just talking about switching between a brand and a generic, absolutely fine, go on cost alone, because we know that the outcomes are equivalent, right? [09:43.000 --> 09:59.000] When we're talking about a clinical decision in steering someone away from a drug that may be more effective than another choice simply on the basis of cost, that's when we're kind of setting ourselves up for long-term problems, potentially, by not considering health outcomes. [09:59.000 --> 10:08.000] So I have a whole bunch of questions for you, but we probably should get to the other ends of the continuum before we dive into deep here and talk about what value-based purchasing means. [10:08.000 --> 10:19.000] Obviously, at its simplest form, it would be paying for the drugs that actually work up commensurate price, but is there any color that you want to add, because that sounds like it's easier said than done? [10:19.000 --> 10:23.000] This actually establishing value-based prices can be quite complicated. [10:23.000 --> 10:36.000] And the first step in terms of establishing a value-based price would be looking at the comparative effectiveness of a drug, what would be described as clinically meaningful improvements that we would be willing to pay higher prices for. [10:36.000 --> 10:46.000] So let's say a new drug comes out to treat a certain condition, we want to know how effective it is in comparison to the existing treatment alternative. [10:46.000 --> 10:57.000] So if it's considerably more effective, that provides a good clinical value, and we're willing to pay a higher price for it because it's improving health to a greater degree. [10:57.000 --> 11:09.000] I think that for payers to really achieve value, they need to think more holistically and more comprehensively about overall health care spend rather than simply pharmacy spend or medical spend. [11:09.000 --> 11:22.000] And that's where we get into the principles that underpin cost effectiveness analysis, where we're not just looking at the cost of the drug, we're not just looking at immediate outcomes, but we're looking at outcomes over a lifetime. [11:22.000 --> 11:27.000] And when we consider those lifetime costs and outcomes, what represents a fair price? [11:27.000 --> 11:31.000] That's really what we're doing when we're undertaking a cost effectiveness analysis. [11:31.000 --> 11:35.000] We're concerned with our quality of life and survival. [11:35.000 --> 11:43.000] And then we look at cost and the cost we include are costs of the drug, costs of any side effects associated with the condition. [11:44.000 --> 11:54.000] If the drug improves quality of life, I mean, from an employer's perspective or a purchaser's perspective, also an employee with a better quality of life probably is also more present and absent less. [11:54.000 --> 12:01.000] So there definitely could be some alignment there, even if I'm just thinking about the, you know, brutally financial aspects of this. [12:01.000 --> 12:10.000] If we're talking about diabetes, patients who are rationing insulin or not taking their insulin, that becomes a problem really fast. [12:10.000 --> 12:16.000] So it's pretty easy to calculate what the medical cost burden is going to be. [12:16.000 --> 12:24.000] The burden of illness is going to be if a patient doesn't take some of these meds, which control chronic conditions that can get exacerbated really fast. [12:24.000 --> 12:26.000] Asma has another one COPD, right? [12:26.000 --> 12:28.000] I think that's what you're talking about. [12:28.000 --> 12:30.000] Then survival, that's pretty self-explanatory. [12:30.000 --> 12:31.000] Exactly. [12:31.000 --> 12:34.000] We need to consider overall costs, right? [12:34.000 --> 12:37.000] When we make a value-based assessment of these drugs. [12:37.000 --> 12:41.000] And I think that's key to being able to make good, optimal decisions. [12:41.000 --> 12:50.000] I was thinking a couple of things while you were talking that I'm sure if there are employers or purchasers listening might be contemplating as well. [12:50.000 --> 12:54.000] One of them is what the actuarial time horizon is here. [12:54.000 --> 12:57.000] And you use the term lifetime, right? [12:57.000 --> 13:03.000] So like on one end of the spectrum, you're calculating the cost effectiveness of the drug over the patient's lifetime. [13:03.000 --> 13:12.000] On the other side of the spectrum, you actually have a lot of pharmacy plans that use a time horizon of one day. [13:12.000 --> 13:22.000] So if the drug doesn't help the patient in one day, then whatever the burden of illness is doesn't even count, right? [13:22.000 --> 13:27.000] Which is crazy when you think about it, because if you have a time horizon of one day, there is no cost effectiveness as a drug. [13:27.000 --> 13:28.000] It's all cost. [13:28.000 --> 13:32.000] Because like think of a drug, I mean, I don't know, maybe like epinephrine, right? [13:32.000 --> 13:35.000] What drugs actually do anything in one day? [13:35.000 --> 13:39.000] But if I'm thinking like an employer, my time horizon might be like three years or something. [13:39.000 --> 13:46.000] Whatever the length of time is that the plan member may stay on my plan. [13:46.000 --> 13:56.000] So I remember back in the day, I was working on some smoking cessation drugs, and there was a really big problem getting employers actually to pay for smoking cessation. [13:56.000 --> 14:01.000] Because if you think about the cost burden of smoking, it doesn't happen. [14:01.000 --> 14:04.000] And so the patient is 65 or over most of the time. [14:04.000 --> 14:12.000] If you do the math as an employer, it's a cost for them to pay for smoking cessation because the impact of smoking is going to accrue to Medicare. [14:12.000 --> 14:14.000] Like how do you think about those things? [14:14.000 --> 14:15.000] That's a great question. [14:15.000 --> 14:18.000] And I think the issue of time horizon is really important. [14:18.000 --> 14:22.000] And I think it's partly coming down to the issue that different stakeholders are looking at different things. [14:23.000 --> 14:28.000] Because I think when we're talking about queries and payers, they're worried about the risk of a claim, right? [14:28.000 --> 14:35.000] So as you said, it's the here and now cost of it, whereas clinicians are concerned with health outcomes over a lifetime. [14:35.000 --> 14:42.000] The smoking example, you know, we're really interested in getting people to quit smoking when they're 35 years old so that when they're 65, they don't develop lung cancer or a heart attack. [14:42.000 --> 14:49.000] So I think, again, it's coming back to this issue of taking a more global look at costs and outcomes, [14:49.000 --> 14:52.000] which I know is really hard to do. [14:52.000 --> 14:57.000] But I think it's going to become increasingly important for payers in today's environment. [14:57.000 --> 15:01.000] We're seeing a lot of drugs being approved on the basis of uncertain evidence. [15:01.000 --> 15:06.000] We don't know exactly how well they're going to work 10 years from now. [15:06.000 --> 15:15.000] So if we look at the 37 drugs approved by the FDA in 2022, I think two thirds of them are 24 of them were approved on the basis of a single study only, [15:15.000 --> 15:20.000] which means we're very uncertain about how they're going to work in the long run. [15:20.000 --> 15:25.000] And that's compounded by the fact that they're associated with really, really high prices, [15:25.000 --> 15:33.000] like the median annual price or one time price for these 37 drugs was $222,000, which is not a pitley sum of money. [15:33.000 --> 15:40.000] So we're worried about incurring these costs and we're also not sure how well these drugs are going to work in the future. [15:40.000 --> 15:45.000] And I think that's really the risk that employers are presented with currently. [15:45.000 --> 15:50.000] And I think there's a couple of things they can do to try and manage this risk. [15:50.000 --> 15:54.000] It's interesting that you say that Luke Pretl had mentioned something similar. [15:54.000 --> 16:00.000] Not only isn't there great clinical data relative to that drug in isolation, [16:00.000 --> 16:08.000] but further, if you're comparing two drugs, there's even less comparative effectiveness between different drugs. [16:08.000 --> 16:14.000] So seems like a lack of data. So I'm on the edge of my seat to hear ways to overcome this. [16:14.000 --> 16:17.000] Yeah. I mean, it's something that employers are going to have to grapple with. [16:17.000 --> 16:25.000] And I think the first step is establishing the value based price to make sure that based on the available evidence, [16:25.000 --> 16:34.000] you're paying a fair price because when the list price is 222,000 or sometimes in the millions of dollars for some of these cell and gene therapies, [16:34.000 --> 16:40.000] that's a huge financial risk, particularly when you don't know how well they're going to work. [16:40.000 --> 16:43.000] So that's the first step, establishing the value based price. [16:43.000 --> 16:49.000] The second step is really thinking about risk sharing agreements with manufacturers. [16:49.000 --> 16:54.000] And these basically fall into two categories. The first category would be financial risk sharing. [16:54.000 --> 17:01.000] So straight discounts on drug prices just to account for the fact that we're not sure how they're going to work in the future. [17:01.000 --> 17:14.000] And the second category would risk sharing agreements are performance based agreements where a manufacturer will agree to refund a portion of the cost of a drug if a patient or a group of patients [17:14.000 --> 17:19.000] don't experience expected outcomes. They don't achieve the result we want them to achieve. [17:19.000 --> 17:26.000] Third category payment by installment could be particularly helpful with cell and gene therapies, which are stratospherically expensive, [17:26.000 --> 17:33.000] as well as being one time therapies where the cost is incurred at the time the drug is administered. [17:33.000 --> 17:41.000] And I don't think any payer wants to be out $2 million, a, not knowing whether it's actually going to work 10 years from now, [17:41.000 --> 17:47.000] and b, not knowing whether their employee is going to be with them three years or even six months from now. [17:47.000 --> 17:52.000] So I think a more and more manufacturers are becoming open to the idea of payments by installment, [17:52.000 --> 17:56.000] which could be one way to mitigate concerns around employee tenure. [17:56.000 --> 18:05.000] From the employer standpoint, the financial agreements tend to be, you know, much simpler and easier to execute just because you don't need to collect data [18:05.000 --> 18:08.000] and have ongoing clinical monitoring for patient outcomes. [18:08.000 --> 18:12.000] But those are definite strategies to help mitigate risk. [18:12.000 --> 18:19.000] Yeah, well, I could see that even that performance based one with the cell and gene therapies, which were touted as one time only, [18:19.000 --> 18:26.000] but now it's becoming, I think, pretty clear, at least for some of them that they actually are not one time only, [18:26.000 --> 18:30.000] that the patient needs them every four years or seven years or something like that. [18:30.000 --> 18:34.000] So in the case of cell and gene therapy, a performance based. [18:34.000 --> 18:37.000] God shagged might be something to think about. [18:37.000 --> 18:44.000] Okay, just taking through your list there, as I'm thinking about this from the standpoint of a purchaser, [18:44.000 --> 18:52.000] staring down the barrel of millions of dollars of potential cost for some of these drugs. [18:52.000 --> 18:57.000] First thing to do is to try to figure out really what is the actual value of this drug. [18:57.000 --> 19:02.000] Bryce Platt wrote an interesting post on LinkedIn that I'll link to the show notes also about this. [19:02.000 --> 19:10.000] And it could be looking at, I, sir, I know you have done a lot of work with Nice, which is the European sort of equivalent, I guess. [19:10.000 --> 19:17.000] Right, but like there's sources that one can go to to determine whether a drug is fairly priced. [19:17.000 --> 19:26.000] The one thing that I would wrestle with there, if I'm an employer and I see that there is one drug [19:26.000 --> 19:30.000] for a patient's condition, there are no options here. [19:30.000 --> 19:33.000] It's an orphan disease and there's an orphan drug and there's one thing. [19:33.000 --> 19:38.000] There's like no generics, there's no, you can do something else and achieve the same result. [19:38.000 --> 19:41.000] And that drug is wildly overpriced by all standards. [19:41.000 --> 19:49.000] Like, what do you do? Because it's not like the employer has any leverage to tell the pharma company or the PBM. [19:49.000 --> 19:54.000] Like, if you say, okay, we're not going to pay that price, then the industry's going to stare you back in the eyes and say, [19:54.000 --> 19:56.000] well, then sorry, you can't get it. [19:56.000 --> 19:59.000] That's definitely a conundrum, particularly in the US. [19:59.000 --> 20:08.000] In other sort of countries like in Europe, for example, in England, where Nice operates, they will negotiate the price based on results of a value assessment. [20:08.000 --> 20:21.000] And I think employers are eventually going to have to move in that direction, because it's really not sustainable, for example, to be paying $2 million for a Zolgensma that we later find out doesn't work as well as we thought it was going to work. [20:21.000 --> 20:26.000] We thought it was a cure or a functional cure for spinal muscular atrophy and infants. [20:26.000 --> 20:36.000] And now as more data has emerged, it's turning out that it's not really a cure, but rather a treatment that's transformed the disease from a fatal condition into a more chronic condition. [20:36.000 --> 20:41.000] And I really think that that example encapsulates what we're dealing with. [20:41.000 --> 20:43.000] I don't think there's any easy answers. [20:43.000 --> 20:49.000] I think one solution would be to hire an independent expert to make a value based assessment. [20:49.000 --> 20:55.000] I think employers, if they band together, have a lot of power to negotiate drug prices in the US. [20:55.000 --> 21:01.000] Using a specialty carve out solution, I know employers have had success with a number of innovative specialty carve out solutions. [21:01.000 --> 21:05.000] If they're able to carve out their specialty spend could be a good option. [21:05.000 --> 21:18.000] Working with a non traditional PBM could also be a good option, but I do think that you raise a really good point about the fact that, you know, at this point in time, a manufacturer can stare an employer down and say, look, if you're not willing to pay the whatever millions of dollars, [21:18.000 --> 21:21.000] you're not getting it. And that's a real conundrum. [21:21.000 --> 21:26.000] When you say a specialty carve out solution, you're talking about something like a Vivio. [21:26.000 --> 21:33.000] We had promoted John on the pod a couple of years ago who took a deep dive into some of the stuff here. [21:33.000 --> 21:42.000] And the points that he made largely is there's a lot of people that get prescribed some of these really expensive drugs, and it's actually not going to work for them. [21:42.000 --> 21:43.000] Exactly. [21:43.000 --> 21:49.000] The worst thing in the world, like it's one thing to pay a lot of money for a drug that actually really helps a patient. [21:49.000 --> 21:56.000] It's another thing to pay a lot of money for a drug and have it have no chance of working and we should know that. [21:56.000 --> 22:04.000] Like, you know, if you actually look at the science that is clear from the outset or if you look at a genetic test or whatever. [22:04.000 --> 22:10.000] So like there's even two scenarios I think even in the we know we're paying too much bucket. [22:10.000 --> 22:17.000] Exactly. And I think employers more and more have to be comfortable with saying no or not right now to some of these drugs. [22:17.000 --> 22:24.000] If we know it's not going to work or if we are very uncertain about whether it's going to work or not. [22:24.000 --> 22:33.000] And I think that's perfectly okay to say, look, there's no evidence to show that this drug actually works and we're not going to fork over $2 million for it. [22:33.000 --> 22:41.000] And I think the more we start having these conversations and the more we start making decisions like that, we set good decision making precedence, right? [22:41.000 --> 22:49.000] We set the precedent that, you know, we're going to make evidence based data driven decisions that we're willing to pay higher prices for drugs that are highly effective, [22:49.000 --> 22:52.000] but we need evidence of that effectiveness. [22:52.000 --> 22:55.000] We're discouraging the use of low value drugs. [22:55.000 --> 23:00.000] We're discouraging or eliminating hopefully the need for pure cost containment measures. [23:00.000 --> 23:04.000] But I think we need to start having conversations like this. [23:04.000 --> 23:17.000] I know up until now, the thinking has largely been like, look, the best way to handle this is to do whatever we can jump through as many hoops as we need to to get people access to the newest drugs, the, you know, latest, greatest drugs. [23:18.000 --> 23:19.000] However, you want to term them. [23:19.000 --> 23:26.000] But given the fact that there's so much uncertainty around them, I think we need to take another look at how we approach this. [23:26.000 --> 23:32.000] And I think, I hope we're at a turning point where employers are willing to say, well, wait a second. [23:32.000 --> 23:35.000] I'm going to actually take a look at the evidence here. [23:35.000 --> 23:43.000] I'm going to do an objective evaluation of whether this drug is going to meaning will fully improve the health outcomes of my plan members. [23:43.000 --> 23:49.000] And if it's not, I'm okay with saying no, or I'm okay with saying not right now. [23:49.000 --> 23:54.000] And in two years time, when more evidence emerges, I'll take another look at my decision. [23:54.000 --> 24:00.000] And I think traditionally that hasn't been the thinking, but we're moving in that direction. [24:00.000 --> 24:08.000] And I think it's going to result in some better decision making and actually improved health and improved financial sustainability for a lot of employers. [24:09.000 --> 24:17.000] If I am thinking about this from the standpoint of a patient or a patient's parents who there's this new drug that came out. [24:17.000 --> 24:22.000] My kid has a fatal condition and this might help. [24:22.000 --> 24:24.000] Like, I'm going to do anything. [24:24.000 --> 24:26.000] It all becomes a matter of nuance. [24:26.000 --> 24:31.000] These are really, really hard conversations to have. [24:31.000 --> 24:39.000] And I am really thinking, as you were talking, a lot of times within employers, one of the hardest things that they struggle with is engagement and communication with plan members. [24:39.000 --> 24:59.000] But unless there is almost some kumbaya moments here where everybody is in a room talking this out and the patient or the parent really understands that this drug probably won't work and that there are side effects that may actually be worse than the condition itself [24:59.000 --> 25:04.000] or that the side effect of the drug, some of these side effects are fatal, right? [25:04.000 --> 25:11.000] Like you're talking about some of these oncology drugs and they are proven to only extend life like some minimal amount. [25:11.000 --> 25:14.000] There's a lot of these situations which are going on. [25:14.000 --> 25:28.000] Unless the patient really has a lot of education and really understands and is really part of the decision making process, then they could very easily feel like there's rationing and things are being done to them and that they have no say in. [25:28.000 --> 25:36.000] And I could see how that could go awry really fast unless all these nuances and the communication and the engagement were really a big part of this. [25:36.000 --> 25:38.000] The patient engagement is key. [25:38.000 --> 25:46.000] I love that you brought that up because I think that is one of the pillars to truly achieve value-based care you need buy-in from the patients. [25:46.000 --> 25:53.000] And you made a really important point about the ideology that denying the drug is the equivalent of rationing. [25:53.000 --> 25:57.000] And I think we really need to work on resetting that paradigm. [25:57.000 --> 26:03.000] I think that's what's driving a lot of the wasteful, non-evidence-based spend. [26:03.000 --> 26:09.000] But when we really truly engage with patients, there's a lot of potential there to help us make better decisions. [26:09.000 --> 26:25.000] And if we just even look at the example of hemophilia drugs, the cell and gene therapies, one of the points that patients who participated in some of the decision making around these drugs raised was the fact that they'd been promised miracle cures in the past that didn't come to fruition. [26:25.000 --> 26:28.000] And that was a very disappointing. [26:28.000 --> 26:45.000] And B, the issue with some of these therapies, particularly cell and gene therapies, which are administered through viral vectors, if a patient receives a therapy and say it doesn't work two years down the line, they may be ineligible for a future therapy that's more effective. [26:45.000 --> 26:54.000] So there's really some complicated issues around patient engagement and also the ethics around offering or not offering these drugs. [26:54.000 --> 26:56.000] And it's definitely a minefield. [26:56.000 --> 27:04.000] But I think it's something that we need to really view as an important aspect of achieving value in care. [27:04.000 --> 27:12.000] And I really think that if we're not able to engage with patients and help them understand that it's not just about access to the newest drugs. [27:12.000 --> 27:16.000] We're going to have huge barriers to achieving value-based care. [27:16.000 --> 27:19.000] So I think that's a very, very important point. [27:19.000 --> 27:27.000] And I think it's something that not just in the US, but all health care systems haven't been doing a great job of it, but we're understanding the increased importance. [27:27.000 --> 27:28.000] Yeah. [27:28.000 --> 27:40.000] There's just article after article really, really well written by physicians, others as well, relative to why shared decision making, especially towards the end of life is absolutely so critical. [27:40.000 --> 27:44.000] Because more is oftentimes really not better and can get what do they say? [27:44.000 --> 27:50.000] Half of somebody's total health spending happens in the last year or something of their life. [27:50.000 --> 27:59.000] It's this crazy amount and it's not really, patients don't want to die in a hospital having just come out of the MRI machine, which literally you hear about. [27:59.000 --> 28:00.000] Exactly. [28:00.000 --> 28:12.000] If let's just say I do a really good job with value-based purchasing and I figure out a lot of the nuances and kind of the unanswered questions that I think we've raised here, which I hope everyone. [28:12.000 --> 28:17.000] It contemplates and I would love to hear if anybody has additional thoughts on this on LinkedIn. [28:17.000 --> 28:22.000] And I actually am going to be interviewing someone from an employer coming up here, how they're thinking about it. [28:22.000 --> 28:23.000] But what should happen? [28:23.000 --> 28:27.000] What does good look like if I do this well or as well as I could? [28:27.000 --> 28:32.000] The first measure of good should be, am I improving the health outcomes of my plan members? [28:32.000 --> 28:33.000] I think that's key. [28:33.000 --> 28:34.000] That should be the goal. [28:34.000 --> 28:36.000] Am I meaningfully improving health outcomes? [28:36.000 --> 28:41.000] Am I helping my plan members survive longer and am I helping them improve their quality of life? [28:41.000 --> 28:50.000] Am I doing it in a way that is sustainable so that I can continue to reimburse the cost of drugs that are effective? [28:50.000 --> 28:54.000] Can I keep paying for good new drugs that come out? [28:54.000 --> 28:59.000] And are my plan members satisfied with the access they're receiving? [28:59.000 --> 29:03.000] Am I providing fair access to treatments that actually work? [29:03.000 --> 29:12.000] I think those are the three big points that we should look at when evaluating whether we're doing a good job with value-based care. [29:12.000 --> 29:20.000] We may even, if we do this really well in the long term, there may even be instances where when we globally look at costs, [29:20.000 --> 29:26.000] when we don't silome medical costs, pharmacy costs, where we're achieving overall cost savings, right? [29:26.000 --> 29:31.000] Going back to that example of preventing heart disease or vision loss in a diabetic patient, right? [29:31.000 --> 29:35.000] If you really, truly accounted for the costs of that, you would be saving money. [29:35.000 --> 29:41.000] And I think that's the kind of goal that we should have in mind when we think about value-based care. [29:41.000 --> 29:47.000] Coming up there, am I meaningfully improving the health or well-being of plan members? [29:47.000 --> 29:49.000] Are these members satisfied? [29:49.000 --> 29:51.000] And that I would not underestimate. [29:51.000 --> 29:55.000] Olivia Webb was on the podcast and I will link to it in the show notes. [29:55.000 --> 29:58.000] She takes a specialty drug just like it's harrowing. [29:58.000 --> 29:59.000] It's so stressful. [29:59.000 --> 30:02.000] It takes hours to get the drug, like hours. [30:02.000 --> 30:05.000] And you're like, what is she doing that at work? [30:05.000 --> 30:16.000] Like, you know, like, you could make it easier and probably get a lot more effectiveness out of employees who are literally spending ten hours a month trying to figure out how to get their drug. [30:16.000 --> 30:20.000] It's just really crazy if you start thinking about it from the employer standpoint. [30:20.000 --> 30:23.000] You start thinking about it from the PBM standpoint, it makes a whole lot of sense. [30:23.000 --> 30:32.000] What's even crazier from the employer's point there, Stacey, just to interject was sometimes patients spend like ten hours getting this drug and it doesn't actually work. [30:32.000 --> 30:40.000] And that's an issue where here we are throwing all this money at something that isn't actually improving the health of a patient in a meaningful way, right? [30:40.000 --> 30:47.000] And let's take a long, hard look at the evidence and let's make decisions about whether that patient's health is improving or not. [30:47.000 --> 30:50.000] Yeah, and on the flip side of that, maybe the drug really does work. [30:50.000 --> 30:51.000] Exactly. [30:51.000 --> 30:56.000] Now you're forcing, imagine, and Olivia articulates this really well, she needs this drug. [30:56.000 --> 31:03.000] If she doesn't get this drug, she just crumbs disease and she will become disabled, basically, or debilitated. [31:03.000 --> 31:10.000] And then you have all of these barriers that are being thrown in her face, keeping her from getting a drug. [31:10.000 --> 31:20.000] The craziest stuff, and I don't want to get off in a total sidebar, but like the prior-off statements, she just fails a prior-off because the prior-off is, is this patient's disease uncontrolled? [31:20.000 --> 31:21.000] That's the prior-off. [31:21.000 --> 31:24.000] And it's like, well, it's controlled because I'm taking the drug. [31:24.000 --> 31:25.000] Exactly. [31:25.000 --> 31:28.000] Like, it's just frustrating on so many different levels. [31:28.000 --> 31:30.000] So there's definitely two sides to that. [31:30.000 --> 31:33.000] That's another component of value which I'm glad you raised. [31:33.000 --> 31:37.000] Are patients able to access drugs that they need, right? [31:37.000 --> 31:46.000] Because if they can't take them or their barriers to taking them, such as cost or administration or whatever the barrier may be, that's another impediment to achieving good value. [31:46.000 --> 31:54.000] That's such an important point that the use of these drugs is accessible and feasible to patients. [31:54.000 --> 32:02.000] Our list of four, then, that we will wrap up this conversation with is, am I meaningfully improving the health or well-being of plan members? [32:02.000 --> 32:04.000] Are these plan members actually satisfied? [32:04.000 --> 32:11.000] Have I actually talked to people who are taking some of these meds and understanding actually the impact that my plan may be having on them? [32:11.000 --> 32:12.000] Am I doing this sustainably? [32:12.000 --> 32:15.000] And that could be in the short term, but it also could be in the long term. [32:15.000 --> 32:22.000] Like, the more that we pay for good drugs, the more incentive there are for manufacturers to manufacture good drugs. [32:22.000 --> 32:26.000] So there's that component too. And then lastly, we added access. [32:26.000 --> 32:34.000] If a drug is working, if it is appropriate for somebody, how difficult or easy is it for the patient to actually get those meds? [32:34.000 --> 32:40.000] Nina, Latvia, is there any place that you would recommend people go to learn more about your work? [32:40.000 --> 32:44.000] Email me, Nina.Lafia, healthcaredecisionmaking.com. [32:44.000 --> 32:50.000] Follow me or connect with me on LinkedIn. I'm looking forward to connecting with the tribe. [32:50.000 --> 32:53.000] Nina, Latvia, thank you so much for being on Relentless Health Value today. [32:53.000 --> 32:54.000] Thank you for helping me. [32:54.000 --> 33:01.000] Hey, could I ask you to do me a favor? If you are part of the Relentless tribe working hard to transform healthcare in this country, [33:01.000 --> 33:05.000] I don't need to tell you that we need as many on our side as we can get. [33:05.000 --> 33:14.000] The most vital thing that you could do to help expand the reach of this show is to leave a rating or a review on iTunes or Spotify, [33:14.000 --> 33:17.000] and or share this show with colleagues or decision makers. [33:17.000 --> 33:24.000] Personally, I cannot appreciate it more when I see the reviews and they really count towards our search rankings. [33:24.000 --> 33:25.000] Thanks so much for listening. Transcription results written to '/home/forge/transcribe2.sonicengage.com/releases/20240207164437' directory
PBMs,brand vs generic,cost containment,costs,formularies,pharmacy,value-based purchasing,healthcare decision making,drug cost,pharma,

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