Transcript of Exploring Untapped Government Policy Options for Getting Cheaper Generics to Market:
A Conversation with Dr. Michael Birrer, MD

Nov 15, 2023

On November 9, The Capitol Forum held a conference call with Dr. Michael Birrer, MD, PhD, to discuss potential solutions to drug shortages and lack of competition in the pharmaceutical market. The full transcript, which has been modified slightly for accuracy, can be found below.

TEDDY DOWNEY: Good morning and welcome to our conference call today. I’m Teddy Downey, Executive Editor here at The Capitol Forum. And today’s guest is Dr. Michael Birrer, who is the Director of the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences. Dr. Birrer, thank you so much for joining us today.

DR. MICHAEL J. BIRRER: My pleasure. It’s great to be here and discuss this important topic.

TEDDY DOWNEY: And before we get started, I just wanted to go over a couple of things. Mainly, if you have questions for us, please type them into the questions pane of the control panel. We’ll collect questions throughout the call and address them during a Q&A session later in the call. So, Dr. Beer, I think the number one topic that we’re wanting to tap into that big brain of yours is what is the problem that you are running into when it comes to drug shortages? And what do you think needs to happen from a policy standpoint to address that problem?

DR. MICHAEL J. BIRRER: Sure. So, the historic perspective on this is helpful. I’ve been in the oncology business for about 40 years. And, of course, drug shortages go beyond oncology. I mean, you’ll get antibiotic shortages and other drugs. But again, my experience has been oncology. And the historic perspective is we sort of lived in this ivory tower for a while until about, from my perspective, about ten years ago. I was up at Harvard at the time, at Mass General, and we had this massive shortage of pegylated liposomal doxorubicin, which is a liposomal preparation of atrium myosin. It’s otherwise known as Doxil.

And it was very shocking at the time because shortages had not really impacted oncology that dramatically. There were challenges in terms of synthesizing and certainly developing drugs. Drug development in oncology always takes a long time and even isolating, synthesizing, certain compounds like Taxol, pegylated liposomal or Paclitaxel, which was originally isolated from yew tree bark. I don’t know if you remember that story. But it was very difficult, complex. And then the environmentalists got involved and it became even more complex. And eventually, we were able to synthesize it.

So, there were those problems, but we really didn’t suffer from shortages. And the pegylated liposomal doxorubicin was really the first one that splashed out. I was again at MGH and I had patients flying in from the UK because that’s the way MGH works. They have a lot of — it’s a referral center. And they were asking me, could I just bring it on the plane and bring it here? And I said, well, no, I don’t think the FDA will allow that.

But that emphasized the fact that a lot of the problem with that particular compound, not all of it, but a lot of it, was supply chain. You know, it could get to certain countries, but not others. And that was because our local synthesis of that compound had, if I remember correctly, the facility had been shut temporarily by the FDA because of violations, and we didn’t have a lot of backup.

So that was the historic, historic perspective of the first sort of challenge. And then we went through sort of a quiet period. But it really splashed out over the last couple of years in that we began to experience shortages of really standard chemotherapeutic agents. We’re in better shape now, but we’re still in the in that time period. And this would include cisplatin, which has been around since the mid-seventies, carboplatin, which came in during the eighties, methotrexate, 5FU. Those are the ones that are coming to mind. These are very commonly used, relatively old, oncology drugs. And they’re all, of course, off patent.

We began to suffer some pretty severe shortages. It affected me because my expertise is in gynecologic cancers. This would be ovary, endometrial and cervix. Cisplatin is used as a chemo sensitizer for cervix. Carboplatin is standard for ovary. And so, we had to, on a local level, look at our patients and look at the use of these drugs for our patients. And, for lack of a better description, stratify patients according to who should get the drug if we’re running short and who should not. And part of that equation was is the regiment curative or is it just palliative? Meaning make the tumor go away but not keep it away? And so, these are the kinds of decisions that were made in hospitals across the country to deal with this shortage.

So that’s the historic perspective and that’s where we are now. And to be perfectly honest, as somebody who knows a certain amount about this process, a certain amount about drug development, I don’t think this is going to go away. It’s going to be a continual problem, which is why I think we need to think outside the box a little bit in terms of solutions. Now, I can continue in terms of exploring what I think precipitated this.

TEDDY DOWNEY: Yeah, that would be great. I’m familiar with supply chain issues in other markets where there was maybe consolidation and like a factory gets shut down and then you just don’t have access anymore. But how drugs are paid for is a lot different than how other typical things are paid for. So, I’m curious how, from a market standpoint, why there isn’t more redundancy in the production and what kind of companies are sort of making the decisions — not to say that they’re necessarily at fault, but that kind of the way they’re doing things is contributing to sort of fragility.

DR. MICHAEL J. BIRRER: Yeah. So, I think for your audience, to just sort of step back and say how is drug development done here and what are the market forces on it? It’s been estimated that now in the U.S. — and I’m talking primarily in the oncology arena — it probably takes $2 to $2.5 billion to bring a new drug to market. And that’s because it takes at least five years, more likely closer to ten years, all the pre-clinical testing that would be the animal models, even the in vitro testing. And then the early drug development trials, which would be phase one, looking for the actual dose of the drug that would be optimal from an efficacy standpoint and a toxicity standpoint, all the pharmacokinetics and pharmacodynamics. All of that takes time and money.

And then that will evolve into phase two trials where you’ve got your dose and you want to say how effective is this? And so, you look at that dose in a larger number of patients, usually between 20 and 40. It’s not huge. And you get a signal.

And then if the signal is good, meets your endpoint, good response rate, so on and so forth, you go onto a phase three trial, which is usually randomized. It usually is your drug versus what’s the standard of care. Because what the FDA wants and what patients want is you want to move forward. You want a drug that is better than what you can already get.

Now, there are noninferiority trials where you’re looking for a second drug that might be no worse than standard of care. Those trials do exist. They’re bigger trials. But the bottom line is you can see the phases of the trials. You can see the preclinical testing. All that takes time. And that’s where the five to ten years come from and all the money that’s invested in it. And companies now, the good news from a drug development standpoint is that the timeline has gotten actually a little bit better. It used to be a lot longer. And I think part of that is because the science is so much better early on. We can identify the targets. We can develop really novel agents that affect only that target and nothing else. So that strengthens the possibility that it’s going to be effective and lowers the toxicity. But even under those circumstances, five to ten years, and you’ve got to accept that 80 percent of the drugs that you test are going to fail. It could even be as high as 90 percent. And that’s an area where a lot of people are doing a lot of work now.

Now, the reason I bring this drug development up is because the regulatory environment is to, for lack of a better term, protect the companies so that they can be financially solvent while they undergo this fairly tortuous route. So that’s the patent laws that protect the companies while they’re doing this development. So that once they get a drug approved, they’ll be protected. In a sort of monopolistic phase, if you will, where they can regroup that money, actually get even more money for more research and to develop even better drugs. And so that’s the way drug development is done in this country. It’s done in a similar way in other countries. Although, Europe, for instance, is much more regulated than us.

TEDDY DOWNEY: I don’t mean to interrupt, but I thought, if I remember correctly, you said a lot of the drugs that are in shortage are old, off patent drugs.

DR. MICHAEL J. BIRRER: Yes, we’re going to get to that in a second. So, I’m just trying to lay that out for everybody. And again, because it’s monopolistic, the prices of these are enormous, $12,000, $15,000 per month kind of costs. But that’s sort of to regroup that money.

Now, when that patent runs out, then it’s a free for all. Anybody can come in. There’s no sort of monopoly control on it. Anybody can come in and synthesize that agent. Either it’s exactly the same or maybe a little tiny difference. And that’s where the generic market comes to bear. After the patent runs out, anybody can do this.

But the FDA does weigh in on that. And I think they do this in an appropriate fashion. Meaning that you want to make sure when somebody else is coming to the market and they’re synthesizing that drug, they still are doing it in a decent fashion.

So, the FDA does have a lot of requirements to make sure that the drug hits the target, the drug pharmacokinetics and pharma dynamics are all the same drug exposure. And that’s where you get into sort of bioequivalence. It doesn’t mean it’s the same drug, but it’s bioequivalent. So, you know that you’re getting a generic. You’re getting roughly the same efficacy and activity that you did with the brand name.

That whole process, though, is a lot shorter for the generation generics. The problem is — and this is what we’re getting to  is that because it’s quicker, because there’s really no research and development on it — that’s all been done before — the charges, the prices, for generics are much cheaper. And that’s good for us because patients get these drugs. They’re not paying $12,000 to $15,000 a month. They’re paying a lot less. And you know this because you go to the pharmacy and you ask. You say, oh, yeah. Generics are fine. You get that. You’re assured that the FDA has checked that generic makes sense. So, everything’s hunky dory.

The problem is — and that’s what these drugs are, cisplatin, carbo. They’re all standard of care, well off patent and all generic now. And that’s the problem. The profit on that is so small that a lot of companies either do not want to enter the generic market or they’re exiting it. Now, this is a little bit reminiscent, in my view, of what happened with vaccines in the sixties and I think early seventies. If you remember, we had MMR. We had pertussis, diphtheria. And we had a lot of companies leave that market because the profit margin was so small. And there, they had the additional issue of liability. You know, these are great drugs, vaccines. Obviously, they cure serious childhood diseases. But occasionally, you’ll get some side effects and some serious side effects and all sorts of very broad and deep lawsuits. And so, it drove a lot of companies out of the market. And we had that challenge.

And so, the federal government recognized how important these were to our health. They actually weighed in, in part, mitigated the liabilities associated with it. Which is why I think it’s a great model for how government can assess the situation and then weigh in to make sure that the public gets these terrific drugs.

For oncology, it’s a little different. We don’t have that liability issue quite as much. But we’re clearly having recurrent problems with the standard of care, chemotherapeutic agents. And they’re all off patent. And they’re very cheap. And part of it is that a lot of companies aren’t making enough money on this. So, what do we do? What do we do to solve that?

TEDDY DOWNEY: Can I ask you why they’re not making money on it? Because, just intuitively, if you don’t have a lot of generics entering and doing it — you know, my experience with the generics is if there’s only one or two doing it, they aren’t nearly as aggressive on lowering the prices if there’s five or more or whatever, kind of a handful all trying to get in.


TEDDY DOWNEY: So, are there just a lot of people, a lot of generic companies, producing these? Because, if there are and they’re driving down the price, it doesn’t seem to match up with the lack of redundancy in the supply chain. So, I’m curious. Do the payers just not pay? What is causing it to be so low margin, so low?

DR. MICHAEL J. BIRRER: Well, I think it comes in two flavors. If you look at the more recent oncology drugs, what you’re describing is true. When, for instance, some of these molecularly targeted therapies come off patent, they’ll get generic versions of it or biosimilars for the antibodies. They’re not that much cheaper than the brand name. Or at least if the brand name comes down, it’ll only come down about 20 or 30 percent. But that’s the more recent molecularly driven drugs.

What we’re referring to here are drugs that were developed in the early seventies and eighties. These are chemotherapeutic agents. I think in those cases, they’ve been sort of around for a long time. And a baseline level of cost has been established for them, which is incredibly cheap. And that’s what the insurance companies are used to. So, they’re not going to pay for a higher charged carboplatin, for instance.

Now, what compounds this for these agents is that, while we don’t have a great generic drug market — we simply don’t in this country. We have some, but not much — countries like India and, to a lesser extent, but rising, China, have massive generic drug established companies. So, India  and I’ve been there multiple times — you can get a generic drug for almost any drug we’re using on patent in the United States. Quality is a question. I don’t think their quality assessment in India is anywhere near what we do here with the FDA.

TEDDY DOWNEY: Doesn’t the FDA have to go to those companies’ facilities though if they’re sold here?

DR. MICHAEL J. BIRRER: Yeah. So, what’s happened is, for instance, when I describe the pegylated liposomal doxorubicin challenge back ten years ago, ultimately, the solution of that was, I think it was Sun Pharmaceuticals, which was out of India, and that in the long term solved the problem. It took a while though. And the FDA had to go in and do due diligence to look at the formulation, look at its PK, look at its pharmacodynamics and its performance, before it can approve it. And that takes time. So that kind of gets to one of the solutions. I mean, again, I’m not so sure I have insight in terms of the solutions to this, but that’s one of the solutions, which is we do a lousy job at predicting, with some lead time, where we’re going to be short. We’re always, to a certain extent, in a reactive mode.

TEDDY DOWNEY: Can we just get back to the payment a little bit? You said the insurers. Are oncology drugs primarily, you know, you’ve got your Medicare, you’ve got Part D. You’ve got commercial insurance. It sounds like these are chemical drugs. So, I’m guessing that’s Part D, not Part B. So, you’re getting paid out of the drug benefit. Is the issue simply that if the insurers paid a little bit more for these generics to allow for the generic companies to have more redundancy or create a little bit more competition around them, wouldn’t that solve the problem? I just don’t want to go too far away from the problem that you identified, which is that they pay so little for it. They’re just accustomed to it and they don’t build in any payment that would assume there would be more redundancy.

DR. MICHAEL J. BIRRER: Yeah, I think that’s worth exploring. And, of course, the insurance, I mean, again, your assessment of the various payers is correct. So, for Medicare it’s mostly going to be B, outpatient. But there will be some prescriptions. Some of our oncology drugs, you stroke a prescription for, but mostly it’s B.

TEDDY DOWNEY: B. Okay. I have another question after.

DR. MICHAEL J. BIRRER: B is outpatient. And then you’re going to get Medicaid for those who can’t really afford it. Medicaid chronically underpays in a very big way. And then, of course, you’ll get private insurers. I think providing better reimbursement would help. I don’t think it would hurt. It would help. I don’t think it’s sufficient though to solve the problem. Because there’s going to be a disconnect between those reimbursements in developing a robust generic drug development operation in this country. It’s going to be more than just the reimbursements.

This is why we sort of went down this road to have this teleconference. Because I passed the comment, I said, I’m not a big government kind of guy. But I think for generic oncology drugs with this recurring problem, this is where I think there is a role for government. And the Biden administration, along with Moonshot, is trying to guide the FDA to address this issue. They’re probably not doing it as aggressively as I would like.

But what I mean by that, I think in addition to reimbursement, the FDA itself needs to be more streamlined in terms of its quality assessment of these agents in these companies. I think they’re still a little too bureaucratic and slow. That doesn’t help. That discourages companies from going down this pathway.

And then the third part, which we touched on, is that I don’t think they do a very good job — and this mostly from the regulatory standpoint — of anticipating shortages. It’s again, oh, we’ve got no carboplatin. We’re down to 30 days. It’s got to be anticipated with a much broader lead time.

Now, the solutions to really think outside the box, and to throw them out there for your audience, is could — other than doing those changes to try to encourage generic drug development right here in this country — could the FDA do one of the following?

One, which is fairly extreme, but certainly worth discussing, is could they stockpile drugs? Could they selectively identify the ones that we have recurrent problems on and stockpile them? The complication on that, as you could predict, is it probably varies by drugtodrug because it’s going to be relevant for stability and storage. But that’s certainly worth discussing to make sure that we have a — I mean, we certainly do that with vaccines because they could be freeze dried. So, that’s worth discussing.

Perhaps the fallback — which is another possibility that might be easier to do — is could we proactively identify a number of companies in India or China prospectively, not at the time of the crisis, but prospectively, and engage them to say, look, we would like to collaborate, contract, with you, however you want to say it, to synthesize carboplatin and have the facility to do that in a 30 day process, according to these requirements, if we need them? And, of course, that could be done in this country too. But again, some place like India, where they have a very robust generic drug market and infrastructure, might be easier to do that.

I think that’s got to occur. I think the market is great and providing some more money for generics, would help. But ultimately, I think government needs to get involved in this to make sure — to prevent this from occurring again.

TEDDY DOWNEY: That makes a lot of sense. We’ve done a lot of digging and written a report about sort of some of the bottlenecks that drive up pricing in oncology drugs, namely McKesson’s sort of dominance, in oncology, owning the GPO and obviously being a major wholesaler and rolling out these oncology networks. Are they at all involved in contributing to the shortage? I mean, we’ve only looked at the bottleneck that drives up pricing where they can capture some of the spread in the Part B market specifically because there’s no insurer involved there. Does that affect the generic market as well? Or is that not relevant?

DR. MICHAEL J. BIRRER: Yeah, I hear what you’re saying. I’ve actually had personal experience on that. We’ve hired a number of people that came through the McKesson process. I think that’s mostly with pricing. I don’t think that’s contributed to the generic market at all. Now, it could in a very tangential way. And this gets into a little bit more of the — for lack of a better term – oncopolitics, I guess. But I think it really focuses on pricing.

But the one tangential relationship is that some of these generic drugs can be used as standard of care. Newer drugs come out that perhaps they’re noninferior or perhaps they’re a little bit more superior, maybe a better quality of life, if FDA approves them. They will be selectively used because of the pricing issue you just described with certain groups as opposed to the cheaper generics. That then discourages generic use, which you could say, well, that means there should be no shortage. Except people leave the market and then you end up with this shortage.

So, it’s a double-edged sword. I mean, I wouldn’t want to discourage development of new active drugs because that’s how the field moves forward. It’s better for patients. But NCCN guidelines and FDA indications should really be very careful in terms of incorporating that into their decisions.

I’ve seen a lot of cases with NCCN, which I don’t know if you’re familiar with that, but that’s kind of a rules and regulation organization founded about 30 years ago by Bob Young. And they parallel FDA indications. You know, what you find on the labels that FDA comes out with. But NCCN is a little bit more flexible on it. And so, they’ll sometimes recommend some very expensive drugs in indications that do not fit the FDA label. And insurance companies follow sometimes the NCCN guidelines, and so they end up using the expensive drugs. But you get the same bang for your buck with cheaper generic drugs. Again, chasing people out of the market. So that’s not quite what you’re asking. But is an interaction between both the generic market and these really expensive drugs.

TEDDY DOWNEY: What is it about these drugs in particular that distinguishes them from other generic markets that don’t have shortages? Is there anything that separates them? Like, why is the market broken in this place and not in other generic markets? Is it because they’re made in India? Are the other companies less, you know, have their act together less? Because there’s a lot of generic markets that seem fine or they’re low margin, but they make it up on volume. I mean, it’s kind of been a low margin business for a long time, except for relatively recently, and you haven’t had these shortages. So, I’m trying to just figure out what changed or what distinguishes these specific products.

DR. MICHAEL J. BIRRER: Yeah, well, I mean, I think that it’s a great question. To be fair, the perspective is it does happen in other markets. I mean, we’ve had antibiotics shortages and other things. So, I do think we need to put it in that context. It’s not only oncology drugs.

The second issue, I think, is that anything in oncology gets exaggerated. And I think that’s for two reasons. Cancer affects a lot of people and has a lot of emotional overtones in terms of being that dreaded disease. So that tends to hit home in terms of the press. In addition to that, cancer gets exaggerated because, to be perfectly honest, if you look across our hospital systems in this nation, as opposed to when I trained which was centuries ago  I mean, again, I did my internship and residency at Mass General in the eighties. Cancer was probably 10 percent of the — maybe 10 percent of the revenues of the hospital. When I went back in 2007, it was almost 55 percent of the revenues. So, cancer is driving the revenues for a lot of these hospital systems and a lot of these hospitals. And so that also exacerbates this whole process because it’s such a huge financial component of these systems. So, I think, first of all, it does happen in other systems. But cancer tends to exaggerate it.

And then third, you touched on it. We just have a disproportionate arrangement in the United States between what the generic market is here for oncology and what’s found in India and other countries. Why did that happen? Maybe that’s also a symptom of this problem, which is the new drugs come out and because of the cost of development, they get priced so high. That’s what’s driving the entire system. So, it just discourages generic development of oncology drugs in the United States. That’s gone offshore and that’s in India. That’s a little different, I think  although, I don’t have my finger on the pulse of this as much as oncology — but that’s different than antibiotics and rheumatology drugs, non-steroidals, so and so forth. There you have, I think, a better United States generic system.

TEDDY DOWNEY: So, we’ve talked a little bit about pricing. We’ve talked about this option for, you know, the U.S. government to be a little bit more proactive from a contracting standpoint, from a strategic supply standpoint, reserve kind of standpoint. It comes up a lot about manufacturing here versus India, you know, incentive. You know, we have this big investment, the IRA and infrastructure and things like that. Do you think like kind of a strategic national investment in production of generics in the U.S. is important because it’s just going to be a higher quality? It’s going to be subject to higher FDA standards, more frequent review?

Because in terms of India producing these drugs, we still import a lot of generic drugs from India, right? They make it. We sell it here. So, it’s not like that doesn’t happen. But it sounds like you’re saying that those are subject to imperfections, maybe shut down facilities more often. I don’t want to put words in your mouth, but that’s kind of the implication that I’m drawing here. Is that accurate? Or how should we be thinking about the quality difference between generics made in India, China versus the U.S.?

DR. MICHAEL J. BIRRER: Yeah. So, I think you bring up some really good points. I think I put out the simplistic, reflexive proposal to say, look, identify a few Indian companies, due diligence, get an agreement with them that they would be part of this. There would have to be some sort of arrangement and they’d get paid for it, but it would be proactive.

The flip side is what you’re describing. And I think it saves you — it would save the FDA and it would save a little bit of the anxiety with patients who wonder about the quality of the drug they’re getting. Now, the FDA is awfully good at this. And I’ll give them an A+ — well, I’ll give them an A. I don’t like to give the government an A+ for anything, but give them an A. They do a very good job on quality assessment.

But if you had something, you had a fairly limited number, it wouldn’t have to be that broad of companies that were in the United States, subject to all the rules and regulations and either — I mean, I would never support NCI or the federal government or the FDA saying we’re going to build a factory and it’ll be a government factory producing X, Y and Z. I think that’s a model I would not support. It would be better to say, look, it’ll be in a private sector, but there’ll be a number of companies, federal government. There could be a limited number of drugs. The federal government would probably be obligated to subsidize them. They’d all be generic. And the pricing could be arranged. It would still be cheap, but the pricing could be arranged to recover that money. So, from a taxpayer standpoint, it’d be a wash. And it would provide availability for these drugs so we wouldn’t have to worry about it in the future. And it would have the quality. If you’d asked me this 15 years ago, I would have said you’re crazy. But I don’t think that’s crazy anymore. I think it’s worth discussing that, yeah.

TEDDY DOWNEY: Okay, great. I just want to check to see if we have any questions from the audience. We don’t. Anything else? We’ve got some policymakers. We’ve got some law enforcement people on the line here. Anything that we’re missing, any solutions, that you wanted to talk about that you think would be explored? I mean, we covered a lot of ground here. Or any issues in oncology that you want to complain about or companies that are doing anything wrong? You’ve got a great opportunity here. So, I don’t want to leave any stone unturned.

DR. MICHAEL J. BIRRER: I can touch the third rail with a sort of real out of the box proposal. But again, these things are discussed and it’s worth putting them out there as a policy discussion. In terms of the sort of outrageous pricing of these and the lack of competition with generics, you could change the patent policy and alter it and make it most likely shorter. The challenge on that is that then it’s likely the companies compensated for that will raise the prices. And I certainly would not like price control. Price control would be a disaster system.

This is the other dirty little secret a lot of people don’t like to talk about. But the truth is that the pharmaceutical industry in this country — and some of these companies are headquartered in Switzerland, but I still consider them U. S. based  we have the most robust R&D in the world. And so, we don’t want to change that. That’s helping patients. But there might be some fine tuning on that, I think, that would help both patients and still protect the companies so that they can do business going forward.

And then we already talked about potentially creating a modest, but government supported, generic drug structure here. I think there’d be a lot of appetite for that. I’ve also talked to people who have thought about sort of subsidizing with federal dollars, providing generic drugs for patients. Again, that’s sort of a Medicare or Medicaid, an altered Medicare kind of approach. I think we’ve been there, done that. I don’t think that’s going to work. I think we need to actually build infrastructure so we have the drugs.

TEDDY DOWNEY: One of the issues that we deal with a lot — and, you know, this idea of changing the patent policy comes up a lot. But one of the other things that we’ve been hearing — and I’m curious how it goes in oncology — is the insurers are so vertically integrated and they’re replacing medical decisions with financial decisions, the sort of corporate inputs in the medical decision-making process, either from the vertical power of the insurance companies — or I guess it’s a little different, in part, for you because a lot of your stuff is through Part B. So, you’re not always dealing with insurance companies. But on the flip side, we did talk about McKesson having a lot of influence here, just having rolled up a lot of these oncology networks and the big GPO there. And then we’ve seen a lot of private equity buying up medical provider practices. Do you have any issues with that in oncology? Or is it really not something you run into very much?

DR. MICHAEL J. BIRRER: Well, it’s a mixed bag. We’re required a lot, by particularly private insurance, to get pre-authorization. And that is cumbersome. It’s an additional regulatory step which requires hiring additional people, which just drives up the cost of health care because they have to make the phone call. And then even when they make the phone call, they don’t get prior authorization, which means that the physician, like myself, we have to get on the phone to do a peer to peer.

We usually win that. I’ve been pretty impressed, at least down here. And I’m in Little Rock, Arkansas. This is not a wealthy state. We have a lot of poor people. We win most of those discussions if the drug we’re arguing for is FDA approved and we’re within the indication or it’s on the NCCN list. You’ve got to think about that ahead of time. If you’re trying to do something off label, it’s probably not worth your time.

So, it’s a mixed bag. Sometimes you lose it. Sometimes you win it. Some of the newer therapies like CAR Tcells and biospecific antibodies are very, very expensive. There is an effort, particularly from the private insurance, to limit that. And so, it really comes down to how hard you want to argue it and how much time you have. And that indirectly raises the cost of medicine. Because you need to bring in an army of assistance to be able to make those phone calls and do that stuff.

TEDDY DOWNEY: How discouraging is it when you lose those fights with the insurance company? And what happens to the patient?

DR. MICHAEL J. BIRRER: Well, there’s good news, and bad news. The bad news is that it’s very discouraging and patients get very annoyed and angry. And sometimes it’s clearly the right drug and they’re making a bad decision. On the other hand, the good news is where we’ve evolved in oncology is that there’s a lot of choices. There’s a fair amount of redundancy. Meaning that for a given disease, you might have four different drugs you could pick from. So usually there’s a fallback position.

And then, again giving credit where credit is due, a lot of these pharma companies will have compassionate use programs where they’ll provide the drug for free if the insurance company won’t cover it. But again, it involves a boatload of paperwork. So, you’ve got to do diligence on that. We have one APRN who that’s all she does. She will fill out the forms and send them to the big companies to say, you know, we need this drug. Medicaid’s not going to cover it. Can we get free drug?

TEDDY DOWNEY: And then one last question here related to this and we can wrap up. I know you’re extremely busy. You’re a prolific writer. You practice medicine. I don’t want to take up too much more of your time. But what is the quality of the expertise on the other line when you are arguing with the insurer’s medical expert?

DR. MICHAEL J. BIRRER: Yeah, minimal. Minimal. It’s probably one of the most depressing aspects, I think, of the conversation. It’s called peertopeer, but it really isn’t. And particularly from an academic standpoint, I don’t think there are where they should be to be making those decisions. I’ll go out on a limb on that, yeah.

TEDDY DOWNEY: That seems problematic, profoundly problematic.

DR. MICHAEL J. BIRRER: Yeah, that can work for us because you can kind of — you can dance around it and convince them. But, I mean, you have to think about it from a practical standpoint. These are big companies. They’re insurance companies. They’re really not academic health systems. They’re not like MD Anderson. They don’t have that expertise. Now, they will bring people in and they’ll pay them. But I don’t think it’s as good as it should be.

TEDDY DOWNEY: Yeah, yeah. I mean, I just look at how much money they make. It seems like they could afford better medical experts, but who am I to say that? But, Dr. Birrer, this is an amazing conversation. I’m excited to get the response from our audience in terms of how these ideas percolate in our community. I think your level of expertise, how much you’re paying attention to all these different things, is incredible. And I wish you the best of luck going forward, both in your medical practice and your advocacy. Because I think this is just extremely important work that you’re doing.

DR. MICHAEL J. BIRRER: Well, I appreciate it and I really appreciate you creating this and inviting me to The Forum. It’s been fun. And I’ll leave you with a positive message. This is just an unparalleled time in oncology where we’re really doing very good things for our patients. And this kind of discussion, I hope, would evolve so we’ll do even better things for them.

TEDDY DOWNEY: And I couldn’t agree more. And thank you so much for your time. I know you’re extremely busy and thanks to everyone in the audience for joining us today.

DR. MICHAEL J. BIRRER: All right. Thank you. Goodbye.