Roy Vagelos0:00
Ladies and gentlemen, let's begin this next polemic that will take place on pricing in the Trump era, and drug pricing of course. This is a big deal, and so we have brought together a number of heavyweights to discuss the various topics. But I will give you a little bit of a preamble. First of all, this industry, the biopharmaceutical industry, has brought about incredible improvement in the health of people in the last 40 or 50 years. Incredible. I mean, you can just spout out the various innovations that have been introduced that have made major improvements in health. And these have been done by a collaboration that takes place between people who do basic research at universities and find fundamental knowledge that is needed, supported entirely by government and philanthropy, and then industry steps in. Biopharmaceutical companies take over and they try to make drugs. And as one of my friends on my left here says, getting a real drug to market is hard. And it is. It's a very risky business, and it's very expensive. But what kind of things have been done? We've seen reduction in cardiovascular diseases dramatically by introduction of drugs for high blood pressure and cholesterol. Incredible reductions in death rates from cardiovascular diseases. We've seen improvements in almost every aspect of our health. Infectious diseases, of course, vaccines, hepatitis B, which prevents liver cancer, the human papillomavirus vaccine, which prevents cancer and cervical cancer. Right down the line. And this is done well. So 20 years ago, the public had an enormously positive reaction to the reputation of the biopharmaceutical industry. Over the last 20 years, the reputation has gone into the dust. We're down there along with smoking cigarettes and a couple of other bad things. So why? And it boils down really to, other than the rogue people, things that are caught up where people go to jail and unusual episodes like the Mylan EpiPen pricing, huge increases because it's a product that is controlled by a company where people must have it and you can put any price on it. But other than that, there have been problems with our industry in pricing. And this pricing at one time was thought to be not too difficult. You figured out what the value to the patient was, and you saw what other things cost on the marketplace, and you made a judgment and put a price on your product. But the scene changed. There were individual items that happened that I attach to these changes, but they're not inclusive. But the one thing that hit me, and it was maybe 15 years ago, Len can remind me, when Avastin came on the market by Genentech. Avastin was introduced for metastatic colorectal cancer that had been treated before and failed, so it was an important disease and unmet need. Avastin was put into these patients. The average value to the patient, that improvement, was an extension of life of three to four months, filled with side effects. The price was $50,000. I almost fell out of my chair when I read that initially. And it stuck. Not only did it stick, but Avastin became a multi-billion dollar product that put a floor on cancer biotech drugs. Anything better than that had to be a multiple of that. It just had to be. And so those are the incidents that stick in my mind. Now, I've been accused of being opposed to high price drugs, but that's inaccurate. For instance, this morning there was a discussion of a hepatitis C drug that was launched at over $80,000, and that was said to be very high and people screamed about it. But this is a drug that cures people. Better than 95% of people are cured of a disease that otherwise causes chronic liver disease or death from liver cancer. It cures them. This is a bargain. $80,000 for a cure from that, and you're not treating your general population, you're only treating the people who have the infection. HIV price? Exactly. I'm not sure, $25,000 to $30,000 a year. A bargain. HIV, everybody's going to die. Now everybody who gets a triple combination goes back to work. Incredible value. Is it worth $25,000 to $30,000 a year? Absolutely. And it goes right down the line. There are some wonderful drugs. However, something else has happened in addition to some abnormally high-priced launch of drugs. The other thing that's happened is increases in prices after the launch. And while these were modest, and I would say there have been experiments in the past on how to control this, Merck in the early 90s agreed and announced that they would increase prices no faster than the increase in the Consumer Price Index. The industry hated it, but they followed. Within a year, every major company agreed to the same thing, and it worked. Obviously, it hasn't continued. A really good drug, Gleevec, terrific drug, wonderful introduction by Novartis of a drug that cures some people, but most people respond, they go back to work, they live almost normal lives. The price at launch was $26,000. What is it today? $146,000. That's a jaw dropper, isn't it? That's incredible. These are increases of over 10% per year at a time that we've had some inflation, but this is crazy. And so that has stunned people. And people say drug prices are too high. And our president, who is otherwise crazy, also says that drug prices are too high, and he's going to do something about it. Well, yeah. So what else has happened that's new? I'm telling you things that you know. But let's say what complicates the issue. And we have, by the way, representatives here on the podium to speak to all these issues. We have PBMs, pharmacy benefits management groups, that come in. They gather large numbers of people that they control, for which they provide all the drugs for this group. There are three PBMs that I believe control about 80% of the population that needs drugs in the US. And they negotiate to get the drugs that they're going to provide to their population that they control. They negotiate with each of the biopharmaceutical companies, and they get the prices. They get either discounts or rebates, whatever you like to call it, of 30, 50, 60%. And so they're reducing the prices. Some of that is returned, it benefits the patients or the payers, but a good deal of it they keep. And the amount that they end up keeping, I believe, is almost equivalent to the amount that is kept by the inventing company, which is incredible. And so we have middlemen. And not only do they negotiate prices, but if they think the price is so high and the cost to them, to their formulary, is too high, they manage the utilization by putting hurdles for doctors to cross in order to get the drugs delivered to the patients. So not only do they change the prices, but you have a whack price, wholesale acquisition cost, and then you have a net price, which is what you end up with. And then they can regulate the amount that you can sell. So if you have a product that you're anxious to break through, they could sell at a much lower price and reach a fraction of the population that you need to reach for the good of the people who deserve that drug. So you have that. Then you have the issue of international pricing. What happens when you have a good drug and you want to get it on the market? You get your price in the US. You go to all the countries overseas. All these prices are regulated. It's all price regulation. They all negotiate down. You never get the US price. So it's decreased by between 30 and 60% to get onto individual markets, country by country. They negotiate you down. And so, excuse me, as it turns out, American people pay the most and the highest prices ever. And it's a terrible situation because it's that money that supports the research and development. So Americans essentially pay for the R&D that's going into drug discovery and vaccine development, et cetera. So we have that. Is there a way to come up with fair pricing, to actually relate the benefit to the patients to the price? And in the UK for a number of years, they've used the NICE approach. NICE, which is the National Institute for Health and Care Excellence. But they negotiate, they try to relate to the quality, the cost for quality. And you're going to hear about that because there's a non-profit, independent group called ICER in the United States, not related to government at all. It's independent. It's the Institute for Clinical and Economic Review. And they look at every new product or service, and they put a value on it, and they come up with the economic effectiveness, cost effectiveness. And they publish their results with a recommended price. But you don't have to take it. You can not pay any attention to it if your company and just go on and do it, or you can negotiate with them and try to convince them to work with you so that you come up with an understanding that when they publish, they don't knock you out of the market. At any rate, so those are the complications. And it's a system that's working amazingly. People continue to come up with new drugs. But the system cannot continue as it's going because there's tremendous pressure now to do something about pricing. And while I myself think we need to be in a position where there's a complete understanding, transparency in the pricing, so people know what the prices are, how they relate to value to patients. Transparency for everyone. And that there should be a growing feeling that going back to where we started, that the industry is working to improve health and to do it at a reasonable cost for people. That means fair prices at the launch and then price increases that try to recover inflation or consumer price index, something like that, where everybody could understand it and would agree that this is a fair thing to do. Now, I don't know that we can get there, but we have certainly people who can speak to all of these. And the first panel is filled with experts. The first one is Len Schleifer, who is the founder and CEO of Regeneron. And I must admit, I'm chairman of that group. And we had another Regeneron speaker earlier, George Yancopoulos, who was explosive. He gave a very exciting talk, kept me on my toes, wondering what he was going to say. But it was exceedingly entertaining and informative. Then I expect Len Schleifer has an MD PhD. He trained first at Cornell, then went to University of Virginia for his MD PhD, which he did with Al Gilman. And then he trained in neurology and started an academic career in neurology. But within a very short time, decided that he wanted to start a business. And he did that in 1988. That startup company has been enormously successful, and there are 6,000 people employed in that company here. And so he brings the focus on how you price exciting new products and to make it worth it, because the most important thing is for people to have an incentive to discover new products. That's what we have to be able to guard and be sure we retain. But we have to do it with fair pricing and with the people who look at us feeling that they're getting a good deal for their health improvements. So Len will give us the company. And Peter Bach is a director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering. And he's something of a critic of pricing of cancer drugs and maybe other drugs as well. And in 2015, he put out a Drug Pricing Abacus to help people determine fair prices, which is his focus. He trained undergrad at Harvard, then an MD at the University of Minnesota and University of Chicago later. He is triple board certified. And so he's a real doctor who understands this. And he will talk about his view of fair pricing. Then we have Steve Pearson, who is an MD with a master's degree in an MBA, I believe. He is the founder and president of ICER. And he's a good guy because he evaluates the value of products in a technology that he will explain to you, which seems to make sense when you read about it. The objective is to improve patient care and improve costs both. And so we will hear from him. Then we will go to... Let's see, he's an MD at UCSF and then a Brigham and Women's training, and then a master's degree in health policy and management. And he spent time at NICE in England, so he's enormously well trained. Then Steve Miller, MD, Senior VP, Chief Medical Officer at Express Scripts, a PBM. So he was trained in pathology, so he's ready. He's used to dealing with very ugly things. And he did cardiology at UCSF, Washington University. He did pulmonary, I'm sorry, nephrology and transplantation work. Has an MBA in addition from Washington U. Since 2006, he's been the Chief Medical Officer at Express Scripts. And he knows the field better than everybody because he knows all sides of it. So let's start. Len, would you start off the discussions, please?