Transcripts For CSPAN The Hill Holds Forum On Prescription Drug Costs 20170723

Of the people, most of the people, who were is central to his political rise. Tonight at 8 00 eastern on cspans q a. Commissioner scott along with Industry Experts discuss Prescription Drug access and costs as well as balancing industry competition with public safety. This is two hours. [inaudible conversations] quite so it like to thank our sor i would like to thank our sponsor. This morning, we are focused on the cost of medicine. Are rising faster than Overall Health care spending. The concern the warehouse is expected to unveil the executive order even as we wait for direction with a how can the entity help manage costs and keep it successful for all americans . Are marketbased solutions being explored . We will hear from government leaders and Patient Advocates as they explore a landscape where patients can get the medicine they need at and up at a price they can afford. If you notes of housekeeping. In addition to those of you here in the studio, we are Live Streaming and we ask that you keep your phones on silent but we encourage you to join the conversation on social media. You can follow us on twitter at the hill of vents and you can comment. We will take questions throughout the program. Keep an eye out for members of the team who have handheld mics. Finally, there is a short survey on your chair spirit we would love your feedback on the event. Feel free to give that to a member of the staff on your way out. Before we get underway, i would like to invite megan stott meghan scott, executive director of the affordable Prescription Drugs to make remarks. We appreciate distinguished panelists and also all of those in the room and watching online. There is nothing else you could possibly be focused on so thank you for being here. Aside, the very real issue of rising jet prices and the impact they have on American Families and employers, taxpayers, the health care system, and our economy could not be more timely. We are pleased to have representatives from across the supply chain as well as a representative of the patients who rely on those drugs. Addressing the ongoing challenges one that deserves a substantive dialogue and cooperation across the entire health care system. I would like to share with you a little bit about who our members are and why we come together now. Public sector retirees and health plans and other stakeholders they partner with. These diverse organizations know firsthand the real value these partnerships allow them to provide to their members through sustainable and affordable subscription description drugs. The issue is front and center for many because about half of all americans get their coverage through the employer system, far more than any other source of coverage. Amid the rising drug prices, employers have had to find ways to make sure their employees, members and families could access the medicines they need. More and more sophisticated purchasers have chosen to. Artner according to a survey in 2009, of more than 250 employers, only 47 of employers were partnering to manage the benefits. As tread prices continue to rise , four years later you saw that number hit about 61 so the organizations are really working to find ways to ensure that employers and members have access. The average list price in 2016 grew by nearly 20 10 but the average net price growth fell to around 3 and that is real savings being driven through negotiations with manufacturers. They are also essential to the affordability and sustainability of government programs, which were talking about a lot these days. Without pbms, looking at premiums about 60 higher. Value by building highquality Pharmacy Networks and reducing prices. Encouragexpertise to they achieved the Health Outcomes at a lower cost and they provide patient focused programs and tools aimed at improving Health Outcomes and avoiding unnecessary cost such as hospitalization. Has appropriate that the htag is whatsnext. Ensure access and affordable and sustainable framework. We believe solutions should build on what is already working for government programs, employers, unions, and other organizations most americans rely on for health coverage. Opportunityimmense to encourage an effective use of medicine to both improve Health Outcomes and significantly reduce Unnecessary Health care spending in the public and private sectors. We finally need to do things that increase competition for Prescription Drugs by facilitating faster reviews, identifying little or no generic taking a closer look at at the competitive practices to it when there is greater competition, employers, and text is all benefit. A big thank you to the hill for hosting this conversation today and with that, i will turn it back over to johanna and well get it started. Thank you all. [applause] thank you. Lets dive in. We begin this morning with a conversation between two members of congress who oversee matters related to health care. The congressman of texas is a Ranking Member of the House Energy Commerce committee on health and congresswoman diana is a Ranking Member of the energy and commerce subcommittee on oversight and investigation. Joining me is the Hills National correspondent. Thank you for being here this morning. Aboutl chat a little bit the crisis and we will open it up to your questions. There will be people with microphones all around looking for you with your hand up. What role does Congress Play . Particularly our commerce committee, we have jurisdiction over all of the issues of exclusivity and availability of drugs and Medicare Part d. People like us think what we should be doing is having indepth investigations and hearings to figure out why all of a sudden, high prices of Prescription Drugs seem to be pervasive everywhere. Onhave urged our colleagues the other side of the aisle to have a robust investigation. It is not just a simple issue of Prescription Drugs are going up, lets reduce the prices. As we just heard, it is a complex system that seems to be growing more complex and more opaque by the day. Congress needs to take an active role. I agree. We are democrats so they do not let us call hearings. I would have an aggressive hearing schedule of our hill subcommittee on a number of issues. Would like us to work with cms more and make sure we do not , but also, drug prices to see where we can get some things that stick out like sore thumbs. Venture capitalists coming in and buying pharmaceutical and raising the price astronomically. Not a dime of that goes into research. Again, we do not want to dry up research because that is how we discover these cures. Since diane and the chairman where the main sponsors, we want to continue that intensity with fda funding, nih funding, the good news is the first two years, it was 2 billion of new money for nih. Then it was 1. 2 billion in their draft bill. Can get that up. Overoal was 10 billion five years. You bring up an interesting toance between the prophet the company and then going into research and transparency a lower cost for consumers. How do you strike that balance . I do not think we have figured out how to strike the balance here otherwise, we would have to get solutions we frequently do. This morning, we do not have that to present. Grownms as the system has more complex, your previous speaker talked about complex system where you have haitian, employers, unions, insurance pharmacies, and the pharmaceutical companies themselves. You have a complex system and for each, it seems there is negotiation and rebates. And then over all of that is the drug research, patent exclusivity, and the development of new and exciting drugs and other drugs that really are presenting new and innovative cures for people. It is difficult especially when we have not had hearings, to determine exactly what that cause is or what the solution would be. Congressman tom reed from new york and i are the cochairs of the congressional diabetes caucus. That has inrugs exclude inexplicably skyrocketed in price is influence p we have undertaken and many investigation of our insulin to try to insulin,t how is it which obviously every type one diabetic and many type two diabetics rely on, how is it it up. Presently spiked we have been systematically talking to representatives and of course, is always someone elsess fault. What we are trying to do is get a full picture. Were trying to convince the chairman of the full committee and our respective subcommittee chairs to have a series of investigations. We could use influence pricing as an example. It is not clear exactly what you do at this point. I think jane would agree. Insulin is a good example. When you see some of the Market Forces that happened, i think we can agree on a bipartisan basis that we need to make sure we do not see that kind of jump in. Rice someone can go by the patent. That does not help the system. It just raises the price for the consumers. Congress appears to be moving toward a bipartisan fix of the Affordable Care act or some kind of bipartisan negotiation. See role would you like to inrmaceutical pricing play some kind of next version of the aca and is that something you address . Rep. Green i hope that is where we go to. There has been a push in the senate yesterday morning on the not have ag, we do democrat or a republican solution and we need to sit down across the aisle and have an american solution for health care, that would be all encompassing. Access is important where i come from. I want people to go to some of the great medical facilities and the Medical Center in houston. But they have to have some type of vehicle whether through their employer, through the exchange, and medicaid. One of the sticking points is we shouldnt allow states not to take the whole medicaid. The Supreme Court decision, it was actually the my district,but in 46 hours with my constituents expanded it,icaid 100 reimbursement for three years, 90 and particularly in texas, one third state. 9, 8, 210, it is really a good deal. We want to make sure we get those great facilities we have. Maybe you have information we do not have about bipartisan negotiation and the Affordable Care act, but as jean mentioned, i worked with the former chairman of energy and commerce for three years to develop 21st century cures. The best legislation is Bipartisan Legislation and with convince the house to work because we realized the Affordable Care act provided opportunities for millions of americans but also needs improvement. Areas where i0 think we could research it on a bipartisan way. One of them was Prescription Drug pricing. Despite our many approaches, we have not seen any appetite on that part of republicans to work and a bipartisan way, which i think is unfortunate. I think all of these solutions will have to be bipartisan. Rep. Green the best example, we cannot do it. We First Century cures and mouse is overwhelmingly bipartisan. Works with diabetes, working on the next generation of antibiotics, legislation have to the senate, we been trying to see how to jumpstart the medical research into the new antibiotic resistant illnesses. We have done a great on cures how we will provide health care to americans. Tosome of the things trying provide pharmaceutical compass to explain will that help the market . Rep. Green i think transparency is important. Anyone wholso know has a patent, they may not want to share some of it. Transparency and drug prices so people will know, know. Hysicians want to this is thenow that cost and the goal should be you need to prescribe the most effective thing for your patient. That is what the doctor should do. I think transparency should help. Also for employers and unions who have plants. Couple things i think we need to investigate and issue with this transparency we need to investigate current inclusivity roles. We really want to encourage development of new therapies and new drugs. Some of those take years to develop and many hundreds of millions of dollars in development. To recognize that on the one hand but on the other hand, if there are adequate generic drugs being developed, that will give price competition. Transparency to see if the withng really is in line what the drugs cost to both research and produce. Finding a legislative solution is not easy and you cannot just take a magic wand and developed a formula or Something Like that. The information yet because it all goes back to the investigation and the hearing. I would start legislative call me crazy. I think we have more information before we legislate. That is where i think it would really benefit. We start to access for these therapies. We have very targeted an excellent insulin. Parents of diabetic children have to decide whether they will hide hundreds of thousands of dollars a month. The white house is reportedly working on an executive order for drug prices. What do you think they will do . They dont call us first. Rep. Green i would like to see leadership out of the white house. [coughing] but you cannot jump from one issue every day to Something Else. You have continuity. That would help us if we got leadership out of the white house to sit down and say, ok, lets see what we can do to a compass the goals. It will not be done in one session of congress. It is something we have to get started on. And have a buy in from everybody. Heard a proposal to cut new drugs to the market. Where do you see the balance between cutting regulations to increase access and protecting patients in the long run . Well i think we need to look at both as part of that. It takes a long time to get from the lab table to the bedside. Over a time of five years, half 1 billion. I will give one example. The fda cant do it when we had the ebola scare three years ago, there were u. S. Citizens doctors being treated and i asked one of what would happen if the doctor who is aware and have the knowledge, there was something, if you all could try that . Fda 24old it took the hours to get information. The sad part is they dont know if that pharmaceutical help treatment and survival, there needs to be more on that. Want to make sure we take on some of the more terrible illnesses. Diabetes is one of them. Also, we had the breakthrough that we passed years ago. Companies in helping get therapies on the fast track for approval. It is targeted for what we dont have treatment for. It does give competition. Earlier, we have had two issues. One is it is really easy to a generic for aspirin. It is ought harder with some of biologic therapies that we have to develop equivalent generic solutions. Some of the expensive treatments are being developed for diseases that affect a relatively small population. Relatively small population. So it is economically not feasible to develop a generic we ,eed to figure out how competition in those areas. We are already, incentivizing the development of any treatment and we have to figure out how we can do the same to have compass competition. I have one more than we will turn to the audience. You mentioned exclusivity. That is a major part of the whole conversation. What do you do about the and justof a patent how long one company can keep a stranglehold on one drug . What we need to try to do is find a sweet spot where you are giving exclusivity for a time that incentivizes and encourages people to develop. Make sure it is not so long that people get a monopoly over that drug and that may have no incentive to keep the price low. Study after study has shown where you have that alternative. It brings the price down. Rework. Nue to work and there are a number of had an exclusivity provisions in the long right now. We have had a small one in 21st century cures. There is a continuing dialogue pressure around that and again, no Silver Bullet around that. As members of congress we have two levers to increase funding. We need public funding for nih, but private sector funding. Exclusive is the is one of those. You have to be careful. Money. Ard to get but also a lot of members have real concern about the use of exclusivity. But if you want those new, breakthrough drugs, those are the only two levers we have. All right, lets open it up to questions from the audience. We have a couple people with microphones here. Any a question right here. Question right here in front. Thank you for your presentation. Think it is very important issues where we need context. One is hospitalization and Health Issues that go to be er. So, [indiscernible] they used those prescriptions or hospital facilities, increasing the hospital cost. We have the effort for that distribution. Yes, of course, you are right. If we repealed the Affordable Care act, that would exacerbate that situation where people who did not have insurance but like they had to go to the hospital for treatment. But youre right. People who do not need treatment go to the hospital and that increases cost. One thing we have seen increasingly in the diabetes realm, people cannot afford to get their insulin. They go to the hospital. Diabetic shock. Get go to the hospital to their insulin. It is a poor way to treat diabetes. Rep. Green is a poor way to treat anything. I should not be in the emergency room with my sinus infection. If you have a huge number of uninsured folks, they dont have anywhere to go except to show up in an emergency room. One more question please . Hi, in with inside health policy. Notwithstanding your comments about the need for hearings of are legislating, other any solutions to drug pricing you all see Congressional Republicans able to get behind . And if Congressional Republicans cannot get behind drug pricing, is it up to the executive branch to fix the problem . Rep. Degette i think there will be Congressional Republicans here in a little while. I suggest you ask them that. I will say one thing that jean and i both fought for gene and i both thought for was the ability of the secretary of hhs to negotiate drug prices in Medicare Part d. We fought hard for that in 2005, 2006. I think that really would help. It would increase transparency and it would send waves throughout the whole system if negotiatee secretary drug prices. Rep. Green whether this is the First Century cures, other things where 21st century cures, other things we worked on over party lines, things like drug pricing. All right, one more . If not, i will take one more shot. What about an agency like the v. A. . The v. A. Has so many Prescription Drugs. What role can they play enforcing the industrys hands . And should they . Negotiates. The v. A. They are the one federal agency that can do it. The believe me, my union to represent employee benefits, companies negotiate for those certain pharmaceuticals, so i think, you know, negotiation can be one of the things, like diane said, but that is one way we can do it, do it like the v. A. Does. When the Prescription Drug plan was part of03, that it. That was part of the problem. Gotcha. All right. Green, diane to get, thank you. [applause] thank you so much. I would like to call scott, the new commissioner of the food and drug administration. We look forward to hearing from him. Dr. Gottlieb. Back over to you. Thank you for being here. Congrats on the new job. Have you found the lights . It is not my first time at fda, but it is my first time in the new facility. I imagine it is different. What role will the fda be playing in the new market . In order for a market based system to work in my view, we need competition and i think there are places in the pharmaceutical market right now where we are not seeing the Competition Congress intended when it put in place the architecture for the modern system of drug pricing and that is what we are focused on. There are places we could affect the amount of competition in the market with generic rugs and also with respect to new drugs. We see places, particularly on the generic drug side where i think there are market failures where people are taking advantage of regulations in ways that were not intended or our own regulations are not working as we intended them to. Example, there are places with respect to regulations where you see solely because we do not have a good framework for demonstrating sameness. There are complex drugs, in particular, drugs that are complex in that they cannot be measured in blood easily or they act locally on tissue. They do not apply. They do not work well. We see competition that should be happening in the market not happening because of falers in the system. You do you have to write a whole new set of regulations to plug those loopholes . Like i said, i do not want to be in the business of playing waccamaw with companies. At we want the system to have clear role people can take advantage of. When i look at the market and places where there are rules that are being four lakh of a better word for lack of a better word, being gamed, theres a set of disparate factors. They use Brand Management to ensure the safety of drugs as ways to deny access to samples and doses to create the generic copies. Paycompany is willing to fair market value and they are using tactics to prevent from getting access to it. That clearly is not what congress intended and what we intended when we created those regulations for a very specific purpose to ensure that drugs can be used safely. I think there are things that we can do to address that. Another thing, there is the negotiation over single share you want Risk Management around the use of certain drugs and where generic drug comes into that market you want the generic drug and the Branded Companies to have the same architecture. It decreases the burden to providers and that is what is provided for in the law, but sometimes there are negotiations over entering into the same system because the Branded Company allows the same system. They will have to come to some compromise. Sometimes the negotiations are protracted. That is used to forestall generic entry. Were going to look and see if we can make a decision and allow the something is to go their own way. That is another thing where we can look at policy changes to more change sooner. This is also happening on the commercial side. Look at the impediments to generics getting access to samples, probably the biggest impediment, the contracts that companies have, they actually have exclusionary language in those contracts that prevent the intermediary from selling to the Generic Company and that again makes it hard for the Generic Companies to get access. Wants to docompany studies. That is fair market value for the branded drug. They should be able to purchase it like anyone else. There should not be prevention provisions to prevent them from getting access to it. That is where we can do something on the fda side maybe. Gotcha. You laid out the drug action plan. It is a multipart plan to address what we are talking about. Were talking about places where we see branded rules. We are looking at issues around complex drugs. We are also looking at issues around the ordinary review process. If you look historically, generic jobs have gone through an average of four cycles before they reach approval, an average of 48 months. Scrutinyommitted to the finale application. That will allow generics to go to market sooner. It also will end what i call regulatory arbitrage where you have situations wheres the chelators can comment and by a drug, jack up the price a lot and know it is going to take fda up to four years to get another competitor into the market. Theyed to make sure that cannot take advantage of the system. First of all, we are publicizing the situations where theres no branded drug. Theres effectively one drug on the market. We will prioritize situations where there is a ack of competitors where there is a of competitors. Some people know if they come into a market and they buy off the low volume generic drug and try to raise the price out of proportion to what seems to be tethered to any reasonable notion of value, that prices going to attract competitors into the market very quickly and they will come to the market very quickly, not for years, but hopefully six months or eight months. You will not have that long opportunity for arbitrage. A situationeate where you see less and less activity. I think there is an important principle at stake, that the high price is attracting competitors. That is good. The market is functioning. But that should come into the market much sooner. Office ofout the generic drugs. I know you revised some of their procedures. I think they have been well. Ing very we have a secondary user fee that we are hoping to pass sometime very soon. That office is much better resourced. I remember when i was at fda, that office was historically funded through the budget. There were parts of the Agency Protected by user fees. Generic drugs historically had not seen increases or had seen cuts. Is an much better shape now and its an excellent management. A change in procedures for the way we will review applications. We will create a template to make it more consistent on how drugs get reviewed and we will be printing out drugs, trying to help Drug Companies learn about common problems and applications. The problem on the generic drugs is the applications go through a lot of cycles. When they, in, they do not come in on the first cycle. This is something we saw on the new drugs side. That and we to do were going to do the same thing on the generic drugs cycle and we will be focusing activity on the new function of cutting down multicycle reviews. They hopefully will be reviewed on the first cycle. What kind of backlog on generics does the fda still face . Dr. Gottlieb we have agreed we will completely eliminate the backlog of applications i the end of next year. I am very confident we will hit that goal. Hope is we can get to a steady state. The reality is the number of ,pplications we are receiving we had a Record Number of approvals and we hope that continues. I am still confident we will get to a state where we are not Still Holding up a backlog. I think we are close to being the now. Where dcb balance between cutting regulations and protecting the public . Dont think it is a choice between more regulation or more safety. I think we can have a situation where we can have a smart regulation that allows us to have a more efficient process. Improve sure that we patient safety. And that is another part of what we are doing. We have an innovation plan. Placeso try to look at across the agency, but especially on the new drugs side, we can have in place a better framework for looking at safety risk benefits, safety and forcacy, new Technology Current rules and make sure we have in place to be approving drugs. So, for example, one of the guidances we have committed to is looking at there are certain drugs, certain signatures. The cancer might appear in different organ systems, but it is driven by the same molecular signature. Targets, you have to improve efficacy and every tumor type. Againstprove it works tumors for this particular molecular driver and we are going to allow approvals rather than study each organ, which obviously will make the review process, the Development Process more efficient. We can do what we call a basket trial. We have patience with liver tumors and we can get overall approval and get the numbers that we need to treat more quickly rather than have to study organ systems individually. That is the kind of thing where we are looking at modern science. Is how we look at standards in a more efficient way to see how programs can be less costly and drugs get out more quickly. New drugs this is something i learned in my prior life as a venture capitalist. Obviously theres a lot of complex considerations. I have never been in a position to price drugs. It bears some relationship to how you are trying to price the product you are trying to develop. Impact that this would how drugs needed to be priced. The cost of capital is not just the cost of developing the product. It is the cost of uncertainty and, in fact, the biggest driver if you look at models of how these decisions get made, the biggest driver is often uncertainty, not the direct cause. If they are understood, they can be financed. Uncertainty and risk is hard to finance. That is what entrepreneurs tend to overestimate. The fda has targeted this niche market of drugs with high cost. Where theres a priority . Dr. Gottlieb private complex drugs it were talking about . This is a highpriority occurs this is a whole class of drugs that should be subject to generic competition, but arent because of the complexity of trying to them in straight sameness. So with those complex drugs and these are things like metered dose inhalers. On the gut, or a drug that is hard to measure in. He gut you can measure the availability of the rug in the blood. These drugs are basically drugs that should be sold as branded drugs at branded drug prices and our ability to put them through the process to me, that is a failure of regulation. Congress clearly intended for that. The reality is, more of the drugs are moving into this arelex realm because these standard formulations, different kinds of complex formulations that allow drugs to have different attributes that make them harder to coffee. The traditional approval process works, you have what was crafted thirtysomething years ago. The Company Comes in and they prove when you swallow their pill, it gets into the blood in the same amount of time and it stays in the blood for the same duration and you can therefore compute it has the same therapeutic effect. That worked well in a world where drugs were chemicals and they got into the blood systemically and got to the target organ and they worked. But when a drug is acting locally on tissue, whether it is an inhaled drug or it cannot be , itly measured in the drive is a complex mixture the old concept does not work so well. The question is do we need new statutory language to create a new pathway for these drugs . But i think there are things the fda can do . We have created guidance in advance of the earliest possible generic for drugs Going Forward so hopefully we will eliminate this process by creating standards. We also will go back and look at complex drugs on the market that are not just subject to generic competition and try to put in place Clear Scientific standards. This is not a trivial amount of spending. This should be subject to competition, but isnt the cause lack of ours or the rules. I want to focus on areas where congress clearly instructed us they anticipated vigorous competition, but for one reason or another policy failures or market distortions we not seeing the competition intended. All right, ive got one more and then i want to open it up to your questions as well. Should it be fdas role to increase transparency in the market . Thats a broad question. I think we are increasing transparency in the pharmaceutical market. When Generic Companies come to us and tell as they cannot get access to the samples they need, we will often send a letter to the company saying there is no son why you cannot sell basically this is the situation. We save the rims that you have in place, we have reviewed the Generic Companys bioequivalence study plan and we have determined they will adequately comply. They will maintain custody of the drug in an appropriate fashion. You can sell it to them. Those letters go to the Branded Companies. We are looking at making them public. That will provide transparency where we believe there might genericpediment to the Company Getting access to the doses that they need. I think that kind of tonsparency could be useful impact some of this behavior. It up took, lets open questions. We have one back in the middle area there you go. Microphone coming right to you. Hello, i am julie. I work for a pbm. Where there is competition, we can drive down cost. There has been great prioritization of breakthrough therapies. I think one of the challenges in the market more generally is you gethere is that competition on the branded side and have several drugs competing. Is there any effort to take a look at getting that third or fourth landed drug branded drug or a particular mode of action . Thank you. Dr. Gottlieb we will sometimes give multiple drugs within a class and there will be multiple drugs and congress can look at this as well, trying to extend the designation to other drugs and a category. As what we would refer to as those drugs is not a situation where the fda is not prioritizing applications. We are seeing very vigorous review timelines and i personally do not cad prioritization of applications because there might already be a therapeutically available product in a given space. I think the challenge i see is more of a commercial challenge, which is companies are more in a category. There are downsides to that to your point. And we are seeing less competition in some of these categories. And also, we have variety. Even if a drug is molecularly similar to another product and targeting the same conditions, sometimes patients do have a differential response. We know that. Its important to have variety in categories to read we have seen a lot of that unfortunately. Right, any other questions . Got one right upper. Microphone microphone is getting there. Dont worry. [laughter] there we go. I, nick hi, nick with inside health policy. I was wondering if you could walk through why the fda has not prioritized those letters previously . I know previously fda has not been able to share, for example when a Brand Company and a Generic Company cannot share im wondering if there are particular legal issues you all are possibly running into when trying to share these letters, and when they are going public, would Brand Information be made public . Dr. Gottlieb with these letters in particular, we are making the Company Aware that the Generic Company is trying to copy their drug, but not the public aware. I think we are looking at the issue of whether there is commercial confidential information in any of these letters and how we would redact that. I dont see an obstacle to making them public. I think theres more we can make public. All of these come down to questions of how much resources you are willing to spend redacting certain materials . And the question of how much legal risk you are willing to take for a policy objective . Things ust be doing we certainly do not do these things as a public shaming vehicle. We cannot do these to inject ourselves into commercial disagreements. We do it when we have a Public Health rationale and if we have a strong Public Health rationale, taking on the burden of using resources to redact things, i think we have to look long and hard at doing that and that is what we are doing. All right, one more question. Anybody in the back . We have not heard from anybody in the back yet. Hi. My name is taylor wouldnt. I am from amgen. My namemaceutical is taylor wooten. Larger flumist larger pharmaceutical companies, will they see a return on investment and will this impede drug innovation in the future . Dr. Gottlieb im not looking to appropriate intellectual property. Make sure weto have competition in the market where intellectual property has lapsed. They make decisions to develop product a star next dictation of how much ip they have to protect , to protect their products. They make economic decisions, whether or not they can out of the capital to make investments subject to the kind of capital they have. Do, i am looking forward to the competition that congress fully intended for there to be comes to market and people are not using our own rules and particular to extend the monopoly past a point that was anticipated or intended and that is happening. People are taking advantage of rules we created for another purpose to extend franchises and monopolies past the point of patent expert he, and it is having the unfortunate effect patent expiration, and it is having the unfortunate effect if we are in fact in a situation the point is well taken, this is over 2 billion to develop a drug. This is in a norm is an enormous capital investment. Its too much relative to what the expected ability is to recoup those investments given what the patent life is. That is something for congress to contemplate. Its not something for us to contemplate. We have to do our job and our job is to make sure products will be subject to generic competition once all of the intellectual property has lapsed and we can legally approve a generic product. All right. Gottlieb, thanks for being here. [applause] senator bill cassidy is a member of the senate health, committee,labor known of the few physicians in the senate and an influential voice on Health Issues. Cassidy and sen. Cassidy he is both. Thank you for being here, senator. We appreciate it. 48 hours of been intense on capitol hill. What are the next steps for addressing the aca . Sen. Cassidy [sighs] [laughter] sen. Cassidy i didnt even have a discouragement. The president very much once i replace with repeal. He said that over and over again. Much wantsident very repeal. E with something similar to what senator collins and i propose you give the power back to the patient, power back to the state to rid she who controls the money typically has the power. If you return it to the state and to the patient, then she has the power, the patient has the power. How can we block grant. Can we take all of these dollars and dispense it back to the with some guidelines provisions such as, for example you can use Health Savings accounts to pay for premiums which allows you to take insurance of their choice. Andeasing competition getting the federal government out of micromanaging someones insurance. We think that is a good approach and we are getting some traction. All right. Lets start on the cost of fixing drugs. What role does congress have to play an increasing transferee transparency over drug prices . Sen. Cassidy you are making a great case that lacked uptrend that lack of transparency is driving up rates. The Insurance Company gets it. When a patient has a deductible, she does not get the discount, and so she is playing three times more for a drug then is the contractual price. If she knew what that point of sale rebate was, she would get that discount. It may be that congress has to mandate that those patients get rebates. There are lots of implications. The degree to which she is paying more outofpocket rapidly pushes her into the catastrophic portion of Medicare Part d. Not only is she paying more than the contractual price, but the taxpayer is paying. Part d benefit goes up dramatically. There is an ag report that lays it out dramatically. That kind of transparency would save money for the patient and the taxpayer. Secondly i think my state is one of the few to do this there is a state that has at least one pbm which, with a gag order on the pharmacist, and in some cases, it is cheaper for the patient to pay out of pocket than to go through her benefit to she pays more under her benefit. The pharmacist is gagged. And he tells the patient, listen, he paced the contract with the pbm. Not all do that, but at least one does that. In our state, you cant have a contract that gags the pharmacist from representing the patients best interest. That is a good thing. Transparency of information benefits the patient. We are all about transparency. About do conversations transparency impact funding of Biomedical Research question mark research . Thatcassidy i dont know it impacts the funding of Biomedical Research. There are folks like Bernie Sanders who would like to march in. Toy spoke about the need increase investment. We all want there to be a cure for alzheimers. If folksarch will come believe there will be an adequate return on investment. That is a good thing. I am afraid that it will chill the investment and the needed cure is that ultimately will decrease cost for our society and improve outcomes for patients, that they would be chilled. All right, and is Congress Starts to address the aca once again, there could be bipartisan discussions going on. Our drug prices part of that conversation. Is that part of the aca that needs to be fixed . Sen. Cassidy i think that is a little separate. Medicarethat is in party, which we are not touching with the Obamacare Repeal or replaced. There is that joke i went to broket and a hockey game out. What broke out was a lot of frustration on the democratic the process and it ended up having a great panel, fabulous witnesses, but a missed opportunity to explore what could be done. Im thinking until we get this kind of repeal replaced behind as it will be difficult to have a poor operative formal Committee Hearing in which we explore. That said, ive spoken with colleagues on the democratic side. Theres a lot of things we agree on. Can we Work Together on those points of agreement, set aside those on which we disagree and find Common Ground . The white house is working on an executive order sen. Cassidy obviously dr. Gottlieb is going to intimate some of that, but there is the Regulatory Regime which delays the approval of certain drugs. Address that. The Supreme Court just this past broughted that they generic biologics out six months earlier. That is a good thing. There is no one Silver Bullet for drug pricing or drug transparency. Right, what about cutting the time from the drug being approved and protecting the public . Sen. Cassidy you have to set up a metric and this is what we do in my office when we analyze this. We look at it as generic, small molecule, Specialty Drugs versus ran name and generic. And really, what you do different in each segment of this and we use a Specialty Drug it may not be a biologic. That, we will break it down. Lets take a generic which has no competitors in the United States and because of the back home, overseas they used to pay . 50, now they pay 15. This is for a drug that is 50 years old. Someone may dispute that, but that is how it is related to me. It may be in this case we should globalize the market. There is a plant in india which is producing the active pharmaceutical ingredient for the drug sold in the united intes as well as the drug the united kingdom. We have a memorandum of understanding between the fda and the eu which says if one certifies a plant in india the other will accept that certification. We already have this working relationship. Could we say and i think we should that this generic small molecule, if there is integrityupply chain for both the drug going to, save the eu, and the United States, that we would allow the sale of. Drug from here to there if you go to france and buy a lot of of certain drugs that only has one supplier here, bring it back, and sell it. We have used Market Forces to create competition as opposed to the heavy hand of government regulation. I think that is the way to go as an example and again, i will say it once more. Small molecule specialty brand and generic, and when you break it down, you come up with Different Solutions for each problem. Gotcha. Ottlieb was a peer question mark what you think about the trump administrations head of the fda . Sen. Cassidy i think he is all about trimming processes to improve throughput. There are rules that have been held up there are complicated rules to get right but if implemented, would dramatically shorten introduction of generic competitors. Thats a good thing. Once you get a generic competitor, prices begin to plummet. Will bring attlieb lot of energy and insight into this job. More and we will turn over to questions from the audience. But what role does an agency which by so many pharmaceuticals, negotiates the room prices, what role do they have in bringing down prices across the market . Sen. Cassidy they certainly show it is possible and they certainly show what a drug company is going to go down to in order to have a larger market share. I always thought it would be quite trumpian if president went,went,hmm, v. A. , we buy 80 ofare, this drug and we should negotiate. That would save billions in the short run, but i do fear it would quell investment in the long run, and President Trump is a business guy so he will quickly pick up on that. On your hand, could you imagine him doing it . Absolutely. The v. A. Show you what is ofsible with that sort negotiating position. It may encourage our president to go in the direction of going that position even more. Let me say one more thing. One thing i am concerned about though is the high price of drugs go back to the patient it should be about the patient. There is the social contract with pharmaceutical companies where they are given a really nice rate of return and god bless them because we all need them there are people in this room who are alive because of advances in pharmaceuticals over the last 30 years. When i was a medical student, the most common surgery was cutting out parts of someone stomach because of a bad ulcer disease. And nowng came tagamet we never do that surgery. Altering drug is no overthecounter. Be a commono surgery was taking out pieces of someones bowel because of Crohns Disease and people with almost neverse now have surgery. We need that investment. On the other hand, there are some patients denied lifesaving drugs because of the price of drugs and we have to recognize that. So Medicaid Programs which typically medical rate medicaid across the nation, the Medicaid Programs cannot afford the medicine to treat patients as rapidly as they would wish to save those peoples lives. Thats just a reality. One thing the v. A. Did was right driving down the price, they are therapy. Ush out and the price of drugs effectively deny treatment to some who needed and the v. A. Drug and price is good for patients and that is one thing where you look at the impact on access for other conditions and payers . Gotcha. A right any questions for the audience . Right over here. Hi. I guess i have to take issue, whator, unfortunately with you said about hepatitis c curative drugs. As mentioned bva the v. A. A great example. I think they are down to 24,000 as a cure. But for medicaid, it is around the same price, because the rebates, competition and discounts, and so, we feel that this is 24,000 for a cure and that will save money down the road. There are a lot of drugs that are a lot more expensive. Most of those costs are borne by the federal government. Sen. Cassidy you say most of the costs are borne by the federal government. Technically that is true. They were about 50 . If you look at cap c hep c, that is quite a figure. Most state governments cannot put up that amount of money. We worked on a spreadsheet. I am a liver doctor. You might interest that i have an interest in this. Because ofhat is treatment in louisiana. If we treated everybody we possibly could in the first four years, we would save money in the longterm because he would hepaticer transplants, cancer, etc. , but you have got to treat them upfront and thats a very expensive price tag. But that said you still want to reward investment. Two things we looked at, one, the Mortgage Rate of financing. In the mortgage, you would say we will pay you off over 30 because we will realize the savings for the Medicaid Program the 30 and we can realize mortgage. The Netflix Subscription is that you would pay a certain amount, and theut on bid company would be guaranteed some reasonable this is what i get from you over the course of events and you can treat as many as you wish. That we need to come up with alternative means of financing. I will tell you. To say otherwise is not the new reality. You are wellmeaning, but so am i, and that is the reality of the situation. All right. Sen. Cassidy a thank you for taking the time. Sen. Cassidy thank you. [applause] thank you to the senator and to read. Next up we will be rethinking pricing, how are stakeholders within the Health Care Industry finding ways to address the rising cost of medicine . What kind of collaboration is taking place . What can patients expect . Welcome onto the stage the senior director of Global Policy james lilly and company, ceci connolly, the Senior Vice President and chief medical officer of of them are x, and the help policy editor kim dixon will be leaving this one. Over to you. Kim hi. Thank you for coming. We had a few discussions that touched on some of the challenges we face with skyrocketing drug costs. Ttlieb talkedr. Go about the regulatory side. Most of the people in the green room thought that that was a step in the right direction, but there might the differing opinions about what congress can do. You talked about increasing competition, speeding up drug approvals, regulatory hurdles. What more can be done . Is that enough . I think that there were some opinions . More observations, kim. And thank you to you and the hill. It has been a great morning. I have been in d. C. For many years. I think commissioner gottlieb is off to a significant start in his role. We have heard encouraging things with respect to spurring competition. He mentioned what may seem like a small thing to laypeople, which is getting samples to Generic Companies, that its very significant and it has been a huge roadblock. If he can have success and areas like that, we believe it really bringpur competition and down prices i will just toss that on the table one baby step, frankly, for congress, which would be a bipartisan bill on transparency. Transparency is not going to solve our drug pricing problem by any means, but getting information to the public would sure be a nice start. Kim drug prices are controversial. When you talk about that bill and more transparency in r d why dont you talk about that bill and more transparency in r d . Sure. I want to talk about this in context and a few figures spending was roughly 14 , and that figure is expected to continue roughly at the same percentage over the next decade. Growth, 20 inng 2016, net prices 3. 5 , eli lillys net price increase in 2016 was 2. 4 , and just to put those costing context as relates to the Overall Health care spending, i think its important, what has occurred over the number of years as hras savings accounts, and individuals are facing the duck dibbles, insurance, and out of pockets deductibles, insurance, and outofpocket spending will increase and as congress wrestles with health care, the Affordable Care act, drug pricing, i think one of the areas they could focus on is the out of pocket expense and senator cassidy spoke to that to some extent. Lilly listedcy, the net price in the aggregate percentage discount which has decreased almost 50 . That is one of the ways we are trying to pay put more information out to understand how we price our medicine. Primarily in the states where a number of uses of legislation while they are wellintentioned, the challenge is they dont do anything to address out of pocket expenses today. There are competitive provisions create challenges and do not speak to the value of medicine and we want to work toward that goal of transparency, absolutely. Kim do you want to jump in . Thank you. This is a vexing problem because we have the best of all worlds. We have innovator drugs, casesful drugs, in some may be curative. If patients hand, cannot afford it, it will have patient. T to the we are challenged by keeping up ins pipeline and competition lifesaving drugs, but we are also challenged by the cost. My opinion is speeding up generics in transparency and all of these things being recommended which are important will not fix the systemic problem to rid we simply have a issue and it will take Bipartisan Legislation. Transparency, speeding up generics not enough. What would be bipartisan solution you have to look of the whole Health Care Ecosystem . Ms. Sigal you have to look at patients being treated. You have to look at my world. You have to make sure the diagnostics are working. Patients are being treated. There are many studies that show many patients are not being treated and not given the right rugs. It is a systemic issue and it is a complex issue because we want to keep innovation. There is the difference from the pharmaceutical industry that drug prices really are not rising, and maybe they arent as a whole within the whole ecosystem, but we know that they ,re forced to shut the drugs drugs that are saving peoples there those are rising are Specialty Drugs, drugs that are saving peoples lives, those arising within certain classes. Bill, if you can address specifically r d costs, and, you know, with the industry be willing to give more information on how much it costs to develop a drug . Again, speaking to transparency legislation, when you look at what is introduced, of looking at the byproduct or input cost basis creates an anticompetitive concern that i mentioned earlier. If i can add to that kim sure. Let me join everybody in thanking the hill for this panel. If i had been here a year ago i would have been the chief of the drugs association. We switched names. There was discussion about the importance of generic competition this month already. It will shock you to hear me associate myself with all of these remarks. Senator cassidy mentioned the promise of bio similars that offset thetential to increasing rise of specialty medicine. The other thing that i went to say up front is not all prices are going up. Generic prices are going down. Thee is price deflation in overall market place. The media and others will often highlights a single incident of that alleges price gouging. In two examples, neither one of products is classed as a generic medicine. I got a phone call from the removinging if we were someone from our membership. The reporter took me to task and said, how can you defend them . I said i am not going to defend them because they are not a member. They are not a member because they are not eligible to be a member. Be aare not eligible to member because dora prim is not a generic drug. There are a lot of people talking about solutions to Prescription Drug cost. Governmentewer agencies taking meaningful action to do, among other things. Nhancing competition he has the potential to be transformative, and while that marketplace, but it is good for patients. It will help constrain costs. Ismatter who you think responsible for where we are in the drug pricing debate is like the old picture of the three stooges where they are pointing at each other. , and what more people are coalescing around, a key component and i underscore component of the solution is marketbased competition and nowhere is that opportunity more prevalent than increasing the Competition Among generics moving forward. We agree with that, providing perspective. Competition is a good thing. I think the challenge when you look at big numbers and large groups of people is the individual who takes the becific drug, that drug can very expensive, as was pointed out on the panel and some of these drugs are very difficult for people to afford. So, where i think we all come in and Work Together specifically in the pbm industry is to provide the mechanisms to work with our partners and pharmaceutical companies to evaluate the drugs providing value. System tosing the i do think that in a complicated system, it requires effort on the part of the pharmaceutical companies in terms of patient advocacy. The pharmaceutical managers which have the systems that dr. Gottlieb talked about to turn into low price at the level of the patient. I would like to comment that in the previous comment as well that the Solutions Lie in collaboration. How we can Work Together to arrive at extra mental solutions and valuebased agreement. Contractual relationships and moving generics to market with our partnership with the fda. I think we are in agreement with that. I think competition is incredibly important. Even with the innovative drugs, if you look at what is going on about three or four or five drugs are all going to be used in combination. They all have to be specific to a biomarker. They have to get the right combination which is right for them. So, it is evolving. It is not static. High,r, if the copay is then it will not benefit the patient. If they cannot afford it, then it is of no value. So, we have to preserve innovation and Patient Choice and outcomes. This word of value is kind of like motherhood and apple pie. We all want highvalue and to deliver highvalue chick it is great. I am valuable and you are all valuable people. But lets get real here. Insulin is valuable, incredibly valuable. Think of all the people with diabetes in this country. When congresswoman up the diabetes challenge today. In 2015, 1 in three americans will have diabetes. Just think about the implications for our society. Our Incredible Team went and told the Pricing Trends of the past seven diabetes products and form products. What happened to them between 2010 and 2015 . Across the board, the increases in those products went from 93 to 325 . Insulin has not changed. Not one bit. Theirat is going on in and how are all these people with diabetes going to afford this . How is our society going to afford this . I agree with that point so much. I think we have a tendency to talk about components in isolation. So, when you look at the dynamic that you just pointed out, you would expect a portion that a patient pays to increase as well with the total price that product, so ier think it is very hard to point to a specific piece. That thed not to say total price of the product is not an issue either. Said that, in terms of the past few years, whether it be by these bad actors or summer sensations, had you keep the motivation going . What specifically do you see happening or could happen in the next year given the political environment . Well, nothing is going to happen. Dont sugarcoat it now. [laughter] 80 mployees say that about employees pay about 80 of the cost of health care that we offer. That includes families and retirees as well. We are bearing the brunt of these cost increases. I do not think you would find a single employer see a layoff notice go to the good men and women of the fda. We all agree that we must find the fda. At the same time, when congress says, well, in the next five years, there will be one bill thatne bill only, lets do and then talk about drug pricing later. They are using washington talk and not real talk. The real talk is that we are going to miss the one opportunity that we could have to do something meaningful on drug prices. Here we are saying that we will have some hearings later. I love hearings. You get to submit testimony for the record, and there is interesting conversation, but usually it produces nothing. So, we have to focus right now on what we can do to work with the administration and our pdm partners who are engaging with some interesting valuebased purchasing agreements. We are huge partners on that and we love that, but at the same time we have pbm and Drug Companies trying to do the right thing, but it end up creating problems in the prices for medicaid for example. Things that congress looked at a couple of years ago and said, this is too complicated. Lets find Something Else to do. We are worried. Eightst are going up at unsustainable rate. People say it is not the cost of the drug that matters but the copay, but no it is the cost of the drug that matters. You have to wonder where the drug price is going up. Some folks say it is the supply chain and middlemen, but others say it is the cost of the drugs that they are straight up charging to people buying them. Eventually, we have to figure it out to stop going the way we are going. The would just go to podium. [laughter] agreeould like to strongly in part and disagree strongly in part. Unfortunately, washington is what it is as we all know. Do not underestimate some of the forces that do not want to attach that discussion to it. At the same time, there will be vehicles later in the year. There will be vehicles through which the federal government will need to find money. I think there is also a political dynamic. A lot of people on both sides of the aisle campaigned on this issue including the president of the United States. Cycle going into the midterms, if nothing meaningful is done in this space, that i think the folks who ran on it are going to be reminded about that fact nonstop. All the way through the 20 18th midterm cycle. I think when of the things we have to focus on is where we can see the opportunity for alignment. I would propose that there are three different areas. If this was a simple solution, we would have found it and not be here talking today. There is certainly the regulatory aspect of it. I will not go into that part of it, because you are you heard from the commissioner this morning. But there are additional Things Congress can do short of completely disrupting a market and making it a overall regulated utility. There are ways to create competition. Bipartisan incentives that would allow for that type of competition to be accelerated and save the federal government money. The third thing we have to do ultimately is make sure that the market is working efficiently. Genericity is utilization is up 4 from may 2016 to may 2017. Generic revenue is down 15 . The reason for that is because level of competition in the marketplace. Been ans also incredible amount of consolidation in the supply chain. There are three to four wholesalers and large retailers and the pbms have consolidated as well. You can expect 10 or 12 Generic Companies to be competing solely on price when there are so few purchasers in that market, it is just something we have to factor in. 10ot of people talk about years ago how you needed to get the eighth or 10th generic to get the commodity pricing. You get there now with three or four. Isn it functions, the Market Driving astronomical savings year after year. 3 billion in savings from generics in 2015 alone. So, we have a lot to fix. We also have to make sure we do not disrupt the mechanics driving that level of savings. So, when you talk about drugs, we are not talking about a car. You can take a car, you can take an uber, you can walk, or you can take a bicycle. When you talk about medicine, innovative drugs and those targeted towards a specific population, that is more complicated. If the patient gets the wrong then it will not help them. They have to receive the treatment which is a validated diagnostic. 700 Centers Across the united , some of them are only about 2 or 5 of the population. Who is to think about getting the drugs. We heard last week about carty. This is going to get very complex. What Patients Want are the drugs and treatments that will work for them. They want access to it, it has to be affordable. How were going to balance these issues is going to be very challenging eventually. We have to get the patient the right treatment, and it has to work for them. Quality of life is very important. Go ahead. Assuming we are going down the line, i will speak next. I agree with my colleagues on the panel. The perspective i want to make sure the audience leaves with is that the pharmacy benefit managers role is to take competition, take choosing the right drug in a perfect situation, and to implement that for patients. That is how we fit in. It is a difficult thing. Perfect information is why it is so hard to get there. I will give you a simple example. Opioid epidemic. The cdc has come out with guidelines that say that doctors should prescribe less than seven days of morphine and acute medication. They have also said he should have less than 50 morphine equivalent dose average per day. Nothing more than that. They also understand that, if you take an opioid with the benzodiazepine, your risk of overdose will be more lethal than a Motor Vehicle accident. That those things should not be done together. Implemente do is we programs that allow the script to only have seven days worth of supply. Flag the doctor and patient risk about an opioid and benzodiazepine taken together. So, that is how we fit into the equation. Act to the previous comment about employers. That wes, you forget are not just a pharmaceutical manager but also an employer as well. We have retirees who are on a health plan, and there are steps that have been taken in terms of providing the employer contribution to the health plan upfront in the plan. You are helping individuals manage their health care expenses, looking at exempting and preventing chronic medications from the production phase. I think those are voluntary decisions as an employer which helped individuals through their Consumer Choice in selecting a health plan and also understanding how they progress through the year. Thing to build on that. Unfortunately, i think there are a lot of companies that would probably like to offer first dollar coverage for things like insulin for diabetics or inhalers for asthmatics, but under the current rules, if we do that, the patient loses their eligibility. It is something we think is important. I absolutely agree. I think it is very important. I think it picks up on a theme that the others have tried to hit on today would you getting the right care for the right patient at the right price. Of that is thinking smart about your health. So, managing chronic diseases and prevention. Proper prevention measures will help these individuals live healthier lives and not have the more serious illnesses that are on. It will cost all of us much more money, so some of this is just about being a little smarter about the investment of front which makes sense. It takes thinking a little more longterm which is especially difficult in washington with the scorekeeping and all of that. Spending the money now will save us later on. I would like to see policymakers with the industry starting to track that and illustrate that in a more meaningful way. Will get news on capitol hill when talking about drug and how do you, see obviously it is in a state of flux right now but how are you figuring out how your industry will be impacted . I know the aca was a coverage bill which impacts pharmaceuticals. It is not get a lot of attention. Have you taken a position just on the latest repeal bill . I was going to ask which one . It is a moving target. In the time that we had been in here, who knows what is happening. Our position continues to be that we want to make sure people have appropriate access and coverage for health care, and that includes apprehensive Prescription Drug coverage for some of the reasons you just talked about. Having access to both generic and bio similar medication Going Forward is, in the continuum of Overall Health care, when the most Cost Effective vehicles you can have to maintaining public cost. That said, with the issue in the u. S. And getting meetings with what is going on, the answer is yes. Drug costs wasn such a big discussion through the campaign cycle. That whatever happens or does not happen in that space trilogy to whatever does or does not repeal and replace, the issue will come back out on its own. There was a meeting the other night where President Trump rock a bunch of republican senators brought a bunch of republican senators together for dinner. In the discussion, they talked about the repeal act. Issues was selling insurance across state lines, and the other was what we are going to do about Prescription Drug costs. It may not be getting the focus right now because of other things, but i have every expectation that this issue will circle back around. Second all of the comments that this has to get past before they start sending they started before sending out notifications to the fda. They do not deserve that. People believe the cdo and 13 Million People do not have coverage anymore, that is not really a good thing. Do, andnk what it will then i will stop and let other panelists speak, i think we will take the sensitivity on the issue of Prescription Drugs and elevated higher. The dropping coverage, the reason why it is so important and so much of the recent debate goes back to that is just just try to think back to 2008, 2009 when we had a very high number of uninsured americans. You can all recall very well what occurred. Individuals with preexisting conditions could either not get any insurance or they faced very high insurance hills. Or, they went to the emergency room when they were terribly sick, far too late in the progression of their disease. Not good for their health or for anyones wallet, because those get passed on to employers, taxpayers, and all the rest of us. The reason we come back to that is because it is a linchpin piece of our system. You hear them talking about managing a risk pool. Is the 32 million the right number . Who knows . However, even if the cbo is off by half, 15 million or 16 million uninsured, that is ok . Who wants to say how many million uninsured is ok . Stress costto inaffordability, but try to think about how much 13 million 50 million 15 million, 60 Million People losing insurance will cost. We have to fix this. It is a complicated problem. Taking some of the people we reallysurance have to think about the patient, the individual. These are people who are sick and need help. We cannot forget about what the impact will be on families and how treacherous this is going to be. How devastating it will be for people. Particularly the underserved and the people who are themselves challenged. One thing i have to do for my job that is not very fun is that i have to read the whole cbo report. To readot had a chance the repeal only bill yet, but i have looked through the others. Those started with the number 23 million. When you start to read the report beyond the first page, you see that 11 million of those people are people no longer forced to buy something that they do not want. About half of the remaining, another 5 million or so, are who dowho have not not live in a state that will who live in states that have not expanded medicaid. 3 million or 4 million have coverage through an employer, and the cbo says it will not offer coverage anymore. They say it would have to be an employer with highly paid individuals who are healthy. So, if you dive into the number, it is closer to about 4 million or 5 Million People. I think that is a number we should be concerned with. Goingk those people are to need help, and something has to be done to make sure that people get coverage. However, women talk about numbers in the 20 million 30 million, then i do not think we are telling the truth. We are doing washington talk again. Certainly, the Affordable Care act consumes a lot of the attention and time whether it be during hill visits or other dialogue. There are policy solutions that we are looking to pursue. One of them being that he based agreements and risk rising that it is not being over bullish, what looking at the tools over bullish, but looking at the tools to shift to valuebased deals and shifting to realworld outcomes, there are also barriers either regulatory or legislature. Statute, the best price for amendments, the ability for pharmaceutical managers to have conversations , aor to fda approval clarification on instances where we had discussions with stakeholders and members of congress about the potential to have value based agreements flourish. We want to be part of the potential solutions. We will take a few questions if there are any out there. Someone in the first row . Dress. Ck thank you. Much. You so this has been fantastic. Part of the title today is ensuring access. We have been very future focused, but we have systems in place right now to manage costs including what we heard in the beginning, the role of pbm and payers. Ist we see in our population that even when everything is in place, someone has insurance, the drugs are other formulary, and they are innovative treatments for people who are otherwise out of options, out of cs, erics out of generi what our Research Shows is that 63 of people who meet criteria are denied access. Their insurance request is denied. We know it is a burden on Health Care Providers and on patients. The therapies are not getting to the right patients at the right time. So, what can we do to fix but we already have in place . How can we Work Together to make sure that those patients, who have a genetic condition and a treatment that is great for them, who are still denied . I can start. I think, first when a patient requires a drug and it is appropriate and eight do not get it, then it is and they do not get it, then it is a failure in the system. So where do so what are the solutions . I think it comes from other and more perfect information at the level of the provider. I can tell you some of the things we are working on. We are working on electronic communication within the doctors workflow, so there can be real time or more immediate answers. A dialogue around that which is more seamless for the patient. I cannot speak to the numbers you were referring to, but i can say that, ideally, it should be 0 for people who need it. Some of these tools to provide information at the level of the physician can help. Quickan offer a couple of thoughts. Someexample that 20 of do nots to date today fill out their prescriptions. Generally, the doctor does not learn about it from their patient, so we already have this information gap which is hurting patients. So, if you are in a more integrated system where your health plan and providers are coordinated, you can get more of that realtime information sharing which is so important. Then, clinicians are aware that they need to do something for this patient. So that is an important linkage. Also, empowering pharmacists more. And this becomes a state issue when it comes to practicing, licensing, and what pharmacists can be empowered to do. They can play a Critical Role in making the connections and getting the right drug to the right patient and etc. I think what you have pointed out is a very important thing. Certainly, integrative Delivery Systems are one way to deal with it. Things we can do today and that i think people are doing are looking at the pharmacies which typically will fill the medication and then process the claim. If the patient does not show up, then they will reverse the claim and put the medicine back in stock which can be seen in the electronic footprint of the pharmacy, so we use information like that to go back to the physician and say that maybe your patient is not fill the medication. You might want to have a discussion. The issue of abandonment is certainly a problem. That is an example of abject failure in the system. There is recent data for generics where it is 7 . A recent study shows that it is because the affordability issue is an increasing concern Going Forward, so we do have to stop it across the board, but in markets where the generic is available, you are two thirds more likely that the patient will start and stay on the 30. I am afraid that we are and start on the 30. Im afraid we are out will start and stay on the therapy. Im afraid that we are out of time. I would like to thank all of you and our panelists for being here. Thank you for joining us. Thank you for joining us. Remember your surveys on the way out. The full video will be available today. Hill later thank you again. Tonight on q a. When we look at president obamas domestic legacy, i think you are two things which are very important which will have longlasting, good consequences for the United States which can be summarized in four words. Sonia sotomayor and elena kagan, his two nominees to the Supreme Court. The second part of our twopart documentary series. He talks about his book rising star on the making of barack obama. The point to emphasize here is that over the course of his presidency, there were scores and scores of people in illinois who had known him in years earlier who were deeply disappointed with the trajectory of the obama presidency. They were disappointed in two ways. Number one, disappointed that he forgot the people, many of the people, most of the people who were essential to his political rise. That is tonight at 8 00 a. M. Eastern time on cspans q a. White house, a new to medications director, anthony scaramucci, took questions from reporters at the press briefing after sean spicer announced his resignation as press secretary. He announced that Sarah Huckabee presss would be the new secretary, the first woman to hold the position since the george w. Bush administration. This is just over 35 minutes