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[inaudible conversations] [inaudible conversations] to explore some of the most pressing issues of the health care industry. Were focused all of the cost of medicine. And with the over rising prices. To examine the ways to reagan the drug caused. How can every entity keep medicines accessible for all americans . And to be explored with a hearing from government leaders and Patient Advocates as they explore at a price they can afford. And in addition to those here were also Live Streaming please keep your phone on silent but we encourage you to join the conversation and we will be taking questions and to please give the survey to a staff member of the way out. Good morning banks for this important conversation of today we appreciate that distinguished speakers and panelists we go this is a slow time in washington and for health care and there is nothing else to be focused on so thanks for being here but and with the rising drug prices in the impact of american in families and taxpayers and it could not be more timely were pleased to have representatives across the supply chain as the patience to rely on those drugs. And addressing those challenges across the entire health system. Powerball eight touche share the affordable Prescription Drugs and with the pharmacy benefit managers publicsector employees and health plans and other stakeholders. And those that allow them to provide to their members of affordable prescription diet drug coverage because half get coverage through the employers system far more than any other. With the rising drug prices 80 to find ways to ensure employee members and families can access. That is why more sophisticated people are choosing to partner with us. Were there to do 50 employers only 47 percent were partnering to manage these benefits as drug prices continue to rise then the number hit 61 percent because they are looking to make sure they have access. And then by a growing 10 it was held to around 3 also essential to the affordability of of Government Programs that we talk about about and a recent study found that teeeighteen will save 800 and 86 billion for Medicare Part deep and without pbm they have previous 66 higher that savings generated that teeeighteen helps highquality reducing point of sale prices to encourage the use of the most effective medicine with those of achieving the same health outcome. And avoiding unnecessary costs such as hospitalization and very appropriate it is time to find solutions with that approach to ensure access and approved clinical outcomes we believe they should build on what is already idi working that most americans rely on for their coverage brothers the immense opportunity with the effective use of medicines for those approved Health Outcomes with the public and private sector. And lead to increased competition for Prescription Drugs and to identify with no generic competition and looking at those anticompetitive practices. So a big thankyou to the hill for hosting this conversation know i will turn over and really get things started. So lets dive friday it with us to democratic members of congress from a the committee related to health care. The congressmen from texas the Ranking Member House Energy Commerce committee on health the in the Ranking Member Energy Commerce subcommittee oversight and investigation. Join me on stage is my colleague from the hill. Good morning. Biggs for being here this morning we will talk about Prescription Drug prices and welcome your questions as well so what role does Congress Play . We have jurisdiction over all the issues of patent and exclusivity with Medicare Party and basically we have jurisdiction and and so people think what we should be doing is to have that in depth investigation to figure out why all of a sudden high priced Prescription Drugs are pervasive and we are urging our colleagues of the of their side of the aisle to have a robust investigation and hearings. It is unjust the issue of the of prescription of drug czar going up but it is a very complex system and it gets more opaque during the day and Congress Needs to take a more active role. The telesco hearings because i am a democrat but i would have a hearing scheduled and but also were drug prices and for what sticks out is a venture capitalist to come by the pharmaceutical then raise the price astronomically so that is how we discover and then to continue that with that intensity with nih funding the good news is the first two years appropriations gave 2 billion and hopeful leave we could get that for research at nih. You bring up this interesting balance that goes into research and transparency. I know of we know how to use strike that balance. But it seems that as it has grown more complex to have patience or employers unions and Insurance Companies and pbm, pharmacies and the Pharmaceutical Company and each step there is negotiation or a rebate and overall of that is the research and the development of new and exciting drugs. So that is difficult without its investigations or hearings so what that solution would be but the congressman and by from the professional diabetes caucus or one of those that have skyrocketed ted price is what we have done and with a Committee Investigation for insulin. Type one and tied to rely on this so how it is it it is suddenly spiking up in price . So we have been talking to representatives and of course, it is always somebody elses fault. And then to convince the chair bin and then to have these investigations and hearings. But that is not so clear this point. If you see those Market Forces to agree are of the bipartisan basis that you dont see that job bid price so that doesnt help the system but raises the price. As congress appears to be moving toward a bipartisan fix of the Affordable Care act, what role would you like to see with the next version of the hca . I know there has in it a push for bipartisanship by did yesterday of the floor to say we dont have a democrat or republican solution that we have to sit down across the aisle to have an american solution across health care and that is all encompassing of what my folks to go to the great medical facilities and of texas and the Medical Center in houston. They have to have the vehicle whether an employer through medicaid or the exchange. And a Sticking Point is we should not have allowed the states to take all the of the decade. With a Supreme Court decision that was in the senate but in never district 46 thousands would get medicaid with 100 percent reimbursement and typically so bad is a good deal to serve that many more people. To be sure they get to those great facilities. All of us work like that and works on diabetes with tom reed, john shimkus and i work on the next generation of antibiotics that we wanted to gain with the legislation going to the senate. We were trying to see how we could jumpstart that medical research into that new antibiotic resistant illnesses. The chairman burgess and i worked together on trauma care. We can do it. We just need to look at it. We did really great on cheers, but now with whats happened in the senate and i would hope we would do that really bipartisan on how we are going to provide healthcare to americans. Some propose requiring pharmaceutical companies to explain their drug pricing models. Is that something that would help the market . I think transparency is important, and although we also know, anyone who has a patent or they may nae want to share some of it so they could have a knock off, but think transparency in drug pricing so people will know. Even if the physicians will know that win, if they have a rate of drugs for certain illnesses they would know this is the cost aand array. The goal would be to prescribe whats most effective for the patients and thats what doctor should do. I think the transparency would help both on the end result but also for employers and unions who have plans. A couple other things i think we need to investigate in pursuit of this transparency is we need to investigate the current exclusivity rule, and if they are appropriate because as jean said we really want to encourage development of new therapies and new drugs, and some of those take years to develop and many, many hundreds of millions of dollars to develop. So we need to recognize that, on the one hand but on the other hand, we need to see if there are adequate generic drugs being developed that will give price competition. And we also need to have the transparency to see if the pricing really is in line with what these drugs cost to both research and to produce. Finding a legislative solution to that is not easy and you cant just take your magic wand and develop a formula or Something Like that. When we dont even have information yet because we havent had, it all goes back to investigation and the hearings. I would be really loath to start legislating for me actually have on the crazy i think we should have the information before we actually legislate. Surprise surprise. I know, crazy. And thats what i think it would really benefit. Its not a partisan issue. Because we all support the development of new drugs and therapies and we all support access for patients for those drugs and therapies. But from the insulin and i know we have some new and very targeted an excellent insulins. Those are not going to do any good if the formulary doesnt offer those insulins and parents of diabetic children have to decide whether they going to spend hundreds of thousands of dollars a month because theyre in transplant will not cover that insulin. The white house is working on an executive order to do with drug prices. What would you like to see them do . Hardly wait to see that. And what you think it will do . They dont call us first, believe it or not. I would like to see leadership out of the white house on, but the, but again you can jump from one issue every day to Something Else so you have to have some continuity. I think that would help us if we got the kind of leadership out of the white house to subentity okay, lets see what we can do to get accomplished somebodies goes there and begin it will not be done in one session of congress. The cures took three years, and so its something we have to get started on and half buyin from everybody. We have heard as will proposals to cut verse relations to speed generics are even some new drugs to market. Where do you see the balance between regulations protecting patients in the long run . Well i think when you look at both the cures as part of that. One of our issues with the fda was it takes such a long period of time to get from the lab table to the bedside. And carers gave the fda over a period of five years half a billion dollars, but also to streamline and prioritize some of those pharmaceuticals i need to be on a fasttrack pic at our give one example. Fda cant do it. When we had that ebola scare three years ago, there were u. S. Citizen doctors who were being treated, and i asked one of the doctors, i said, what would happen if that doctor who was aware come have the knowledge to do, is there something in the route that you all could try that. And i was told it took the fda 24 hours to get permission for them to get permission to administer that. The sad part is they dont know if that pharmaceutical help with the treatment of the survival, but the just need to be more test on the. The fda cant move, and we just want to make sure they take on some of the more terrible illnesses. And obviously diabetes is one of them that costs so much. But also we have the breakthrough therapy bill we passed some years ago and has been extremely successful in helping Companies Get therapies on a fasttrack as the fda for approval. And its targeted at therapies for diseases that we dont have treatments for. But i think encouragement in generics is always really important because that does give the competition because acid earlier we have really two issues. One of them is that some of the come its really easy to develop a generic for aspirin. Its a lot harder with some of the biologic therapies that we have to develop equivalent generic solutions. Secondly, some of the expensive treatments are being developed for diseases that affect a relatively small population. Not really Rare Diseases but a relatively small population. And so its economically not feasible to develop a generic. We need to figure out how to incentivize competition in those areas. On the one hand, already we are incentivizing the development of any treatment for some of these diseases. And went to figure out how we can do the same so we can have competition. Ive got one for and then we will turn to the audience, but you mentioned exclusivity and thats a major part of this whole conversation. What do you do about the lifespan of a patent and just how long one company can keep a stronghold on one drug . This is a very lengthy and complex conversation that we had when we did 21st century cures. What we need to try to do is find that sweet spot where you are giving patent exclusivity for a period of time that really incentivizes and encourages people to develop these therapies. On the other hand, you want to make sure that its not so long that people essentially get a monopoly over that drug and then they have no incentive to keep the price low. Study after study has shown where you got a generic alternative that brings the price down. So we continue to work and rework, theres a number of patent exclusivity provisions in love right now. We had a very small winning 21stcentury cures but theres that continued dialogue and pressure about that. And again theres no Silver Bullet about that. As members of congress with two levers to increase funding. Its been both public funny for nih but the private sector funding from pharmaceuticals, exclusivity is one of those levers. But just federal money going into nih and you have to be careful because its hard to get money, its also, its a lot of members had some real concern about the use of the exclusivity. But again if you want those new breakthrough drugs, that the only two levers we have. You either come up with money or longer patents. Lets open it up to questions on the audience. We have a couple of people with microphones. Anybody. Right appear in front. A question right here in front. Thank you. I think its very important effort to reduce costs on Prescription Drug but i want to mention there is another important way that you should consider and have a very good effort to rule on the subject. One is hospitalization and health provider, you know, er and whoever sends somebody to the hospital or to see the doctors, when they are unnecessary to do so. So not only are they allowed to use those prescriptions are hospital facilities and so on, increasing the hospital calls but also medical costs. So if you can really take your effort this direction, its very important and everybody [inaudible] you know, youre right. Of course if we repeal the Affordable Care act that would only exacerbate that problem quite a bit answer was back to a situation where people felt, people who didnt have insurance felt like they had to go to the hospital for treatment. But youre exactly right is when people who dont need that treatment come to the hospital then that only increases costs. One thing that weve been seeing lately in the diabetes realm is people who cant afford to get their insulin because the prices in their formulas have gone up so much, theyre just going over to the hospital. They go into diabetic shock. They go to the hospital so they can get their insulin. That seems like a very poor way to treat diabetes to me. In fact, its a poor way to treat anything. I should not be in emergency room with my sinus infection. But thats why if you have a huge number of uninsured folks, thats where theyre going to go because they dont any other option except show up at the emergency room. One more question. Im with Insight Health policy. Im wondering, not list any comments about the need for hearings and investigations before legislating, are the any solutions to drug pricing that you all see Congressional Republicans being able to get behind . If Congressional Republicans cant give me a drug pricing isnt up to the executive branch to be pursuing administrative fixes to the problem . Well, i think theyre going to be some Congressional Republicans here in a little while. I would suggest you ask them that. I will say one thing that we both fought for, is the ability of the secretary of hhs to negotiate Prescription Drug prices under Medicare Part d. We thought hard for that when we the past that law in 2005, 2006. And i think that would really those of the complex generics, complex drugs and particular drugs which either are complex in that they can be measured in the blood easily or a act locally on tissue so they traditional ways for demonstrating seamless to the process dont apply, dont work well with those drugs. Thats where were focused can focus on places where we see competition that should be happening in the market, not happening because there rbos in the system. How do you fix that sort of factor of people taking advantage of the regulations as written . You have to write a whole new set of regulations to plug those little . Its a little bit of code ive said it only been playing whackamole with companies but we want to have them play clear consensual so people can take advantage of. When i look at the market and look for the places where i think there are rules that are being for lack of a better word, forestall generic entries to branded drugs, its a disparate status factors. We need to address them one at a time. So for example, we see situations where Branded Companies use Risk Management plans we put in place to ensure the safe use of drugs as ways to deny Generic Company secretly to get access to the samples they need in order to create their generic copies to vendor the bioequivalence studies to apply for fda for generic caprylic and though the companies are going to pay fair market value and cant purchase those drugs. Branded companies you contact is to prevent them from gaining access to it. That is what congress intended and what we intended when we created those regulations for a specific purpose to ensure that drugs could be used safely. There are things we can do to address that. Another thing that forestalls generic entry, one of the things you want is theres a Risk Management plan in place around the use of certain drugs and i generic drug comes into the market you want to generic drug and the branded drug at the same Risk Management architect. You want all the companies be using the same system to decrease the burden of providers. Thats whats provided for in the law sometimes those negotiations over entering into the same system because the Branded Company on the system they have two about the generic and entry in the system or come to a compromise. Sometimes negotiations become protracted and thats a situation where that is being used potentially to forestall generic entry and we will look at whether or not we can step in and make a decision that when we will cut off those negotiations and just love the Generic Companies because always on the own separate. Thats another thing we can look at policy changes to try to create more competition sooner. Theres a number of these areas where we see this happening. Its happening on the commercial side. We talked about an impediment but the biggest impediment is that in contract the Branded Companies that with specialty Pharma Companies and distributors, they had exclusionary language that prevent the intermediate from selling to the Generic Companies. That makes it hard for the Generic Company to get access to the physical samples. That doesnt seem to make sense to me. If the Generic Company wants to enter the market and two studies and is willing to pay fair market value for the branded drug in order to do the studies, they should be able to purchase it like anyone else. They shouldnt be provisioned that prevent them forget access. Thats an example of where i think we can do something on the fda site and maybe do something working with some of our partners to try to address some of those other restrictions in the market. You laid out the drug competition action plan. Tell us about that. Its a multipart planter we have laid out certain elements so far to try to dress exactly when talking about. Were looking at places where we see Branded Companies gaming are rules. Were looking at the issues run the complex drugs. We are looking at issues related to the ordinary review process, these everyday generic drug review process. If you look historically, generic drugs have gone through an average of four cycles of you before they reach approval, an average of 48 months. We have committed to approve new generic drugs and eight to ten months depending on the application. Thats going to allow generic drugs to come to the market soon. Its also going to end what i call of regulatory arbitrage where you have situations where speculators can comment and buy out a low drug that is not use a lot, jack up the price a lot and know that its going to take fda up to four years to get another generic competitor in the market. We need to make sure people cant take advantage of the system and so will be doing is publishing a list of all the situation where theres no competition to branded drugs. Theres only one drug on the market, if the drug is contradicted we will prioritize the situation with this lack of competitors so people will know the market has lack of competitors and we will commit to rethink to generic drugs more quickly try to get those review times down. So people know if they come into a market and that bio a lowvolume generic drug and try to raise the price out of proportion to what seems to be tethered to the knee reasonable notion of value, that price will attract competitors into the mark very quickly and those competitors will come to market very quickly, not for years but hopefully six or eight months. You will not have that long opportunity for an arbitrage like you had a stroke with thats whats great the situation were people of being able to come into these markets. You see less and less of that now but you see of it. Theres been commentators with felt its abusive. Theres an important principle at stake here at high prices attract competitors and that the market functioning button competition should come onto the market much sooner. Talk about the office of generic drugs. I know you revised some other procedures. How do you want to see them operating in the future . I think theyve been operating very well thanks to the use of the, nap in the Second Generation of use of the related to generic drugs. That office is much better resourced to i remember a time when i was at fda that office was historically funded through Budget Authority. Whenever there were cuts to portions across agency, the parts of the ages it were protected use of these nike cut and the parts of her only fight if the Budget Authority would. Generic drugs historically had not seen increases or seen some cuts over the time. I was there. I think was historically and under resourced unit. I think its a much better shape now. An excellent management. What we announced this week was some change in the procedures for how theyre going to review applications, we put in place what we call a map which is guidance to reviewers about streamlining the review process making it, creating a template to make it more sort of consistent in how drugs get reviewed. We will put out guidance to manufacturers trying to help Generic Drug Companies learned about what some of the common problems are that we see in applications. The problem of the generic drugs that can a problem on the new drug site as well for a while, is the applications go through a lot of cycles. When they come in and they dont come in a form where they could be put on the first cycle. This was something we saw and the new drug site and we made a concerted effort to try to reduce will be called multiple cycle reviews. We were able to do that and we will do the same thing of the generigeneric drug sector we wil focus a lot of our activity on the review function try to cut down on multiple cycle reviews when they come in, they can hopefully be reviewed and approved on the first cycle. Thats the goal. What kind of backlog on generic this fda still face . I do have the exact number on the backlog because weve been working it off. Well completely limit the backlog of applications that i inherited by the end of next year. So we are working to the backlog and to think well hit that goal. Goal. Im very confident well hit that goal. The hope is we can get to a steadystate. The reality is that there is the number of applications that we are receiving and approving is increasing. We had a Record Number of approvals last month on the generigeneric drug site. Im confident well get to steadystate where we are still building up a backlog. I think were close to being there right now. And would use the balance between cutting regulations and protecting the public . I dont think, the people talk about this on the new drug side. I dont think that its the choice between more regulation or more safety. I think that we can have a situation where we have smart regulation and efficient regulation that allows us to have a more efficient process, get drugs to the market more quickly potentially. But also make sure we are improving patient safety. And approving what we know about the risks and benefits. Thats another part of what we are doing. We have an innovation plan we been unveiling pieces is to try to look at places where across agency but especially on the new drug side. We could have in place better framework for looking at safety riskbenefit, safety and efficacy, better framework for, knew as a technology that is sometimes hard to evaluate against a current standards or our current roles. And make sure we have in place the right policies to be approving drugs more efficiently against more modern scientifically valid standards. So for example, one of the guidances we are committed to us looking at, so there certain drugs that target certain signatures of disease so say a cancer where it might appear in different organ systems, but its driven by the same molecular signature, so if the drug targets the underlying molecular driver of the cancer, gf to prove efficacy in every tumor type . Just to prove it works or can you prove it works against tumors with his particular molecular driver and we will allow approvals based on targeting the molecular driver rather than study in each organ which is going to make the review process, the Development Process more efficient. You can do a week call and ask a trial where you approve patients have different types of tumors, liver tumor, tumors in lenny get an overall approval, you get to numbers, the number number they need to treat more quickly that way rather than have to study organ systems individually. Obviously, a lot of complex considerations are made and how a drug is priced and i dont know all the issues that go into that but certainly the cost of capital to do an entrepreneurial endeavor bear some relationship to how you price a product and to the extent that we can affect the cost of capital, we can also make an impact on how drugs need to be priced for the cost of capital isnt just the direct cost of developing a product we know that is also the time, cost of uncertainty and the biggest driver if you look at models of how these decisions are made the biggest driver is often time and uncertainty, not the direct cost. The direct cost can be understood to be financed. Uncertainty and risk is hard to finance. Thats what entrepreneurs tend to overestimate. I want to go back, the fda has targeted this niche market older drugs with highcost. Why are those a priority . Well, older drugs with the complex drugs are talking about . This is a high priority because this is a class of drugs that should be subject to generic competition under the rules of congress established but arent. Only because of the complexity of trying to demonstrate sameness and go to the typical process. These are things like metered dose inhaler and oral drug that you follow but asked locally on the gut or that is hard to measure on the blood and they measure the availability of the drug in the blood. These drugs are basically drugs that are generic competition but for our ability to put them through the generic drug approval process and to me that his failure of regulation. To come up with the regulatory standards that allow the drugs to go through the process how congress intended for that happened. More drugs are moving into this conference room. They do extendedrelease formulation, to kinds of complex relations that allow drugs have Certain Applications and make them hard to copy. It basically works by you have the old pill that crafted 30 something years ago when most drugs were pills and they were chemicals and you that your company is that when you follow their pill the generic pill, gets into the blood in the same amount of time it stays in the same duration and you can impute that all of the therapeutic effect. That worked wellin a world where drugs were chemicals and they got into the blood systemically and they got to the target organ and he worked. When a drug is acting locally on the issue, its a topical drug, eyedrop, inhale drug, or can be easily measured in the blood because of the complex formulation because of the complex mixture the old process doesnt work so well. The question is do we need a new statutory language to create a new pathway for these drugs. Perhaps but i think there are things that the fda can do. Committed to putting out guidance and two years in advance of the earliest possible generic entry date for any complex drugs Going Forward and hopefully will eliminate this problem Going Forward by putting out the standard for how the Company Drugs have sameness in the same setting. Also committed to going back and looking at those on the market to competition and trying to place scientific standards. This isnt a trivial amount of running its a billion dollars a year that should be subject to competition but isnt because of our rules for lack of a rules. Again, thats for a policymaker i want to focus. I want to focus on the areas where congress clearly instructed us that they anticipated there would be vigorous competition but for one reason other usually policy failure, we are not seeing the competition that was intended. I have one more and then i want to open it up to your questions, as well. Is it the fdas role or should it be the fdas role to increase transparency in the pharmaceutical market . The broad question. I think we are increasing transparency and one of the things he committed to this week is oftentimes when Generic Companies come to us and say they cant get access to the drugs they need, the samples and doses to be there studies will often send a letter to the Printing Company say there is no reason why you cant tell them. We say, the rams that you have in place we have reviewed the Generic Companies bioequivalence study plan and we have determined that they will adequately comply with the maintain cup custody and you can sell it to them. Those letters go to the printed copies and we set about 150 of them. We are looking to make the public because and i think we can. That will provide public transparency rather than situations where we believe it or sending a letter that there might be an impediment to the Generic Company getting access to the dosages they need. I think that kind of transparency could be useful in the market to help affect some of the behavior. Lets open it up to questions. I work for prime therapeutic to the pdm and where theres competition we can drive down lunch and cost and theres great prioritization and breakthrough therapies. One of the challenges in the market generally has less of a priority for what in the old days was called. [inaudible] drugs. You would have competition in several drugs competing in a particular branded class is there any effort to take a look at getting that third or fourth branded drug for a particular mode of action and condition . We oftentimes give designation to multiple drugs in a class so that the multiple drugs that will be prioritized in this is Something Congress can look at, as well. [inaudible] as far as what you referred to as the need to drugs, its not necessarily a situation where the fda isnt prioritizing applications but were doing rigorous review timelines at the agency right now and i certainly dont see a deep prioritization applications because the challenge i see is more of a commercial challenge which is companies are reluctant to be the second, third or fourth drug and thats more commercially driven than the regulatory issue and their downsides to that for the point you see less competition in these categories. Also, its important to have therapeutic variety so even though its like larry similar and targeting the same conditions, patients have a differential response and its therapeutic varieties. Microphone is getting there. Dont worry. Nick inside Health Policy. I was wondering if you could walk through why fda hasnt publicized those letters previously restrict what issues are there there. I know they havent been able to share, for example, a Brand Company and Generic Company and they can share with companies and im wondering if theres a particular legal issues that you could be running into when trying to share these letters and if they are public is basic information, like the brandname company with the generic be made public . With these in particular these letters are being sent to the Brand Companies is a were making the brand to be aware of the fact that generic applicant is trying to copy were not making the public aware. There is confidential information is already been shared with third party. They are looking at the issue of whether there is not commercial, confidential information and how we would protect that. I think there is more we can make public and a lot of these questions of how much resources you are willing to spend redacting certain materials and how much legal risk youre taking for a policy objective. We have a strong rationale we can be doing these things is because certainly dont do them as a public shaming vehicle. We can be doing them for just injecting ourselves into commercial disagreements and i think we do them one have a Public Health personnel. If you have a strong public rationale of taking on the burden of using resources to redact the legal risk associated we have to look long and hard and doing that. One more question. Anyone in the back . We have one. Im haner and im just thinking if larger pharmaceutical companies are spending hundreds of millions of dollars to put new drugs, innovative drugs into the market the generic drugs, and more quickly are these Companies Going to see and return on investment and will this impede new innovation in the future . Im not looking to appropriate intellectual property. What im looking to do is make sure that we have competition in the market when intellectual product has left products. They come about thats what they make decisions to develop about how much it they have and protect their products and whether or not they use patents to protect and they make on i am looking to make sure that when that period has expired the competition that congress fully intended for there to be under comes to market and that people arent using our own rules, in particular, and ways to extend monopolies past the point that was anticipated or intended. That is what is happening in some cases. People are taking advantage of rules recruited for another purpose as a way to extend franchises in monopolies past the point of patent expiration and a way to have the important having the unfortunate disadvantage to consumers in certain situations werent getting the competition that congress intended them to have. If in fact he had the cost of drug that is over 2 billion to draw up a drug its an enormous Capital Investment and its too much relative to what the expected ability is to recoup their investment given what the patent license is on products that come to market. That is something for congress to contemplate and not something for us to contemplate. We have to do our job in our job is to make sure that product is subject to generic competition once all the intellectual property that protects drugs has lapsed and once we can legally approve the generic product. Scott, thank you for being here. We appreciate it. [applause] read is saying that our last headliner, senator bill cassidy is a member of the senate health, education, labor and pensions committee. One of the few positions in the senate in an influential voice on Health Care Issues. Welcome, senator cassidy. He is both. There we go. Thank you for being here, senator. We appreciate it. The last 38, 72 hours have been intense up on capitol hill and lets start with this. What are the next steps for addressing the aca . It didnt mean that as a discouragement because i came away in her as a sign. The president very much wants a replace with repeal. He said that over and over again. He wants something done and its clear that they are willing to do more to achieve something. First senator collins and i propose and now senator graham and i which is that you give the talking point, if you will, power back to the patient, power back to the state and she who controls the money, typically has the power if you return it to the state and to the patient, the dollars, then she has the power, patient has a power. How can we take all these dollars that the federal government dispenses with strings as to how you spent a dispenser back to the state with guidelines with some provision such as for example, use Health Savings accounts and paper premiums which allow state to pre fund the purchase the entrance of their choice and i would be a way to give the power back to the state and increase competition. We think thats a good approach and were getting some traction with that one. All right. Lets start on the cost of Prescription Drugs. What role does have to play in increasing transparency over drug prices . Youre making a great case that transparent, the lack of transparency, is committing to the rise. For example, pointofsale rebates, the negotiates sharp discounts and the Insurance Company gets it but when a patient has met her delectable she does not get the discount. So she is pain three times more for a drug for the contractual price. If she knew, what that pointofsale rebate was, she would get the discount. It may be that the congress may mandate those patients get pointofsale rebates. Lots of implications. Not only is she paying more than the actual price but the taxpayer is being so in the part d benefit it goes up dramatically. That transparency would save money both of the patients and for the taxpayer and this is my state one of the few to do this there is a one pbm which put a gag order on the pharmacist and in some cases its cheaper for the patient to pay outofpocket than it is to go through her benefits because she pays more on her benefits, hardenable, higher copay. But the pharmacist is gagged and he tells them that they pay cash filled get a better price to lose the contract with the pbm. Not all do that but at least one does that. In our state, louisiana, there is a law passed that you cannot have a contract which gagged the pharmacist from representing the patients best interest. That is a good thing. Again, transparency of information benefit the patients. How does conversation about lowering the prices in transparency impact funding of Biomedical Research . I dont know if it does that but certain folks Bernie Sanders for example, would like the socalled margin and im not sure it will have a lot of traction. Again, mr. Gottlieb spoke earlier about in response to a question about the need to encourage investment. We are all hoping theres a cure for alzheimers and that investment in a cure for alzheimers will come as people think theres an adequate return on their investment. Thats a good thing. Im afraid that if we start taking, getting their intellectual property it will chill that investment in those needed cures that ultimately will decrease Prosperous Society and improve outcomes for patients may be chilled. As Congress Starts to address the aca once again, as the senate takes up that there could be some bipartisan discussions going on, are drug prices a part of that conversation . I think i will be something a little bit separate. One, a lot of drug pricing is an Medicare Part d and were not touching that with the Obamacare Repeal replace. Number two we have a hearing of what the old joke . I went to a fight and a hockey game broke out. We had a hearing on drug pricing and what broke out was a lot of frustration on the democratic side about the process related to the repeal of the aca. It ended up having a great panel. Fabulous witnesses but a missed opportunity to explore that which could be done. Im thinking that until we get this kind of repeal replace behind us it will be difficult to have a cooperative formal Committee Hearing in which we explore it. That said, i have spoken with colleagues on the democratic side when theres a lot of things we agree on, can we Work Together on the sports of agreement setting those aside that we disagree and come to Common Ground so that our efforts, bipartisan, to address the issue. The white house is working on an executive order that would address drug prices. What do you want to seek . Obviously, doctor gottlieb is going to implement some of that but theres a lot of the regulatory explication of the regulatory regime, as i heard doctor gottlieb say, which delays the approval of certain drugs. We want to address that. The Supreme Court just this past week ruled, made a ruling that would bring generic biologics out six months earlier. That is a good thing. There is no one simple bullet for drug pricing Price Transparency but theres a lot of things you can do in the margin which collectively make a difference. Where is the balance though between cutting regulations and cutting the time until a drug is approved in protecting the public and going through those scientific studies . When you approach drug pricing you to set up a metric. This is what we do in my office. We analyze this. We look at it as a generic, excuse me, small molecule Specialty Drugs first brandname and generic. Really what you do is different in each segment of this. Where you have a Specialty Drug though you might not be a biologic but their price like special drugs of the bonus category. If you look at that and break it down, lets take a generic which has no competitors in the United States and because of the absence of competition they have jacked up the price. Someone from back home in louisiana buys a lot of the interim biotic those made 20 years ago in these to pay 50 cents and now they pay 13. For a drug which is 50 years old. Again, i know what im told. Someone may dispute that but thats as its related to me. It may be that in this case, we should globalize the market. Most likely, there is a plant in india which is producing the active pharmaceutical agreement is for the drug which is sold in the United States as well as the drug we just sold in the united kingdom. I can tell you that we already have a memorandum of understanding between the fda in the eu equivalent that says if one certified plant in india than the other would accept that certification. We already have this working relationship. Could we say district believe me, i think we should for this generic small molecule that if there are adequate supply chains integrity for both the drug going to, see the eu in the United States, thats we would allow sale of a drug here to there. You would imagine, walmart, going to france, buying a lot of a certain drug which only had one supplier here, bringing it back in selling it. Weve used Market Forces to create competition as opposed to the heavy hand of government regulations. I think thats the way to go as an example that i thank you have to have this approach. Of say it once more. Small molecules, specialty brandname and generic and when you bring it down you come up with different solutions. What have you seen out of the trumps admission fda . Theyre all about decreasing the Regulatory Burden and theres a lot that you can still do by transparency of intense and by trimming processes to improve input. Theres been rules that have been held up, granted their completed rules, but once implemented would dramatically shorten introduction of generic competitors. That is a good thing. I think gottlieb will bring a lot of energy and a lot of insight into this job back i have a couple more. Well turn it over to questions from the audience. What world does an agency like i asked congressman, like the va, which by so many pharmaceuticals and negotiate the prices what role they havent bringing down prices across the market . It they certainly show us it is possible and they show what a drug company is willing to go down to in order to have large market share. I always said it would be quite transient if present trumpet looked and said va, medicare, tricare, you name it, we buy 80 of this particular drug, maybe we should negotiate. And using that position to negotiate whichever price he wished. I can tell you 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 the other hand, can you imagine him doing that . Absolutely. The ba shows you what is possible without negotiating position and it may encourage our president to go in the direction of strengthening their position even more. Any questions . Let me say one more thing. One thing that i am concerned about is a high price of drugs desperate going back to the patient should be about the patients in the social contract with pharmaceutical companies in which they are given a nice rate of return, and god bless, we do need them, but they give us research to keep us all healthy. In this room there are people who are alive because of advances in pharmaceuticals over the last 30 years. I would use the example of. [inaudible] it was our most common surgery was cutting out someones stomach because of a bad ulcer disease then along came and now we never do that surgery. And. [inaudible] is sold over the counter. This altering drug is now overthecounter. Similar, Crohns Disease. It used to be a common surgery was taking out pieces of their bowel because of Crohns Disease. People with Crohns Disease now have an infusion and they never had surgery. We need that investments. On the other hand, there are some patients denied lifesaving drugs because of the price of drugs. We have to recognize that. Medicaid programs which typically medicaid across the nation with hepatitis c and the medicaid problems cannot afford the medicine to treat patients as rapidly as they wish in order to save those peoples lives. That is just a reality. What the va did is by driving on the price they were able to afford more drugs and push out hep c therapy for a lot of thats would not have received. We have to recognize that prices of drugs effectively denied treatment to some needed in the va success of driving on price is good for patients and that is something we have to think seriously as we look at the impact on access for other conditions and other payers. Any questions . Carl with the agents of what i have to take an issue with, senator with what you just said about the have titus c cure. You mentioned the va is a great example and i think there down to 24000 for a cure but for medicaid its around the same price because the rebates and discounts. We feel that this is a 24000dollar cure that will save money down the road and theres a lot of drugs that are expensive. We feel the Medicaid Program should be able and most of the cost is the federal government. If you feel that way but thats not reality. I dont mean to be rude but if you look across the nation, most of the cost are borne by the federal government. Technically, yes. They pay 57 on average but if you look at the Disease Burden by those with hep c because its disproportionately among those it is quite a figure one hundreds of millions of dollars. Most state governments cannot subtly put up with that amount of money. I am a liver doctors you might have an interest in this but we put up what is the disease prevalence in louisiana and cost of liver transplant and liver cancer it will because of therapy and if we treated everyone we possibly could within the first four years we would actually save money in the long term because you have fewer transplants et cetera but you have to treat them up front and is a very expensive price tag. That said you still want to reward investment. Two things we have looked at, one we call the mortgage way of financing and the other would be that netflix suspicion way of financing. In the mortgage you would say give us will treat everyone we can upfront and then will pay you off over 30 because will realize the savings for Medicaid Program over 30 and this way we can budget for those savings but the savings will pay for it so that would be the mortgage. The netflix prescription and its not mine but someone else came up with it was that you would get a pay a certain amount to whomever, put it out of that, and he would treat as many people as you possibly can. The company would be guaranteed some reasonable okay, this is what we expect to get you the normal course of events we will give you that plus a premium but you can treat as many as you wish. It may be that we dont need to lower the cost but we do need to come up with alternative ways of financing because the price tag of some medicines is absolutely limiting access to therapy. It just totally as a to say otherwise is not reality. I dont say that to be rude because you are wellmeaning but so am i and that is the reality of the situation. Center, thank you so much, next up we will be rethinking pricing. How are stakeholders within the Healthcare Industry finding ways to address the rising cost of medicine. What kind of collaboration taking place and what can patients expect. Welcome onstage bill reed, senior director of Global Public policy and anti counterfeiting at eli lily and company. James, Senior Vice President of Health Policy at the. Ceci connolly, president of the co of alliance. [inaudible] chief medical officer of. Kim dixon will be leading the conversation. Thank you very much for coming. Weve had a few discussions that touched on some of the challenges that we face with skyrocketing drug costs. I know they talked about some of the things going on in most the people in the green room to think that was a step in the right direction but there might be differing opinions on what Else Congress can do. He talked about increasing competition, drug approval and getting rid of some of the regulatory hurdles. What more can be done . I think the cc had opinions more of observation. Thank you for you on the hill for having this. Its been a great morning. I have to remark that ive been in dc for many, many years and i think that commissioner gottlieb is off to a start in his role. I think we have heard some very encouraging things from him with respect to competition. He mentioned this morning what may seem like a small thing to delay people from getting samples to Generic Companies but its significant and its been a huge roadblock. We can have success in areas like that, we believe that it really will spur competition and start to bring down prices. I will toss out one baby step, frankly, for congress which would be a bipartisan bill sponsored right now by senator baldwin in mccain on transparency. Transparency is not going to solve our drug pricing problems by any means but getting information to the public would sure be a nice start. Costs are controversial in the Healthcare Community so why dont you talk about what you think about that bill and the ideas of more transparency. Sure. Thank you for the opportunity to speak today. I like to take an opportunity to put cost in context and a few figures relative to 2016 retail in this position and ministering was roughly 40 and that figure is expected to continue roughly to the next decade. Medicine spending growth roughly three5 in 2016. Brand that prices the. 5 and lilies that price increased in 2016 was 2. 4 in just to put those cost in context, in the overall health, its important. What has occurred over the last number of years as Health Savings account, hras, individuals are facing more pressures in terms of their deductibles and copays, coinsurance and outofpocket spending has increased in a significant percentage since 2013. As congress wrestles with healthcare, the Affordable Care act, drug pricing and drug spending, i think one of the areas they can focus on is the outofpocket expenses senator cassidy spoke to that to some extent. Im transparency, lily issued an integrative report earlier this year showing over a fiveyear period the change in list and that price and the discount which has increased to almost 20 . Thats one of the ways we are trying to put more information out in terms of consumer, patience, stakeholders to understand how we price our medicines. As i looked at transparency legislation, primarily in the states, a number pieces of legislation last year and this have been introduced and moved to the legislative process while they are wellintentioned the challenge is they dont do anything to address patient outofpocket expenses today and there are in some instances anti competitive provisions that would create challenges in terms of Public Disclosure which we are working through and dont speak to the value of medicine and that would be my take on some of the legislation. We want to Work Together in terms of that goal of transparency. Absolutely. Did you want to jump in . An official thank you for inviting me and doing this. This is a vexing problem because we have the best of all worlds today and we have innovative drugs, wonderful drugs that are targeted, science that in some cases may be intuitive and on the other hand if these drugs cant sustain it in patients cant afford it it will have no benefit to the patients. We are challenged by keeping up this pipeline and competition and a lifesaving drug. But we are also challenged by the crop. Its speeding up generics in transparency and all these things that are being recommended which are important will not fix a systemic problem. We have a Health Care Issue and it will take Bipartisan Legislation and working together want to benefit. Transparency, is that not enough . What is this bipartisan solution. You to look at the whole healthcare ecosystem. You have to look at where they are getting treated and my world where we have innovative drugs that are personalized and of the being treated and their many studies showing that that many patients are being treated and given the right drugs. Its a systemic issue. And its a complex issue because we want to keep innovation but if patients dont have access or cant afford the drugs it will not benefit the patients. There is this defense from the pharmaceutical industry that drug prices are not rising and maybe they arent as a whole and the whole ecosystem but we do know there are Specialty Drugs some sections of some drugs that are saving peoples life. Those are rising in certain classes and those headline numbers we see. Bill, i dont know if you addressed specifically are in the cost and with the industry be willing to give more information on how the cost to develop a drug. Again, speaking to the transparency legislation. When you look at introduced and how it progresses to the alleged the process the challenge of looking at a by product or in a quick cost basic increase. If i could add to that, let me join everyone in thinking that hell, kim, for facilitating this panel. As johanna said, i am the ceo for the medicines and i wouldve been one we switch names. I didnt switch jobs. Thats too bright for this. One of the reasons we did that is in addition to the present the generic competition it will shock you for me to associate myself with all those remarks. We also represent and that is exciting and most people know about the promise of file similars that have reap enormous benefit but first victim system savings. The only thing i want to upfronts a is that not all drug prices are going up. Generic prices are going down. Theres price deflation in the overall generic marketplace. Now, the media and others will highlight a single incident of a case that is alleged to have skyrocketed price increases or price gouging and into examples that have happened over the last two summers each neither one of those products have been traditionally characterized as a generic medicine. , i got with them in august i got a phone call from the media asking for moving the manufacturing of our membership because they want an inappropriate action of our commitment. I got the word no output for this reporter took me to task so how can you defend them and i said not going to defend them because theyre not a member and are not eligible or not eligible because we have not been a generic drug. Theres a lot of confusion in the marketplace and i think one of the things we have to do touched upon some of the work that the fd is undertaking theres a lot of people talking about solutions to Prescription Drug costs. There are fewer Government Agencies in the executive branch or legislative branch thus far and are actually taking meaningful action about enhancing competition. He is the exception to the rule because since he has come in he has been an activist commissioner and have the potential to be transformative. That is good for the marketplace because its good for patients. It will help constrain costs and help increase access and i think that no matter who you think is responsible for why we are where we are in the drug pricing debate theres a lot of fingerpointing going on across the picture of the three stooges where someone is holding the camera and pointing at each other. The reality is what more and more people coalesce around is a key component and i want to say component of the solution is to increase marketbased condition and nowhere is the opportunity for that more prevalent than increasing competition from generics Going Forward. We agree with that. Providing the pharmacy benefit perspective competition is a good thing. I think the challenge when you look at the big numbers in large groups of people is the individual who takes a specific drug and that drug could be very expensive. And some of these drugs are very difficult for people to afford. 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 if the drug actually provides value which is important more so today into use our systems to drive lowercost alternative when those are appropriate and certainly to generic products. Train when they are the most costeffective. I really do think that in a complicated system it requires effort on the part of pharmaceutical companies, certainly in terms of Patient Advocacy that the fermi benefit have the systems that allow competition that dollar. Doctor gottlieb talked about to turn into low price at the level of the patient. I like to complement that. The solution lie in collaboration in terms of supply chain. Is how we can Work Together in partnership to pursue Experimental Solutions in varying places like value based or contractual relationships and generics to market partnerships with the fda. I think we are in agreement in terms of that. I think competition is incredibly important. Even in the innovator drugs if you look at what is going on we have 34, five approved drugs and will have ten or 11 and they will all be used in combination and they all have to be specific to a buyer marker in the Patient Population that has to receive it. They have to get the right combination that is right for them. Its evolving. Its not static. On the other hand, as i said earlier, if the copays are high, if they dont have the right diagnostic, the Healthcare System that knows what is right for them it wont benefit the patient and if they cant afford it, it is of no value. We have to preserve innervation, preserve the patient choice, preserve outcomes and figure out how to pay for it. Its hard. Im so glad that you picked up on that. This word value is a motherhood and apple pie. We all want value, we love value, we deliver value, for highvalue and its great. Im a valuable person in your all valuable people. Lets get real here. Insulin. Valuable. Incredibly valuable, right . Think about the people with diabetes in this country. Congress brought up diabetes challenge in our country today. By 2151 in three americans will have diabetes. Just think about the implications of that for our society. Now, our Incredible Team at a chp went and told the Pricing Trends of the top seven diabetes products, insulin products, and what happened to them between 2010 and 2015. Across the board the increases in those products ranged from 93 to 325 and insulin has not changed. Not one bit. What is going on there and how are all of 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. When you look at the dynamics that you just pointed out you would expect the portion of the patient pays to increase, as well, with the total price that society pays for a product. I think that its very hard to point to a specific piece. Certainly with the members pain as a part of it but its hard not to say that its the total price of the product as you pointed out is not an issue. When we had our prep call, you said theres been a change in the last few years for the summer sensations and how do you keep that momentum going and what specifically does what it sounds like you are all the green, sort of, what specifically do you see happening or could happen in the next year given the political environment on the hill . Nothing will happen. [laughter] employers pay about 80 of the cost of health care for the people that we ensure which is not to the people who work for us but also for their families and sometimes their retirees, as well. We are bearing the brunt of these cost increases. I dont thank you would find a single employer would want to see a layoff notice go to the good men and women of the fda. We all agree that the dollar has to go through and we must fund the fda. At the same time, when Congress Says well, in the next five years there will be one bill and one bill only that talks about drugs and is a must pass piece of legislation, lets do that in the lets talk about drug prices later. They are using washington talk. That is not real talk. Well talk is we are going to miss the one opportunity that we have to have a must pass piece of legislation which we could do something meaningful on drug prices. Now, here we are saying okay, will have hearings and i love hearing this. You get to submit testimony for the record and we get to keep the last questions and witnesses an interesting conversation and usually it ends up producing nothing. Right now we will have to focus on what we can do for the administration. What can we do working with our pbm partners who, by the way, are engaging in really interesting value based purchasing agreements getting Drug Companies to finally have some skin in the game. We love that. At the same time, government is in the way even of that. We have pdm and Drug Companies trying to do the right thing and its ending up creating problems with prices that medicaid would charge some problems related to stark law and into kickbacks, things that congress looked at a couple of years ago and said this is completed lets find Something Else to do. I know that might be less via but we are worried. Our costs are going up in unsustainable rates and were being 80 of those costs and were not saying things like its not the cost of the drug that matters is the copay. No, it is the cost of the drug that matters. Eventually will have to say where is that cost going up. Every time you vote conversation about drug costs everyone does this. If the supply chain and middleman and other people say its the cost of these drugs that they are straight up charging for the people who are buying them. Eventually will have to figure it out. We cant keep going the way were going. If we could go down the line. Ill just go to the podium. I would like to agree strongly and disagree in part. I agree with you on the loss of opportunity of negotiations. Unfortunately, washington is what it is, as we all know. We dont underestimate some of the portions the dont want to attach that discussion to it. At the same time, there will be vehicles later that the year. Tax extenders and there will be vehicles in which the federal government will need to print money. I think theres also a macro political dynamic. A lot of people on both sides of the aisle campaigned on this issue including the president of the United States and if we come through a cycle is recklessly candid, 2017 is more better year to getting legislation enacted, if nothing meaningful is done in the space then i think the folks who iran on it in a media savvy world will be reminded of that fact. The 2018 midterm cycle. I think one of the things we need to focus on is where can we see the opportunity for alignments. I would propose that there are three areas in terms of a simple solution we would have found it and we might not of all been talking about it. There is certainly regulatory aspect and i wont go into that because i thank you heard from a former worker and commissioner gottlieb. There are additional things that condors can do short of completely disrupting the market and making the industry overall a regulated utility to increase condition. There are plenty of incentives, bipartisan incentives that would allow for that type of competition to be accelerated and save the federal government money. Imagine that. The third thing that we have to do ultimately is make sure that the market is working efficiently as other people the last point of generic utilization is up 4 and generic revenue is down 15 and the reason for that, in many ways is the over level of intellect the place. One of the challenges is there has been an incredible amount of consolidation within the supply chain. There are three wholesalers, threefour large retailers. Expect ten to 15 Companies Competing on price and there are so few purchasers in that market is something we have to factor in. You get there now in threefour generics in the marketplace. When it works and it functions the market is driving an astronomical level of savings higher yearoveryear, 250, 300 billion of savings and generics in 2016 alone. We also need to make sure we dont disrupt the mechanics the drive that savings. When you talk about drugs, youre not talking about a car, to take a car from here to k street, you can take and uber, limousine, walk, bicycle and youll get there. When you talk about medicine, in particular, Precision Medicine and innovative drugs and drugs that are targeted with specific population, thats were completed. Cheaper to help them. [inaudible] we are doing master protocols in rare populations and were doing the long mess of protocols, 700 Centers Across the United States and some of them tumors are 2 , 5 of the proposition. If you find these station patients and screen them efficiently 80 or 90 will get the wrong drugs. You have to think about that also. We are starting with the beginning and we heard last week about immunotherapy and now will deal with combinations and this will get complex about what the patient wants is the drug in patients trend that will work for them. How will he will balance these issues will be very challenging. Eventually, well have a much smaller population and now cancer is a rare disease. We have to get the patient the right treatment and it has to work for them and quality of life is really important. Just assuming were going on the line. Ill speak next. I agree with my colleagues on the panel. The perspective that i want to make sure that the audience leaves with is that the pharmacy benefit manager role is to take competition, to take choosing the right drug and in an imperfect situation and implement that for patients. That is how we fit in. Its a typical thing. Imperfect information is a part of why its so hard to get there. Without the industry in the middle a give you a simple example. Were in a morphine Opioid Epidemic in the cdc has come out with guidelines that say the doctors should prescribe less than seven days of morphine in acute medication. Theyve also said you should have less than 50 morphine equivalent dose average. Day, nothing more than that. They understand that if you take an opioid with benzodiazepine your risk of overdose which is actually more lethal now to americans than Motor Vehicle accidents that those things should not be done together. What we do as we implement programs that allow the script to have seven days of supply and allows us to flag the doctor in patient risk and the risk of drugs taken together and we drive more quickly to the generic being utilized over expensive drugs. That is how we fit into the untrained equation. Back to the previous comments about employers. I think sometimes you forget that lily is not only a pharmaceutical manufacturer but were an employer, as well with tens of thousands of employees there with dependents and retirees that are on a health plan and there are steps that lily has taken in terms of providing the employer contribution to the health plan upfront to help individuals manage their Health Care Expenses and looking at exempting preventative and chronic medicines from the deductible and i think those are important dimensions as voluntary decisions that help individuals through what is their Consumer Choice in selecting a health plan and how they progress through the year. Unfortunately there is a lot of companies that would like to offer first dollar coverage for things like insulin for diabetics or inhalers or asthmatics but under the current role if we do that the patient loses their eligibility to contribute to their health and savings account. One of the things i think the imitation is working on is changing those rules at the irs. That would be a game changer. That would make people live better. It seems like something that hasnt gotten a lot of attention. Its not sexy, i guess. We think it is important. I absolutely agree. It is important and i think it picks up on a theme that allen and others have tried to talk about today which is getting the right care for the right patient, right time, right price. Deftly a part of that is thinking smart about your health. Prevention and managing chronic disease and having that first coverage on the things for diabetes, high blood pressure, cholesterol et cetera are going to enable those individuals to live much healthier life and not have the much more serious illnesses early on that cost all of us much more money. Some of this is simply being smarter about the investments up front that make sense and it takes thinking about longterm which is especially difficult in washington and with scorekeeping and all of that sort of thing but spending that money now will save later on and i would like to see policymakers with the industry starts to be able to track and illustrate that in a much more meaningful way. Can you get meetings in capitol hill to talk about this . How do you see. Its in a state of flux right now but how are you gaining out how your industry will be impacted and i know the coverage bill impacts pharmaceuticals and doesnt get a lot of attention so have you taken on the latest available its a moving target and in the facts its a bit of a moving dynamic. Our position has been and continues to be we want to make sure that we have appropriate access and coverage for health care and that includes comprehensive Prescription Drug cares and in many ways some of the ways we talked. This is one of the most costeffective vehicles you can have in maintaining and advancing Public Health. That said, i will tell you on the specific issue, that you asked which is can you get meetings in this overall dynamic that is going on the answer is yes. I think the reason for Prescription Drug cost is such a big discussion, as i said earlier, to the Campaign Cycle that whatever happens or doesnt happen in that space relative to whatever does repeal or replace the issue will come back around on its own. There was a meeting the other night with President Trump and a number of Senate Republicans to go for dinner was the primary directive was to try to convince them to vote and support the repeal effort. In addition to that discussion he raised two issues in one of those was about selling insurance across state lines and asking what are we going to do about high Prescription Drug costs. You may not be getting the focus right now because of other things but i have every expectation that this issue will circle back around and if it doesnt happen within the user is still open in the senate and i would expect that this has to get past before they start sending notices to fda employees. I know the goal is great coverage and affordable coverage but 32 Million People dont have coverage anymore if you believe the cbo and it doesnt look like something that would be a good thing i think what it will do and ill let other panelists opine is what it will do is take the sensitivity on Prescription Drugs. I would say with respect to coverage reason why this is so important and the recent debate is coming back to that is because just try to think back to 2008, 2009 when we had a very high number of insured americans and you can all recall very well what occurred. First of all, individuals who had preexisting conditions either couldnt get any insurance or faced high insurance bills and they went to the emergency room when they were terribly sick, far far late in the progression of their disease, not good for their health, not good for anybodys wallet because those costs got passed on to employers and taxpayers and all the rest of us. People come back to that because it is a linchpin piece of our system and you hear the talk about managing a risk pool. You have to get anybody into a risk pool to manage around and its the 32 millions the right number. Who knows. Even if the cbo is off by half okay, 15 million, 60 million more uninsured, thats okay. Who wants to say how many million more uninsured is okay. People want to stress cost and affordability. With 30 Million People losing their insurance it will cost the system. Its too late to save them and theyll get emergency and the stress on the system will be much worse. We have to fix this and this is a computer problem. I taking 2030 million without insurance they have to have good insurance and we have to think about the patients and individuals. These are people that are sick and need help. We have to think about the impact on families and treacherous this will be and devastating. In particular the undeserved challenge today. One of the things i have to do my job is not much fun and i have to read the whole cbo reports for these things. I havent had a chance to read the one for the repeal only bill but i certainly had to delve through the american after act and i started with 23 million and when you read the report be on the first page what you see is that 11 million of those people are people who are no longer forced to buy something that they dont want. About half of the remaining is another 5 million or so who live in states that are not expanded medicaid as far and cbo things more states will expand and they dont state what states those are or when they will expand but that is certainly going to happen. Theres an additional fact. Three4 million currently coverage through an employer in cbo says their employer wont offer coverage anymore and in the next paragraph cbo says actually, probably not in it would have to be an employer that has highly prayed individuals who are healthy but our model says were keeping them anyway. If you really delve into those numbers it is a number that somewhere closer to four or 5 Million People would have Medicaid Expansion today and would not have it in the future. Thats the number we should be concerned with i think those people are going to need help. Something would have to be done to help those people when we talk about numbers in the 2030 million we are not telling the truth or. Were doing washington talk again. Certainly the Affordable Care act and the Prescription Drug user fee act consumed the attention whether hill bills its or their our policy solutions that we are looking to pursue one being value based agreements and its not the Silver Bullet but in the set of tools to look at the shift from value based care and the potential to connect reimbursement to potential real outcomes but there are barriers. Best price, amendments to best price, asp reporting, the ability for pharmaceutical manufacturers to have conversation with payers prior to fda approval and clarification of that are instances where we have discussions with stakeholders and members of congress. Niche costs and including what we heard in the beginning from the pbms and as payers. You know what we see in the costs really emea population and is join other propositions as well the drug is on their formulary and they are innovative treatments for people who are otherwise out of options, our Research Shows that we published recently 63 of people who meet the criteria are denied access or denied their insurance request and we know thats a burden on Health Care Providers and its certainly a burden on patients and it means the innovative therapies arent getting to the right patient at the right time. So what can we do to fix what we are to have in place and how can we Work Together to make sure that those patients for example have it genetic condition and the treatment thats great for them are denied. Thank you. I can start with an answer. I think first when a patient that requires a drug and its appropriate and they dont get it thats a failure of the system so i fully agree that should not happen. Where do i think the solutions are . I think the Solutions Come from better and more perfect information at the level of the provider so i can tell you some of the things that we are working on. We are working on electronic communication within the doctors workflows so that there can be real time or more immediate answers and dialogue around that that is more seamless for the patient. I cant speak to the numbers that you were referring to let i can say ideally it should be 0 for people who need it and some of these tools to provide information at the level of the physician will help. I can just offer a couple of quick thoughts and i will go even simpler than then you are unfortunate example which is Something Like 40 of the patients dont fill the prescriptions written for them often because of cost by the way but generally the doctor doesnt learn bad about his or her patients and so we have our to god this information gap which is hurting patients and so if you are more of an integrated system where your health plan and your providers are all kind of connected and corrugated you get much more of that realtime information sharing which is so important because then the clinicians are aware that we need to do something here for the patient so thats an important linkage and also frankly empowering pharmacists much more and this becomes a states issue as many of you know in terms of practicing and licensing and what pharmacists can be empowered to do but a pharmacist can play a Critical Role again in helping to make connections and getting the right drug to the right patient at the right time etc. Cc i will just quickly add to that i think what you point out is a very important thing and certainly integrated Delivery Systems one way to deal with it. Things that we can do today and i think people are doing are looking at the pharmacies which typically will fill a medication and then process a claim and then if the patient doesnt show up they will reverse the claim and put the medicine back which can be seen in the electronic footprint of the pharmacy system so we use information like that to go back to the physician and say, maybe your patient didnt fill this medication and then have that discussion. The issue of abandonment that ceci raised thats the definition of total abject failure of the system. You dont get patient adherence if you walk up to the counter and imagine the meeting with Vladimir Putin in the spring or summer of 2016 or whenever it happened when somebody said i have a rain wave. You know that candidate Hillary Clinton who is 10 or 12 points ahead in every poll . We are going to mount an intelligence operation to beat her and help the most implausible president ial candidate ever and we think we are going to be able to make a difference. But you need to know certain this is kind of a risky operation because hillary i know she is friends but i dont think even her best friends have a forgiving temperament is one of Hillary Clintons outstanding qualities. For this goes wrong for us you are going to be alone in the room with the new president of the United States is going to be very angry with you and the flak that Vladimir Putin says i will take that risk is an example of someone who is not a prudent calculator of business. He is taking wild risks. The hospitals are being attacked almost daily pick the federal government the banks are being attacked almost daily now. We are not going to eliminate this threat. We have got to learn to live with it. We have lived with millennials with a flu virus. They never eradicate the flu virus. You do certain things when you know you are exposed and you know the flu is going around. You get a shot and you isolate yourself from folks who have the flu. The hygienic steps you take in the physical world. The u. S. Institute of peace hosted a Panel Discussion on combating isis in iraq and what can be done to protect minority communities in the country. Before the Panel Discussion began iraqs ambassador to the u. S. Gave brief remarks. This program is one hour and 45 minutes. [inaudible conversations] ladies and gentlemen let me welcome you to the United States institute of peace. We are very pleased to welcome you here this afternoon. My name is phil taylor on the executive price Vice President of the institute of peace, very pleased to be able to cohost this was with our kurdish friends. We will have an opportunity to introduce everyone at the right time. The Kurdistan Regional Government Special representative Bayan Sami Abdul rahman is here and we also have the ambassador from iraq ambassador fareed yasseen. Welcome, glad to have you here. Both will have an opportunity to speak to you before the Panel Discussion. Three years ago this month isis targeted many of iraqs minority groups christians have cds pokemon and others to this assault on northern iraq. Isis also targeted arabs and kurds in many more areas. Last year the secretary of state and the u. S. Congress and just last week the administration labeled as genocide the attacks on the chaldeans syrians and other groups by isis so the last administration and this administration are in agreement and have

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