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islam is something else and so on. very good. we need to see more counteraction against isis in that case in order for the islamic countries to swhow make the contrast between we are not that, we are going to defeat a phenomena which is actually bringing a bad image to us and to the islamic community in general.

they participate together with us in order to -- in order to fight the radicalization phenomena. in bulgaria went very well with our modeling community from the very beginning of the creation of isis. i have to say we have quite a stable environment when it comes to observing radicalization, there are very small attempts here and there in order to do that. as you know, bulgaria has 10% of muslim population.

this engagement is extremely important. the radical forwards or action up to extremes and feeding isis with ideas which are basically imcompatible with the modern world, whatever world it is. their ideology is inhumane and completely and on stleet and unacceptable for anyone. i will stop here on that. i'm sure you will have questions. the big news or positive news was also the declaration, the joint declaration between the

european union and nato, work that has not been done for, was done in a few months and here we need to give credit for the general of nato and also for pushing this forwardened and achieving this closeness. and identifying nato can join forces in order to tackle common challenges, one of them is the migration process. pressures on u.s. borders. it's tackling basically the

human trafficking that works and criminal activities of -- related to human trafficking in that area. >> i'm tempted to ask but i will wave my questions as others are requesting, i want to remind that this is on the record and because you're so tweetable, i just want to underscore what the hashtag which is gmfgitov. [laughter] >> we will see how nato we -- beefed up there and community

coming apart and actually enhance unity at the summit, your point that we stopped making history and history has now hit back, i think it's worth unpacking too and maybe the point, you spent some time talking about, which is you looked at the examples of afghanistan, libya and sir yeah, they go to complicated to negligent i have examples and there's really a question for the alliance about how do we project stability to what is an unstable region. let me turn it over to you and -- if not i'm going to jump in. one of the questions i had was the point about projecting the presence in the black sea region and i am not someone who follows bulgarian policy very closely, but i did notice that your president led the delegation to

nato summit and was clear that bulgaria sought interest to enhance presence in black sea region. at the same time the prime minister was talking about how important it was to demilt orize, can you help us unpack as seemed to be different views? >> i know there was a bit of confusion and part of it was med icon fusion and part of it was political -- political messaging, but we try to clarify our position and actually we did but sometimes it's not that widespread what is the exact position we are going with to the nato summit.

prime minister at a certain point didn't mean milt orization in the black sea is not a approach in general. so we need a wiser approach. at the same time, we know very well what's on the other side. annexation from crimea, from what we see there's military buildup so there needs to be some sort of type of balance and nato knows that and we know that. bulgaria's position was very clear on one thing even with limitations of themont negro

convention but we need that enhance presence, it needs to be under the the flag of nato and under the command of nato. it is and will be during the meeting of the -- [inaudible] without trying to build nuclear capabilities, that's what we are looking at the black sea with our partners, nato partners have access and at the same time we would -- we would be -- we would like to see more not only black

sea countries to be involved in this, because you know that there are several black sea formats, none of them is working, none of them. so now what we need is nato presence, the nato black in the black sea and the command needs to be -- that was our position. i know we didn't reach a huge audience because it's a very not interesting position, might be perceived at not scandalous. that's why it took so much attention. this is actually the position with which we went to the nato summit and this is what we want

now, this is what we will continue to defend in the upcoming meeting of ministers of defense in october. >> very good. we could have a mic over here. that was very clear, so thank you. [laughter] >> please introduce yourself. >> i'm ze, the -- zeth, on the theme of history biting back, the question for you i i want to get the reflections of our neighbor and our partner nato turkey and your thoughts on where that is going? >> first, of course, turkey is was and will remain nato partner

and an essential part of our defense infrastructure. turkey is undergoing quite a difficult period and we -- what was happening there, the bulgarian government said basically one one very important thing, we hope that they'll not be spiral violence and no retaliation without regards to the rule of law and the constitution and so on. that's a very important point and we have questions around what's going on and we -- at the european level we actually adopted conclusions, you probably know them.

we have called for turkey to respect the human rights charter of council of europe and protocol, 130, -- 13. unacceptable. and, of course, the people who are -- who need to be brought responsibility and justice need assured fair trial and rule of law needs to prevail.

however, though, turkey remains our neighbor. i will repeat this, turkey is essential part of our defense infrastructure, specially when it comes to fight against isis, stabilization of syria and iraq and also a partner related to the management of the migration and the refugee crises. the european union and bulgarian and we work with turkish authorities in order to achieve sustainable solutions about the migration crises and the agreement is important to us and we will continue to insist for that agreement to be implemented. we will continue to insist also, of course, for turkey to start

implementing the readmission agreement between the european union and turkey. we have signed the protocols but there's formality turkey -- but has not adopted any mechanism for implementation. that is the last bid and we are trying to talk to turkish colleague and friends in order to -- for this to happen as soon as possible so that we can have a -- i apologize, so that we can have a structured management process around migration and the refugee crisis. at the same time, of course, we work very well on our border issues when it comes to the communication between the border guard, border guard authorities, that is also an essential point

that needs to be made. so in a nutshell, yes, we are worried, we are looking very closely at what's happening. they have a lot of questions but at the same time, turkey is an important part in nato and a neighbor with whom we are working on a llt of important and crises issues. part of main challenges of our history right now. >> we will fit in one more short question and then unfortunately we sl have to let the minister go. right here. >> stanley, i wonder where the money will come from. i'm looking at an article about deutsche bank, europe needs to

capitalize its banks. where does europe come up with this money to recapitalize the banks, spend more on defense, deal with the refugees, do you tax people? where do you get the money? >> maybe the vice president is responsible for the budget. i'm not really sure how accurate is the quoted number or what exactly is the -- what other mechanisms exist in order to -- to deal with the -- with the different financial conundrums

around europe. you know, there was this talk about -- members of portugal and spain and the financial situation there and whether they will have any type of sanctions and so on and it was decided that they -- no sanctions will embe imposed on them but the fiscal discipline and financial discipline inside the european union and the euro zone is extremely important. so whatever -- whatever the european needs, i'm not really sure we will find a way to not only to find the resources but also to we structure a lot of the systems which will allow the -- the function of the financial system. i actually -- i have to say, i

mean, a few years ago when it comes to the greek crises, when it come to the crises of other countries and it will not. the european union is mature enough in order to deal with those issues, but, of course, you're right to be skeptical when it comes to, well, if these crises continue developing, well, then we are in trouble. so right now specially with the brexit, what opens up is as opportunities is more important. i mean, right now what we have as an opportunity and as a chance is to actually move the

european project forward tardz more integration, fiscal integration, integration in other areas which we identify as essential and necessary to achieve cohesion and strength. the problem of the european union even now is that it is not integrated enough. it's not that we have a lot of europe and that's why it doesn't work, it's actually we don't have enough europe or enough -- enough cohesive policies and the founding fathers of the european union have dreamt about federal europe. that's what it is, that's how it started. at a certain point, the european

union was developing and -- and was able to project stability and reassurance without going to further integration because the environment around was stable and was not challenging, no one was challenging us from the outside or if it was, it was bearable or manageable. well, now the challenges are too much and the european union has two choices, either to follow the british example or to start talking about more integration and more -- this is my personal opinion, i have to say. now, here i have to launch a disclaimer. this is a very personal view but it is shared by a lot of my colleagues and we have a chance right now to really start talking and working on more

integration because this middle -- how oh to put it even, position where we are as union is hurting us all of the time and does not allow to respond to challenges as quick and as decided as we want to. around migration crises, it took months and i don't know how many councils in order to reach a decision which was acceptable for the majority of the country, for everyone, basically. well, if the european union develop its integrated institutions which bring the mechanisms through which we take faster decisions which, again, reflect the positions of everyone, but there's -- there's a different type decision-making

process, but then we will be able to react to those things much quicker, so i think that's the -- that's the emphasis of the whole thing. i wouldn't be that much worried about the -- where the money will come from. we will figure it out. and i'm not the one to ask, sorry, i might be giving you not the answer that you're expecting, you're expecting but i'm probably not the one exactly to dig deeper into those issues but as of until this moment, as in the past, in this moment, i think, that we will be able to -- to stabilize the banks. let me add up something else, bulgaria was basically a bankrupt country, we had a huge foreign debt.

it was a disaster with the help of the european union and did what we needed to do and the frame in five or seven years the bank system was in place, it was stable, the micro economic framework was out there. we had paid foreign debts, huge actually, what do we call them, huge interests and right now we are actually after islands, if i'm not mistaken, after islands we have the country with the biggest economic growth in the union. we have a little bit of 3% last year and this year it's going to be more or less around that.

europe is not that in bad shape as one might document it. we have huge challenges. >> well, i'm so sorry to cut this off and you are all just so patient which i really appreciate. >> i can probably take one more question. >> can we? >> okay, in that case, please. >> thank you for coming to gmf. i work here at gmf. my question is in regard to kinder security, by nature, nato, the european union even the united states is on defense when it comes to cybersecurity, i think that's fine and the way it should be, what are ways european union and nato can play better defense? >> well, one of those -- one of those ways to deal with that and

to be better is exactly the closer cooperation with nato and the european union, nato has developed better capabilities of kinder defense than the european union and this -- the -- the sign declaration during the nato, the summit was exactly one of those ways in order to join efforts and infrastructure and information exchanging and capability in order to tackle exactly that, that issue. and national states need to do their bid and ensure that we work much closer together and exchanging information. you will be surprised how less -- how little information we share with each other, really.

you'll be surprised. i was stunned actually when i saw the figures and data about this. basically countries have been doing this by itself and nato has the capability which -- which is required by default from nato and needs to be much hurt integrated an that corporation needs -- cooperation needs to be deepen and that's what i see as the major instrument. we have lots of -- a lot of knowledge in that regard, but we need to share it and actually sometimes when anything proves itself to be a good practice, well, that probably should become the standard for all the

-- the allies. and exactly through nato, that's the other major, major use or major positive role of nato is that this is the transatlantic bond u.s. and nato can do anything together. i don't know whether it's anything, but a lot. [laughter] >> and kinder defense is one of those things. i have to admit, in my country we have capabilities but not in the level that is required in order to really to be sure that we have a reliable cyberdefense.

we have a lot of work today. we have adopted an antiterrorist wall and law on cyberdefense. so we are basically walking around that -- walking down that road but -- but we still have a lot to -- a lot to do in that regard. >> well, now i really will bring it to a close and i thought one of the things that was so powerful about your message this morning was your focus on moving european project forward deepening the transatlantic bond, the key is having a positive narrative about what it is that we are trying to achieve together n. that case, bulgaria is such an inspiring example, you mentioned statistics from 1997 and you think about the past -- the path bulgaria has traveled. >> crises around us, the

challenges are actually an opportunity for us to think about how we can deepen our cohesion, both eu cohesion but the transatlantic one because one of the most, let's say, one of the biggest goals of those who are challenging us is to cut the transatlantic bond. >> well, thank you for spending all of this time in the u.s., thank you for coming to gm, if this morning and please join me in thanking the minister. [applause]

[inaudible conversations] >> today a look at the treatment of religious refugees seeking asylum in the u.s. and whether it can serve as a model for refugee policies in other countries. live coverage from the u.s. commission on international religious freedom begins at 9:00 a.m. eastern time here at c-span2.

>> coming up this weekend on american history tv on c-span3, the life and legacy of alexander hamilton. >> hamilton's argument was that the war had been a common struggle. all the stakes were fighting for the liberty of all, for the whole country, so he assumed the deaths of the 13 states along with federal debt and they would be treated as one debt and be paid off at the same time. >> saturday evening a little after 7:00 eastern, editor richard on the economic achievements of alexander hamilton and then at 10:00 the the last bomb, documents the final months of the b-29 air campaign against japan, including the august 1945 atomic bombings of hiroshima and presidential debate between

democratic vice president al gore and republican texas governor george w. bush. >> law abiding citizens should be able to protect themselves and their families. i believe that we ought to keep guns out of people who shouldn't have them. >> gun shift measures are certainly needed with the flood of cheap handguns that have sometimes been working to the hands of the wrong people. but all of my proposals are focused on that problem, gun safety. >> also this weekend at 8:00 eastern, c-span series the contenders, key figures who ran for the presidency and lost but changed political history saturday night, the 1928 democratic nominee and former new york government al smith and sunday 1940 republican presidential nominee. >> as i was driving up the streets, every store window and

vacant store window and had pictures of my opponent and his associate on the new ticket. i don't know of any more appropriate place to put those pictures. >> medical researchers discuss efforts to treat hepatitis c in the united states and the challenges of cost treating the disease. it's an hour and a half. [inaudible conversations] >> well, good afternoon, everyone. welcome to our briefing and update on hepatitis c in the united states. good afternoon, i'm carl smith,

here in washington, d.c. before we get started i wanted to make some house-keeping announcements. you could first follow us on twitter at aidsadvocacy and we will be live tweeting. we are also on facebook, so be sure to like the aids institute and also the presentations will be on the aids institute's website and you can see the web address there for the -- the briefing presentation and also just remember to please silence your phones. as our name implies, we've long been advocating for people living with hiv and aids here in the united states. but for many years, we have also focused on vie rule hepatitis, given the many similarities between the two, both are

potentially infectious deadly diseases and both impact the public health. there's also a number of people infected with hiv and hepatitis c and orc and if you're in any way directed to the healthcare policy world or read current events, you undoubtedly have heard about the new treatments for hepatitis c drug that is actually cure people but you probably have heard very little about what actually is hepatitis c, who it impacts, what treatment looked like just three years ago and why it's so important to cure people living with hepatitis c. so that's our purpose today to get past some of the headlines and hear from a panel of experts including the person who has been living with hepatitis c, we believe that the aids institute that the patient is the most

important person in all of these discussions. before we hear from our panelists, i would first like to thank senator and her staff for sponsoring the briefing, the senator has been a great champion for people living with hepatitis b and c here in the united states congress. we are first going to hear from three leading experts and then we will meet our patient, i will then ask some questions to the panelists and then open it up to you for your questions, so let's get started. since full bios were handed out already, i'm not going to read full introductions but we are going first hear from dr. john ward, the director of division of vie rule hepatitis at the cdc in atlanta. dr. ward is responsible for planning and directing national and international research, surveillance, public health

problems related to vie rule hepatitis, prevention and control at the cdc. please welcome dr. john ward. [applause] >> thanks, carl, good day, everyone. i just would like to echo carl's thank you to senator harano's support for bringing us today and spend a few moments talking about public health problem that the cdc regards as urgent and critical one for the united states. the key take aways are really itemize here. we have a large burden about people living with hepatitis c, about 3 and a half million. an infection that poses progressively complications the longer one is infected with the lifetime risk of mortality of

40%. we have proven strategies and tools that when brought together with have dramatic impact on increasing morbidity, mortality and transmission but we have barriers standing in the way of people gaining access to those. that said, recognizing those opportunities there's efforts underway to begin the put the u.s. on the path toward the elimination of hepatitis c. as i mentioned we have about 3al million people living with hepatitis, based on surveys of the general population, we find that the great majority of those persons born 1945 to 1965, the so-called baby-boom generation, the reason for that is that many people were infected years ago before the virus was discovered

in 1989 when the blood supply was not screened for blood-born virus and risk factors that were common at the time, transmission within health care, through unsafe healthcare practices as well as injection drug use. we don't want to lose sight off that the general population surveys don't include critical population that has high prevalence for hepatitis c including those in correctional settings or native american, but hepatitis c virus when you contract it, typically causes few symptoms or symptoms that are mild, they often do not prompt you to go seek medical attention but then sets up in the liver and creates inflammation which then leads to scarring, that scarring grows

more severe over time leading to most severe scarring known as cirrosis. in addition, hepatitis c causes diseases outside the liver. it increases your risk of diabetes and various kidney disease, among us. and so we begin to model what happens if you don't treat -- if you don't diagnosis care and treat people properly, you have wave of increasing morbidity and mortality over time leading up to about 2030 we believe that in the absence of a million people

can die of complications so really driving us to act, when we look at the statistics from our health system, show that those projections from the models are coming to past, unfortunately. healthcare cost arising as you can see in one of the slides and mortality from hepatitis c is increasing and in 2013 the number of deaths from hepatitis c exceeded the number of deaths from all the 60 other infectious diseases required to be reported to cdc combined. so it's easily the most common cause of infectious diseases that are reported to cdc. because of this large proportionate of people who are in this baby boomer cohort cdc recommended a one-time test for all people born in those years

and show that it was a good value for the u.s. health system. we also recommended testing for people who are ongoing risk in particular people who inject drugs. transformational when we began threat to hepatitis c. we haven't been able to treat and cure a chronic viral infection to this extent and with this degree of safety. one pill, several pills a day, eight to 12 weeks, 90% cure. the benefits are profound for the individual in lowering their risk of liver cancer and mortality from hepatitis as well as profound public health benefit. just a modest implementation of the cohort strategy and linking those people with treatment we can overt over 320,000 deaths in

the coming years as well as decreasing transmission to others. that said, so-called care for hepatitis c is not good and it's not up to the task to seize that opportunity and reach that goal, that's the second bar on this graph and then there's a decrease in proportion that had been effectively staged for liver disease, their strain of hepatitis c properly detected and then a smaller number who have been treated and successfully cured. there's a variety of reasons for that, low provider knowledge, public awareness, health systems that don't have the tools in place to make that an easy process moving from diagnosis to care in treatment and also concerned about the costs of drugs for hepatitis c that has

resulted in payers putting up policies that limit access to these life-saving medications. now, fortunately, there's been a variety of events over the last several years that has begun to losen up these restrictive reimbursement policies. when the first drugs came out around 2014 they were priced 84 to 96,000 per course, that said, the center for medicaid and medicare put medicaid programs on notice that theirpolis should be in line with national recommendations for treatment and that they should not be unduly denying treatment to people who fit those recommendations. in the same time period new drugs that were introduced at a lower price point through negotiation systems such as the

va began to get very favorable prices as low as $11,000 and through legal action where patients were protesting and resulted in restrictive criteria being deemed inappropriate. what you have seen in the map over 30% now of the medicaid programs have broaden their reimbursement criteria expanding access to the treatments, so that's definitely heading in the right direction. so while the cost of drugs is becoming less of an issue, we don't want to lose site of the systematic changes in place so that populations particularly with those limited to poor access in health care are not being -- are not missing out on these life-saving treatments. this is just one demonstration

project that we put together and put in place with our local collaborators in philadelphia targeting neighborhoods with poor access to health care including the homeless. first of all, found a high rate in hepatitis c, 11%, 11 times general of population of the u.s. but also show that despite those limitations, we successfully tested for current infections and persons linked to care and site where is they could receive treatments, so the barriers can be overcome and the opportunities for the individual in public health can be realized. at the same time we are also battling a second epidemic among people who inject drugs in particular. we are seeing large increases in transmission. really tracking along increases

in drug use and injection drug use particularly oral prescription opioids as well as heroin. when we look at the demographic profile of these persons becoming infected, they tend to be use, less than 30, almost white persons, equally male or female and living in nonurban areas, parts of the country. for the u.s. as a whole, we have seen 150% increase in hep c -- hepatitis c transmission and you can see by the map it's a national problem with the states in red reporting increases of hepatitis c, some states more than others. i will show you in a moment but almost all states having an issue now with new infections adding to the disease's burden. given that we have younger

people infected, increasing number of women of reproductive age and that poses risk or infant, 5 to 15% of infants born to hepatitis c infected mothers will become infected themselves and as we reported several weeks ago, we have seen about a 22% increase overall in the country of women with hepatitis c giving birth to infants and in states like kentucky which we profiled in the report, we have seen explosive increases where one in 67 infants are born to an hcb infected mother. a whole new population that we have to resphond and see how we can prevent transmission for them.

hepatitis b is one and also hiv who had explosive outbreak in southern indiana in scott county last year where population -- where a community that had high prevalence of hep c, hiv was introduced an spread rapidly because of social networks, ripe environment for transmission of hiv. we have done modeling as shown here highlighting counties that are most vulnerable to hiv outbreaks. the key driver of that is that these counties have high rates of acv transmission, hiv can follow. what we are trying to do is help those communities ramp up prevention services. the other map shows you where services are located in the country.

you can see a big disconnect between where the most vulnerable counties are and where the programs are and we need to bring that prevention service capacity to bare in the vulnerable counties. we've also done modeling to show how big of impact can you have on hcv transmission. number one, just making service available, persons that are injecting have access to clean equipment, have some effect, 27% decrease. if you ramp up access to drug treatment so people can help people get off drugs, that also can reduce transmission, but the biggest impact is when you put together those two interventions together with a robust testing linkage and access to hcv therapy. that's what our model shows and now we look forward to putting that into the test in the field to see what are the right strategies to have the biggest

impact on this population. so really our priorities looking forward are to improve state and local capacity to detect transmission, investigation the social networks so you can begin to plan interventions appropriately, assist state and local and other -- state and local health departments and their collaborators in implementing the interventions and then doing some prevention research with the previous slide as the case in point so that we have the best evidence to guide what we are doing for this critical population that's responsible for the greatest number of new infections in the country. but taking a broader view, bringing together the right set of interventions, you can prevent upwards of 80% of new

infections. so we have a powerful package of intervention. and so the national academy of science previously known as instate of medicine has put together a panel for setting goals of hepatitis c and what's need today reach them. that panel has put out preliminary findings to show that, indeed, they believe that the elimination of hepatitis is feasible in the united states and now they're hard at work identifying the barriers of which i've given you some examples of and providing some solutions to reduce barriers so that elimination goals can be achieved. our priority is to strengthen the state and local capacity to detect people living with

hepatitis c and get them into the preventive care and treatment services that they need to establish at least one regional training and technical assisting center in those states with vulnerable counties that i have shown you, accelerate adoption as routine service throughout the u.s. health system working with a variety of payers and then given this move toward elimination begin to set state and local projects that are really bringing together the diverse stakeholders and interventions need today reach those goals. and we feel that collectively we can overcome those barriers, that we have those interventions and what our main task now is to bring together these populations who are living with hepatitis c or at risk for hepatitis c with these interventions and truly come together and eliminate hepatitis c as public health threat in the united states,

thank you. [applause] >> thank you, john, we are going to hold questions after all panelists speak. next i would like to hear from dr. michael freed at the university of north carolina cha pel hill and serves on the governing board on the american association for the study of liver diseases, so please welcome dr. freed. [applause] i want to thank carl and his organization for putting this together. the take messages are shown in the title of my talk here. therapy for hepatitis c save lives. but i will also now discuss why this is so important in the

patient -- to the patients we see with hepatitis c. here are my disclosure in terms of consulting activities, we know the top list are generally entertaining and humorous and we all great, great joy from seeing them but this is one top 10 list that unfortunately we don't want to be on and we see here that viral hepatitis is listed as number 7 as a leading cause of death worldwide. for the the longest time hiv infections overshadowed and rightly so. there was an immediate rapid progression of hiv infections leading to deaths while hepatitis c like dr. ward mentioned is an insediuos

disease that takes toll over 20 to 30 years. the number of deaths with hiv decreased and more people succumb to go hepatitis c than hiv infections and this occurred by 2007 and as dr. ward showed, the projection suggest that this is going to increase through 2036. you see where we are in 2016 and by 2032 where it's estimated to be the peak in terms of patients dying of my cases of hepatitis c, needing liver transplants were still in the uptick of that disease burden. and i can tell you from what i see in my clinic every day, these numbers as john had mentioned are bearing out in truth. now, this is what a normal liver looks like. this is a liver that all of us would be proud to call our own.

it's a nice red healthy looking liver but over time with hepatitis c infections or any disease, you see this scarring, the liver that ultimately will cause complications from either liver failure, the inability to process insettic functions what a liver does or complications and one unpredictable one is development of liver cancer and we are seeing explosion of liver cancer in patients with hepatitis c with advanced scarring and we are faced with managing the patients hopefully we can catch early where we still have opportunities to treat. now, the treatment for hepatitis c is shown here, it's involved and incredibly simple. we see on the left-hand side the level of the virus.

when patients go on treatment for a duration of time anywhere from eight to 24 weeks depending on some of the features of the liver disease and prior treatment, you see the virus drops down and at the end of treatment virus can be detected in the blood but the real cure after you stop therapy if it's undetctable 12 months after treatment is discontinued, we call that a sustained biological response which is to cure of hepatitis c infections and as dr. ward mentioned, there's really no other viral inif he thinks that we can think of that once established chronic, you can treat it for finite period of time and it does not come. why is that so important?

well, i showed you and you've seen the statistics that this disease will progress in many patients, but if you achieve a sustain response or cure for hepatitis c you can break that cycle. what we see are patients from who had advanced cirrhosis but nevertheless about a third of them developed a cure of hepatitis c infections and what you can see is whether it's liver failure or liver-related mortality or carcinoma those who achieved cure had lower rate any my cases compared to those who did not sustain a cure. remarkably what you see in the lower corner that even mortality actually improved in those patients. and this has been demonstrated

in a number of other studies. this is compilation of studies that have looked at this aspect of hepatitis c therapy and basically whether you have all stages of hepatitis c infections from mild disease to cirrhosis, when you treat hepatitis c successfully you impact mortality substantially. so curing hepatitis c will decrease liver inflammation, decreases liver scarring and it stops the disease progression. ..

>> as i'm sure you're going to hear about shortly. the power cord -- great. thanks for bearing with me. i hope everyone had some refreshments while we're waiting. we talked about what we have benefits. i think that's quite clear from the data and doesn't talk about some things we really can't measure a value to. i've been managing hepatitis c really sends the year after it was discovered in 1990. the treatment advances have just been unbelievable. i'd like to take you through some of those advances over time.

in 1999 we had a drug that was injectable. you had to inject it three times a week. sometimes every day. maybe it got about a 16% chance of a cure. we've added a drug ever increase rates to about 35% of two or. we were extended the half-life of the interferon, we can objected to once a week and to get made about a 45% chance of cure and the most common types of hepatitis c. and then we were able to take that right acting antiviral agent that attacked the hepatitis c infection, combined with others and the cure rates increased over 70% what was fantastic. however, these drugs had substantial side effects to patients who are being treated. fatigue, flulike symptoms according to your. patients could get anxiety, depression. everybody get some type of degree of anemia and managing

these patients was very complex. patients themselves had very poor quality of life as we will hear about with these early types of drugs. nevertheless, if you were treated and were able to tolerate the therapy, you had for the first of demonstrated you could cure this disease with his relatively toxic drugs. because they have so many side effects they were relatively few candidates for the treatment because all the comorbidity ahead. they would not talk with these medications for. frequently patients did not get the full benefit of these medications. as we heard around 2011, around 2033 of new medications that were all oral treatments for hepatitis c. you could take one or several pills for relatively short bit of time with almost no side effects and your cure rates were over 90% of all patients who got treated. this shows you the top schematic

and where the series of drugs attack the very regions of hepatitis c. on the bottom table pc the commercial names that you have all heard about often on television, et cetera, magazines being pushed about these medications. combining drugs from different classes that you see is how they affected a near universal cure for hepatitis c. taking drugs that attacked different parts of the virus and how it replicates, combining them just like they did with hiv infections but these are specific for hepatitis c and achieving incredibly high rates of two or. we now have these regiments that you see here harvoni, et cetera, with rates of to between 90-95% of sometimes higher for certain populations of hepatitis c. they can be as simple as one bill or several pills with almost essentially no side

effects associated with them. this gives you an idea, this is a compilation of a number of studies. this is cure rates on the left. almost all the regiments across the board approach 100% sure and patients were taking these medications. whether or not they have cirrhosis, these can ethics very high rates of you already. dr. ward mentioned about -- trying to give you a stress test here today. dr. ward mentioned about the cascade of care and that we have a ways to go in this. fortunately, we have a tremendous impact over time in the cascade of care. so the currently available therapies can true almost going to ask us to care the biggest barrier controlling hepatitis c infection. we've done much better in the air of the direct acting antiviral agents. we still have a ways to go. here's a couple of samples of patients i have seen in the

clinic. 50 sexual been wh who injected drugs until 1980, married and one daughter, insured by medicaid. a sympathetic, measure of the information isn't that great but when you look at image of fibrosis he already had advanced fibrosis, the stage before cirrhosis which already gives an increased risk for liver cancer and subsequent progression to cirrhosis. this patient i think all of us would recognize he's got scarring. we see in the benefits from treating hepatitis c. of course, we want to treat this patient. this patient would be eligible for treatment and all of these cities except miami beach, baltimore, chapel hill, north carolina, or chicago, illinois. the answer as of a few weeks ago was chicago, illinois, weather only on treatment for people who have cirrhosis already come and anybody else are being denied by the state medicaid program. another example, a 20 sexual

woman is addicted to prescription drugs and then went on to heroin, completed a drug rehab program in 2012, very, recently graduate from college, completely turned her life around the mild fatigue but, of course, because she's only been infected with hepatitis c for short putter time toledo hepatitis c takes decades before you get advanced fibrosis, she had a very mild infection, scalable and. very mild fibrosis. this person would be eligible for treatment if she lived in which but the cities of detroit, miami beach, chapel hill or los angeles? the answer now as of about a month ago is patients who live in florida who were on state medicaid now have done away with fibrosis restrictions on being able to treat patients. this patient was denied therapy in north carolina because they are still denying treatment to those of fibrosis. i have the patient is completely

put trucks behind, turn her life around and could easily turn this page on this for difficult chapter in her life and yet i am not able to give her a 12 week course of treatment, cure or she can move on with her life. these are some of the challenges we face on an everyday basis managing patients. when you look at the map and it's all over, and as we for the good news is it is changing, but still third two states as of a few weeks ago still required evidence of moderate or that scarring of the liver in order to prove treatment for hepatitis c. if you have advanced scarring you already at risk for complications of hepatitis c and risk for liver cancer. this is a data from our clinic that was put together by our pharmacist looking at patients were too prescriptive before. we prescriptive and for all patients with think are appropriate candidates we will write prescriptions for

regardless of the roles of the various payers they have. if we think they need to be treated we were right to a prescription recognizing some these patients will get tonight and they'l to have to appeal the process. that's what happened to you will see the initial denials occur in about 20% off 1000 plus patients were treating over a 15 month period. we were able to appeal, some good but some still got tonight. when you look at what some of us cause of you know, the most frequent reason was because they didn't have enough scoring to the message being let's wait and to your disease gets worse before you allow us to treat and cure your hepatitis c which is not acceptable to me or any of our patients. medicare the highest approval rate over all. medicaid the lowest approval with diffuse successful appeals. just to summarize, the burden of hepatitis c is immense and often underestimated. during hepatitis c will have a

definite positive impact by decreasing the incidence of cirrhosis, carcinoma and improving the overall policy of life for patients with hepatitis c. multiple there is exist that arbitrarily restrict access to all who would benefit from a cure for hepatitis c infection. all of us will continue to be the champions to affect change in the shape policies to give us greater access to drugs for all these patients. thank you very much. [applause] >> thank you, dr. fried, thank you for putting up with those technical difficulties. next we'll hear from dr. john coster who is director of the division of pharmacy at the center for medicaid and chip services at cms. john is a pharmacist by training, has been long and often health care policy in washington, d.c. he's going to talk about medicaid role in the treatment of hepatitis c.

>> thank you very much. good afternoon, everybody. pleasure to be here. i want to call this may be the reality check of presentation part of this webinar or this briefing today. because of these drugs are very, very good these are drugs you've heard about but also very, very expensive. so i want to describe today for you the role of medicaid as a pair in coverage of all drugs including hepatitis c because it's important to understand those of you who work with states and medicaid programs and patients, what the rules are, what the current state of coverage is for medicaid, what we've done at cms. i went the division of pharmacy or center for medicaid and chip services. medicaid is no larger than

medicare in terms of number of patients that are covered to recover about 72 million individual to so they're very big program to its mortar member we are a federal-state program. for our 56 individual medicaid programs if you've seen one medicaid program, you have seen one medicaid program. they are different. so cms we overstep states operate the programs but in general we don't dictate to them how to run their programs. why is there 56? 50 states, the district and six territory. medicaid provides matching funds to states, based on different factors but in general it's a least 50% medicaid pays to states or services. there's been a huge shift toward managed care. about 75% of all patients on medicaid are in some form of managed care. there have been great advances in therapy to treat hepatitis.

medicaid programs, treating patients with hepatitis b this with the launch of these new drugs but i've talked to probably more with medicaid program directors, pharmacy program directors about this issue over the last two years than any other issue i've dealt with. i can tell you they want to provide as much comfort as possible to patients by as many of the medicaid directors told me, if we started covering everybody with hepatitis c from the time this drug was launched at $94,000 per patient, we would have no way to cover anyone else's coverage. let's talk about the rules of medicaid. prescription drugs are an optional benefit in medicaid believe it or not. it's not a medicare benefit but every program covers prescription drugs. how does the program work? for a manufacturers and drug to be covered under the medicaid program, manufactures have to sign an agreement with the secretary of the department of health and human services, hhs. that agreement basically says in

exchange for the states covering all the prescription drugs of a manufacturer that side of rebate agreement, the manufactures will be repaid to the states. this was a program and acted back in 1990 because the states were having trouble negotiating with manufacturers for the cost of prescription drugs. so congress and the law that created the program decided that we will do a bargain. states, we will give you access to lower prices, and manufactures, we will give you better access to medicaid patients. they must sign an agreement in order for the drugs to be covered under medicaid and their required to pay statutory rebates to the states. the states collect the rebates and the federal government gets its part of the money by reducing the match that is paid to the state for that particular quarter. these rebates are collected on both drugs provided to patients in fee-for-service medicaid and as a result of the ford motor

act now on my and each chip or scratch. the state is collecting all this money from manufactures on rebates and in exchange the state is to provide coverage access to the prescription drugs of the manufacture that signs the rebate agreement. how do states control costs? all of you are in some type presumably of prescription drugs coverage. i have employees health benefits. many of you met federal couple of programs and we'll basically prescription drug coverage. just like medicaid, your private health insurance uses there is cost management tools to manage the cost of the drug benefit. medicaid is a lot in addition to the rebate program to use of various utilization management tools. these are standard, practice. talk to anybody and private sector, other government programs, these are tools that are commonly used to manage the drug benefits. things like prior approval, many before a drug is dispensed to a patient they may have to jump through hoops in order to show that drug is medically necessary

for a patient. states use preferred drug lists, other private sector entities use one of us. i can tell you if you talk to any commercial payer they want to be medicaid as among the most generous covers of prescription drugs. there's a lot of formularies that are highly restrictive, meaning you can't get drug sometimes at least in medicaid. if you're a manufacture with the rebate agreement, medicaid has to cover your drug although he may have to jump through hoops to get it. there's a drug review. medicaid uses cost measure tools to manage the cost and quality of the benefit that provided. i mentioned before the our rebates that also paid on prescriptions that are dispensed to patients in managed care plans. this is a huge plus for the states as well because prior to affordable care act states were not collecting rebates that were

in medicaid managed care organizations. that's where a new revenue for the state and helping also managed the cost of the benefit for individuals in managed care which as i said was 5% of all patients. here's the rebate amount that are paid to the states by manufactures. so for brand name drugs, the real expensive drugs, states are getting about 23.1%, a benchmark. this is approximately the price retail pharmacies are paying for these drugs. it's a pretty substantial rebate that manufacturers are paying to the states initiated coverage of the drugs. for generics it's a little amount. it's about 13%. states are getting rebates with respect to drugs they are covering for medicaid patients both in managed care and fee-for-service medicaid. but states also have the ability

to pool their purchasing and get supplemental rebates. this was one of the key drivers of lowering costs for states not only for hepatitis drugs but for all drugs. medicaid programs, state and federal, we don't have the ability to control cost costs of launch prices for prescription drugs. when the first drug came out to treat hepatitis c, the new direct agent at $94,000, i think everyone was in some sort of sticker shock because we're used to seeing high drug prices but $94,000 for an eight to 12 week course of therapy was pretty high. the states don't have the ability to control the launch price is a prescription drug. only when competitors come on the market do you really get the ability to pit one manufacture against the other. in addition to the basic rebates that states get, at some point as competition comes on the market the states are able to

leverage supplemental rebates. they do that through preferred drug list. first you had, then you had harvoni. these are the names of hepatitis drugs and maybe we'll have another one pretty soon. once you have competition, the states can leverage that. prices can come down. the price of of the therapy rit now are a lot less expensive than $94,000. that's why you've seen some the states opened up coverage. there may states that have moved to zero coverage meaning you have to any level of cirrhosis, f. zero, in order to gain access to the drug. some other seven from f3 to f2. i think we're moving in the right direction with respect to access the chapter number the context in which this entire thing started this deficit to look at the cost of these drugs and saying with all these other people that went to manage, we just have to prioritize. states use competition in order

to leverage manufacturer pricing, edited most of the states have done a pretty effective job because they pooll their purchasing. they go to manufactures fancy we will make your drug preferred, tried to channel all our hepatitis life to the to if you give a good discount in return. i talked about coverage for prescription drugs with respect to fee-for-service to with the advent of managed care you should also note what are the rules? managed care organization's are private sector entities that the states contract with the cms does not contract with individual medicaid managed care organizations. the states are responsible for contracting with the. as part of the country to states have to have parameters in the contract about what type of prescription drug coverage that medicaid managed care entities to provide the medicaid managed care companies have to provide prescription drug coverage in an amount, duration and scope that is no less than what they fee-for-service plans have.

so, for example, one of the things we were concerned with at cms is this hepatitis drugs will do is give several states have had in their fee-for-service programs had blue secretary to gain access to the hepatitis drugs dan did managed care. states, the organizations cannot have medical necessity criteria that are more stringent and fee-for-service. we were concerned in certain states fee-for-service viewing had to f2 which some might argue is in itself a restriction on many of the managed care organization sat f3, a higher standard for medical necessity. that's not permitted under our rules. as these drugs rolled out, as we look at the price come as we heard from the states, and we encouraged states because we don't dictate to states that we encouraged states to look at the coverage policies as the drugs cannot as more competition of it as the prices came down. last november we got concerned

about certain restrictions that some states are putting in place and what we did is we put out a guidance your we don't put out a guidance every day. last time we put out a guidance about a particular class of drugs with respect restrictions that states are putting on was back in 1996 on hiv drugs. so it does not happen every day. we heard enough from patient groups, some of which may be in this room are clear enough from physicians and we also heard enough from states to know that while we are empathetic with the states played with respect to cost, at some point you can't use utilization management tools to unduly restrict access to coverage. what the guidance said at a don't know if you've seen it but it's online, you can look at it but it advice states on current coverage requirements and permissible restrictions. in other words, we told states here's the coverage rules, here's the permissible restrictions and would recognize the significant costs of these

drugs and that the manufactures have a role in making it more affordable. remember, it's not about price but it is about price. the price was substantial-anything we've seen before. we encouraged the states to use sound clinical judgment when creating the authorization criteria. we pointed out certain things that made hi this country. for example, there were many states were f3 and several with a four, only one left with a four right now which we think f-4 is so unacceptable. even though with f3 there was little data come in saint even if they were at f3 to other criteria to put in place that were serious obstacle to swim coaches and use sound clinical judgment. we encouraged them to work with her physician and pharmacist drug users review board. every state has a board and the sport helps to create these utilization criteria for the states. state medicaid program pharmacy directors don't create these

criteria out of the blue. they work with local physicians, local pharmacist, tried to take accommodations can we treat and what are reasonable criteria. when we got concerned was when the country got unreasonable when it was restricting access to coverage. we did not tell them they have to follow those treatment guidelines because these were private sector guidelines but to our treatment guidelines there out there that we encouraged states to use. stage drug coverage cannot be more restrictive or have a higher medical necessity bar and fee-for-service. these are some the things we said to the states to the state for restricting access to drugs, contractors touched a record imposing physicians be unreasonably restrict access, that they should examine the benefit to providing to ensure that limitations are not unreasonably restrict access. that services covered under managed care should be furnished no less than fee-for-service

medicaid at the ncos have to be no more restrictive. i think we've made progress but i do know we've gone as far as we would like but for example, that are several states are f. zero that had a higher score before. two states just move the f3 def to the others are in the process but in the. the states can't just turn on a dime. sometimes they will wait, work with her board, they have to wait for next quarter for and begin to change the criteria but i do think we are making progress. at the end of the day we tried to work with states, encourage them to move towards greater access to the states have to try to balance that with the fact hepatitis drugs which another number one spend by far the most states does consume a lot of resources and they have a lot of of the patients they have to also care for. i hope they give you some of the sense of release of the thinking of the states. there are certain states we are very concerned about with

respect to whether coverage policies are. we are trying to work with the states to encourage them to move further towards more access. this is just not a turn on the switch type thing. we expected it would take some time but we can change them wonder what states are doing, work with them and encourage them to increase access to important drugs within the scope of the resources they have. i must have done that by mistake. thanks. [applause] >> thank you very much, john. you i think it a great job of supplying a very comforting to the issue for the audience. so now we will take a break from the presentations. i'm going to bring up, and please welcome mr. allen thompson, from washington, d.c. please be patient of the medstar health clinic in washington, d.c. and he's been living with hepatitis c. so please welcome.

[applause] >> i bet this is the first time you have done this before. it's going to be easy. do you want to tell us a little bit about yourself and how long you've been in d.c. and to some background on your family? >> my name is allen thompson. i've and washingtonian. i was born right down the street. i'm 65 years of age. i am living with hepatitis c, first diagnosed i think in early 90. they said i probably had longer than that. i have of the melodies. high blood pressure, degenerative arthritis, and

hepatitis c. it was recommended to me by my primary care physician, because of my arthritis, and had to stay off, stay in bed for weeks at a time, that i tried to get disability insurance. so i did. of course medicaid came along with that. now, as i said, i've had other problems. i broke my leg about eight years ago, and during that time i contracted nurses, virus, a couple of times. i don't know if it had any effect.

have to ask my doctor, doctor fishbein, whether that anything to do with my hepatitis c worsening. spent much into the having cirrhosis of the liver. >> the right speed but you were never sick with your hepatitis? >> not that i've ever noticed. didn't have any complications, other than my trying to take the previous two medications. >> it's really interesting to we heard about hepatitis being a silent epidemic from some of our previous speakers. here you were living with cirrhosis of the liver and you didn't even know it. but thank god for the doctors and the blood work and things like that so they recommended that you take interferon, and you want to tell the audience how that is ministered unto him administered and how you reacted

to speak as well, i met dr. fishbein when i had contracted my second bout. i had any operation, replacement surgery, and she also checked my hiv status at the time. the nurse assistants and her staff come herself quite a bit, biggest pension -- it consisted and persisted, it was months after i got out of the hospital with my late replacement surgery, that i got on the harvoni spent what about the interferon? >> interferon was my initial, i say back in the mid '90s. i took that for about two months speak as an injectable? >> i think was the injectable at the tiger it's been so long. >> and how did you feel when you

are on that drug? >> i didn't have many side effects. what we found out it wasn't doing anything for me so they took me off. >> so you were on it twice, and medicaid paid for the interferon, and it didn't work, right? >> right. >> do you know other people living with hepatitis c, and how are they doing? >> sure. i have friends who live with hepatitis c and public diet might as well. in fact, a cousin of mine, i think hepatitis c was the initial reason that they died. and other people that we all know like ray charles, natalie cole, they died with hepatitis c. >> after interferon didn't work twice for you, then you would put on one of these new drugs. that's just a pill, right speed

was right. harvoni is a pill a day. by the second time i was on interferon, it was along with -- that's what had a tremendous amount of side effects, all of them. >> so what is all of them? >> well, sleepless nights. wasn't able to eat. constipated. a lot it was terrible. terrible treatment. so i was skeptical when i was introduced to harvoni, because i've gone through so much with the second treatment that i had. so talked to some of the people that i knew that had gone through treatment, and my primary care doctor said they knew it was successful. so i tried it.

dr. fishbein was very insistent spirit and the results so far speak with the results so far are very good. i had no side effects that i know of. a couple of sleepless nights. i was on six months, because i have been on the other to, interferon treatment. the doctor said i should have it at least six months. >> and i guess today now you have viral suppression spent so far, after four weeks spent i think it's safe to say you are about cured. so congratulations to you. how does that make you feel? >> i feel very, very good. just not knowing that i have the disease, as of this moment. to say that i have a couple more

months before were really find out, but i'm hopeful. >> right. so are we. you saw the pictures that dr. fried put up of a liver with cirrhosis come in this this equation for the doctors to is his liver going to look normal now after being treated? >> it actually comes to actually, discarding can't ever. it's not going to go back to normal but he than 10 -- the main thing is it will prevent further publications, further decomposition of his liver disease. one thing we have to be vigilant for, if you've progressed to cirrhosis even if you're cured you're still at risk for liver cancer. that's why they still recommend screening for liver cancer with liver imaging every six months in people with cirrhosis. that risk is lower but it's not gone so it's important that gets done.

the good news is if you been feeling well and if not have any competitions, your likelihood of having any competition is markedly diminished with the cure of hepatitis c. >> thank you. any last comments? what do you think about what you heard today from the states restricting access? in d.c. he was able because of the severe nose of your disease, you are able pashtun in some states you are not able. any comments on that? >> i think it's a tragedy, all people that are infected with hepatitis c are not -- this is the only disease that has a cure. >> thank you very much for your courage for being here today, and for telling your story. appreciate it. thank you very much. [applause]

>> we have some time for questions. may be picking up on the last point that we just heard about some states restricting access to only the patients who are very sick. you said it is unacceptable. why? >> i think that it's relatively easy to measure by looking at a blood test. and also by look at the statistics that the overall health, less cancer, less cirrhosis, less decomposition. the parts that are more difficult to put a price tag on our how people feel after their cured from hepatitis c. as we've heard from mr. townsend and diabetic patients with hepatitis c for probably 30 years and i to have a liver transplant.

if you get a transplant, if you have hepatitis c before trent but you get hepatitis c after transplant. it resets the clock but you are still affecting your new liver. we have tried multiple medications on this person and offkilter regarding into a truck of these two medicines and he was cured after 24 weeks of treatment. to him of course is no longer living under the hepatitis c infection can what he said was when asked how he's doing everything he said it was the first in his able to share a bowl of ice cream with his granddaughter without worrying about it. to him that was like an important thing. it wasn't that we save his liver and everything else. you can't get hepatitis c from sharing a bowl of ice cream, i want to show that but this was the thing even though we try to educate him about those, these are things he's worked about for his family.

that had a major impact on this individual. those are things that are hard to measure. >> this is a question for doctor ward. i've looked at your budget, at its $34 million, division. we talked about just hepatitis c did i think your division is to focus on hepatitis b as well and combined its 5 million people at least living with hepatitis b and c. and the united states. your budget, i know the hiv budget at cdc is at least 20 times larger than that. so could you talk about what you do with $34 million that that is distributed and what you do with that money? >> first of all we set the prevention policy for the country and not just for the testing that i talked about today but also the vaccination policies for hepatitis a and hepatitis b, and to evaluate how well those are working.

particularly as we protect young children from hepatitis. we then work with state and local health departments to develop their surveillance capacity and do what we can to strengthen the ability to detect trends in transmission and then advised people living with hepatitis c and hepatitis b and helping the state and local health departments in the clinical setting get those people in to the care and treatment that they need. based on our current budget, we are able to give money to surveillance to seven sites in the country, five states and two largest cities, and give about on average about $70,000 to state health departments.

for them to do some prevention work. that's what we are able to do now. we are always looking for ways to improve the efficiency and effectiveness of those interventions. >> great, thanks. find a one of our key advocacy activities at the agency is to get that number, more funding, so our country can do a lot better job first testing incidents for hepatitis in the united states. so now it's up to questions from the audience. we do have a microphone for our c-span audience, and so please identify yourself and please stand. >> i wonder if you could talk more about the demographics of people -- i believe that sexually and drug use are the two main ways of transmission are there others? can you talk about, you know,

more drug use as opposed to sexual transmission and others? >> hepatitis c virus is a blood-borne virus, exposure to contaminated blood is the biggest risk. when you look at baby boomers, our national survey, only about half are able to propose the way that they got infected. with injection drug use being the predominant risk but 50% -- back in the days before the viral, virus was this effort, -- a lot more transmission with health care as well as maybe some incidental exposures, including drug use could have played a role. now as we have shut out some of those routes of transmission, although we've seen a return of injection drug use, the large majority of patients being

infected they are drug injection users. it can occur but it's not very frequent, not on the order of hiv or hepatitis c the smh in you can't get child transmission and other exposures like unregulated tattooing and things like that are associated with transmission. certainly other types of drug use like snorting cocaine has been associate with it. just to add on to mr. thompson's experience with hepatitis c, among the baby boomer population we calculate about one in four already had the severity of disease that mr. thompson had. award has cirrhosis. that's a very sick population. african-americans have about twice the prevalence as the white americans. that's obviously for american

indians compared to whites because of the variety of risks in both of those populations. and people who have poor access to health care and medicaid populations also have a higher prevalence. one of our priorities at the cdc is to help improve that kerry cascade into federally qualified health centers. you typically -- it's been improve city of formal care act. now we are getting infant care setting or would like to make sure those people are getting tested and getting the care and treatment that they need and then bringing that together with the detection and response capacity improvement in these states that are seeing large epidemics of transmission. >> so i did the math by hand. mr. thompson is in that age

cohort that dr. ward talked about one between 1945-1965 when we see a large number of people infected with hepatitis c. any other questions? >> thank you to the panel for coming today. i'm with a national network of physicians. advocate on behalf of patients for improved therapy. mr. thompson's doctor, dr. fishbein, happens to be a physician who is associated with our allies. we've been working with our hepatitis therapy axis working group, we find that complies with these drugs being very expensive and very high but also an incentive is there secure. could you all speak of that in terms of what you see either in research or with your personal clinical experts about compliance?

>> i think compliance has been excellent with these medications. i think people recognize that they are miraculous in terms of being able to cure asthma good at people who take these medications. they have been waiting for these medications for many years, simple medications with minimal side effects. i think it's important before starting treatment for patients that you do educate them that it's very important that they adhere to these medications. gobbledygook only risk factor is not taking the medications. there are a few other things but for the most part if you take these medications on a regular basis as prescribed, like i said give a 90% plus kids adventure. that's across many different kinds of popular things. we've done a lot of real world studies going on now and the data looks quite good, even not just, the date in the real work is similar to the dated in the

clinical trials that have been published. i think it's a message that's very important to take your medications, high chance of being cured. >> i know some programs have restricted access to these drugs because of someone's prior or current alcohol use or substance use. could you comment on those? >> that's also variable but some states do require pretreatment drug testing or an alcohol abstinence prior to starting these medications. i don't think any of those have been demonstrated to impact the outcomes of treatment like they have in the past with interferon-based treatment where they were much more rigorous in terms of side effects and the tears issues. if you are trying to break the cycle of new infections, treating people who inject drugs is an important group not to overlook. certainly some of those

restrictions would prevent you from treating the patient improperly. you can get reinfected actually feature hepatitis c and you still have activities that put you at risk for infection you can get reinfected with hepatitis c. it's important that patients understand that and try to break that cycle of all levels. >> this is a question for doctor costa. this is a don fishbein so you've heard minute already but i know you're not on the medicare side. however, we see about our patients are not aging into medicare. so mr. thompson, he actually lost his medicaid during his treatment because he is a six-month event he moved to medicare. this is going to start costing the government and taxpayers a lot of money. my question is on the managed medicaid or innovation. because 75% of them, it costs

70% of medicaid is now managed medicaid, how are we enforcing the fact that everyone that you are encouraging the managed medicaid to follow the fee-for-service restrictions? because what we are seeing is not, that is not the case at all. >> we are aware of that and that was one of the reasons we decided to go to issue the guidance to reaffirm two states, and for managed care plans, frankly, that the our rules regarding drug coverage. the amount has to be similar to that in fee-for-service and you can't have a higher than medical necessity criteria. estates are really responsible for managing and overseeing their contracts -- that state. passionate we just put out a new managed care will a few months ago that i think will give us a little bit more of a hated

oversight of those contracts. bad it was probably 50/50 that reason was about half the reason we did the guidance is because we saw such disparities in states between fee-for-service and managed care. in one state you could have fee-for-service, have one medical necessity criteria and if you have multiple managed care plans each with a different set of criteria. it just seemed a matter of equity that everyone should be the same period that's part of what we're doing right now is looking at what's happened with those states. since the guidance without and who remains, which did continue to have those disparities. we don't expect that, we don't expect the managed care plan, the managed care plan may cover a different drug than the fee-for-service but they can't have different criteria for medical necessity. we also need managed care plans

to cooperate with the states. because they are a partner in providing care to medicare patients. i hope that answers your question. >> dr. fried wants to add to the. >> i just want to comment about right now there are restrictions that states and other payers are making are based solely for economic reasons. there are no medical reasons why you should restrict treatment for people with mild disease. did make they can are good people with mild disease are fantastic candidates for treatment because he couldn't they are not going to to with the hepatitis c in the future. most of the guidance is, i was at all of th all of the guidanca double .1, the guidance from the infectious disease society of america comment about all patients with hepatitis c are potential candidates for treatment. that's based on account of experts recognize that you can to these patients are preventing long-term complications and improving quality of life for

all of these with hepatitis c. >> next question. >> i work with dr. fishbein. to respond to your idea with regards to of course would be, it is an economic issue as far as having to pay, all patients on hepatitis c regardless of the score. it would still actually still be actually worse because if you actually treat only patients that going economic basis of just f. three or four, of course would look at those that still at zero f. two they're still going to progress. technet for patients for a three and a fourth a soft have screens that would have to be a long time, a long-term effect. so wouldn't it be best for insurance companies to action look at it in a broader perspective? that way 20 years down the road there benefiting from it and

these patients are not getting the screens that they wouldn't need to do? >> i couldn't agree with you border i think try to treat people earlier to prevent the long-term competition is important but it's hard to see the cost savings with such a long horizon. that's one of the big issues we have to overcome is that recognizing these treatments, really treating everyone in the spectrum is important to preventing those complications. >> the other benefit that we are trying to properly evaluate and assess is we treat and cure summit, how many infections -- the current model projections are really about the benefit of curing the patient answers reducing the health costs, which are paramount of course. the other benefit is preventing transmission to others but i

think that's the study and the demonstration projects we are seeking to develop to answer that question. because i think -- >> i have seen so many studies that talk about the cost effectiveness of treatment because then people do not progress to liver cancer or liver transplants, et cetera. which are very costly. i think i saw a question in the back of the room, and that will be our last question. >> this is for john koster. senators wyden and grassley without a report on how they develop the price of the hepatitis c drugs as well as impact on the u.s. health care

system. and one widely reported piece of that report was that there some 700,000 medicaid patients that were estimated to have hepatitis c, after the program spent $1 billion to treat about 2.5% of those patients in 2014. what of the less widely reported piece is that report, that company documents showed as they were setting their list price in contracting strategy, that the company do that patient access would be reduced as the price was increased, but that the reduction in patients would be offset as a result of the higher price in terms of revenue. i'm curious about two pieces. i guess first off, i don't know

if you have any updated date on 2015 in terms of the amount of spending, the number of patients, i think important medicaid states have been able to get to this year. but then secondly i know that when you all sent out letters to companies at the end of last year, or when you send out letters to medicaid states to put up the kind he also sent out letters to companies, and i'm just curious whether cms feels that the companies are doing everything that they possibly can to make sure there's access or whether there's still attention where companies could be doing more? >> that's a good point, because at the same time we put out the guidance we did send letters to for other companies that make these drugs, merck, j&j, gilead. and basically asked them to do

more, or what more could they do to help make these drugs more comfortable. at that point in time the drugs were still in the 80, $90,000 range and states are struggling as they still are now in many cases to pay for them. we do think there's more that manufactures could do in competition to help bring down the prices on the drugs but they did start out at a point where the relatively high for a lot of states and for commercial payers to pay for them to i don't know that i can tell you exactly what that is. we are hoping to manufacturers to come up with innovative ways to help states a fourth and we just recently put out a guidance on value-based purchasing, outcomes-based purchasing which is something we're interested in seeing if manufacture a willing to engage states on that. it's the manufactures have some risk in again. you can't just set a price, ask

states to pay and see the outcomes on the outcome. manufacturers have had some skin in the game. we are hoping over the next couple of months as we work with states that still have restrictions that we find may be unacceptable, that the manufactures of these drugs will come forward with some new innovative ideas. admittedly prices have come down because of competition that they came down from a very, very, very high point. so i think that's the best answer i can give you right now to your question, because like i said in my comments, we don't have the ability to control prices. i think everyone struggles to not just medicaid. medicare does and commercial payers. pricing can be managed better through competition and utilization management tool but it's the launch price is i think has everybody backs.

the president does have the proposal in his budget that would create a full purchasing system for federal and state purchasers because as i think you mentioned, medicare buys these drugs, medicaid advisor the drugs, public health service buys the drugs but we don't have a coordinated way to pay for them. in many ways it's the manufacture benefits that there is of a disparate purchasers because we can't go are purchasing but we do think if there was a pool purchasing among federal payers or at least cms buyers, that would maybe get a better launch price and get faster price reduction then we saw with this particular class. >> just to add, i don't have any inside information on drug pricing but just by what i've read in the papers, we are now seeing that the drugs are in the $20,000 range. i've also seen that they are less than the cost of you would be in england pixel looks like

as john said, because of competition the price of the drug has gone to the other comment i wanted to make as i was going to ask this to you, john, because i see a lot of scary numbers come at you just mentioned 700,000 as well in the medicaid program. but as dr. ward talked about, around 50% of the people in united states who have hepatitis c don't even know what. so the estimates of the three-point some odd million people with hepatitis c in the united states are just estimates. it's not the number of people who are diagnosed with hepatitis c. so it's going, just like with hiv, i mean, i could do scary math for that as well and take the $1 million, 1 billion, sorry, patience and multiple it by the cost of the drugs but we

know that not everyone with hiv is knowledge of their status as well. .. a decade, we have hiv testing for teenagers and announced a couple years ago people are at risk and baby boomers be tested for hepatitis c at least once. like hiv it will be a long time before people learn their status and get treated and improve, doctor freed and ward talked about people with hepatitis. hopefully we could eliminate it someday as well because we have that possibility. so thank you very much to all of