hep c drugs pricing

1. High cost of Hep C drug a barrier to treatment
2. The cost of the curing Hepatitis C – BBC Newsnight
3. With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs
4. Louisiana Is Getting an Unlimited Supply of a $24K Hep C Cure (HBO)
5. How a buyers club provided affordable hepatitis c medicine
6. Hepatitis C Treatment Update
7. Are High Cost Hepatitis C Medications Worth the Price Tag?

High cost of Hep C drug a barrier to treatment

today a Senate report found that Gilead,Sciences which makes a cure for a fatal,form of hepatitis is more interested in,profits than patients the cure was,invented under the leadership of a,celebrated doctor in the Department of,Veterans Affairs but at $1,000 a pill,even the VA cant afford to save the,lives of vets who need it,chip Reid has been looking into this in,2013 Vietnam veterans ioan Israel was,told he had five years to live he has,stage 4 liver disease caused by,hepatitis C which has infected as many,as two hundred thirty thousand veterans,most contracted it in Vietnam where it,was spread by battlefield blood,transfusions and vaccinations the longer,it goes the harder it is to treat after,decades of suffering earlier this year,Israel was overjoyed to learn theres a,cure I felt like my prayers were,answered I am ready to be cured the drug,sophist Bevier is sold as sovaldi and,harvoni and claims to cure up to 99% of,hepatitis C patients but theres a catch,the retail price for a twelve-week,treatment is eighty four thousand,dollars the Department of Veterans,Affairs gets a 50% discount but even,with that the VA told Israel they cant,afford to give it to everyone who needs,it including him come back next year,and then all the time Im thinking about,that well my condition is getting worse,dr. Raymond Shaughnessy founded the,company pharmacy and led the scientific,team that discovered so fast Bevere he,also works for the Department of,Veterans Affairs and has since 1983 he,says hes only a 7/8 government employee,and what he does with his remaining time,is up to him so youre only spending 1/8,of your time on your private companies,well even less than that,even less yes Im very efficient,dr. Shahnaz he made more than 400,million dollars when he sold his company,for 11 billion dollars to pharmaceutical,giant Gilead in 2012 can you see how,that looks to an average veteran youre,taking it personally if youre surprised,that a government scientist can make,that kind of money given federal laws,surrounding conflicts of interest so,were we has anybody ever questioned the,arrangement you have that allows you to,become very wealthy while working 7/8 of,your time with the government,nobodys ever questioned yet I think,Ive done everything Ive disclosed,everything to the VA the VA declined our,request for an interview but approved,the arrangement and in a statement said,federal employees are allowed to invest,in private companies provided all,conflict of interest rules are followed,gilead the company that now owns and,sets the price on sovaldi and harvoni,told us the cost is in line with the,previous standards of care but in this,2013 trade journal dr. Shahnaz II said,it only costs about fourteen hundred,dollars to manufacture the full 12 week,treatment thats less than two percent,of the retail price why is it so much,more expensive than what it cost to make,it thats a good question I mean I think,the price will come down eventually,Zion Israel wonders if the price will,come down in time to save him in the two,years his doctor says he has left its,just not right that the vets would risk,their life and come here and because of,$84,000 you know if you cant get cured,of medication produced by the country,that were protecting dr. Shahnaz ii,says the drug he helped create has saved,hundreds of thousands of lives around,the world but Scott the VA concedes that,funding for US veterans is limited so,far theyve treated about 35,000 thats,just 15 percent of the veterans infected,with hepatitis C chip Reed with a,revealing story in our Washington,newsroom chip thanks

The cost of the curing Hepatitis C – BBC Newsnight

Im waiting for the results might for my,end of treatment results so shes going,to fax them straight through him and,then hopefully you get back to me,Sean reading desperate and unable to get,hepatitis C treatment within the,healthcare system has taken matters into,his own hands,millions worldwide face this dilemma,Ive been making film about access to,treatment for the hepatitis C epidemic,for over a year I found out I had Hep C,in 1998 its highly contagious and can,cause cirrhosis and liver cancer,previously treatment was very toxic now,there are new drugs which cure with,virtually no side effects I live in,Germany where I was prescribed treatment,with the new drug havona,I am now cured Ive come back to the UK,to find out why people here arent,receiving the same treatment as me Im,starting with dr. Andrew hill an expert,in drug pricing if you look at the cost,of these treatments theyre,fundamentally cheap drugs they cost,hundred pounds per course to make that,12 weeks of treatment for one person,that same treatment is being sold in the,United Kingdom for 35,000 pounds so its,just such a huge price that the National,Health Service and nice have been,hesitating theyve been waiting to,decide who should be treated first yet,be on our investigation dr. hill told me,about the US Senates investigation into,pricing which is focused on one,particular pharma company Gilead using,Gilead,own documents the evidence shows that,the company pursued a calculated scheme,for pricing and marketing its hepatitis,C drug based on one goal maximizing,revenue regardless of,the human consequences how many billions,do they need to make before they start,lowering the prices these drugs are,fundamentally cheap but theyre not,being accessed by most people because,the prices are so high one of the,reasons theres so little protest about,the high price of hepatitis C treatment,is that patients are often stigmatized I,went back to see my old doctor to ask,him about this stigma being silent about,hepatitis C is doing no-one any favours,I think there is an incredible amount of,stigma and I think that stigma probably,comes from the days of hepatitis C being,labeled as a disease of intravenous drug,use and of intravenous drug users not,being a useful part of society I went to,see doctor Magdalena Harris who is,researching the experiences of people,with hepatitis C for them a trip to the,dentist is always complicated the issue,of the last appointment Ive been,hearing that for the last ten years in,conducting research for people living a,few potaters see that Im given the last,appointment of the day by my dentist,which is absolutely unnecessary we need,two distinct eyes this and say this is,this is an infection its no different,from any other infection its an,infection that people catch and that,needs to be treated one person who,hasnt been able to access NHS treatment,is Jew Janice nary recently diagnosed,her appointments keep getting postponed,she isnt sure how she was infected with,hepatitis C whats she planning to do,about treatment I dont know I dont,know what what I should do really I am I,suppose I mean Ive been trying to sign,up with trials without any success I,know you can also get her drugs from,India cheaper and I dont know,Julianas life and health are being,badly affected because she isnt getting,treatment ten years ago when I had,breast cancer and stopped the HRT I was,quite fit and well and during the last,ten years I have gradually got worse my,stamina has gone my mobility has been,drastically reduced whereas before I,could walk for hours without getting,tired now I dont Im not able to walk,at all I use a mobility buggy outside,some people are taking treatment into,their own hands and to finding answers,online buying drugs off the internet is,is a new thing its an emerging way of,being treated and one issue is do you,know that the medicine that youre,buying is genuine all these places will,give information for anybody and how to,Shaun reading couldnt get treatment in,Ireland the Irish Health Service like,the NHS cant afford to treat everyone,online he found the Australian based fix,Hep C buyers club through them he bought,clinically tested generic drugs buyers,club I became a member of the buyers,club and had my appointment via Skype,with doctor Freeman,I sent him all my documentation from my,blood test results from Ireland and he,said yes its possible he can if I come,over to Australia I can come to him he,can give them to me,Shaun paid about seven hundred and fifty,pounds for treatment that will cost the,NHS around thirty five thousand pounds I,have now completed twelve weeks of,treatment,last Monday sorry last Sunday night I,went from my blood test on Monday,I am now waiting for my end of treatment,results as we speak,my GP dr. Johnny Fleetwood and Dublin is,on the phone mm-hmm he has the results,of my end of treatment tests and so good,afternoon dr. Fleetwood Im very well,thanks a little bit upper hands of a,nervous but excited at the same time,excellent,Johnny GaN is brilliant news anything,are you go yeah you know Ive lived with,hepatitis since 1980,thats 36 years in the UK it is legal to,get three months treatment delivered to,your door so for those patients who can,pay for it,the online buyers club may be an option,but most will have to wait and see,whether the NHS can afford to treat them,this is billions of pounds in funding at,a time that the NHS is in very difficult,financial situation so it just doesnt,seem feasible that were going to be,able to eliminate hepatitis C within the,next 15 or even 20 years with prices,this high but we could we clearly,definitely could if we could get these,drugs at lower prices that report from,Kate bramble degree asked to speak to,Gilead who you had mentioned there about,the cost of their drugs but instead they,sent us a statement while we appreciate,senator Wydens attention to this issue,we respectfully disagree with his,conclusions both solve our D and harvoni,are deemed cost-effective by the,National Institute for Health and Care,excellence the one-time cost of Salvati,sovaldi or have harvoni pales in,comparison to the lifetime cost,associated with untreated HCV well with,me now virginia executive director of,the association of the British,pharmaceutical industry good evening to,you Devon we know that the drug,companies have to be recompense for the,research the billions they spend on,research do you think theres any limit,to the price they should be allowed to,charge,I think were focusing a lot on price,and what I didnt hear at all,not really you know impactful video was,the value that were getting through the,way these medicines are being introduced,in healthcare and when nice gives an,approval thats not just a tick because,we think its great that its a curative,treatment thats because theyve looked,at does it make sense to spend the,British payers pound on this medicine as,opposed to any other intervention we,could do really carefully so it really,does make sense doesnt it no ones,going to dispute its a great these are,great drugs is really really great drugs,but look lets suppose it has a hundred,thousand pounds of benefit do you think,its reasonable for the drug company to,charge,ninety nine thousand nine hundred and,ninety nine pounds and say look youve,still got a pound of benefit and thats,thats the benefit of an open system,that we have like in the UK where we can,negotiate and lets be honest I mean the,list price that weve been hearing about,is it necessarily whats getting paid by,the healthcare services there is some,very competitive and effective discount,going on wait wait wait wait so we you,think we might be paying less than,thirty five I would almost a guarantee,that with that within the process of the,way we negotiate access Arrangements,under dies and directly with the NHS,that the government does a very good job,of making sure that its being a careful,buyer when theyre investing in new,medicines and lets re

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With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs

JUDY WOODRUFF: Now: the latest on a medical breakthrough thats starting to have an impact,on a hidden, deadly epidemic in this country.,New drugs can cure up to 95 percent of patients with hepatitis C, a virus that often leads,to debilitating or deadly results.,The drugs can save lives, prevent expensive hospitalizations and liver transplants.,But some states are feeling the squeeze of the cost of this medicine.,Special correspondent Cat Wise has our report for our weekly series on the Leading Edge,of science.,CAT WISE: Three-point-five million Americans are living with a potentially deadly virus,,and half dont even know it.,Its hepatitis C, a blood-borne pathogen which attacks the liver and can eventually cause,serious liver problems, including cirrhosis and liver cancer.,Three-quarters of those with the virus are baby boomers, exposed from unscreened blood,transfusions, I.V.,drug use, and other blood-to-blood contact prior to the early 90s.,But now the opioid epidemic has led to a 20 percent rise in new infections from 2015 to,2016.,One state where the young and the old have been hit hard by the disease is Oregon.,Oregon has the highest hepatitis C mortality rate, per capita, in the country.,Its estimated about 100,000 Oregonians have been infected with the virus and more than,500 die every year.,Its been a very difficult disease to treat, but over the last four years, theres been,a revolution in hep C drugs.,Many are being cured around the country now, and here in Oregon, many are coming here to,the Oregon Clinic for those treatments.,DR.,KENT BENNER, The Oregon Clinic: We never talked about cure of hep C until the last few years,,and now were all talking about cure of hep C.,CAT WISE: Dr. Kent Benner is a gastroenterologist and hepatologist at the clinic in Portland.,He says people are still dying from the disease, often because they havent been tested and,arent aware they have virus until they are quite sick.,But Benner says much has changed since he first started treating patients several decades,ago.,DR.,KENT BENNER: Treatment at that time was interferon.,This required injections, shots several times a week.,Quite a few side effects.,We felt we were doing well if we could cure 15 or 20 percent of patients.,Since late 2013, theres been a remarkable development from a number of different companies.,They have developed drug combinations that provide 95 percent cure rates in patients,we treat.,CAT WISE: Costly liver transplants are often the only option when the liver becomes too,badly damaged.,But at earlier disease stages, the liver often starts to heal once the medicines have cleared,virus from the body.,DR.,KENT BENNER: Not only are we seeing liver function improve, but patients with more advanced,liver disease occasionally can come off the transplant list.,CAT WISE: Sixty-four-year-old Rob Shinney, who recently had knee surgery, is one of those,cured by the new hep C drugs known as direct-acting antivirals, or DAAs.,Like many others of his generation, he doesnt really know how he contracted the virus.,Under the care of Dr. Benner, Shinney began a three-month treatment in late 2016 after,his liver showed signs of moderate scarring known as fibrosis.,Tests later confirmed he was virus-free.,ROB SHINNEY, Patient: I had a serious chronic illness hanging over my head that I knew could,kill me.,And thats gone now.,CAT WISE: We spoke at a local pub he visits now and again with his choir friends, something,he never did when he had the virus.,ROB SHINNEY: I swear I felt like I was 20 years younger.,I had energy.,I could do things.,Its great just to be able to sit around and have a beer with everybody and, you know,,just enjoy life.,CAT WISE: The cost of the drugs used to cure Shinney, who has private insurance, arent,cheap.,Since Gilead Sciences Sovaldi first hit the market in late 2013 at a whopping $84,000,for a course of therapy, competitors have steadily lowered the costs.,Last year, a new medication called Mavyret was released for around $26,000.,Many payers often, though, negotiate even lower prices with the drug company.,Still, the drugs are expensive, and they arent a vaccine.,If someone is cured, they can become reinfected.,Access to the drugs varies widely around the country.,A report last year by two national advocacy organizations found that many public and private,payers choose to limit access to DAAs due to their cost, as well as other concerns.,Oregon is among a number of states which have had restrictive Medicaid requirements, including,denying coverage to patients in the early stages of disease and those who are abusing,drugs and alcohol.,But some of those restrictions are beginning to ease.,DR.,DANA HARGUNANI, Oregon Health Authority: In January, we just started covering individuals,with lower stages or lower levels of fibrosis.,CAT WISE: Dr. Dana Hargunani is the chief medical officer for the Oregon Health Authority,,which oversees the states Medicaid program.,She says, while the state is starting to expand access, costs are still a significant issue.,Oregon has spent more than $94 million on the drugs since 2014, covering about 1,500,people.,DR.,DANA HARGUNANI: The newer treatments for hepatitis C have a significant budget impact for our,state.,We had to get additional funding through the legislative process.,Were trying to manage our limited resources to ensure coverage for those who need it immediately,for the hepatitis C treatment, as well as all the other individuals in our Medicaid,program.,CAT WISE: Hargunani says another reason the state delays coverage until patients have,mild liver scarring, not everyone needs the medicines.,DR.,DANA HARGUNANI: One in five individuals who get infected with hepatitis C will spontaneously,clear their infection.,Right now, the data doesnt help us understand how to know which individuals will need to,have a high-cost drug to treat and cure their infection.,DR.,BRIANNA SUSTERSIC, Central City Concern: Luckily, he doesnt have any evidence of cirrhosis.,CAT WISE: Dr. Brianna Sustersic is a medical director at Central City Concern, a federally,funded health center in downtown Portland which serves a large number of homeless individuals,,many of whom have substance abuse disorders; 25 percent to 50 percent of the patients have,hep C.,DR.,BRIANNA SUSTERSIC: The Medicaid requirements have limited access to treatment for many,of our patients.,From a public health standpoint, if we are able to treat the population who is contracting,this, and spreading it, then we can move toward eradicating the disease.,CAT WISE: To prove that point, and to meet a big need, the clinic and a local syringe,exchange program began a small drug company-sponsored study last year to treat patients who otherwise,wouldnt have qualified for the medications; 56-year-old Kim Trano is now virus-free thanks,to that trial.,She says shes felt a lot of stigma being a recovering drug user and it was hard to,learn she had initially been denied drug coverage.,To those who would question giving expensive medicines to someone who might become reinfected,,she says:,KIM TRANO, Patient: Everyone is worthy of a chance.,If I were to relapse, I would all precautions not to be reinfected.,And thats pretty easy to do.,Most people know how to do that.,CAT WISE: The new medicines combined with the big surge in those looking for treatment,has led to a unique care model.,Chris Hulstein is not a doctor.,Hes a clinical pharmacist and part of a new program at Portlands Providence Hospital.,Over the past year, about 50 patients have been successfully treated by Hulstein and,his colleagues.,Another 30 are currently in treatment.,CHRIS HULSTEIN, Clinical Pharmacist: A lot of the specialists are very busy managing,very complex patients, and that is their role.,Having a pharmacist being able to manage the patient gets patients treated faster and more,successfully than we ever have been able to do before.,CAT WISE: Hepatitis C advocates are now working with

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Louisiana Is Getting an Unlimited Supply of a $24K Hep C Cure (HBO)

okay,Damien Belen is used to doctors Damien,has hepatitis C a chronic liver disease,spread through blood he got it from his,mom he was 12 when he found out its,like a little shadow thats behind you,you dont know how to tell people Hep C,is quietly the most widespread,infectious disease in the u.s. affecting,more than 2 million people and because,its easily spread through shared,needles the opioid epidemic means its,getting worse,hows it going good to see you Im gonna,go over your last lab but first how are,you doing theyre good yeah working hard,you know slinging those drinks treat and,cure you as soon as possible you gotta,enjoy those drinks as much as possible,Damiens dr. Jason Halperin is an expert,in infectious disease he sees patients,five times a week at a clinic how urgent,is the Hep C crisis in the country its,incredibly urgent people die of Hep C,more than any other infection that,exists in the United States the HIV TB,influenza so it is of urgent need to,treat and cure,when Damien was diagnosed there was no,cure but in 2014 the pharmaceutical,company Gilead released a groundbreaking,drug its the one and only cure thats,one pill once a day for 12 weeks only,Damien cant get it because hes not,sick enough so here is the letter,January 22nd 2019 denial notice it has,many many pages but the only thing that,really matters is this first sentence,and UnitedHealthcare communion plan will,not pay for the care the medication is,so expensive Medicaid has had to ration,the pill treating only people whose,livers are already damaged by Hep C or,he could pay out-of-pocket with a price,tag of 91 thousand dollars,its Louisiana Health Department with,its strapped state budget making the,decisions on who gets treatment but dr.,Rebecca key the state Secretary of,Health thinks the disease can be,eliminated entirely and shes been,trying for three years to get a better,deal here we have a cure for an,infectious disease this should be a,solvable problem but its not because a,drug is too expensive so she got,creative she dug up an obscure 1910 law,that gives the federal government the,right to use any patent as long as it,pays the holder a reasonable price so,you considered taking away the patent,from the Hep C makers well we asked the,question not surprisingly the,pharmaceutical industry was less than,enthusiastic sure about this idea so we,said okay what else this time he would,negotiate with pharma but changed the,terms for one set price should get,unlimited drugs for people on Medicaid,and in prisons what we came up with why,dont we spend the current price up to a,cap that we pre negotiate so thats our,subscription price and then after that,price we get rebated back 100% of our,spend the pricing scheme worked in,Australia in 2015 since Louisiana,suggested the idea Washington State has,also followed suit,how much did Medicaid spend on the Hep C,Kara last year so last year we spent,around 30 million 30 million dollars how,many people were you able to treat about,300 but lets say you had the,subscription model how many people could,you treat our goal would be ten thousand,people next year,all three manufacturers of Hep C drugs,responded to the states request for,proposals shes been in talks with,Gilead to settle on a price for the,generic version of their drug at,cluesive it really wasnt until there,was more competition in the market that,we were able to get some traction whats,it like to negotiate with a company like,Gilead,what power do you have to really,negotiate with them yeah I mean we have,the power of our state spend on drug,pricing but it really is a David and,Goliath,and we are David any negotiation if you,cant say no its its not really truly,a negotiate,the deal should be a win-win sales of,Hep C meds are down in this contract,with locked in a market for five years,still the June first target date to get,an agreement came and went the,for-profit drug industry is extremely,difficult to change because theyre,for-profit they have shareholders and,those shareholders want to make money,youre not offering up enough money is,that whats happened well we just dont,have it and what would I say to somebody,who says well its just not fair that,youre not treating everyone I would say,to them you know it would cost me seven,hundred and fifty million dollars to,treat everyone in Medicaid and that,would take away my K through 12 budget I,mean what do I do you tell me this week,doctor G in the Health Department,finally broke through with Gilead and,reached a deal it isnt everything dr. G,hoped Louisiana is paying a lot more,than they did last year but starting,July 15th the state will have unlimited,access to the cure,for five years and a big incentive to,treat as many people as they can,Gilead goes through with the deal arent,Gilead the people that created this,problem yes the fault is on the drug,companies because theyre pricing so,high but mostly I blame policymakers,because its our policies that allow,these drugs to be so high this model is,an example of a voluntary agreement one,where a company and a state agree to you,know without having to regulate it we,asked Gilead if the company bears any,responsibility for making the drug so,expensive and they did not respond to,our question what does it tell you about,that the landscape of the negotiation,market that even though you have all,this support you still cant fully force,the prescription drug companies to to,play ball yeah I mean the rules are,stacked against us the idea is you know,Pharma why should you care right so,right now we give you this money and we,get restricted access why do you care if,were going to treat someone who cost,you dollars a pill you know why does it,matter to you if were gonna treat,someone,in Medicaid whos not getting treated or,if were going to treat someone in jail,youll never make that money yeah so,what is it to you that we treat them and,we save their life,[Music]

How a buyers club provided affordable hepatitis c medicine

[Music],[Music],when I first started peoples contacted,me from all over the world it was a,pretty steep learning curve like how to,organize this it just sort of kept on,getting bigger and bigger until I was,like getting 200 emails a day,I might get a find rested jail,if I dont do what Im doing,people will die its straight from the,script of Hollywood movie Dallas buyers,club an Australian man in his 60s is,taking on the global pharmaceutical,company,Greg Jeffries has supplied more than 100,Australians who have hepatitis C with,life-saving drugs from India because he,says the Australian medical system has,failed them his land at the House and,Princess Street Ive always been very,healthy you know like as I said even in,my drug years I you know I surfed a lot,I was outdoors Ive really not had any,health issues until sort of when I hit,my 50s,then I started to get these mysterious,things going wrong with my health which,now the doctors can figure out and,suddenly my health just went back,something I started getting nosebleeds a,reason my gums started bleeding if I,scratched myself I would bleed and very,quickly the doctor did the tests and I,discovered I had hepatitis C it took a,lot of talking to specialists to the,hepatitis nurse at the hospital to,figure out that actually Id got it back,when I was 20 or using intravenous drugs,it was good to know how I got it and,then of course the next big question is,how you get rid of it,a new drug is curing hepatitis in just,weeks it is being called the best drug,launch in history a miracle drug it,actually cured habitated thief I did,research and and you soon discover that,wow theres a really good cure available,really effective really safe and then of,course I found out that it was more than,a hundred thousand dollars Australian to,buy it which is the price of a house,here this new treatment would just been,released in the USA everyone was talking,about it then mostly people were talking,about the fact that it was so expensive,[Music],expensive and you soon discover that the,pill look you have to pay a thousand,dollars per pill for actually cost less,than fifty cents to make and its at,that point we start to say well theres,something wrong with the whole system,they dont care if people die because,they cant afford the drug,I just want top dollar,what keep trying guys what are you doing,guys youre needing Hep C treatment huh,to over two years but in Sweden they,have only get the medicine for the,people thats you know really really,really see I can ship direct to to you,in Sweden say you would have the,treatment in basically two weeks its,amazing okay,so Laura was good looking I think,theres a more thorough,to have hep-c you know your blood is,infected can affect other people in your,life like my daughter like my wife Im,afraid of my shaving stuff,[Music],I dont want my daughter to get my,toothbrush is feel like youre bloody,and hurt people I know I got my Hep C of,dirty needles sharing with other people,you know I didnt care about anything,you know I know the risk about sharing,needles but I didnt care I just care,about the next fix the Hep C is the last,thing for me to deal with to feel normal,in that way you know Ive fought the,addiction I fought a lot of problems in,my life you know but the Hep C is still,there and dragging me backwards you know,[Music],generality kappa god Ive seen what how,sick you can get if you live with the,hepatitis E for too long my father has,had it for a long time and he was like,you know walking dead autumn approaches,authoritative restrain ro volsung know,there are may americana some seed upon,medicine M asam ticular many who live in,the river tamping you know I mean I,think that Thomas I am pistol we know or,else along with some medicine,I just starting look up on the internet,all stored my father about this and he,felt as Ive seen on the internet you,can buy some medicine from overseas,I read all the stories and every stories,everybodys talking about great great,great and he told me that he can fix the,transportation from India,thats what too good to be true,[Music],when you do the research you discover,that India makes a huge amount of,pharmaceuticals that get sent all over,the world as generics you know,[Music],I started to find people in India who,could ship from India to different parts,of workers theyd been doing that with,generic HIV drugs amongst them I got an,email from Parag who was you know a,licensed exporter of pharmaceuticals and,often to help in any way could the,sources are very reliable and they said,that a brand is going to be important,since all we had to figure out what the,rules were in all the different,countries for forgetting generics into,peoples place Serbia we just the first,shipment we just sent there it got,seized basically were doing a,country-by-country assessment we would,use third-party volunteers in other,countries where the rules were better we,just figured out ways of getting around,every blockage that we can so nowadays I,can guarantee delivery to absolutely,every country on this,hey hey how are you the present for the,patient the patients so me and our were,introduced by Greg about a year ago our,was probably you know looking to source,the Indian licensed generics a big,reason for us to collaborate with a lot,of these BIOS clubs which might have not,of illegality in their way of operations,but definitely on a ranking of morale,they have a much more higher ranking as,compared to a big pharmaceutical company,[Music],[Laughter],[Music],I come in India and I take the meds from,here the generics I give to the patient,the treatment the treatment is very well,I choose the doctor dont show my face,because I protect me and my family it is,very risky for because of the custom you,know how you pass with the treatment if,they stop me I tell is for me and my,family,[Music],[Applause],Im very relieved Im very happy,nothings happened and I passed the,border the custom and everything and all,is okey in our country we have a lot of,poor people who dont have money for,treatment who wait at the doctor for the,on prescription something some people,receive it but in the last moment in the,high three positions its already too,late about million people every year,going through this theres about a,million new infections every year one of,the very early things that I had to deal,with was the fact that in a lot of,countries what I was doing was illegal,arms smuggling drugs,and that caused me some concern but the,reality is a high portion of the people,who I get medication too will die if,they dont have the medication so,ethically morally I have no problem is,breaking the law in countries where it,is illegal to do what Im doing I became,aware that that I was treading on the,toes of Big Pharma,very early in the piece I got a letter,from Gilead and it was a,cease-and-desist official legal little,suddenly I couldnt access my my blog,website anymore that password had been,changed I said well could you tell me,what the complaint was about no is there,anything I can do to fix it up nope,using gilead own documents the evidence,shows that the company pursued a,calculated scheme for pricing and,marketing its hepatitis C drug based on,one goal maximizing revenue regardless,of the human consequences its time to,talk to Gilead the manufacturer of,sovaldi it is an outrage that you have a,company whose profits have soared in the,last few years their revenues have,doubled I believe in the last year,theyve come up with the drug they are,charging the general public a thousand,dollars a pill for that drug,the original price was were about the,same as the therapies that were,currently available the therapies that,are available five years ago had about a,five to ten percent cure rate and were,quite toxic we saw that the new regimens,avowedly being one of them as being more,effective much more effective eighteen,ninety ninety five percent a much safer,so we thought pricing at around about,

Hepatitis C Treatment Update

[Music],welcome this is brian wood medical,director for the mountain west aetc,project echo telehealth program,each of our weekly sessions starts with,a short talk focused on issues relevant,to hiv clinical medicine,the following talk was recorded live,here at university of washington we will,now take you to this weeks talk,[Music],great thanks hillary and welcome,everyone so this is gonna be a two-part,series im gonna cover some of the,clinical aspects of hepatitis c some of,maybe some new things you may not have,seen and then next week david hatchy is,going to talk about some of the common,drug drug interactions,so if you have questions like that i,mean you cant wait maybe ill call on,david in that area so just a little bit,of my disclosures here none of them are,relevant to todays talk but i tend to,over disclose,so what i wanted to do is briefly just,give a quick epidemiology update because,that has changed in the last couple of,years and then move on to some of the,new practice guidelines from the double,asld and idsa hcv guidelines,talk about what to do when people,have interruptions in their hcv therapy,and then wrap up with this question,about pregnancy and acv therapy,so just a little bit of the background,about hep c,and this is data from the cdc is that,were seeing more cases of hepatitis c,both in acute hepsy and chronic hep c,so this first study was reporting over 3,000 cases of acute hep c and i think,thats probably a massive underestimate,because it can often be occult and not,recognized so we think that there are,more likely to be somewhere around 50,000,new cases of hepatitis c every year,and this is a three-fold increase over,roughly the last 10 years from 0.3 in,2009 now to around 1.2 per hundred,thousand,and you can kind of see that its not,all age groups that are being affected,this is part of the whole opioid,epidemic so,younger folks are be more affected than,other age groups so this biggest line,here,is the 20 to 29 year old age group and,then followed pretty closely by the 30,to 39 year olds,the one thing i will point out is there,still is some increase in the other age,groups and i think that is also a,reflection of injection drug use,particularly with opioids,so this next slide shows where we are,with the chronic hepatitis c and if i,were to show this slide 10 years ago it,would have been a kind of a classic just,peak in the baby boomers so those folks,who were born between 1945 and 1965.,so it was kind of like that one humped,camel now were were looking at a,two-humped camel and what you can see is,that the,younger folks so,folks between approximately 24,to mid 30s,represent the most number of cases,theyre now surpassing the baby boomer,cohort,and just a little bit about how its,impacting mortality is it was the number,11 cause of death in 2017 which is i,think the most recent,reliable national data that we have,representing approximately 17 000,deaths and this death rate is around,four per hundred thousand but its often,listed as an underlying cause of death,and deaths in which theres not the,primary cause so 29 percent listed hcv,is underlying cause of death,and in those cases where theres like a,liver-related cause of death its its,like hcc,alcoholic cirrhosis or some other kind,of neopos in the liver so we think that,this is probably contributing there the,good news is this is declining probably,reflects some of the newer antivirals,that have started coming on board in the,mid 2010s,if you look at which states are most,affected by hcv mortality i just want to,draw your attention to the pacific,northwest where both washington oregon,have some of the highest age-adjusted,mortality and then also the southwest so,new mexico texas and oklahoma and a,little bit here in d.c,so this is still an issue even with some,great antivirals out there were still,not out of the woods,so i want to turn from the epidemiology,now start talking about some of the,changes the asld idsa guidelines and,just a disclosure that i sit on that,committee and dont speak for them today,but i just want to let you know some of,the changes that weve made,and overall i think there was just a,push to make the treatment guidelines,simpler and streamlined theres a bunch,of medications that were just theyre,not longer being marketed or rarely used,so weve tried to take some of those out,so theres updates on how to order your,workup labs how to monitor patients,while theyre on therapy and then what,what to do with vosavi or softwall box,failures,so the initial labs and work up are,listed here in the green box,and just a kind of a simple thing you,should be doing and usually this is a,couple tubes of blood get a cbc,a liver function test nine our,creatinine so i think theyll probably,give you,three tubes of blood,and from that you can calculate both,the asc to platelet ratio or opry,or something called the fib four so the,fib4,is very similar to the apparatus using,the ast and platelets but it does take,into account the age,and so ive seen a couple people,have maybe a really low opry or a very,high opportunity but then when you do,the fib 4 it gives you a little bit,different information so if i had to,choose between those two,i would use the fib for and this,information is available on the acv,online website if you wanted to you know,bookmark that and be able to get to it,quickly in my office where i have fiber,scan available almost everyones getting,that otherwise known as transient,elastography,it takes about five or ten minutes just,a,sound wave that my staff is trained to,do and and i do it as well,but it is is very accurate about ninety,percent sensitive for picking up severe,fibrosis and i like to use both the fib,four,and the transcendental osteography,because theyre a little bit different,test,if you didnt have fiber skin i think,the next best option would be fiber,short thats a blood test it costs,around 250,i will just warn you that in my,experience for the last like five years,its probably the least accurate ive,seen it overestimate and ive seen it,underestimate,so if you get something wacky its,usually the fiber shirt thats not right,and then if if you wanted a tie breaker,sometimes imaging is helpful you do not,need to get ultrasound on everyone,thats not necessarily often will add to,your costs and not really help you that,much in your work up and then liver,biopsy is still the gold standard so if,you have maybe some,tests that are contradicting themselves,say that your fit four was really low,and the fiber scan is high youre not,really sure what to do that might be a,situation where you want to get a liver,biopsy,so in addition to those tests the other,thing you want to get on your initial,workup would be urine pregnancy tests,especially if the womans of child,bearing age just want to make sure that,they do not get pregnant while on,therapy,and then kind of normal things many of,you guys already already know the hiv,status but if you dont get hiv and then,hepa and b serologies,so the asld guidelines now have a very,simplified hv therapy and this is for,someone who has no cirrhosis,you would basically your two options are,going to be,glycopreprimbrandosphere or maverick for,eight weeks,or sophosphere vapours for occlusa for,12 weeks now someone who would not,qualify for a simplified therapy as,someone whos been treated before with,the daa and failed,and then well go over cirrhosis on the,next slide anyone whos hiv or surface,antigen positive and theres some,considerations there with drug,interactions,current pregnancy,known or suspected parachute carcinoma,or prior liver transplant those tend to,be,managed more in a specialty situation so,what about cirrhosis its its basically,the same thing,and the only thing i would warn you,against is using an hcv protease,inhibitor in anyone who has childs,class b or c,so maverick does have that protease,inhibitor if their childs a you can you,can treat them,i just say probably watch them a little,bit more cl

Are High Cost Hepatitis C Medications Worth the Price Tag?

in late 2013 to drugs were approved by,the FDA to treat chronic hepatitis C,virus one of these agents with saval d,the third drug receiving breakthrough,therapy designation from the fda the,breakthrough therapy was the first drug,approved to treat chronic hepatitis C,without the co-administration of,interferon a drug with numerous side,effects that often led to non adherence,with treatment regimens unfortunately,along with this new treatment regimen,comes a hefty price tag thousand dollars,per day or eighty four thousand dollars,for an average duration of treatment,thats not including the cost of,co-administration of ribavirin and,possible interferon savall DS launch was,thought to be the biggest in history and,has already been used to treat,approximately a hundred and seventeen,thousand patients suffering from chronic,hepatitis C Saval D has demonstrated,higher than ninety percent cure rates,associated with its use but is this,worth the costly price tag with that,ninety percent curate curate stacy is,that price tag worth it well I think to,say that this of all the example is a,very unique case study is certainly an,understatement theres really no doubt,that its very expensive but its sort,of interesting to think about it if it,wasnt a drug that cured the virus in 12,weeks but instead was used over 15 years,to suppress the virus and potentially,reduce and end-organ damage at a cost of,fifty six hundred dollars a year over 15,years we would think of it much,differently however thats not the,reality the reality is eighty-four,thousand dollars in 12 weeks hitting,budgets in a particular budget year and,I think thats really one of the ways,thats made this discussion so unique i,think the other real issue that we see,with the hepatitis C treatment,population is the sheer numbers the CDC,really estimates that approximately 3.2,million Americans have hepatitis C so,certainly in the specialty space were,used to dealing with very high cost,drugs we see high cost drugs all the,time but we typically see them in,orphan disease states more theres very,few patients across the country being,treated and the issue with this is that,we really have a tsunami of patients to,be treated that are hitting payers all,at once with this incredibly high cost,so I think those are a couple of things,that really make this of aldi and the,hepatitis C example very unique within,this past year I was thinking that it is,worth the price tag for some patients,but maybe not all patients so its,important to understand the hepatitis C,is a very slow progressing disease and,then all patients are going to end up,with cirrhosis or liver transplant so,the CDC estimates for every 100 patients,that infected with chronic hepatitis C,but 60 to 70 of those will go on to have,liver to liver damage but only five to,20 will actually develop cirrhosis and,and may and which may lead to liver,transplantation or liver cancer so when,you think about that you know should all,of the patients that have hepatitis,Sierra infected be treated with these,drugs we know it is a cure for every,patient but if not every patient is,going to go on to develop cirrhosis and,have these you know severe effects of,the disease it really makes you question,it and I know recently I read that a,large portion of the patients I believe,there were fifty percent or more did not,have advanced disease that were treated,with civ all d of those hundred and,seventeen thousand patients so I think,you know as new therapies entered the,market place i think you know payers,need to be thinking about you know which,patients are the most important to treat,do we need to treat all of them and is,that the way would that we can afford,the treatment for those that you know,really do need it very good any other,comments you know becomes a very,challenging dilemma and really specialty,pharmacies is somewhere in the middle we,do a large portion of hepatitis C and,you know one particular Medicaid area,the state Medicaid program we had,they had not approved the drug in the,beginning of the year and they were,trying to make it go through formulary,and you know figure out how theyre,going to handle it well it turned out,that we had ninety percent of those,referrals where were sending from my,organizer or our organization so we went,down and we met with the state Medicaid,program and when you hear the program,tell you that if they approved every,authorization thats out there they,would spend the whole years budget and,and how do you balance that how can a,program pay for the hepatitis C patients,and that everyone else who needs a medic,a prescription the fundings not there,and then the other interesting we met,with another large player in the midst,mehdi space and they looked at their,claim data and said what we only did for,we only paid for fortran liver,transplants last year how much is all d,really helping our organization in our,patient population so i think,appropriate use is something important,with these with these higher cost agents,thats an eye opening statement that you,got from the state that was a meta,believe its kinda thats thats the,dilemma in the challenge it can even,commercial health plans are facing we,all know that patient affordability is,as a barrier to start a therapy and in,fact if the co-pays are high enough it,could be actually a denial for that,patient to get treatment is that an,issue with the with the Hep C drugs are,we seeing high co-pays and patients are,you know essentially not being able to,get therapy because of affordability,issues any thoughts at our organization,were for the commercial patients were,not seeing that the manufacturers are,supporting copay offsets and those are,being effectively applied so were not,seeing that but in the non-commercial,you know those government payers we are,seeing patients who do have financial,barriers in that regard were leveraging,the funding organizations penn ave path,cdf to help,appropriate utilization its great,especially pharmacy does that yeah,absolutely i think you know if you look,at in our organization the the cost,barrier is really almost nil in this,space theres plenty of funding we work,directly right with the liver,foundations and and there theres the,opportunity to once the patient is,approved you know the co-pays not,usually a limiting factor and of course,with the Medicaid population if they do,get approved you know again the copay is,not an issue harvoni was approved by the,fda in october for the treatment of,hepatitis c patients with genotype 1 the,combination drug is manufactured by the,same organization as savall d harvoni is,a combination ns5a inhibitor and a,nucleotide analogue ns5b polymerase,inhibitor this once daily drug is,demonstrated efficacy with consistent,SVR rates above ninety percent in,addition to this newest agent several,other hepatitis C drugs are expected to,appear in the marketplace soon Renee do,you believe this competition will lead,to decrease costs within hepatitis C yes,and no so harvoni came to the market the,first oral agent it combines two,antivirals as we mentioned its a once a,day treatment and it was FDA approved,for shorter treatment duration so some,patients can actually qualify to use it,for eight weeks which offers a little,lower price and then other patients,standard pretty much as 12 weeks and,then the worst patients 24 weeks there,are other competitors ready to come to,the market one of the competitors a BMS,product pulled their application because,they couldnt achieve SVR rates close to,where her body was the next competitor,ave products its questionable as to,whether or not it will come to the,market approved without the use of our,brevard and that particular product,contains three antivirals if it is,approved with the use of ribavirin,patients will have to take multiple,tablets and some of them twice a day,which we may make adherence an issue,so in order to have competition in terms,of decreasing the price to harvoni these,pr