G

ilead Sciences won regulatory approval on Tuesday to sell a new hepatitis C combination drug, which can combat all six strains of the disease, and priced it below its older treatments.

The new drug, which is called Epclusa, combines the older Sovaldi medication with the newer velpatasvir, and costs $74,760 for a 12-week course of treatment, although that’s before any rebates are offered to payers. This is less than the list prices for both Sovaldi and Harvoni, another Gilead hepatitis C treatment.

Gilead has been widely criticized for its pricing policies ever since Sovaldi was launched in early 2014. At the time, the medication sported a list price of $84,000, before rebates, for a 12-week course of treatment, or about $1,000 a day. This caused public and private payers to worry the drug would become a budget buster.

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That’s because the medicine can cure more than 90 percent of patients, which prompted an upsurge in prescriptions, and also because Gilead initially lacked competition. Pricing concerns were magnified when Gilead later released Harvoni at a list price of $94,600 for 12 weeks, and some payers responded by restricting coverage to patients whose disease was at a more advanced stage. Late last year, a US Senate investigation concluded the company placed profits over patients, and the Massachusetts Attorney General threatened Gilead with a lawsuit over its pricing.

Gilead has argued its treatments are more affordable than paying for liver transplants, cancer, and hospitalizations. To what extent the newest drug will cause payers concern is unclear. Epclusa will cost roughly half of the most commonly used treatment regimen for patients with Genotype 3 of the disease.

This genotype is “the most difficult to treat and one of the reasons Epclusa was granted priority review by the FDA,” wrote Leerink analyst Geoffrey Porges in an investor note. He forecasts global Epclusa sales of $1.8 billion this year and $10.3 billion in 2017, before eroding to $2.2 billion in 2021, as more competition kicks.

Meanwhile, the older standard of care is a combination treatment that includes Sovaldi and Bristol-Myers Squibb’s Daklinza. The Bristol component has a $63,000 list price, suggesting the combined cost of this older treatment may place Bristol at a competitive disadvantage.

An executive at one large health plan welcomed the additional treatment option.

“Keep in mind that most hepatitis C cases, about 70 percent, occur among people with the genotype (or strain) that is most prevalent,” genotype 1, said Michael Sherman, chief medical officer at Harvard Pilgrim Health Care, the second-largest health plan in New England. “Having more options is a good thing and I don’t think this will lead to increased costs, although we will have to see what the rebates look like.”

Meanwhile, a spokesman for Express Scripts, which is the nation’s largest pharmacy benefits manager and has tussled with Gilead over its pricing, wrote us that “we are pleased that they have been responsive to the discussions we have been having over the past few years, and complement them on their restraint around the list price of this new drug. We will continue to negotiate with Gilead in regards to net pricing for our clients.”

The safety and efficacy was evaluated over a 12-week period in three Phase 3 studies of 1,558 people with or without cirrhosis, according to the US Food and Drug Administration.

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The approval is expected to give Gilead a boost. Although Sovaldi and Harvoni generated combined sales of more than $19 billion last year, a 54 percent increase from 2014, sales fell more than 5 percent in the first quarter of 2016. This was explained, in part, by added competition. AbbVie began selling a pill in late 2014 and, earlier this year, Merck launched a pill at a much lower list price.

One consumer advocate charged the pricing for the new drug was out of line. “Gilead still doesn’t get it — their pricing is outrageous. Once again, Gilead has shown that it is more concerned with protecting its profits rather than making its drugs available to all Americans,” said Tahir Amin, a cofounder of the Initiatives for Medicines, Access & Knowledge, which has challenged Gilead patents in other countries.

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  • Epclusa is much safer than the interforan and riboviran treatment. I did the epclusa treatment and it’s been four months so far showing no virus I still have to go for three more blood test results must be negative

  • I’m constantly amazed at why people don’t use their computers for doing their own research. It’s almost like social media, forums, you tube etc. is all they aspire to. How about “Google Scholar” or just type keywords in the form of questions in regular Google search. It’s not hard to get these drugs for cheap nowadays.

  • What a joke! Only the wealthy can afford these drugs. I’ll never have a chance to be cured unless I get to stage 3 liver disease, then Kaiser will cover me-sort of. I might as well eat crap food, and gain tons of weight so that my liver becomes so bad, they have to treat me. Makes sense. They want you to become sick, so they can cure you…heroes!

  • I purchased Sofosvel from Beacon Pharmaceuticals in Bangladesh for $960 and after taking the medicine for 1 month I tested negative for Hep C. I will take the 84 day course and continue to be tested but this is such good news. I highly recommend getting in touch with this company and have this item shipped through EMS. I have had this disease for over 30 years but didn’t find out until recently.

  • How long will it take to get rid of side effects. Like rash on skin. Eye lids feel and look burne. They are so red around my eyes. How long does it take to detoox when finished taking the 12 weeks.

  • What about effects that might not show up for some time down the road? This is the 1st cure I have ever heard of from any pharmaceutical.

  • Is Sofosvel (produced by Beacon Pharmaceuticals in Bangladesh) the same as Epclusa? Is Sofosvel FDA approved like Epclusa? I’m in contact with a medical supplier in Bangladesh to purchase Sofosvel for my father; I want reassurance that Sofosvel is exactly like Epclusa.

    • dear Carmen
      I have the same question since I have the case with my wife.

      please advise if you got any reply

    • Mohamad El zein: Yes, Sofosvel is the generic brand of Epclusa, and I purchased 12-weeks worth of Sofosvel for my father from a medicine supplier in Bangladesh called Medicine for World. Contact Ahsan.

      E-mail: medicineforworld@gmail.com
      Phone/ WhatsApp/ Wechat: +880 1916942634

      My father just started his first pill last week.

      Best wishes to your wife.

    • Hi Abubakar: I purchased Sofosvel (generic of Epclusa) for my father from a medicine supplier called Medicine for World. They are reliable and will send you the medicine by DHL, but they are not responsible for the customs in your country.

  • Please get in touch with me.I was told with my infection level over 7,000,000 gen o type 3 I’m in3 rd stage of cirrhosis I have had hep c for over 28 years second month on Sovaldi 400 mg my level is 28 your medicine does work contact me for hole story you won’t regret it thanks call me 765-684-2114 or 765-520-0253 any time

  • Well … it is certainly good to have more drugs to combat this awful disease, so I welcome the addition of Velpatasvir to the arsenal.

    However, while there is some technical accuracy in the article regarding pan-genotypic drug availability in the US, but the implication is false, and for the EU and many other places Gilead’s statements about the lack of a pan-genotypic treatment are totally false.

    In the EU the sofosbuvir/daclatasvir combo (Sovoldi from Gilead and Daklinza from BMS) has been approved as pan-genotypic for quite a while.

    Back when Pharmasset was developing sofosbuvir they were cooperating with BMS on the sof/dac combo. When Gilead bought out Pharmasset they ended that cooperation and instead went with their own drug, ledipasvir. Why share when you can keep it all to yourself, right?

    Except the sof/led combo (Harvoni) wasn’t particularly good with genotypes 2 and 3, so genotype 2 got stuck with sof and ugly ribavirin, and Gilead decided to cooperate with BMS for genotype 3 approval. In Europe however, BMS went through the approval process on their own and doctors there have had the sof/dac option ever since.

    As for pricing, France was getting Harvoni for $55,000, Germany and the UK a bit more. But things got interesting when Australia couldn’t get the deal they wanted. It started out rather slowly, but word got out about the generics available from Bangladesh, India and China and hundreds of Australians started bringing those generics into the country. (Australian law explicitly allows self importation of generics.) People from other countries started doing it too. Gilead must have gotten nervous about the word spreading too far, as they finally came to the table and gave Australia a price far below that in any other first world country. Now France wants to renegotiate.

    US insurers have been getting Harvoni for about the same $55,000 that France was paying, so a price of nearly $75,000 for Epclusa is not really a price drop at all, and success rates aren’t much improved either … sof/dac iss getting roughly 96% compared to Epclusa’s roughly 97%.

    About my own treatment: I was the very first American to show up in Dr. Freeman’s office, about 8 months ago. I was genotype 1a and was treated with sof and dac. I had my blood drawn for my 24 weeks after end of treatment test yesterday … will see the results in a few days, but I was “undetected” from 6 weeks into treatment through 12 weeks after EOT, so I’m really only doing this test as a confidence builder for other people. BTW my Sofosbuvir and Daclatasvir were from China and were compounded by a pharmacy in Sydney, Australia, and cost me a grand total of US$1150 for a twelve week treatment. Yes, I said One Thousand, One Hundred and Fifty US dollars for 12 weeks of treatment. I brought them back to the US with no problems at all.

    Dr. James Freeman has been running trials of many generic versions of sofosbuvir, ledipasvir and daclatasvir, and presented his findings to the International Liver Congress (EASL) about two and a half months ago. He demonstrates that the generics are the equivalent of the brand name drugs in every way except price. It has gotten quite a bit of press in trade journals and almost none in the MSM.

    Options include:
    BANGLADESH
    Incepta … Sofosbuvir = Hopetavir, Daclatasvir = Virodacla, Sof/Led combo = Twinvir, Sof/Dac combo = Corevigen
    Beacon … Sof = Soforal, Daclatasvir = Daclavir, Sof/Dac combo = Darvoni
    Julphar … Sof = Hepcee, Dac = Daclacee, Sof/Led combo = Combicee
    Beximco … Sof = Sofovir-C, Sof/Led combo = Lesovir-C
    INDIA
    Natco … Sof = Hepcinat, Dac = Natdac, Sof/Led = Hepcinat LP
    Hetero … Sof = Sofovir, Dac = Daclahep, Sof/Led = Ledifos
    Mylan … Sof = MyHep, Dac = MyDacla 60, Sof/Led = MyHep LVIR
    Cipla … Sof = HepCVir, Dac = HepCDac, Sof/Led = HepCVir-L
    Dr Reddy’s … Sof = Resof, Dac = HepCFix, Sof/Led = Resof-L
    Abbott … Sof = ViroClear, Dac = DalsiClear, Sof/Led = LedviClear
    Zydus Heptiza … Sof = SoviHep, Dac = DaciHep, Sof/Led = LediHep
    Sun Pharma Ranbaxy … Sof = Sofab, Dac = Daclafab, Sof/Led = Sofab LP
    Biocon … Sof = Cimivir, Sof/Led = Cimivir L
    Emcure … Sof = Spegra
    Wockhardt … Sof = Novisof
    Strides Arcolab … Sof = Virso
    UTH Healthcare … Sof/Led = Safino L
    Aurobindo …. TBD
    Laurus Labs … TBD
    Sequent … TBD
    ALGERIA
    Beker Laboratories … Sofosbuvir = Sofos 400, Sof/Led = Sofosled
    PAKISTAN
    Genix … Sofosbuvir = Sofos
    MOROCCO
    Pharma 5 … Sofosbuvir = SSB 400, Daclatasvir = Dakasvir
    EGYPT
    (I don’t have the names, but am aware tht there are multiple producers there.)

    As for price, you can get the Indian meds for between $1000 and $1600 for a 12 week treatment, depending on supplier. Darvoni, the sofosbuvir/daclatasvir combo from Beacon Pharmaceuticals in Bangladesh is presently priced at about $700/12 wks.

    If you want more particulars and to talk to people using these generics search FixHepC dot com . There are a few thousand of us now.

    Oh, I should add … I’ve never made a penny, nor do I anticipate ever earning anything from helping people find generic versions of these drugs. It’s like this … I was sick enough that I was having difficulty getting to work every day. I would tire with even a small amount of exertion and was experiencing many, many side effects of the disease, BUT my liver hadn’t reached anywhere near the stage that an insurance company would cover the drugs … I wasn’t sick enough. Some insurers will only cover the meds for patients on the organ transplant wait list.

    I found my cure, but I’m still angry. And I intend to help everyone I can.

    • Oh this is great news I was undetected for 12 weeks but it came back parently a mutation resistance to the drug why was undetected man I have so much energy I was like my old self again but the fatigue is what bothers me I was really planning on going to India at some point
      …so lower pricing gets me excited..thanx
      .will h.

    • Does anyone have a list of good suppliers from India for Sofosvel that will ship to the USA? I received an invoice from Beacon Pharmaceutical Limited but other competitors said Beacon does not talk with the public so I am fearful of a scam.

    • All these rebates you’re talking about often,or never in my case are available if you’re on Medicare. So who,on disability but worked all their lives until they couldn’t canot afford any of these drugs . Now if I were a drug addict I’d get 100% paid for thru Medicaid. I worked thru interferon,ribaviron treatment so sick I could barely crawl…Finally I had to give up my career due to HepC and a hoste of other health issues. I’m on disability based on my income so I have Medicare not Medicaid so I have to pay 20% of all medical and have part D for meds…I can’t even use a coupon let alone rebate . What do I do? What do all of us do that make to much for help but not enough to survive do? Can’t even get a supplemental insurance due to preexisting conditions until I’m 65..so much for ACA..another loophole Insurance Commissioner told me.

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