February 8, 2014

At $1,000 per pill, Sovaldi price is 1,100% more than Gilead’s AIDS drug combination
Stribild ($80 per pill); pharmacy industry sources say Solvaldi’s price suggests a
retail markup of 279,000% over production costs.

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In a series of letters to be sent to state Medicaid directors starting today, AIDS Healthcare Foundation (AHF) President Michael Weinstein will ask the state directors to block Gilead Sciences’ new $1,000-per-pill Hepatitis C drug Sovaldi (sofosbuvir) from inclusion on their respective state Medicaid and other drug formularies. The drug was approved by the F.D.A. on December 6, 2013 and Gilead immediately announced that it would price the drug at $84,000 for a twelve-week course of treatment—or $1,000 per tablet—making it one of the most expensive drugs ever marketed. Suggested treatment guidelines also require that Sovaldi be used with another drug, ribavirin (a nucleoside inhibitor), further adding to the cost of the prohibitively expensive course of treatment.

“When is enough, enough? At $1,000-per-pill, Sovaldi is priced 1,100% more than Gilead’s most expensive AIDS drug, Stribild, it’s four-in-one AIDS drug combination, which was priced at $80 per pill a year ago when it came to market,”said Michael Weinstein, President of AIDS Healthcare Foundation. “At that time, Stribild’s price was 35% more than Atripla, the company’s best selling combination HIV/AIDS treatment, and made Stribild the highest priced first-line combination AIDS therapy. Now, Gilead has set a new benchmark for unbridled greed with its outrageous price for Sovaldi—a price that some pharmacy industry sources suggest represents a retail markup of 279,000% over the cost of actually producing the drug.”

In his letter to state Medicaid directors, Weinstein wrote, “Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).  This represents a retail markup of over 279,000%. (NOTE: With only 10 to 30 grams of Sovaldi needed for successful treatment, the difference from the $30 production cost for Gilead’s full course of treatment—30 grams x $1.00 per gram—to $84,000 for the 12-week treatment program represents a retail markup of 279,000%.)

Weinstein’s letter to state Medicaid directors also reminds them that, “Gilead did not pay to research and develop Sovaldi. In 2011, it purchased Pharmasset, the company that had already developed the drug, for $11 billion in cash.  The pricing of Sovaldi is being driven by Gilead’s desire to recoup its investment in Pharmasset, and assumes it can accomplish this by charging Medicaid and other taxpayer-funded programs whatever it wants.”

“Gilead is now seeking a bonanza on a financial investment—not on its R&D costs of a drug—by gouging cash-strapped government programs, essentially treating states like its own private—rigged—stock market,” added Weinstein. “With regard to Sovaldi, it’s time we stopped thinking of Gilead as a drug company and recognize them for what they are here: a pharmaceutical hedge fund bent on exploiting government-funded drug programs like Medicaid and ADAP at the expense of the American taxpayer.”

AHF's letter to State Medicaid Directors on Gilead's Sovaldi:

Re: Formulary Status of Sovaldi and Forthcoming Hepatitis C Medications

AIDS Healthcare Foundation (AHF) is deeply concerned about the fiscal impact of new FDA approved Hepatitis C medications on your Medicaid program, and the effect of that impact on the health care of people inyour state. The first of these new medications, Gilead Sciences’ Sovaldi, is exorbitantly priced at $1,000 per pill.

While the approval of Sovaldi and similar treatments is a welcomed advancement for people in need of better treatment for Hepatitis C, the unjustifiably high price manufacturers are seeking to charge for these medications will unnecessarily drive up health care costs and limit access to potentially lifesaving care. Therefore, AHF urgently requests that your Medicaid program deny Sovaldi and other new Hepatitis C medications from being added to your state formulary until these drugs are made affordable.
AHF believes that the price Gilead is charging for Sovaldi is not remotely justified. For one, it is exponentially more expensive than medications for other severe chronic conditions. For example, Gilead’s own Stribild, a costly new four-in-one combo treatment for HIV/AIDS is $80 per pill. At $1,000 per pill, Sovaldi costs 1,100% more than Stribild, the most-expensive AIDS combo drug on the market.

In addition, Gilead is charging a higher price for this drug even though the cost to produce it is small. According to industry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).  This represents a retail markup of over 279,000%.

Finally, Gilead did not pay to research and develop Sovaldi. In 2011, it purchased Pharmasset, the company that had already developed the drug, for $11 billion in cash.  The pricing of Sovaldi is being driven by Gilead’s desire to recoup its investment in Pharmasset, and assumes it can accomplish this by charging Medicaid and other taxpayer-funded programs whatever it wants.
Private drug plans have taken notice of these facts – along with community outrage over the cost of Sovaldi –and have delayed paying for the drug until Gilead agrees to significantly lower the price. For example, Express Scripts, CVS Caremark, Catamaran Inc., and Aetna are all taking steps to block or delay the use of Sovaldi.   Given this, AHF believes it is imprudent for your state to cover this medication until a better price is available.

Most critically, by taking action to ensure a better price your state will not be putting patient health at risk. There are alternative (and less expensive) treatments for Hepatitis C already available. In addition, Gilead’s patient assistance program provides the treatment for free to people making less than $100,000 a year who cannot access it elsewhere. These steps, while not ideal, will ensure patients continue to receive the care they need until newer medications are made affordable.
Once again, AHF urgently requests you to take action on this matter by denying Sovaldi and other unjustifiably high-priced Hepatitis C medications from your drug formulary until an affordable price is available.

Source

8 comments :

  1. This is old news and I still don't get why the AHF wants to keep Solvadi from those of us who need treatment, can't take Interferon, and are dependent on Medicaid. I wonder what their hidden agenda might be and I wonder why we don't hear from anyone with HCV protesting this move.

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    1. I tend to agree with you. That is why when something comes out I post it. Hopefully soon we will see someone protest against this. I have though seen criticism about this move by AHF. Gilead has stated that they would work with government programs (Medicare and Medicaid) to help bring Sovaldi to those that need it.

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    2. Apparently Gilead is helping a lot for those of us who can't afford Sovaldi. Can I ask where you saw the criticism? A lot of my frustration is that I keep seeing people who are on Sovaldi and talking about how great it is, but I have yet to see anyone not able to get on say anything. Frankly, I am jealous. :)

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    3. I read so many articles a day, If I can run across it again I will post it here in a reply for you. It was criticism against this move by AHF.

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  2. I cannot take interferon, and I am on Medicaid. Even though my income in zero, I do not qualify for the patient assistance program because I am insured by a state plan. So, since the AHF did'g do enough research, I get to go without drugs if they win? I am AB- blood type and in ESLD...can you guarantee me a new liver in time, since your plan wwould kill mine.

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    1. Christine, I actually do not believe that anything will come of this request by AHF. At least that is the reaction by many.

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  3. Gilead is un-ethical with pricing like that. Doctors Without Borders/MSF is asking the government of India to deny a patent for Solvaldi and make it available as a generic drug. Otherwise, thousands in India will die because of the cost.

    Also not that a second drug is needed for Hepatitis C Genotype 1a, the most common form of Hep C. Solvaldi alone is not good enough. The combination of a new drug generically named ledipasvir along with sofosbuvir (Solvaldi) is in late phase 3 in the clinical trials, and the combo has yet to be approved by the FDA.

    The combination of these two drugs will bring a 12-week treatment for Hepatitis C genotype 1a to well over $100,000.

    Some insurance companies are saying you must first try the older and less successful 48-week treatment using interferon injections before they will pay for the new drugs. That is not good.

    Gilead is showing nothing less than greed over having a cure for hepatitis C and saving lives.

    New interferon-free treatments from Bristol-Myers Squibb and AbbVie have also completed phase 3 trials and are to be submitted for FDA approval in the second quarter. Hopefully, they will not resort to price gouging like Gilead. They are just as successful but multi-pill and the AbbVie regimen uses ribavirin which has a few side effects but was well-tolerated in the trials.

    If you can wait according to your doctor, it seems like a better route. Nobody wants to take Solvaldi from anyone who needs treatment. Just the opposite! It should be priced so anyone needing it will be able to get it. That is what the controversy is about.

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  4. When you have cirrhosis already it is kind of difficult to think about waiting. With cirrhosis, as you already know I'm sure, the liver can decompensate at any time or it can hang in there for years. It is a gamble to wait and the longer you wait, the greater the odds are of failure.

    I have been waiting for over 20 years now and feel I don't have time for politics. Regardless, I am just me and there is little I can do except whine and complain. So be it.

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