January 29, 2014

PRESS RELEASE

Jan. 29, 2014, 6:54 p.m. EST

Gilead is not the original developer of Sovaldi, its new Hepatitis C medication that will cost $84,000 for a 12-week course of treatment; instead, it bought the drug developer, rival company Pharmasett, for $11 billion cash in 2011. Gilead now seeks a bonanza on a financial investment by gouging cash-strapped government programs, treating states like Gilead’s own private—rigged—stock market.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.

WASHINGTON, Jan 29, 2014 (BUSINESS WIRE) -- 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, its 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 toindustry reports, Gilead produces Sovaldi for approximately $1.00 per gram (with only 10 to 30 grams needed to successfully treat patients with Hepatitis C).1 This represents a retail markup of over 279,000%. (note:With only 10 to 30 grams of Sovaldi needed for successful treatment)(note:the difference from the $30 production cost for Gilead’s full course of treatment—30 grams x $1.00 per gram—to $84)(note:000 for the 12-week treatment program represents a retail markup of 279)(note: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 in your 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).2 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.3 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.

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 279,000 individuals in 32 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter:@aidshealthcare .

1 NPR,"$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices.” December 2013.http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices

2 NPR,"$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices.” December 2013.http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices

3 Bloomberg: At $84,000 Gilead Hepatitis C Drug Sets Off Payer Revolt http://www.bloomberg.com/news/2014-01-27/at-84-000-gilead-hepatitis-c-drug-sets-off-payer-revolt.html

SOURCE: AIDS Healthcare Foundation

AIDS Healthcare FoundationLos Angeles, CA, USA Ged Kenslea Communications Director+1-323-791-5526 [mobile]+1-323-308-1833 [work] gedk@aidshealth.org orAIDS Healthcare FoundationWashington, DC, USA Tim Boyd Director of Domestic Policy+1-213-590-7375 [mobile] timothy.boyd@aidshealth.org

Copyright Business Wire 2014

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Online Expert HCV Advice Now Available

aasldsmallidsasmall

Embargoed for Release Until:
Wednesday, January 29th 6 p.m. ET

Contacts:
Jennifer Ford, IDSA (703) 299-0412
Greg Bologna, AASLD (703) 299-9766

Online Expert Advice for Clinicians Treating Hepatitis C Now Available at
HCVguidelines.org

Today, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society-USA (IAS-USA), announced the launch of a new website, HCVguidelines.org, that will offer up-to-date guidance for the treatment of hepatitis C virus (HCV) infection.

It is estimated that between 3 and 4 million Americans are infected with HCV and have chronic liver disease as a result. The most recent generation of direct-acting antivirals has the potential to cure most patients with HCV. However, the rapid pace of drug development has left medical providers and insurance companies unsure what the optimal treatments are. The guidance provided through HCVguidelines.org will assist clinicians in using these and other treatments in the care of their patients.

HCVguidelines.org is the result of an ongoing collaboration between the two medical professional societies and IAS-USA. A panel of 27 liver disease and infectious diseases specialists and a patient advocate developed evidenced-based, consensus recommendations for the screening, treatment and management of patients with HCV. This guidance will be made available for health care providers who treat the disease and others who need updated information on the best practices. The site will be updated regularly to keep pace with improved diagnostic tools and new drug options as they meet Food and Drug Administration approval.

"Recent changes in HCV testing guidelines have led to the diagnosis of increasing numbers of patients who were previously unaware of their infection. The guidance provided through HCVguidelines.org comes at a critical time as more and more of these patients seek treatment that has the potential to effectively 'cure' them," said Adrian Di Bisceglie, MD, FACP, president of AASLD.

"In just the past three months, two new medications became available for treating HCV that hold a great deal of promise for patients living with this disease, and more are expected. HCVguidelines.org provides physicians with the latest information and informed guidance on the available treatment options based on a rigorous review of data," said Barbara Murray, MD, FIDSA, president of IDSA.

"An estimated 3-4 million Americans are infected with HCV and are at risk of progressing to chronic liver disease as a result," said Michael Saag, MD, FIDSA, a member of the Board of Directors of the IAS-USA and a co-chair of the guidance panel. He added, "The presence of a readily available, frequently updated guidance document is a great service to providers and their patients, who will benefit from modern treatments that result in cure of HCV up to 95% of the time."
About AASLD
AASLD is a medical subspecialty society representing clinicians and researchers in liver disease. The work of our members has laid the foundation for the development of drugs used to treat patients with viral hepatitis. Access to care and support of liver disease research are at the center of AASLD's advocacy efforts.

AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists and has grown to an international society responsible for all aspects of hepatology.

About IDSA
The Infectious Diseases Society of America (IDSA) is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has nearly 10,000 members, was founded in 1963 and is based in Arlington, VA. For more information, see www.idsociety.org.

Visit www.idsociety.org/Hepatitis_C to access IDSA's extensive collection of resources on hepatitis C, including the Society's Core Curriculum for HCV at www.idsociety.org/HCV_Curriculum/#Introduction.

About IAS-USA
The International Antiviral Society – USA (IAS-USA) serves as a collaborating partner for the AASLD/IDSA Hepatitis C Virus (HCV) Guidance and is responsible for providing expertise and administrative support to HCV Guidance Panel members and processes. A representative from the IAS-USA serves as a co-chair of the HCV Guidance Panel. For more information, see http://iasusa.org

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