User:Oceanflynn/sandbox/B.E. v. Teeter

 B.E. v. Teeter (2016) is a Washington Western District Court lawsuit filed on February 16, 2016 by plaintiffs B. E. and A. R., "Washington Medicaid enrollees" with Hepatitis C (HCV) against Dorothy F. Teeter, as Director of the Washington State Health Care Authority, with Judge John C. Coughenour presiding. The plaintiffs are suing Washington State’s Medicaid program for access to "the life-altering medication they have been prescribed, known as Direct-Acting Antivirals (DAAs)." "Plaintiffs bring a claim under 42 U.S.C. § 1983, alleging violation of Title XIX of the Social Security Act (also known as the "Medicaid Act")" against Teeter and WHCA and "seek declaratory and injunctive relief pursuant to 28 U.S.C. §§ 2201 and 2202." The counsels for the plaintiffs are Kevin Costello, Amy Louise Crewdson, Eleanor Hamburger, and Richard E Spoonemore. The counsels for the defendants are Angela D. Coats McCarthy and Nissa Ann Iversen. In May 27, 2016, Judge Coughenour found in favor of the plaintiffs, "that Washington state must provide all hepatitis C patients covered by Medicaid with treatment while the case proceeds. That sent the state’s Medicaid budget for hepatitis C treatment from $24 million in 2015 to $222 million by 2017. Washington gets help from the federal government funding Medicaid, but the state will still see its hepatitis C-drugs bill rise to $48 million in 2017 from $6 million in 2015." On January 5, 2017, Judge Coughenour announced a Fairness Hearing to be held on April 4, 2017 "to consider whether the proposed Agreement is fair, reasonable, and adequate and should be finally approved." By July 2016, a "federal court ruling eliminated similar restrictions in Washington. Several other states, including Florida, Connecticut and New York, have increased access to treatment without court battles."

Prior events
While Gilead "isn’t involved in the lawsuit, the company and its foundation have donated hundreds of thousands of dollars to the researchers, lawyers, patient advocates and medical expert who have helped build the case." Gilead Sciences has priced Sofosbuvir—brand name Sovaldi— at $1,000-a-pill. The American biotechnology company Gilead, "and its foundation have donated hundreds of thousands of dollars to the researchers, lawyers, patient advocates and medical expert who have helped build the case." Robert Greenwald, director of the Center for Health Policy & Innovation, which is partially funded by Gilead, at Harvard Law School provides talking points for industry lobbyists. ""If we had a cure for Alzheimer's or cancer or M.S. at $30,000, we would not be in the same situation we're currently in. People would be storming the White House and legislators, demanding access to a cure. We as a nation should try to figure out how to meet those costs. It's myopic to think about pharmacy line items."

- Robert Greenwald, director of the Center for Health Policy & Innovation 2015

In June 2015, Biotechnology Industry Organization—renamed—Biotechnology Innovation Organization (BIO) in 2016 —the largest trade organization in the world representing the biotechnology industry, provided members with "talking points" on how to promote access to drugs despite their "price tags".

Social context
John C. Martin, the former CEO of Foster City, California-based biotechnology company Gilead Sciences. is credited with the rise of sofosbuvir—the brand name is Sovaldi—from "zero-to-blockbuster in a couple of months" with profits topping $10 billion for 2014. Martin led the development of the most widely prescribed HIV pill. In 2014 he led the development of Sovaldi—"a treatment for the liver virus hepatitis C that can cure 90% of patients and generated $12 billion in revenue in its first year on the market." By March 2014, despite outrage against the price, sofosbuvir rapidly became a "top seller" in the United States. During Martin's tenure as CEO since 1996, Gilead shares rose 100-fold, and the stock posted a 157% gain just from 2013 to 2015.

A March 6, 2015 Bloomberg Businessweek article reported that, Gilead’s "market capitalization" "soared from $29 billion to $167 billion" [from 2010 to 2015] and Martin's net worth exceeded $1 billion.

""After Sovaldi received approval from the U.S. Food and Drug Administration in December 2013, Gilead announced the drug would cost $84,000 for a 12-week course, or exactly $1,000 a pill. That’s more than double what Pharmasset, the biotech company that developed an early experimental version of the drug, initially said it planned to charge—until Gilead bought Pharmasset in 2011. For 2014, Sovaldi generated $10.3 billion in sales, making it one of the most lucrative pharmaceutical launches ever. In just the final three months of 2014, Harvoni added $2.1 billion. Gilead’s market capitalization has soared from $29 billion to $167 billion in five years. The net worth of its chief executive officer, John Martin, exceeds $1 billion.""

- Specialty drug Bloomberg Businessweek March 6, 2015

Issues
In April 2014 U.S. House Democrats—Henry Waxman, Frank Pallone Jr., and Diana DeGette—wrote Martin questioning the $84,000 price for hepatitis C treatment Sovaldi. They specifically asked Martin to "explain how the drug was priced, what discounts are being made available to low-income patients and government health programs, and the potential impact to public health by insurers blocking or delaying access to the medicine because of its cost."

In August 13, 2014, JAMA published a frequently-cited "Viewpoint" by CVS Caremark's Troyen Brennan and William Shrank, researchers for CVS Caremark, in which Brennan and Shrank sought to rationalize the high price of sofosbuvir (Sovaldi) saying that in the American " market-driven health care system ], Gilead investors deserve a reasonable return on investment, that is Gilead "should be able to recoup the costs of development".  The CVS Caremark JAMA 2014 article was cited in a 2015 article by Steven Lucio, in the pharmaceutical industry's premier source Pharmacy Purchasing & Products Magazine, saying that Sofosbuvir is an example of how specialty drugs "present both benefits and challenges.

Decision
In May 27, 2016, Judge Coughenour found in favor of the plaintiffs, "that Washington state must provide all hepatitis C patients covered by Medicaid with treatment while the case proceeds. That sent the state’s Medicaid budget for hepatitis C treatment from $24 million in 2015 to $222 million by 2017. Washington gets help from the federal government funding Medicaid, but the state will still see its hepatitis C-drugs bill rise to $48 million in 2017 from $6 million in 2015." On January 5, 2017, Judge Coughenour announced a Fairness Hearing to be held on April 4, 2017 "to consider whether the proposed Agreement is fair, reasonable, and adequate and should be finally approved."

Outcome
By July, 2016, the State of Colorado struggled with a similar decision. In Colorado, Dr. Judy Zerzan, Colorado’s Medicaid’s chief medical director estimated it would cost an "additional $1.14 billion to treat all hepatitis C patients with Medicaid regardless of how far their disease had progressed....The prices of the medications that have been set by the manufactures for hepatitis C have had a very significant and negative impact on this public health issue,” Dr. Zerzan told the legislature’s Joint Budget Committee in December [2015]. The high price of the drugs has forced Medicaid into policies that treat “the sickest patients first,” she said."