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B.E. v. Teeter
CourtUnited States District Court for the Western District of Washington
Full case name B. E. and A. R. v. Dorothy F. Teeter
DefendantsDorothy F. Teeter, as Director of the Washington State Health Care Authority
Counsel for plaintiffsKevin Costello
Amy Louise Crewdson
Eleanor Hamburger
Richard E Spoonemore
PlaintiffsB. E. and A. R.
Court membership
Judge sittingJohn C. Coughenour
Keywords
C16-227-JCC

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"[1] with Hepatitis C (HCV)[1] against Dorothy F. Teeter, as Director of the Washington State Health Care Authority, with Judge John C. Coughenour presiding.[2][1] 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)."[1] "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."[1] 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.[2] In May 27, 2016, Judge Coughenour found in favor of the plaintiffs,[3] "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."[4] 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."[5] 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."[6][7]

Prior events

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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."[4] Gilead Sciences has priced Sofosbuvir—brand name Sovaldi— at $1,000-a-pill.[4] 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."[4] Robert Greenwald, director of the Center for Health Policy & Innovation, which is partially funded by Gilead,[4] at Harvard Law School provides talking points for industry lobbyists.[4]

"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[8]—the largest trade organization in the world representing the biotechnology industry,[9][10][11] provided members with "talking points" on how to promote access to drugs despite their "price tags".[4]

Social context

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John C. Martin, the former CEO of Foster City, California-based biotechnology company Gilead Sciences.[12][13] 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.[14] 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."[12] By March 2014, despite outrage against the price, sofosbuvir rapidly became a "top seller" in the United States.[15][16] 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.[14]

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.[17]

"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

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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."[18]

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".[19]: 593  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.[20]: 10 [18]

Decision

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In May 27, 2016, Judge Coughenour found in favor of the plaintiffs,[21] "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."[4] 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."[22]

Opinion of the Court

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Outcome

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By July, 2016, the State of Colorado struggled with a similar decision.[6] 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."[6][7]

See also

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References

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  1. ^ a b c d e CASE NO. C16-227-JCC (Washington Western District Court, May 27, 2016, retrieved February 25, 2017
  2. ^ a b B.E. et al v. Teeter, retrieved February 25, 2017
  3. ^ 40, May 27, 2016, retrieved February 25, 2017
  4. ^ a b c d e f g h Andrew Martin and David Glovin (September 19, 2016), How Big Pharma Pressures States to Pay for Pricey Pills, Bloomberg, retrieved February 25, 2017, The Biotechnology Innovation Organization, an industry lobbying group, gave members talking points in June focusing on access to drugs over their price tags. Or, as Robert Greenwald said in a 2015 PowerPoint presentation on the new class of hepatitis C drugs put it: "Reframe the response. Shift the focus from cost to cure." The presentation sought to make people aware the disease has a cure, not just that it was costly to treat, said Greenwald. He runs the Harvard Law School center that's representing the Washington plaintiffs. It's also partially funded by Gilead and other drugmakers....While the drug giant 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. {{citation}}: Italic or bold markup not allowed in: |publisher= (help)
  5. ^ Case 2:16-cv-00227-JCC Document 63 (PDF), January 5, 2017, retrieved February 25, 2017
  6. ^ a b c Jennifer Brown (July 29, 2016), Only the sickest Coloradans on Medicaid get breakthrough treatment for hepatitis C, Denver Post, retrieved February 25, 2017, It's not until the final two stages of liver damage that needy Coloradans with the blood-borne hepatitis C virus get access to a life-saving drug with a 90-percent cure rate and an exorbitant price tag...Now pressure for change is increasing against the state Department of Health Care Policy and Financing, which has restricted access to the breakthrough drug due to its cost. State officials say they must balance the public health issue with the taxpayer expense of paying the prescriptions of the more than 9,000 people with hepatitis C on the government insurance system...A drug called Sovaldi approved in 2013 was a game-changer: 12 weeks of therapy without the excruciating side effects, and its cure rate is 90 percent. Estimated cost of the 12-week treatment is $30,000 to $40,000, down significantly from the initial $1,000 per pill — a total of $84,000 — when the drug was the only one on the market but still a potential budget buster for Colorado's Medicaid department. {{citation}}: Italic or bold markup not allowed in: |publisher= (help)
  7. ^ a b Elana Gordon (August 11, 2016), "A cure at what cost? More states easing restrictions on Hepatitis C treatments", NewsWorks, retrieved February 25, 2017 {{citation}}: Italic or bold markup not allowed in: |work= (help)
  8. ^ "Biotechnology Innovation Organization changes name to Biotechnology Innovation Organization | Business Wire". www.businesswire.com. Retrieved 2016-01-04.
  9. ^ Anna Edney (June 19, 2012), Biosciences Defy U.S. Jobs Slump as Research Labs Hire, Bloomberg News {{citation}}: Italic or bold markup not allowed in: |publisher= (help)
  10. ^ European Biotechnology Network. "List of European and International Biotech Industry Associations"
  11. ^ "GEN's 30th Anniversary: Biotech Trade Associations", Genetic Engineering News, June 15, 2011. "which formed from a merger of Association of Biotechnology Companies (ABC) and the Biotechnology Industry Organization."
  12. ^ a b Herper, Matthew (6 May 2015). "Gilead's John C. Martin: One Breakthrough Drug After Another". Forbes. Retrieved 27 October 2015.
  13. ^ "John C. Martin, PhD". Gilead. 2013. Retrieved 27 October 2015.
  14. ^ a b Staton, Tracy (22 January 2015). "Gilead's John Martin scores 'best CEO' trophy for huge stock gains". Fierce Pharma. Retrieved 27 October 2015.
  15. ^ D. Armstrong (March 21, 2014), Gilead’s $84,000 treatment questioned by US lawmakers, retrieved December 8, 2014, Generally speaking, it is more effective and better tolerated than alternative treatments. Unfortunately, the current per pill cost—$1,000—results in an $84,000 treatment course, creating barriers to therapy for many. Patients, providers, and payors alike have expressed outrage, and the debate has even drawn the attention of the US Congress.. Despite these concerns, sofosbuvir rapidly has become a top seller in the United States ...."
  16. ^ Cite error: The named reference pppmag_2015 was invoked but never defined (see the help page).
  17. ^ Paul Barrett and Robert Langreth (March 6, 2015), Pharma Execs Don't Know Why Anyone Is Upset by a $94,500 Miracle Cure: The company selling a costly breakthrough to millions of hepatitis C sufferers thinks price is the wrong thing to talk about, Bloomberg Businessweek, retrieved February 25, 2017, 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. {{citation}}: Italic or bold markup not allowed in: |publisher= (help)
  18. ^ a b Armstrong, Drew (21 March 2014). "Gilead's $84,000 Treatment Questioned by U.S. Lawmakers". Bloomberg. Retrieved 27 October 2015.
  19. ^ Troyen Brennan and William Shrank (August 13, 2014), "New expensive treatments for hepatitis C infection", JAMA, 312 (6): 593–594, doi:10.1001/jama.2014.8897, Abstract: "Treatment of infection with hepatitis C virus (HCV) has changed substantially in the last 3 years, with new therapies now reaching cure rates (defined by sustained virologic response) higher than 95%. As little as 3 years ago, treatment involved an arduous course of pegylated interferon and ribavirin, which caused serious adverse effects in more than 80% of patients; less than 50% of patients could finish the treatment course. Because HCV infection can be indolent, with slowly developing liver injury in the form of scarring and fibrosis, many patients were so-called warehoused by their physicians, followed up closely while waiting for more promising treatments." {{citation}}: Italic or bold markup not allowed in: |journal= (help)
  20. ^ Steven Lucio (February 2015), The Increasing Impact of High-Cost Specialty Therapies, vol. 12, Pharmacy Purchasing & Products Magazine, "Sofosbuvir also is an excellent example of both the benefit and the challenge of specialty medications (Brennan and Shrank 2014). On one hand, this agent offers up to a 95% response rate as part of an interferon-free treatment regimen for hepatitis C (Brennan and Shrank 2014). Generally speaking, it is more effective and better tolerated than alternative treatments (Brennan and Shrank 2014). Unfortunately, the current per pill cost—$1,000—results in an $84,000 treatment course, creating barriers to therapy for many"(Lucio 2015 citing Brennan and Shrank 2014). {{citation}}: Italic or bold markup not allowed in: |publisher= (help)
  21. ^ 40, May 27, 2016, retrieved February 25, 2017
  22. ^ Case 2:16-cv-00227-JCC Document 63 (PDF), January 5, 2017, retrieved February 25, 2017

Category:United States civil rights case law Category:Specialty drugs Category:Pharmaceutical industry

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