For decades it has been a death sentence. First comes the fatigue, the joint pain, and the jaundice, and then the cirrhosis, the liver cancer, and finally death.
Naomi Judd has it, as does David Crosby. It killed Allen Ginsberg, Mickey Mantle and, just last year, Natalie Cole. And those are just the famous ones. The Centers for Disease Control and Prevention estimates that 3.5 million people in the United States are infected with the Hepatitis C virus, 60 to 70 percent of whom will go on to develop chronic liver disease.
There is now a cure. You can have this cure, if you’re the right person, in the right place, with the right medical history and the right insurance. If, however, you’re, say, a low-income Vietnam veteran, a caregiver making $16,000 a year, or a chemist so disabled by Hepatitis C that you can’t work, you’ll likely have to wait for serious liver scarring before your insurance will cover your cure.
Unless the students and faculty of Harvard Law’s Center for Health Law and Policy Innovation clinic have something to say about it, that is.
In February, the center filed a class-action lawsuit against the Washington State Health Care Authority on behalf of its Medicaid enrollees, challenging the agency’s limitations on coverage of Hepatitis C treatment. [See an update on the lawsuit.] At issue are HCA’s stringent guidelines regarding who receives treatment, and when. CHLPI’s goal is to resolve the kind of disparity in Washington’s medical system that is restricting vulnerable and at-risk populations’ access to a lifesaving drug that treats a chronic and debilitating disease. Along the way, they hope to put other Medicaid providers on notice: It’s time to comply with treatment guidelines and the law.
Damage Demanded
When the Food and Drug Administration approved ledipasvir-sofosbuvir, which goes by the brand name Harvoni, in October 2014, the drug was hailed as a lifesaver. Just a two- to three-month dose is enough to eliminate HCV antibodies in 96 to 99 percent of people infected. Purging the disease before it becomes chronic also greatly diminishes the likelihood that the person will go on to develop diabetes, cirrhosis and liver cancer.
And yet in Washington state, and in many other states, the Medicaid provider has been refusing to cover the drug for people before they develop significant liver scarring—and have a Metavir fibrosis score of F3. By F4, that liver scarring would be rampant and the patient would likely have cirrhosis. In effect, rather than heading off the disease before it could do damage, HCA has been requiring those who want the cure to first become seriously and irrevocably ill.
Seattle-area chemist David Morton, who believes he was infected on the job in the late 1980s, is one such patient. With a Metavir fibrosis score of just F0 to F1, he was denied coverage for Harvoni by his insurer, Group Health Cooperative. While his liver may be intact, his life is not. Hepatitis C causes him such extreme fatigue that he is unable to work. Instead, he has become the face of the disease, and a vocal advocate for the right to the cure.
“People die from complications of Hepatitis C. I’d like to know that, while I can’t stop my death, I can prevent my death from Hep C,” says Morton. “It’s a virus, and it seems like our society is interested in stopping viruses in people. It appears there’s a way to eradicate this virus, and I’m advocating for its eradication.”
Budget in Balance
CHLPI would also like to eradicate the virus—for everyone. When the center’s director of litigation, Kevin Costello, and Washington lawyers Amy L. Crewdson and Eleanor Hamburger filed the complaint in mid-February, they argued that HCA was in violation of the Medicaid Act in three ways: in its requirement to provide medical assistance—including drug coverage—to all qualified enrollees; in its mandate to provide timely medically necessary treatment to enrollees; and in its obligation to provide comparable coverage to individuals with comparable needs.
While the state will argue that its restrictions are a result of fiscal policies, HCA’s chief pharmacy officer acknowledged during a public hearing that its restrictions have been at least partially political in nature. That revelation only fueled the fire for CHLPI.
“What we’ve seen, much as we saw with HIV, is resistance. In part, that’s related to costs, but I think we need to be really clear that this work is about particularly vulnerable populations, low-income groups, and people of color,” says Robert Greenwald, CHLPI’s director and clinical professor of law at Harvard.
“If this was a cure for MS or Alzheimer’s disease, we wouldn’t be having this conversation.”
It’s easy to see why the HCA would make an issue of cost. Harvoni was initially billed at $31,500 for a one-month supply, with the full regimen lasting eight to 12 weeks. The maximum price of a cure then was estimated at a hefty $94,500 per patient.
The HLS clinic has filed a lawsuit on behalf of Medicaid patients in Washington state.
The price tag even resulted in an investigation by the U.S. Senate Committee on Finance, which is responsible for overseeing federal programs paying for prescription drug coverage. In December, the committee released a report stating that it believed the drug’s maker, Gilead Sciences, had “set a price as high as it thought the market would bear before significant access restrictions would be imposed.” The Senate committee also asserted that Gilead’s pricing strategy was focused on getting the maximum revenue, even if that meant that fewer patients would be able to be treated.
Going after big pharma will have to be left to the legislature or government regulators.
“While CHLPI would certainly like to see lower drug prices, it is extraordinarily difficult for private parties to sue private companies on the basis of the price they charge for a product,” says Costello.
That controversial $63,000 to $94,500 estimated price is also something CHLPI takes issue with. Greenwald notes that, by law, all Medicaid programs in the U.S. receive an automatic 23.1 percent rebate on drugs and many receive an additional supplemental rebate. While initially Gilead extended an additional meager 10 percent discount, today, according to the drug maker, both Medicaid and the Veterans Administration receive discounts on Harvoni in excess of 50 percent.
Gilead also contends that up to half of people with Hepatitis C genotype 1—the most common form of the disease in the U.S. and the most difficult to treat—will be cured with just an eight-week program. The price then would be $63,000 retail, and less than half that for Medicaid and its enrollees.
“This is the state budget office cutting off their nose to spite their face,” says Costello. “They’re taking the maximum cost, times the maximum number of people, and saying ‘That’s our exposure’ without looking at the larger picture.” Such prolongation means extended costs for treating not only the virus itself but also all of the diseases—such as lymphoma, diabetes and liver cancer—that living with HCV for an extended time causes.
Then there’s the price of a liver transplant. According to the National Kidney Foundation, in 2002 a liver transplant cost around $314,000. A 2014 report by actuary firm Milliman estimated the retail price of billed charges for a transplant and for surrounding medical care to be $739,100.
“We have a cure for HCV,” says Kelly Jo Popkin ’17, a student in the Harvard Law clinic. “Refusing to provide that cure until patients’ livers are completely ravaged runs the risk of increasing transmissions in the state. In addition, the HCA is forcing those living with Hepatitis C to live with increasing symptoms and comorbidities they wouldn’t normally have. That ranges from joint pain and depression to really horrific side effects such as diabetes, lymphoma, cancer, and death. All of that could be completely avoided.”
Litigation is only the most recent phase in CHLPI’s battle for patients with Hepatitis C.
Pen, Pill, Gavel
Litigation is only the most recent phase in CHLPI’s battle. The clinic, which was founded in 1987 as the AIDS Law Clinic and was the nation’s first law school-based legal services program to serve low-income people living with HIV and AIDS, began its work on issues of access and HCV with regulatory advocacy.
Kellen Wittkop ’16 has spent the last four semesters identifying how—and where—policies restricting patients’ access to Harvoni might be considered discriminatory and in violation of federal regulations and law. She investigated how states were responding to the availability of Harvoni, evaluated the varying degrees of regulations states placed on access to the drug, and researched how accessibility to the cure varied by state. Some states, she noticed, had been quick to cover the medication. Others, such as Washington, were restricting access to only those with severe liver damage.
Kellen Wittkop ’16 has spent the last four semesters identifying how—and where—policies restricting patients’ access to the drug Harvoni might be considered discriminatory and in violation of federal regulations and law.
That research led to an article in the Annals of Internal Medicine in August 2015 and to a report that included an assessment of Medicaid programs in 10 states, including managed care plans in five of those states. Pennsylvania responded to the research and the legal implications by eliminating its sobriety requirement (which required a documented history of abstinence from alcohol and drugs for at least six months prior to treatment) and lowering its Metavir fibrosis criterion from F3-F4 to F2. Other states have come up with every reason possible not to comply with the law and what the research shows, says Greenwald
The research also led the center to file the lawsuit aimed at forcing HCA to cover this cure for all patients, not merely those at Metavir fibrosis score F3 or higher.
The CHLPI team believes that it has the law on its side. After months of advocacy by the program, in November 2015 the Centers for Medicare & Medicaid Services, or CMS, sent guidance to all states, reminding them of federal regulations and their obligation to cover medically necessary drugs. CMS also expressed concerns that some states, by imposing conditions limiting coverage of HCV drug treatment to those whose liver damage had progressed to Metavir fibrosis score F3 or F4, were unreasonably restricting access to treatment in violation of the Medicaid Act.
In March, in hopes of getting relief for such patients, CHLPI moved the court in Washington for a preliminary injunction and for class certification. Greenwald, Costello and the students will be on hand when patients, joined by medical experts, testify about the expected trajectory of their disease. The court will consider whether those men and women are likely to suffer irreparable harm before an ultimate court decision, in which case the HCA would likely be ordered to approve interim coverage of the drug.
That would be an initial double victory. As Greenwald says, the center would be winning for people living with HCV while simultaneously mentoring the next generation of lawyers.
Bigger winners still would be people such as Morton. “I may be able to rejoin the workforce and become a contributing member of society,” he says.
Postscript
On May 24, after this article went to press, patients such as Morton got some very good news. The federal court granted the preliminary injunction requested by CHLPI.
In response to the lawsuit filed by the HLS clinic and its partners, Washington state’s Medicaid must now provide life saving drugs to all Hepatitis C patients, not just those who are sickest and whose disease has progressed to cause severe liver damage, among many other effects.
“This marks the first time a federal court has ordered a state to cease improperly restricting access to care for the Hepatitis C cure and sets an important precedent for private enforcement of the Medicaid statute,“ says Greenwald. “Going forward, our plan is to continue to use litigation as another tool in our arsenal to fight against improper rationing of health care under state Medicaid and private insurance policies and to make the promise of health reforms meaningful for all Americans.”
This victory follows an earlier win in Massachusetts. On April 14, The Boston Globe followed up on its article that cited the work of Greenwald and CHLPI with an editorial calling for insurers in Massachusetts to remove access restrictions to drugs that can cure Hepatitis C—the most deadly infectious disease in America today. On April 20, Tufts Health Plan announced it was lifting those restrictions for both its public and private insurance plans. “Since Tufts now joins Blue Cross Blue Shield, two of the larger insurers in the state, in providing relatively unrestricted access to treatment,” says Greenwald, “we anticipate that all other insurers will follow suit in the coming months to remain competitive in the insurance marketplace in Massachusetts.”