Amber Rojas was almost eight months pregnant when she learned she had hepatitis C. After her daughter was born on Dec. 23, 2014, Rojas had hoped to start treatment with a newly approved, highly effective drug called Harvoni.
After filing for prior authorization and waiting for months, the 34-year old mother received an unwelcome letter on August 27, 2015 — her treatment request had been denied because her liver was still too healthy. Rojas said that even though she felt very sick with flu-like symptoms, her insurance provider deemed her “not sick enough to qualify.”
Rojas is one of an estimated 3.2 million Americans with hepatitis C, an infection that attacks the liver. In the United States, hepatitis C kills more people every year than HIV. Drugs like Harvoni promise to cure more than 90 percent of patients, yet many insurance providers authorize treatment only if a patient has extensive liver damage, or a fibrosis score of 3 or 4.
In the first six months of 2015, approximately 130,000 patients started treatment on Harvoni or Sovaldi, two of the most widely prescribed medications, according to the manufacturer.
Harvoni belongs to potent class of drugs called direct-acting antivirals, which block the virus’ ability to replicate, and to infect other people. These new drugs have very few side effects, and most patients can be cured after taking pills for 12 weeks.
With Harvoni’s $95,000 price tag, some insurance providers will go to great lengths to deny claims. Approved October 2014, Harvoni is the most expensive of these new medications, although they all cost more than $60,000 wholesale (prior to discounts and rebates) for a 12-week course of treatment.
Because of the high prices, three common policies are typically employed to restrict access — the first is to deny treatment for patients who are “not sick enough,” like Rojas. Another common policy is to deny treatment for people who use drugs or drink alcohol. To confirm their sobriety, patients are required to pass multiple urine sample drug tests. Finally, doctors themselves are limited: Many providers will accept prescriptions written only by a liver specialist, and some states don’t have enough specialists to service the population.
To Rojas, these policies are discriminatory, and morally wrong. “I feel like I’ve been treated less than human sometimes,” she said. Rojas was covered by Florida state Medicaid during her pregnancy, and nine months after giving birth to her daughter. (Today, Rojas is uninsured, having lost her Medicaid coverage after battling postpartum depression and losing custody of her daughter, she said.)
Florida’s state Medicaid program rejected Rojas’ request for treatment based on a principle of rationing treatment to patients with the most severe liver disease. However, private insurance companies and state managed programs alike commonly employ similar coverage restrictions. In fact, a recent Yale University study found that one in four patients was denied Harvoni after the first request, regardless of insurance provider. Dr Joseph Lim, director, Yale Viral Hepatitis Program in New Haven, Connecticut, led this research. Lim said that even though his study is small (only 129 patients were included for analysis, and all patients were located in Connecticut), it offers a rough snapshot of the coverage rates across America. Lim said that to his knowledge, this is the first published report of rejection rates in the United States.
Some clinicians offered a more bleak assessment based on their personal experience. Of the 800 prescriptions requested by Dr. Douglas Dieterich’s medical group at New York's Mount Sinai Hospital in the past year, approximately 60 percent were denied. And Dr. Hillel Tobias, a hepatologist at NYU Langone Medical Center, has treated 250 patients with the new medications, of which 80 percent were denied treatment on the initial application.
Coverage restrictions often run counter to medical consensus, and are purely cost-saving measures, agreed Dieterich and Lim. For example, demanding that patients have a clean urine toxicity test “has nothing to do with anything,” Dieterich said. The policy is not scientific or medically necessary, just “immoral,” he said.
The American Liver Foundation believes that people living with hepatitis C should have access to medications prescribed by their clinicians, said Tom Nealon, CEO of the foundation. Instead, a “curious” situation has developed in which insurance providers, rather than clinicians, are deciding which patients receive medication, Nealon said.
Some of these policies are on shaky legal ground, according to Robert Greenwald, director of Harvard Law School's Center for Health Law and Policy Innovation, Cambridge, Massachusetts. For example, Greenwald believes some state Medicaid programs are violating federal Medicaid law with excessive hepatitis C prior-authorization rules. In addition, private insurance companies are violating their own contracts, which promise to provide “medically necessary” services to covered patients. “They are completely abrogating their obligation to provide these services in hepatitis C solely based on cost,” Greenwald said.
However, Matt Salo, executive director of the National Association of Medicaid Directors, said state Medicaid restrictions do not violate federal law, because states have a lot of leeway in setting their own parameters around any drug. State Medicaid programs often have limited budgets, and because the drugs are so expensive, they must be able to set policies that triage care, he said.
Private insurance providers do base coverage decision on medical evidence, said Claire Krushing, press secretary for America’s Health Insurance Plans, a national trade association that represents 90 percent of the private health insurance industry. If a doctor and patient disagree with the decision, there is an appeal process, she said. The most significant challenge for private insurance is the “huge price tag” of these drugs, Krushing said, adding that drug makers set the price at the highest point the market can bear.
The issue of cost cannot be ignored. In 2013, the pharmaceutical company Gilead made headlines with its blockbuster cure for hepatitis C, a drug called Sovaldi. The company famously set Sovaldi’s price at $84,000, or roughly $1,000 per pill. (Gilead later developed Harvoni, essentially an even better pill that combines Sovaldi with a second drug, ledipasvir).
Public and private insurance providers balked at Sovaldi’s high price. Even the United States Senate Finance Committee opened an inquiry, sending an eight page letter to Gilead on July 11, 2014 demanding the company justify the price. But on Dec. 19, 2014, competition entered the marketplace when another drug, made by AbbVie, was approved. Gilead and AbbVie each negotiated steep discounts with large, private insurance providers for exclusive coverage of their respective drugs. Considering the competition, this year Gilead announced it will likely offer an average discount of 46 percent off the original price of Sovaldi and Harvoni.
Even discounted, these drugs are still expensive. However, hepatitis C also leads to costly complications such as liver transplant and cancer later in life, meaning these drugs are cost effective in the long run. At a price of approximately $40,000, Harvoni represents a “high value” treatment for most health plans, according to the Institute for Clinical and Economic Review, a non-profit organization that measures cost-effectiveness in health care.
The problem is that the savings can only be measured in overall health care dollars, and won’t necessarily be reflected on the earnings statement of any one insurance program. By employing these policies, many providers are merely trying to pass the buck onto a future insurer, “hoping the patients will die on somebody else’s dime,” said Dieterich.
The stigma surrounding hepatitis C is another layer of complexity that snarls access to quality care. Hepatitis C is highly transmissible via injection drug use, but not all patients have used injection drugs. Many people in the baby boomer generation were infected after blood transfusions and hospitals visits in the 70s and 80s, before the virus was identified. But the stigma remains, silencing some patients from advocating for their own medical care.
Rojas thinks she was infected while working as a medical assistant in 2013, when she was accidentally splattered with a patient’s blood. Rojas said her own doctors have treated her with disregard and even contempt since her diagnosis, even though she has never been an injection drug user.
Another woman, Sally, who asked that her real name not be used because of the stigma of the disease, said she might have contracted hepatitis C as a teenager when she used injection drugs. Or, maybe she contracted the virus years later during her 30-year career as a nurse, in which she has had multiple accidental needle sticks. Because she still works as a nurse, Sally is afraid to tell people in her community about her status.
When Sally finally opened up to a close friend, the friend “physically jumped back,” Sally said. “The first thing she thought of was herself,” Sally recalled. “I didn’t tell anybody else after that.”
To Greenwald, there is no question that many denial-of-coverage tactics are discriminatory. Hepatitis C patients are specifically targeted by excessive restrictions — policies that would not be tolerated in any other disease. For example, insurance providers are willing to cover chemotherapy for lung cancer patients who still smoke, Greenwald said. Greenwald believes hepatitis C lacks a strong advocacy movement because sufferers constitute a vulnerable, stigmatized population that is easy to ignore.
Lim agreed that many insurance policies deny access to people who are vulnerable, especially people who are poor, and the prisoner population. “I would not go to the point of describing it as discrimination, but I think its clear that there is a population of people out there who would clearly benefit from these drugs,” Lim said. “Right now, they don’t have access.”
For now, all Rojas can do is appeal her denial. She relies on Facebook support groups, which she says offer extremely useful information to help her navigate a difficult appeal process.
She believes Medicaid would save money if the program treated her now, instead of waiting for her to incur more medical bills as her liver deteriorates to a fibrosis score of 3 or 4. Moreover, she believes the program should treat everyone with hepatitis C, even people who use injection drugs.
“They’re no different than anyone else,” she said. “If we were all treated like humans this virus would have been eradicated already.”