Hepatitis C drugs Sovaldi and Harvoni out of reach for most, except inmates

Oct. 23--Sometimes Jane Blumenfeld feels like if she were in prison, she would have a better chance at getting life-saving drugs to treat her liver disease.

Blumenfeld is one of 33,160 in California who have chronic hepatitis C infection, a liver disease caused by a virus most commonly spread through an exchange of blood.

Up until 2013, it was considered incurable. But then came Sovaldi and Harvoni, the only two drugs that can cure hepatitis C, preventing liver transplants. A 12-week treatment costs $95,000, and there are no generic versions.

But many Californians such as Blumenfeld who have private insurance or who are covered through Medi-Cal are being told they aren't sick enough to obtain coverage for the medications. In the last year, 94 percent of those who requested the drugs through Medi-Cal were denied coverage.

It's a different story behind bars. California paid $58 million in the last fiscal year to treat prisoners who tested positive for hepatitis C. And that number is expected to grow. Last year, 9,329 prison inmates tested positive for the virus; 702 were treated with Sovaldi or Harvoni.

HIGH COST OF DRUGS

A study released in July by the California Association of Health Plans found serving only 5 percent of those who are incarcerated and in state hospitals who have hepatitis C would cost California $512 million to $921 million. The study was used to illustrate how the high cost of drugs impacts taxpayers. In June, California Gov. Jerry Brown signed a budget that included spending nearly $61 million to treat hepatitis C among the state's inmates.

It's unclear if those covered under private or Medi-Cal insurance are getting the drugs at the same rate as inmates. But many are having to appeal insurers' decisions at the state level.

From June 2014 to August 2015 when data was requested, the Department of Health Care Services received a total of 1,813 requests for Harvoni and Sovaldi made on behalf of 914 Medi-Cal patients. Of those requests, 94 percent of the patients were told by insurers that they were being denied coverage.

At least 97 patients appealed those decisions. Of those, 21 insurers' decisions were overturned by the state, while 73 were upheld. Three appeals were pending.

California's Department of Managed Health Care, which regulates managed care and private health plans, received 209 requests seeking appeals of coverage denials of Harvoni and Sovaldi based on medical necessity. Of those, 164 independent medical reviews, or 78 percent, resulted in overturning the health plan's decision.

PRIVATE INSURANCE BATTLES

In the case of one 43-year-old man, the health plan's decision was upheld because he was close to death due to another illness unrelated to hepatitis. In another case of a 66-year-old woman, three independent physicians found she wasn't sick enough.

Blumenfeld, 64, Westwood resident who has been positive with early stage hepatitis C for more than a decade, said her insurance company, Anthem Blue Cross, wouldn't cover Harvoni. At her level of illness, the drug is not medically necessary, the health insurer told her in a letter.

"Essentially, what they are saying to me is, 'You're not sick enough," Blumenfeld said. "They're saying, 'You don't have advanced liver disease, otherwise we might cover it.'"

Within Anthem's guidelines, Harvoni is considered a primary treatment for hepatitis C for members with advanced stages of liver disease or those at higher risk for complications. Patients must meet at least seven criteria.

A letter from Blumenfeld's hepatologist in March argues that she is qualified because she has tried Interferon, a difficult regimen that failed to help her. Also, Blumenfeld's maternal grandmother died of liver cancer and the possibility of further illness exists.

"With her level of liver damage and treatment experience, the American Association of Study of Liver Damage and Treatment Disease guidelines recommend 12 weeks of the treatment of Harvoni," her doctor wrote.

Attorney Ricardo Echeverria, whose law office represents Blumenfeld, said Anthem isn't denying her the drug but says it's not medically necessary for her until she gets sick at a certain level. That means the decision is hers to pay for it out of pocket.

"The truth is they don't want to pay for it, because it's expensive," Echeverria said. "What needs to happen is there needs to be a dialogue with health insurance companies and manufacturers to work out the price to not leave patients in the balance."

CHANGING GUIDELINES

The California inmates who were given the drugs were diagnosed with stage 3 hepatitis C or those at stage 2 who also are HIV positive. Those guidelines are not likely to change soon, a spokeswoman from the California Correctional Health Care Services said.

But for the general public, health coverage guidelines continue to change as more demands are being made. In June, Anthem Blue Cross client Shima Andre filed a lawsuit in Los Angeles Superior Court, outlying the same complaint as Blumenfeld. Andre had said because she wanted to start a family, she needed Harvoni to be cured of hepatitis C.

After the lawsuit was filed, Anthem changed its guidelines to reflect eligibility if the "individual is a woman of child-bearing potential wishing to become pregnant."

Then in July, the state's Department of Health Care Services changed their guidelines as well, lowering the standard of illness from stage 3 for Harvoni and Sovaldi to stage 2, "as a result of an increasing body of scientific research about the effectiveness of newer hepatitis C medications."

The changes in guidelines are to be expected, but they also place pressure on health insurers that in turn affect premiums, said Charles Bacchi, president and CEO of the California Association of Health Plans. The association has tried to gather legislative support to pressure pharmaceutical companies to lower the cost of drugs.

"Make no mistake, health plans are covering Sovaldi and Harvoni and applying the latest medical evidence on covering it," Bacchi said. "Different state agencies develop their own guidelines. Some can be more restrictive than others. Over time, utilization guidelines change. They are all evolving."

COSTS WILL CONTINUE

Sovaldi, made by San Dimas-based Gilead Sciences, was approved by the U.S. Food and Drug Administration in 2013, and Harvoni's approval followed.

The two medications have been held up as miracle drugs but also serve as an example of the high cost of medicines in the United States.

Those high costs will continue as drugs become better, said Stuart Schweitzer, a pharmaceutical industry expert in the department of Health Policy and Management in the Fielding School of Public Health at UCLA.

"If you look at Sovaldi, two things stand out: The drug is marvelously successful in curing hepatitis C, and it's the first time that people have come up with a cure for Hep C," he said. "You can ask then, how much is a life worth?"

Schweitzer said he's not defending the pharmaceutical companies, but noted the high cost of newer, better drugs comes from the time and length of research and money spent to produce the medication.

"What does happen between giving the drug to someone at an early stage or one that has had it for some time or someone very sick?" Schweitzer said. "It could be that waiting is penny wise and pound foolish. Unfortunately, we don't know that yet. I would hope in the next six months, we are able to get our heads around treatment for Hep C, and there will be more uniformity between private payers and prisons."

Last week, Anthem reached out to Blumenfeld to say she could appeal the company's decision to the state's Department of Managed Health Care. She said she declined to appeal on advice from her attorney.

"The difference between me and the prisoners," she said, "is they don't have to pay $95,000."

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