Many health insurers have established prior-authorization criteria generally limiting access to the drugs to patients whose disease has progressed to at least Stage 3 fibrosis (just before the onset of liver cirrhosis).
The sticker prices of a course of treatment of the drugs range as high as $95,000. To mitigate the burden, major health insurers and pharmacy benefit management companies have entered special pricing agreements with Gilead for its new hepatitis C drugs Harvoni and Sovaldi or AbbVie for its competing drug Viekira Pak.
The companies have not disclosed the details of those deals, but Gilead executives suggested during a recent call with investors that they exceed 50% for high-prescribing payers.
Some providers believe infected patients at any stage of the disease should have access to the drugs, which have cure rates exceeding 95%. When they choose to prescribe them, however, they're faced with seeking authorization from payers and pursuing appeals when requests are denied.
“I'd love to see every patient have a chance to be treated. I am an expert in the infection and would prefer that no one have it,” said Dr. David Thomas, a liver specialist at Johns Hopkins University. “I prescribe the meds for that reason and understand that sometimes it is difficult to get them approved.” Thomas has received grants from Gilead and Merck & Co., which has a hepatitis C drug in development.
Many people are infected with the hepatitis C virus for decades before the onset of cirrhosis. But patients who suffer from the disease are becoming increasingly frustrated with barriers to coverage as word spreads that the drugs are available.
This week, a Los Angeles woman sued Anthem Blue Cross for denying coverage for Gilead's Harvoni even though her physician recommended she take it. The Food and Drug Administration approved Harvoni in October 2014. Without insurance coverage for the drug, she would have to pay $95,000 for a 12-week course of treatment, she alleges in the lawsuit.
Gilead has been tracking this tension between plans and providers. The company found that in 56% of the instances a provider attempted to prescribe one of its hepatitis C treatments in the first three months of 2015, the patients were between zero and Stage 2 on the fibrosis scale.
Gilead CEO John Martin said during an earnings call this year that the company believes a significant number of those prescriptions are not being filled because of health plan restrictions.
Gilead and AbbVie have enjoyed surging profits since introducing their new hepatitis C drugs. They accounted for about $11 billion of a 13% increase in U.S. drug spending in 2014, according to the IMS Institute for Healthcare Informatics. That report also noted a tenfold increase in the number of patients treated for the disease last year.
Another patient whose doctor made repeated requests for coverage for Harvoni is Dean Salvani, a 59-year-old resident of Bellmore, N.Y. Salvani has been denied coverage for the drug twice by UnitedHealthcare.
“There's finally a cure, but I can't get it,” said Salvani, who says he suffers severe muscle and joint pain from the disease. “'You're not sick enough' and 'it's too expensive'” Salvani said, recapping conversations with his health plan's claims staff.
In denial letters provided to Modern Healthcare by UnitedHealthcare, the company confirmed that it denied the authorization because Salvani didn't have at least Stage 3 fibrosis.
“The newer hepatitis C drugs, such as Sovaldi and Harvoni, are effective for patients with the appropriate genetic markers at any stage of disease progression,” United spokesman Tyler Mason said. “Therefore, (we) believe our clinical programs are consistent with clinical evidence to prioritize treatment based upon the progression of the disease, i.e., treating the sickest patients first. Mr. Salvani's current condition may not meet that criteria.”
For every 100 people infected with the virus, Mason noted, only five to 20 will develop cirrhosis over a period of 20 to 30 years, according to the Centers for Disease Control and Prevention.
“Clinicians tend to be advocates for their patients; they would like the best therapy for their patients as quickly as possible,” said Dr. Henry Masur, chief of the critical care medicine department at the NIH Clinical Center. “But people are realistic and realize that if there is no medical urgency, they have to be patient and treat the higher risk patients first.”
But some experts question the safety of the prior-authorization rules that limit access to the new breed of hepatitis C drugs during moderate and advanced fibrosis.
“This strategy appears reasonable when one assumes no health impact from delaying treatment,” David Rein, principal research scientist with NORC's Public Health Research Division, an independent research organization at the University of Chicago, wrote in a paper published in the journal Clinical Infectious Diseases in March.
However, Rein wrote, “doctors know surprisingly little about the health impacts of delaying treatment, and the earliest results from studies examining this issue will not be available for several years.
Virgil DicksonVirgil Dickson reports from Washington on the federal regulatory agencies. His experience before joining Modern Healthcare in 2013 includes serving as the Washington-based correspondent for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's degree from DePaul University in 2007.
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