Physicians face tough predicaments in attempting to prescribe highly effective new hepatitis C drugs for their patients while health plans strive to curb the high costs of those medications.
Many insurers have set criteria generally limiting access to the breakthrough drugs to those hepatitis C patients whose disease has progressed to at least Stage 3 fibrosis, just before onset of cirrhosis of the liver. But some doctors say infected patients at any stage of the disease should have access to the drugs, which have cure rates exceeding 95%.
Last week, a Los Angeles woman sued Anthem Blue Cross for denying coverage for Gilead Sciences' drug 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.
Dean Salvani, 59, of Bellmore, N.Y., said he's twice been denied coverage for Harvoni by UnitedHealthcare. “There's finally a cure, but I can't get it,” said Salvani, who suffers severe muscle and joint pain from the disease.
UnitedHealthcare denial letters reviewed by Modern Healthcare said Salvani's coverage was denied because he hadn't reached Stage 3 fibrosis.
United spokesman Tyler Mason said the company believes its coverage policies “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.” He cited data from the Centers for Disease Control and Prevention showing that for every 100 people infected with hepatitis C, only five to 20 will develop cirrhosis over a period of 20 to 30 years.
Gilead Sciences' CEO John Martin said during an earnings call earlier this year that his company thinks a significant number of prescriptions are not being filled because of health plan restrictions. The company found that in 56% of cases in which a provider sought to prescribe one of Gilead's hepatitis C treatments in the first three months of this year, patients scored between a zero and Stage 2 on the fibrosis scale.
But some experts question insurers' rules barring coverage for moderate and advanced fibrosis. Clinicians “know surprisingly little about the health impacts of delaying treatment,” David Rein, principal research scientist with NORC, an independent research organization at the University of Chicago, wrote in the journal Clinical Infectious Diseases in March.