State Medicaid programs in the Philadelphia region denied nearly half the coverage requests for the most effective - and expensive - treatments for chronic hepatitis C, according to a University of Pennsylvania study that will be presented on Monday.
The findings, based on prescription data for Pennsylvania, New Jersey, Delaware and Maryland, appear to confirm widespread concerns that state budgets are effectively limiting treatment for a potentially fatal condition.
Coverage for the anti-virals was most often denied because the treatments were not considered a medical necessity or because the patients had tested positive for alcohol or commonly abused drugs. The new therapies can cost up to $90,000 for a 12-week course.
“It's the high costs of these agents to treat - and in most cases, cure - these infections and barriers to coverage that have resulted in denials and delays for the therapies,” lead author Vincent Lo Re 3d, an assistant professor at Penn's Perelman School of Medicine, said in a statement released on Saturday.
“It has created a serious health disparity. Patients on Medicaid are more likely to be suffering from these infections, yet they are much more likely to be denied coverage for the drugs.”
There have been reports of denials, mainly in Medicaid programs in several states around the country, but the new study appears to offer the first evidence to back up the assertions.
The U.S. Department of Health and Human Services sent letters of concern to state programs nationwide two weeks ago, and also asked drug manufacturers how they are making the treatments more affordable.
An estimated 3 million Americans are infected with hepatitis C, with especially high rates among Baby Boomers who grew up before tests were able to detect the virus in donated blood. Many are unaware that they are infected with the disease until the appearance of symptoms, which can be followed by cirrhosis and liver cancer.
The Penn research team analyzed data for 2,342 patients' prescriptions submitted to a specialty pharmacy that serves the four states between last November and April, shortly after the the new treatments went on the market. The outcomes of appeals of initial denials were included in the analysis.
They found striking differences by insurance type. Medicaid programs denied coverage for 46 percent of prescriptions, compared with 5 percent for Medicare and 10 percent for commercial insurance.
Although the main analysis combined data from the four states, separate examinations did not find statistically significant differences among them, Lo Re said in an email.
The authors said Medicaid programs should find ways to make the drugs more available.
“The implications of these denials remain unknown, but there may be adverse downstream outcomes for both patients and providers,” Lo Re, said in the statement. “It's crucial to treat chronic hepatitis C patients so that rates of transmission are significantly reduced and the spread of the disease is limited - and lesss people have to be treated.”
Lo Re will present the findings at a national liver conference Monday in San Francisco.