Half of Hepatitis C Patients on Medicaid Denied Drug Access

Patients on Medicaid more likely to have HCV infection and much more likely to be denied coverage.

The high cost of curative direct acting antiviral drugs for the treatment of hepatitis C have presented a hurdle for patients seeking access to these effective therapies.

With a price tag in excess of $84,000 for a 12-week regimen, the full scope of the challenge providers have getting these medications in the hands of patients is increasingly coming into focus.

A new study by Penn Medicine found that approximately 50% of patients on Medicaid infected with chronic hepatitis C virus (HCV) prescribed the new antiviral drugs were denied coverage. Researchers found among the primary reasons for denial were patients not being considered a medical necessity and testing positive for alcohol or drugs.

The study was the first to analyze delay and denial rates among Medicaid, Medicare, and privately insured patients. The researchers evaluated a cohort of patients whose prescriptions were submitted to specialty pharmacies in Pennsylvania, New Jersey, Delaware, and Maryland.

"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," said Vincent Lo Re III, MD, MSCE, assistant professor of Medicine and Epidemiology in the division of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania and the Center for Clinical Biostatistics and Epidemiology. "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."

A pair of studies published earlier this year in the Annals of Internal Medicine found HCV drug restrictions vary across state Medicaid programs, which further suggested that many restrictions are in violation of federal law.

For the current study, researchers evaluated prescriptions from submitted to Burman's Specialty Pharmacy from 2342 patients between November 1, 2014 and April 20, 2015. Of these patients, 517 were covered through Medicaid, 800 through Medicare, and 1025 through commercial insurance.

The results showed 377 (16%) patients were given an absolute denial. Meanwhile, 46% of Medicaid patients received a denial, 5% of Medicare patients received a denial, and 10% of patients with private insurance were denied.

The most frequently cited reasons for denial through Medicaid were "insufficient information to assess medical need" (48%), "lack of medical necessity" (31%), and a positive test for alcohol or drugs (4%).

It was also found that patients receiving therapy through Medicaid waited 10 days longer for their prescriptions to be filled compared with patients covered through private insurance and Medicare.

"The implications of these denials remain unknown, but there may be adverse downstream outcomes for both patients and providers," Lo Re said. "Patients who need treatment, but are unable to gain access, may see their liver disease progress, putting them at a high risk for cirrhosis and liver cancer, and may develop extra-hepatic complications, such as bone, kidney, and cardiovascular diseases. What's more, 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 less people have to be treated."