Some ads are running on television and in major magazines about drugs for hepatitis C, known as Hep C or HCV. Available in the United States since 2014, these drugs can cure the Hep C infection in nearly 95% of patients who have chronic HCV. The problem for some, however, is that insurance companies are refusing to cover the high cost of the medications.
The drugs are called direct-acting antivirals (DAAs), and they act differently than standard antiviral medications. They can clear the infection from most patients, sparing them from lifelong complications, liver disease, and even cancer. What are the numbers like for Hep C infections? According to the CDC in 2016, there were approximately 3,000 cases of hepatitis C. In the US about 3.5 million people are living with the virus. Worldwide the number is estimated at 71 million. The World Health Organization figures show that between 15 and 45 percent of those who contract HCV will recover within six months. Many never become aware that they are infected. It’s spread via contact with the blood of an infected person and needle sharing among IV drug users is a common cause. Those who do not recover from the infection often go on to develop chronic HCV which increases the risk of cirrhosis of the liver and liver cancer. Every year between 350,000 and 500,000 people die from HCV complications. The DAA drugs that are now available could eliminate thousands of deaths each year and save millions in health care costs.
The Infectious Diseases Society of America (IDSA) studied the problem of insurance coverage for the drugs, using data from Diplomat Pharmacy Inc., a major supplier of specialty pharmaceuticals. They looked at insurance information from 9,025 patients who had been prescribed the newer medications for Hep C between January 2016 and April 2017. The team looked at “absolute denials” for coverage of the drugs in three categories of insurance types: Medicaid, Medicare and commercial insurance. Insurers that required their beneficiaries to use a different medication because of formulary restrictions were not defined as denials for the purposes of the study.
The results showed that more than one-third (35.5%) of patients who were prescribed a DAA for a Hep C infection were denied coverage for the drug. The most denials, at 52.4% involved patients who had commercial insurance. About 34.5% of Medicaid patients were denied coverage, and 14.7% of Medicaid patients were denied. The study showed a definite uptick in denials, finding a rate of 27.7% in the first quarter of the survey which rose to 43.8% in the last quarter of the study period.
Study senior author Vincent Lo Re III, MD, MSCE is an associate professor of Infectious Disease and Epidemiology in the Perelman School of Medicine at the University of Pennsylvania. He explained, "From a clinical standpoint, patients who are denied access to hepatitis C treatment are going to remain at risk for the development of liver complications like cirrhosis, hepatic decompensation, and liver cancer. The denial of this treatment can also lead to ongoing hepatitis C-associated liver and systemic inflammation, which could increase the risk of other extra-hepatic complications, like cardiovascular disease, bone, and joint disease, and kidney disease."
Treatment guidelines from the IDSA as well as the American Association for the Study of Liver Diseases (AASLD) recommend treatment with DAAs as a first-line defense for patients with chronic HCV. The researchers state that with the number of HCV infections on the rise, denying access to medications that can clear the infection “certainly can add to increasing incidence of the infection, especially given the growing opioid epidemic.” For more information check out the video below.