Despite the availability of hepatitis C drugs capable of curing most patients, public and private health insurers denied treatment for more than a third of patients whose doctors prescribed the drugs between 2016 and April 2017, according to a study.
Insurance denials were high across all types of insurance plans despite efforts by policymakers and patient advocates to remove reimbursement restrictions, but treatment for commercially insured patients was denied more often than for patients enrolled in Medicaid or Medicare, according to the study published Thursday in the Open Forum Infectious Diseases journal.
"I think much of it is a consequence of the cost of the drugs, which are anywhere from $35,000 to $100,000 for the treatment course," said Dr. Vincent Lo Re, the study's senior author and an associate professor of infectious disease and epidemiology at the University of Pennsylvania's Perelman School of Medicine.
The hepatitis C drugs, known as direct-acting antiviral drugs, first became available in 2014 and cure about 95% of people with chronic hepatitis C, a viral liver disease that can cause liver failure or death. It affects about 3.5 million people and kills 19,000 a year, according to the Centers for Disease Control and Prevention.
Examples of the drugs include Harvoni, Sovaldi, Epclusa and Mavyret. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend these direct-acting antiviral therapies for the treatment of hepatitis C. But the drugs come with high price tags. Harvoni, for example, costs $94,500 for a 12-week course.
Researchers expected denials would have decreased as public health officials gave the disease a vast amount of attention and many new treatments have come to market in recent years.
Researchers analyzed the prevalence of insurance denials among 9,025 patients in 45 states who were prescribed the hepatitis C treatment between January 2016 and April 2017. The data came from Diplomat Pharmacy, one of the largest specialty pharmacies, which was chosen for the study because of its national footprint.
Of the patients prescribed treatment, 3,200, or 35.5%, received a denial from their insurer. Insurers' requests for alternative oral drug treatments because of formulary restrictions were not counted as denials.
Insurers' denials increased over the length of the study period, from a rate of 27.7% in the first quarter to 43.8% in the final quarter of the study.
Commercially insured patients, meaning those who were covered by employer-sponsored insurance or who bought coverage on the individual market, received a denial for treatment more than half the time at 52.4%. Insurers denied treatment for 34.5% of Medicaid beneficiaries and 14.7% for Medicare enrollees.
Insurance industry lobbying group America's Health Insurance Plans said the study "paints a misleading and inconclusive picture of coverage of antiviral therapy for patients suffering from hepatitis C" because it doesn't reflect whether prescriptions were later approved after an appeal, and relies on the data of one specialty pharmacy with claims concentrated in a handful of states. AHIP also said that because the study didn't look at the reasons for insurer denials, researchers do not know which claims for hepatitis C treatment were clinically appropriate.
Researchers noted that the study was limited by their inability to analyze specific reasons that insurers denied coverage for treatment. That's because while insurers may tell patients why they denied coverage, they don't tell the specialty pharmacies, so that data was unavailable.
Denials also have increased when compared with the rate of denials found by two prior studies published in 2016, the study found. Many insurers restrict reimbursement to only the sickest patients, those who are sober, or those who have seen a specialist. It's likely that patients who receive denials didn't have severe enough liver damage, or were active alcohol or drug users, the study notes.
Denials may have also increased over the years because physicians are seeing patients with less severe liver damage more often. When the new hepatitis C drugs first came out, physicians treated patients with very advanced liver fibrosis and cirrhosis who had been waiting years for treatment, Lo Re said. But now that those patients have been treated, doctors are often seeing patients with less damage, he said.
Insurers place reimbursement restrictions on the drugs to save money, but Lo Re said the hepatitis C drug treatments help to eliminate downstream costs.
"Studies show even at minimal stages of liver fibrosis you are saving enormous healthcare dollars by avoiding all the downstream costs of things like liver transplants, hospitalizations to manage end-stage liver disease, and liver cancer," he said.
The CMS in late 2015 warned states that restricting access to the drugs based on saving costs could violate federal law. After that, class action lawsuits and other litigation against state Medicaid programs sprang up, prompting changes to Medicaid reimbursement of the drugs. But less is known about commercial and Medicare reimbursement.
The rate of denials among commercially insured patients is likely the highest because most attention for hepatitis C drug reimbursement has been directed toward public programs, Lo Re said.
"It warrants greater attention from public health sector, policymakers and advocates to continue to draw attention to access to these drugs, because if we are going to achieve the elimination of hepatitis C as a public health problem … we need to treat a sufficient enough people with chronic hepatitis C to be able to eliminate it," Lo Re said.
