Both private and public insurers in the US are still denying patients accessing to cutting edge therapies for hepatitis C at alarmingly high rates, according to research published in the journal Open Forum Infectious Diseases. The study – conducted by researchers at the Perelman School of Medicine at the University of Pennsylvania – found that over 52 percent of patients with private insurance have been denied coverage, while more than 34 percent of Medicaid patients and nearly 15 percent of patients with Medicare coverage have faced the same barriers to treatment.
Gilead Sciences and Merck are two drugmakers who have pioneered the development of the next-generation of hepatitis C treatments, known as direct-acting antivirals (DAA), such as Harvoni, Sovaldi and Hepatier. While these treatments boast a 95 percent cure rate in patients with the disease, that level of effectiveness comes at a price.
At a cost of up to $100,000 for a course of treatment, DAA drugs have seen limited coverage by payors, with insurance companies only approving claims in cases where patients can prove they don’t drink alcohol or use illicit drugs and show signs of advanced liver fibrosis. While patient advocates and regulators have worked to increase price competition and access to these life-saving drugs, the new research shows that there’s still much to be done before all hepatitis C patients are provided with this treatment option.
“Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector,” said study senior author Dr. Vincent Lo Re III, an associate professor of Infectious Disease and Epidemiology. “It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states.”
In their study, the research team analyzed over 9,000 prescriptions submitted to Diplomat Pharmacy Inc., a national specialty pharmacy, between 2016 and 2017. Prescriptions were submitted by patients in 45 states, with 4,702 of them having Medicaid coverage, 1,821 being covered by Medicare and 2,502 by private insurers. In total, 35 percent of the 9,025 patients included in the study were denied access to the DAA drugs to treat hepatitis C.
According to the researchers, reimbursement criteria varies from state to state, which could explain the surprisingly high rate of coverage denial. Still, it’s uncertain exactly what’s causing this phenomenon, however the trend appears to be increasing with nearly 28 percent of patients being denied in the first quarter of the study period, compared to over 43 percent in the last quarter, regardless of whether the individual held public or private insurance.
“From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer,” said Lo Re. “In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the liver, such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others.”
In order to eradicate the hepatitis C virus in the US by the year 2030, the National Academies of Science, Engineering, and Medicine (NASEM) estimates that a minimum of 260,000 chronic hepatitis-infected patients need to be treated each year. The NASEM, along with the American Association for the Study of Liver Diseases and Infectious Diseases Society of America, recommend that non-medically necessary criteria and restrictions on prescribing DAA for hepatitis C patients be eliminated in order to improve access to the drugs.
“Eliminating hepatitis C in the US is a feasible goal, but that’s going to be hard to achieve if payers are not reimbursing for the treatment,” said Lo Re.