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Insurance denials for HCV therapy increase in US

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June 7, 2018

Vincent Lo Re III
Vincent Lo Re

Despite the availability of highly effective direct-acting antiviral therapy for chronic hepatitis C virus infection, both public and private health insurers in the United States continue to deny coverage for the drugs at increasingly high rates, according to a study published today in Open Forum Infectious Diseases.

Vincent Lo Re, MD, associate professor of infectious disease and epidemiology at the University of Pennsylvania Perelman School of Medicine, and colleagues said their findings highlight the need to improve access to direct-acting antiviral (DAA) therapy for patients with chronic infection, who are at risk for HCV-related complications.

“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,” Lo Re said in a news release. “The denial of this treatment can also lead to ongoing hepatitis C-associated liver and systemic inflammation, which could increase the risk of other extrahepatic complications, like cardiovascular disease, bone and joint disease, and kidney disease.”

“Failure to treat and cure chronic hepatitis C infection also maintains a reservoir for transmission, which certainly can add to increasing incidence of the infection, especially given the growing opioid epidemic,” Lo Re added.

DAAs have been available for patients with chronic HCV infection since 2014. They are associated with a high clinical cure rate of at least 94%, according to the researchers. However, the drugs are costly, leading public and private insurers in the U.S. to restrict access to the medications.

“Insurers established varying criteria for reimbursement of DAAs, such as evidence of advanced liver fibrosis, consultation with a specialist, and/or abstinence from alcohol or illicit drug use,” the researchers wrote.

Nevertheless, the Infectious Diseases Society of America and American Association for the Study of Liver Diseases currently recommend that all patients with chronic HCV receive DAA therapy. A report published last year by the National Academies of Sciences, Engineering and Medicine concluded that DAA therapy must be given to at least 260,000 patients with chronic infection in the U.S. each year to achieve the goal of HCV elimination in the country by 2030.

Over the past 2 years, advocacy efforts, threats of legal action, lawsuits and an increasingly competitive drug marketplace have influenced insurers to relax restrictions on DAA reimbursement. Consequently, Lo Re and colleagues hypothesized that the incidence of insurance denials have decreased over time.

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To investigate their theory, the researchers reviewed records from HCV pharmacy services in 45 U.S. states. The analysis included data on 9,025 patients who were prescribed a DAA from January 2016 to April 2017.

Over the 16-month study period, 3,200 patients — or 35.5% (95% CI, 34.5%-36.5%) — were denied treatment with DAAs. Commercial insurers were more likely to deny coverage than Medicaid or Medicare (P < .001). More than half of patients with commercial insurance were denied treatment vs. 34.5% of Medicaid beneficiaries and 14.7% of Medicare beneficiaries. The rate of insurance denials significantly increased over time from 27.7% to 43.8% (P < .001). This increase was observed among all three insurance types.

Eight of the 45 states accounted for 90% of all DAA prescriptions. These states included Pennsylvania (31.5%), California (23.6%), Michigan (14.3%), Massachusetts (6.2%), New Jersey (6.1%), Delaware (3.5%), Oregon (2.6%) and Maryland (1.9%). Insurance denial rates were highest in Maryland (51.5%), Delaware (49.1%), New Jersey (47.2%) and Pennsylvania (45.7%).

A lack of data prevented the researchers from being able to identify factors that were independently associated with insurance denial. Therefore, they reported, the reasons for high and increasing rates remain uncertain.

“The combination of cost and demand for DAA treatments has strained the budgets of many payers since these drugs became available,” they wrote. “As a result, insurers may be electing to prioritize certain patient populations, such as those who have advanced hepatic fibrosis/cirrhosis or who abstain from alcohol and injection drug use, when deciding whether to allocate DAA treatments. Future studies should evaluate the reasons for the increasing denials across insurance plans as well as denial rates in specific patient groups.” – by Stephanie Viguers

Disclosures: Lo Re reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.

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Perspective

Since a cure for HCV has become available, the primary emphasis has been on cost as opposed to the fact that we now have a cure for the No.1 communicable disease killer in the U.S., which kills more people than the next 60 communicable diseases combined, including HIV. Although the initial reaction of the increased costs of the cure to insurers was somewhat understandable, the reality is that insurers never paid the $84,000 list price for a course of treatment. For example, the Medicaid program was required to provide a 23.1% discount and states were able to negotiate additional supplemental rebates.

Now that there are several curative treatment options available and competition on the marketplace, the price of HCV drugs has decreased by approximately 75% over the past 4 years. Yet, insurers are still hiding behind costs despite the fact that treatment restrictions are discriminatory and violative of the law.

A course of treatment in the Medicaid program is now close to $20,000. If you think about it, the price for an HCV cure is only about 1 year’s worth of HIV treatment. We should be celebrating that there is a cure for HCV, as I think we would if there was a similar priced cure for HIV, Alzheimer’s disease, multiple sclerosis or cancer. However, in the case of HCV, we still have a significant number of public and private insurers denying access. That is not too surprising because people with HCV are a particularly vulnerable population. If there was a cure for almost any other disease at $20,000, people would demand and get life-saving treatment. The same should be true for people living with HCV.

It is clear that improving access to the HCV cure is critical for both individual health and public health. On the individual side, treatment access denials that result in delays or denial of treatment are life-threatening. There are people who have literally died fighting for access to this cure. On the other hand, if you are treated early enough in the course of the disease, you truly are cured, eliminating an increased risk for cancer and other effects of liver damage. From a public health perspective, cures can reduce the transmission of HCV. We are seeing a significant resurgence in HCV cases driven by the opioid epidemic. This could be avoided as when someone is cured, they can no longer transmit the virus.

The study showed denials were higher in the private insurance sector than the public insurance sector. That is, in part, the result of both advocacy and litigation efforts of organizations like mine and others that have been focused on the Medicaid program. In 2014, every state Medicaid program had a disease severity restriction. Now, 58% of state Medicaid programs no longer have liver damage requirements. Litigation has happened in the private insurance market but to a lesser extent.

To be clear, both public and private insurers know that they are violating the law. We recently, for example, sent a demand letter to a state. Within 4 days, the state responded, saying it was eliminating restrictions in the Medicaid program. It should not take litigation to make that happen. These insurers are discriminating against people living with HCV and denying treatment for as long as they can until they see that there is a downside. There is a downside — the ongoing threat to individual and public health.

Although there is a lot that is currently being done in terms of litigation and advocacy, more could be done to ensure that those states that are clearly violating the law with restrictions are stopped from doing so. The Centers for Medicare and Medicaid Services has issued a notice to states about their obligations to treat people living with HCV. The courts have determined that failing to do so violated federal law. The American Association for the Study of Liver Diseases and Infectious Diseases Society of America have treatment guidelines that are completely at odds with what the insurers are doing. They need to be held accountable and insurance regulators — both on the public and private side — need to put an end to discriminatory HCV treatment practices.

Robert Greenwald, JD

Clinical professor of law
Faculty director, Center for Health Law and Policy Innovation,
Harvard Law School

Disclosure: Greenwald reports that the Center for Health Law and Policy Innovation receives funding for projects from Gilead and Janssen.