Yale researchers find costly drugs are initially being withheld from patients as their disease progresses.

Last year when several treatments for hepatitis C received approval from the U.S. Food and Drug Administration (FDA), they were hailed as cures for the infection that kills more people annually than HIV.

However, new research from Yale University says that 1 in 4 patients infected with genotype 1, the most common hepatitis strain, are initially denied those lifesaving drugs.

During these delays, patients are often left with few options, says Dr. Joseph K. Lim, associate professor of medicine and director of the Yale Viral Hepatitis Program and lead researcher of the study.

“Patients who are denied can go through several steps of appeal but if ultimately denied, they simply have to wait until they get sicker with progression of their disease to a later stage or at least until eligibility criteria are loosened,” he told Healthline.

The research, published today in the journal PLOS ONE, suggests the drugs’ high costs led insurers to impose new restrictions on authorizing their use.

Researchers reviewed records of 129 patients in Connecticut who were prescribed Harvoni, which combines Gilead Sciences’ sofosbuvir (Sovaldi) and ledipasvir. These medications have been proven effective in people who haven’t been treated before or have been on less effective treatments.

Of those patients, researchers say, 1 in 4 were initially denied treatment. Certain patients, however, were more likely to receive initial approval, including people with advanced liver disease or those on public insurance, either Medicare or Medicaid.

Most patients in the study eventually received approval for treatment by filing appeals with their insurance provider, researchers noted.

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Prior to the development of new drugs for hepatitis C, treatment options were limited to weekly injections of interferon-based therapy that caused severe side effects.

While new hepatitis C drugs have been able to cure patients at a rate higher than 90 percent, their sizable price tags have kept the treatments from patients. A 12-week course of Harvoni costs $95,000, while Sovaldi costs $84,000.

The cost is a major hurdle in treating the estimated 3.2 million people in the United States living with hepatitis C.

The Yale research into hurdles facing patients adds to the growing evidence showing a “cascade of care,” a process filled with attrition from diagnosis to treatment, Lim said.

These kinds of delays only increase the difficulty in curing hepatitis C in the United States, he said.

Still, studies have confirmed that treating the hepatitis C virus, or HCV, are cost-effective even at the current prices, but insurers are holding out for cheaper treatments, Lim said.

“Therefore, restrictive policies may be viewed as short-sighted as some of the patients who are denied may develop liver cancer or liver failure requiring costly treatments, hospitalizations, or transplantation,” he said.

“However, because HCV is slowly progressive for most patients — years between each stage — insurers are expecting most earlier stage patients can safely wait a few years until prices drop on new treatments. This is insurer-centered rather than a patient-centered approach.”

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“In theory, coverage policies should be similar as both public and private payers can obtain significant discounts off retail price,” Lim said. “But in reality, there is significant variation in how state Medicaid plans as well as managed Medicare plans have addressed prior authorization criteria for HCV treatment.”

Commercial insurers, he said, have largely chosen to treat hepatitis in stages 3 and 4, the latter of which involves cirrhosis of the liver. A few exceptions include some private plans that treat as early as stage 2.

In contrast, state and federal plans have ranged from coverage of all stages to only stage 4. These policies continue to change as budget crises create more restrictions, but advocacy helps lift those restrictions.

However, Lim said, with the large numbers of people in the United States with hepatitis C, their collective voices can impact how insurers create policies around these costly treatments.

“The ultimate reason for these restrictions broadly is the high cost of the drug regimens and the large number of patients with HCV seeking treatment now,” Lim said. “Insurers are less likely to worry about high-cost drugs for very small groups, such as rare cancers.”

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