Yale study: Hepatitis C patients denied expensive drugs until late stages

Aug. 28--NEW HAVEN -- Nearly one-quarter of hepatitis C patients are denied a highly effective but expensive treatment because insurers limit the therapy to those with late-stage disease, according to a Yale School of Medicine study.

"The regimen is simply one single pill taken for 12 to 15 weeks," said Dr. Joseph K. Lim, director of the medical school's Viral Hepatitis Program and leader of the study. However, "the cost of the treatment is very, very high," between $84,000 and $95,000, he said.

While three-fourths of patients are approved, it is not until they have reached a late stage of the disease, he said.

The drugs, which are sold under brand names Sovaldi and Harvoni, can replace an interferon-based treatment that includes severe side effects such as hair loss, weight loss, flu-like symptoms, skin reactions and anemia, Lim said. Many patients' disease advances to cirrhosis because they refuse to undergo the interferon treatment, he said.

"It was a toxic therapy that was very undesirable," Lim said. "Some patients waited or already failed prior treatment because the efficacy was lower."

Lim said the traditional interferon therapy has only a 30 percent to 40 percent cure rate.

The hepatitis C virus often is contracted by sharing injection-drug needles, according to the Centers for Disease Control and Prevention.

With the new drugs, "insurance companies are faced with a very, very challenging situation where the costs of treatment are high," Lim said. Because of their exorbitant cost, "most insurers are restricting access to these curative therapies to those with advanced liver disease," including cirrhosis, he said.

Hepatitis C affects 2.7 million Americans, according to the CDC. The new therapy, if given to patients at early stages of the disease, would dramatically improve the cure rate, but insurers, including Medicaid, are reluctant to cover it until patients are in more advanced stages, Lim said. Almost 20,000 people die of hepatitis C each year.

"Although from a population level this is somewhat rational, at an individual patient level this has been very, very disconcerting," he said.

This week, the New York Times reported that the Public Health Service and President Obama's Advisory Council on HIV/AIDS were pressing the administration to increase access to the new treatments.

"It's well recognized now that most public insurers have very restrictive policies for treatment access," Lim said.

Although costs have been dropping as a result of competition, too many patients are denied the more effective, safer treatment, he said.

To change the situation, "It would require two things: One is a greater pressure on state and federal agencies to cover hepatitis C treatment and greater pressure on manufacturers to decrease overall cost of therapy," Lim said. "We need to put pressure on both groups, both manufacturers and insurers, so ultimately patients can access potentially curative treatment."

He added, "I'm cautiously optimistic that within three to five years prices will come down and there will be gradual lifting of these restrictions."

The good news for Connecticut is that its Medicaid program, "since the time of our analysis, has now become more inclusive of who they will cover. Connecticut now has one of the least-restrictive policies for hepatitis C treatment," Lim said. The study covered the last quarter of 2014.

As a physician, Lim said, he wants to see more patients gain access to the more effective cure. "On the face of it, it's very concerning that patients are asked to wait on treatment for a condition that we already have a cure for until they reach an advanced stage," he said.

The study was published Thursday in the online journal PLOS ONE. A call seeking comment from the Connecticut Association of Health Plans was not immediately returned.

Call Ed Stannard at 203-680-9382.

___

(c)2015 the New Haven Register (New Haven, Conn.)

Visit the New Haven Register (New Haven, Conn.) at www.nhregister.com

Distributed by Tribune Content Agency, LLC.