Briefing Shed Light on the Challenges and Opportunities of HCV Treatment

New hepatitis C virus (HCV) treatments may be extraordinarily effective, curing the disease in many cases, but the high cost has posed an enormous economic challenge that has resulted in payers being reluctant to cover the drugs and the creation of new mechanisms to have patients partly pay for drugs, explained Jay Bhattacharya, MD, professor of medicine at the Center for Primary Care and Outcomes Research at Stanford University, and guest editor of The American Journal of Managed Care’s HCV special issue, at a briefing in Washington, DC.

Bhattacharya and 3 authors of papers in the special issue discussed the opportunities and challenges presented by new HCV treatments that can cure the disease but come with high price tags. HCV is not an uncommon disease. In the United States it infects between 2.7 and 4.5 million Americans, and it infects 170 million people worldwide.

The reason why the numbers of people infected can be hard to pin down is because the disease is largely asymptomatic in the early stages, and many people often don’t realize they have it when they first get it, said Bhattacharya. Then, 20 to 30 years later, the affected individual will have end-stage liver failure, he added.

The long time frame of the disease it one of the reasons why insurers are so hesitant to cover the expensive drugs that treat and cure HCV, explained Darius Lakdawalla, PhD, Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at the School of Pharmacy at the University of Southern California. In the paper he wrote for the special issue, researchers analyzed the value of expanding HCV screening and treatment policies in the United States.

The fact that HCV is highly asymptomatic for so many years means that it will take a long time for the benefits of treatment to be seen, he explained. Comparing people who are cured of HCV and who have no viral load with people still infected shows almost no difference in death rates between those 2 groups in the first couple of years. However, years later the disease turns into very costly complications, including scarring of the liver.

“By treating people successfully early in their disease course, you’re saving 1 out of every 6 of them from a very costly set of complications due to scarring of liver,” Lakdawalla explained. “Now the problem from an economic standpoint is that a lot of the people who are infected with hepatitis C are covered by private insurers or by Medicaid. And neither of those kinds of entities is covering people for very long.”

The complication arises because the benefits of treating for hepatitis C might not appear until 10 or 15 years down the line, but typically private payers are only covering people for 3 to 4 years. That means these payers would bear the cost of the treatment, but the beneficiary won’t stick around long enough for the payer to see the benefit in the future.

So how do we encourage private insurers to do what is in the long-term benefit of society, patients, Medicare, and all private insurers? It’s an issue that still needs to be solved and that has implications beyond hepatitis C.

“This isn’t just about hepatitis C, because it will ultimately be about all cures for diseases—gene therapies and other cures that are arriving in the pharmaceutical pipeline,” Lakdawalla said. “Because that’s a key property of a cure: there’s a high upfront costs where a patient gets a therapy for a relatively short period of time and then they enjoy the benefits over an entire life.”

Patients who are not cured of HCV early on develop liver failure. Bhattacharya explained in the opening of the briefing that HCV is a common reason why people need liver transplants in the United States. The value of curing HCV as it relates to liver transplants was the focus of what Anupam Jena, MD, PhD, associate professor of health care policy at Harvard Medical School, discussed, as well as the topic of his paper in the special issue.

The controversy surrounding the HCV drugs is that while there is no doubt that they represent a medical breakthrough, they are so expensive.

“The question that always comes up is … do they offer ‘good value’?” Jena said. “Implicit in that discussion is some notion of, ‘Well, we think we know what the value is.’ What I would argue now is that we don’t have a good, solid understanding of that value.”

There are multiple component of the value discussion: first, that curing someone reduces their cost and saves their life; second, that since HCV is an infectious disease, curing a person lowers the likelihood of others getting infected; and third, HCV is the number one cause of liver transplant. However, there is a whole world of liver disease that has nothing to do with HCV: alcohol abuse, hereditary diseases, toxicity from drugs like Tylenol; and liver disease related to obesity.

Curing hepatitis C will have an impact on those other patients. If, hepatitis C prevalence has been reduced dramatically in 20 years through these expensive treatments, all those liver transplants that went to patients with end-stage liver failure through untreated HCV will now be available to go to patients with other types of liver disease.

“When we think about healthcare, we think about it in a silo…” Jena said. “Here’s a really unique example where treating patients with hepatitis C and curing them of the disease actually doesn’t just treat those patients themselves. It has these spillovers to patients with other forms of liver diseases. So diseases are linked in this really unique way because there is a scarce resource and that scarce resource is liver transplants.”

In his paper, Jena and his colleagues estimated that over the next 20 years, screening for and treating HCV with the drugs available today could spare 10,490 liver transplants.

However, the reality today is that most private payers and Medicaid programs have placed restrictions on HCV treatment access, explained Ryan Clary, executive director of the National Viral Hepatitis Roundtable. These restrictions are based on stage of liver disease, substance abuse and sobriety requirements, and provider limitations.

As a result, CMS issued guidance to state Medicaid programs to start working to expanding access to HCV treatments. However, there has been little response from the programs. There are still 40 states with liver damage restrictions. Although a few (California, Connecticut, Massachusetts, New York, Pennsylvania, and the District of Columbia) have reduced their restrictions.

“This is great movement forward, and it’s evidence that states actually can move to expand access,” Clary said. “In these states, this was the result of strong advocacy or threat of a lawsuit. It’s not as if states suddenly woke up one day and decided, ‘Oh, it’s time to expand our access.’”