Mrs. H., a 52-year-old mother of two who had suffered through prior unsuccessful treatment courses for hepatitis C, was recently told by her insurance company that new drugs would only be covered if she had cirrhosis. Her liver disease was deemed “too mild.” But if she waited long enough for the cirrhosis to develop she would have a risk of liver cancer.
This week, a single tablet regimen that’s said to cure over 95 percent of patients in as little as eight weeks—and other agents expected to be released in the next month—should herald a long-awaited milestone in medicine: the beginning of the end of hepatitis C, the most common and deadly chronic liver disease plaguing millions of Americans. But this landmark will mean little without substantial changes in policy and drug coverage.
Consider the cost of other, accepted drugs, like up to $11,000 per month for cancer treatment that promises only weeks of extra life.
Since the discovery of the hepatitis C virus (HCV) in 1989, its primary treatment has relied on painful injections of interferon (plus oral medications) that carry many side effects, including severe fatigue, dangerous infections, and depression that can be serious enough to lead to suicide. The treatment forced many to stop working, and others to quit prematurely. Among those who managed the full 48-week treatment regimen, fewer than 50 percent were cured. More importantly, the vast majority of people suffering from HCV could not or would not take the treatment. In 2011, Telaprevir and Boceprevir, the first two drugs to specifically target the hepatitis C virus, became available with a higher cure rate than had been seen previously, but they cost up to $70,000 per treatment course, still required interferon, and carried more side effects than the prior options. No one balked at the price however, since so few patients were able or willing to take the treatment. Without a reliable, non-toxic treatment, physicians and patients watched liver disease worsen, progressing to cirrhosis, liver cancer, and early death in many. Those who lined up for liver transplants often died on the waiting list
The arrival of Sofosbuvir and Simeprevir in December 2013, and now Sofosbuvir/Ledipasvir’s single-tablet regimen, this past week should have signaled the end of years of helpless hand wringing. For the first time, highly effective regimens were available without interferon. Treatment courses that used to last nearly a year have now been reduced to just 12 weeks in most cases. Side effects are so low that some patients who took these medications in research studies thought they were being given a placebo. Cure rates are now in the 90 to 95 percent range—not suppression, not control, not maintenance, but the cure of hepatitis C. This is a watershed moment for the over three million Americans, and many more millions abroad, who are infected.
Instead of heralding the benefits of curing HCV, the insurance industry has focused adverse attention on its cost, particularly Sofosbuvir’s price tag of $84,000 per patient for the 12-week course. But the treatment’s value in curing hepatitis C, preventing cirrhosis and liver cancer, and in decreasing the need for liver transplantation has been overlooked. The price is no doubt high, and many wish it to be lower, but this is a one-time treatment and thus a lifetime cost. Consider the cost of other, accepted drugs, like up to $11,000 per month for cancer treatment that promises only weeks of extra life. Perhaps it is simply sticker shock; the thought of $1,000 per pill. But more likely, it is the sheer number of hepatitis C patients that frightens insurers.
Much attention has been given to the recent report from the Institute for Clinical and Economic Review, which claims that “replacing current care of infected Californians with Sovaldi [Sofosbuvir]-based regimens would raise drug expenditures in the state by $22 billion or more in a single year.”
The United States Census Bureau estimates California’s population at 38.3 million; the ICER report itself quotes the hepatitis C prevalence rate to be 1.7 percent of the population; multiple studies estimate that only half of patients with hepatitis C have been diagnosed. Put all of these numbers together and you’ll find that 66 percent of all diagnosed cases of hepatitis C in California would need to be treated to reach the added cost of $22 billion. That is far from realistic. A new study from Kaiser Permanente Southern California, a large health care network serving more than 3.5 million California residents, reports that only 15.3 percent of its diagnosed hepatitis C patients were treated in the 10-year period from 2002-12. Thus it is far more likely that these costs will be spread over decades rather than years.
Though costs are important, we also need to focus on quality of care and ethics. Oral therapy regimens containing Sofosbuvir with or without Simeprevir or Ledipasvir is now the standard of care for the treatment of chronic hepatitis C—endorsed by both the American Association for the Study of Liver Disease and the Infectious Disease Society of America. Denying access to FDA-approved effective therapies to a people solely on the basis of cost has not been our nation’s standard. Unfortunately, hepatitis C does not have the advocacy that many other diseases have, letting the naysayers and the insurance industry trample the needs of the patients.
Sofosbuvir. Ledipasvir, and Simeprevir are not just three new drugs for hepatitis C—they represent the turning of the tide, the potential beginning of the end. By the end of this year a deluge of new drugs will be approved, making hepatitis C treatment even safer, faster, easier, more successful, and, hopefully, less expensive. This is progress many feared would never happen. Rather than worrying about the cost, we should focus on finding and curing as many people with this disease as we can.