The really incredible advances in the treatment of hepatitis C bring to life several relevant questions as we move forward into 2015. First, who should be treating hepatitis C patients (primary care providers, gastroenterologists, infectious disease specialists)? Second, can we really afford to use these new treatments? I recently discussed this topic with my GI and hepatology colleagues in AGA Perspectives, the bi-monthly opinion magazine of the American Gastroenterological Association, but it’s time we extend this conversation outside of our community.
First, let’s consider sofosbuvir and ledipasvir, a single fixed-dose combination pill with over a 95 percent cure rate that was approved by the FDA for genotype 1 HCV in October 2014. Like other all-oral direct-acting antivirals, the simplicity, safety and effectiveness of this treatment should enable almost any physician with an interest in HCV to treat a patient. The pretreatment workup consists of simple blood tests, genotyping and determination of viral load and staging of disease with non-invasive serum tests such as FibroTest or a FibroScan to determine the presence of advanced fibrosis or cirrhosis. Patients at risk of advanced liver disease should undergo specialty evaluation by either a specialist infection disease (ID) physician or gastroenterologist, while patients who pass these tests can likely be treated in a primary care setting.
Unfortunately, although I truly believe that hepatitis C can be easily treated within the community including by internists and family physicians, the reality is that issues associated with both the cost of treatment and access to therapy have made this extremely difficult. Hepatitis C medications cost almost $100,000 or more for a full course of treatment and thus represent a significant burden on the health care system. If, over the course of the next 10 years, we treat 1 million patients — which is necessary if we are to impact the natural history of disease — then the cost to the health care system would be almost $100 billion.
This high cost of therapy has resulted in prioritization of care with restricted access for some patients. Currently, the majority of third-party payers and state Medicaid have limited access to those patients with advanced fibrosis or cirrhosis. And recently, the news has been about exclusivity deals between pharmacies and health plans and the makers of hepatitis C treatments.
In our practice, we have found that the current restrictions require almost one or two full-time personnel to devote continuous effort to help patients obtain treatment. In smaller GI or ID practices, this would create both unnecessary expense and significant effort. It is hard to imagine that an average internal medicine or family practice would have the resources to devote the time and personnel needed to obtain prior approval and authorization for treatment of any significant number of hepatitis C patients. In addition, certain state Medicaid plans — such as New York — have suggested that treatment only be provided by physicians with documented and proven experience in managing HCV patients.
In my experience, this potential rationing of health care to only those with advanced disease makes little clinical or pharmacoeconomic sense. Treatment duration can be shortened in patients that do not have cirrhosis resulting in a lower cost per sustained virologic response. In addition, these patients have reported equal improvements in a variety of physical, emotional and health-related outcomes as is reported for patients with more advanced disease.
Finally, it is ironic that here we are with the ability to essentially eradicate hepatitis C from the U.S. population within the next decade using simple, safe and highly effective therapies, and yet we appear to lack both the economic, societal and political wherewithal to make this a reality. The conversations must continue: How can we make this incredible opportunity a reality for our patients?
Nezam H. Afdhal is director of hepatology, Beth Israel Deaconess Medical Center, Boston, MA.