New Hepatitis C Drugs Entail Economic Burden

The cost of treating people infected with the Hepatitis C virus (HCV) with newly approved therapies will likely place a tremendous strain on the US healthcare system.

Researchers at The University of Texas MD Anderson Cancer Center (Houston, TX, USA) conducted a cost-effectiveness analysis using a microsimulation model of the natural history of HCV infection to fully evaluate the cost-effectiveness and budget impacts of sofosbuvir and ledipasvir, two new therapies to treat HCV recently approved by the US Food and Drug Administration (FDA). The outcomes were quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs.

The results show that using new therapies would reduce the clinical burden of the disease, and is cost-effective in the majority of patients. Yet, while the drugs lead to improved outcomes, the cost of the newly approved oral regimen can reach as much as USD 1,125 per day. As a result, the budget required to treat all eligible patients would be a staggering USD 136 billion over the next five years. Compared with the older, interferon-based drugs, the new therapies would cost an additional USD 65 billion, whereas the cost offsets would be only USD 16 billion.

According to the researchers, these figures represent 10% of the United States’ annual prescription drug spending, which is unsustainable if used to treat the more than two million people currently infected with HCV. The researchers therefore suggest that the newer, more expensive medications would be most beneficial for select groups of patients, including those with advanced disease, have the HCV genotype 1, or are younger. The study was published on March 17, 2015, in the Annals of Internal Medicine.

“While most developed countries factor in treatment cost before approving a drug, US law prohibits considering such costs. Hepatitis C presents an unusual case where we have cost effective therapeutic options that our health care system cannot afford,” said lead author Jagpreet Chhatwal, PhD. “Considering the law also prohibits Medicare from negotiating drug pricing, the new treatment cost could strain the budget of Centers for Medicare and Medicaid Services.”

“We have millions of people who need treatment for hepatitis C and payers obviously don't have the budget to cover this tremendous expense,” added Dr. Chhatwal, an assistant professor of Health Services Research at MD Anderson. “As a result, physicians have to prioritize the new drugs to the sickest of patients, and several payers have added restrictions that only those with the most advanced disease receive treatment.”

Related Links:
The University of Texas MD Anderson Cancer Center