Direct-acting antivirals are probably worth the price, but are there new ways to get them into patients’ hands?
Treating hepatitis C with direct-acting antivirals (DAAs)—by far the most effective therapy—is an expensive proposition, which is significant, given that, in the United States at least, the “Baby Boomer” generation is at high risk of contracting the virus and there have been multiple outbreaks linked with the ongoing “opioid epidemic.”
Recently, however, the findings of a study published in Hepatology have started to change the conversation surrounding the cost of DAAs and lead some to suggest novel (and arguably decidedly un-American) payment models for the treatment of hepatitis C. Billed as the first assessment of real-world clinical and economic outcomes of DAA therapy in hepatitis C, the Hepatology study concluded that patients who take these newer drugs have a lower risk of developing liver cancer and other complications associated with the virus, cost less to insure in the short term, and end up spending less money on their own health care costs over the course of treatment.
“Access to hepatitis C treatment has been frequently restricted because of the high DAA drug costs and prior authorization policies in which only the sicker get treated,” study co-author Haesuk Park, PhD, assistant professor in the department of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy, told Contagion®. “This delay in potentially curative treatment until development of advanced liver disease may have costly consequences. Several economic modeling studies using data from the DAA clinical trials and the literature have forecasted an economic benefit with the DAA use due to lower disease complications. However, none of these studies used real-world clinical and economic outcomes data.”
Thus, Dr. Park and her colleagues performed a retrospective cohort analysis of 26,105 patients with newly diagnosed hepatitis C from the Truven Health MarketScan Database. Notably, of this group, just 30% received all‐oral DAA therapy (DAA group), while 70% were not receiving a treatment (untreated group)—a fact the investigators described as “disturbing.”
For both groups, the team used multivariate Cox proportional hazards models to compare the risk of developing hepatocellular carcinoma (HCC) and decompensated cirrhosis (DCC), 2 common complications associated with hepatitis C. Among the 2157 patients with cirrhosis, investigators found that DAA therapy was associated with a 72% and a 62% lower incidence of HCC and DCC, respectively. Similarly, DAA therapy was associated with a 57% and a 58% lower incidence of HCC and DCC in the 23,948 patients with noncirrhotic HCV.
In arguably the most compelling findings, within a propensity score-matched cohort of 8064 infected patients who had at least a 12‐month follow‐up after treatment, those with cirrhosis in the DAA group, the mean adjusted liver‐related costs ($1749) and all‐cause medical costs ($19,300) were significantly lower compared with those in the untreated group ($4,575 and $33,039, respectively).
“We believe that our findings may present a potential roadmap as this study suggests that DAA therapy is associated with significant reductions in the incidence of HCC and DCC patients resulting in decreased healthcare costs,” Dr. Park noted. “We believe that our findings provide policy-makers and stakeholders with information they need when determining policies that affect the accessibility to these highly effective drugs and the impact on the long-term public health as well as the economic benefits of curing hepatitis C especially during the opioid crisis when infection is actually increasing.”
Indeed, Dr. Park and her team’s findings come at a time when increased attention is being paid to how other countries are managing the costs associated with hepatitis C treatment. In 2 companion commentaries published recently in the New England Journal of Medicine, the investigators describe innovative drug supply and distribution models used in Brazil and Australia that are designed to reduce the costs of DAAs for patients as well as government-run health care plans. Both countries effectively leverage economies of scale to purchase large quantities of generic forms of the DAA sofosbuvir-daclatasvir, while Brazil has also taken steps to foster production of its own generic versions of the drug.
“For the first time, there are medicines that can cure people living with hepatitis C; therefore, it’s the responsibility of governments and/or health care providers to find adequate solutions to provide such treatments,” Brazil Elize M. da Fonseca, PhD, assistant professor at the Sao Paulo Business School and lead author of the article, noted. “The takeaway message of our paper is that it is possible for resource-limited countries to provide access to novel DAAs, even in the context of patent protection. In Brazil, the use industrial policy to achieve health objectives was crucial.”
Part of that policy, of course, is the current status of drug manufacturer Gilead’s patent application for sofosbuvir-daclatasvir in the South American country. According to Dr. da Fonseca, the drug patent remains “unsettled” in the midst of ongoing legal challenges. In addition, Brazil isn’t among the 91 countries included in Gilead’s sofosbuvir licensing program, which is designed to make discounted versions of the drug available.
Dr. Park believes that the United States will need to undertake similar approaches to those of Australia and Brazil to find “workable solutions to the cost issue.”
“However, unlike government-run, single-payer health care system, US health care system is more complicated as our system are financed by a complex mixture of public payers as well as private insurance and individual payments,” she added. “Recently, Louisiana Medicaid adopted [a] ‘Netflix’ model to pay for hepatitis C drugs, similar approaches being implemented in Brazil and Australia, which I think will dramatically increase the number of individuals who receive treatment...I hope to see replication and more innovative solutions around the country.”