- When Merck launched its new drug Zepatier in the U.S., it priced the hepatitis C med at $54,600 for a 12-week treatment regimen—notably cheaper than Gilead's dominant Harvoni which checks in at $94,500 for a similar treatment length.
- Merck aims to further prove Zepatier's cost-effectiveness as it attempts to chip away at Gilead's lead. In a simulated model of 1,000 hep C-infected patients with chronic kidney disease, Merck researchers found treatment with Zepatier was cost-effective in the U.S. market at typically used thresholds. (However, Zepatier was not compared directly to Gilead's drugs)
- Furthermore, the analysis found Zepatier reduced the lifetime cumulative incidence of liver cancer to less than 1% from an average of 23.2%, compared to no treatment.
Merck's clinical program for Zepatier is intended to be inclusive of a broader group of HCV patients than has traditionally been studied. This program includes HCV patients who have chronic kidney disease (CKD) as well as patients co-infected with HIV and patients who are injection-drug users.
Hepatitis C often leads to chronic kidney disease, and increases morbidity, mortality and economic burden in patients who already have CKD. However, there has been some debate about how to address HCV in CKD patients. These patients have often been excluded from HCV trials as CKD is usually a co-morbidity.
“The decision to treat chronic HCV in patients with advanced CKD is often based not only on the potential health benefits, but also the risks and costs of therapy," said a Merck study author.
One of the challenges, however, is communicating with payers about the benefits of treating HCV in patients with CKD.
"To evaluate whether use of Zepatier provides good value, we developed a computer-based model of the natural history of chronic HCV genotype 1 infection, CKD, and liver disease; and projected the associated lifetime costs and quality-adjusted survival," the same author said. The model looked at Zepatier compared to no treatment and pegylated interferon plus ribarvirin.
In the model, use of Zepatier increased average remaining quality-adjusted life years (QALY) and was cost-effective at a threshold of $50,000 QALY in 1,000 simulations. Additionally, Zepatier reduced the risk of having to undergo a kidney transplant compared to no treatment.
Merck will need studies like this to help convince payers Zepatier represents a convincing cost-effective therapy. Last month, the Department of Veterans Affairs announced it would cover hepatitis C treatment for all veterans, regardless of disease progression. While the VA didn't cite the introduction of the cheaper Zepatier as a factor, Merck was quick to note the VA's decision and indicated it priced its drug as part of a strategy to expand patient access in public plans.
But, Gilead's Harvoni and Sovaldi are well-entrenched with equivalent or better efficacy and safety, and Zepatier will have its work cut out for it.