According to the Centers for Disease Control and Prevention (CDC), Hepatitis C (HCV) affects an estimated 3.2 million people in the US. Of those people who are infected with HCV, approximately half do not know they are infected and have not been diagnosed. In addition, traditional therapies for HCV have posed challenges for patients due to side effects and resulting adherence issues.
Recent advances have resulted in dramatically improved treatment options for HCV over the past few years, culminating with the approval of Sovaldi® (sofosbuvir) at the end of 2013 and the promise of other highly effective therapies arriving in late 2014 and through 2015. While Sovaldi is highly effective and better tolerated than traditional interferon-based treatments, it has attracted a lot of attention and spurred much debate. Much of the debate has been focused on the high cost of the drug.
CVS Health Chief Medical Officer, Troyen A. Brennan, M.D., and Chief Scientific Officer, William Shrank, M.D., reviewed the HCV treatment landscape and the impact of new treatments in a recent commentary published in the Journal of the American Medical Association. In their comments, Drs. Brennan and Shrank suggested that the discussion around Sovaldi had been inappropriately focused on the price per pill (i.e., approximately $1,000 per pill), rather than on the total cost to the health care system. They concluded that the controversy is really about the “increasing total cost of specialty medications” and point out that while the total cost per pill is attention-grabbing, the more important issue is the number of people who are eligible for treatment, a large pool of patients in the case of HCV.
In addition, in the months leading up to the Food and Drug Administration’s approval of Sovaldi many HCV patients who were not experiencing symptoms or adverse effects, held off on pursuing treatment while waiting for the availability of the new, highly effective drug. This resulted in a large number of patients using the drug once it became available and a resulting surge in spending. New data from the CVS Health Research Institute shows that over the last several months (May through August 2014) there has been a plateau and an actual downward trend in Sovaldi utilization. Experts anticipate this suggests another surge of patients will begin therapy when a number of new therapeutic regimens of similar efficacy and shorter duration are introduced in the Fall of 2014.
The new CVS Health Research Institute data also looks at therapy discontinuation rates for Sovaldi in real world use. In clinical trials, more than 95 percent of patients achieved cure rates and almost all patients completed therapy, with only about two percent discontinuing treatment. However, clinical trials rarely capture the real-life challenges faced by patients taking a new drug. The data shows therapy discontinuation rates of 8.1 percent, approximately four times higher than in trials. In addition, patients who were completely new to HCV treatment were more likely to discontinue therapy.
A further analysis found that patients who received their HCV medications and care from CVS Caremark specialty pharmacies experienced substantially improved adherence (discontinued their regimens only 5.9 percent of the time) compared to patients who received their medications and care from pharmacies outside the CVS Health system (discontinued at a rate of 8.5 percent).