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WOONSOCKET, R.I. — An analysis done by the CVS Health Research Institute provides insights regarding patients taking Sovaldi (sofosbuvir), a new and costly treatment for hepatitis C introduced in December.
The data shows that over the last several months (May through August 2014) there has been a plateau and actual downward trend in Sovaldi utilization. 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.
“Despite the current plateau and decline in Sovaldi utilization, we expect to see another peak in spending for Hepatitis C medications upon the release of the new all-oral treatment,” stated Troyen A. Brennan, chief medical officer of CVS Health. “While the simplicity of the new treatment regimen may help reduce discontinuation rates, careful follow-up such as that provided by pharmacies specializing in Hepatitis C in conjunction with the patient’s physician, is still required to ensure patients are completing their course of therapy and deriving the maximum benefit.”
In clinical trials for Sovaldi, more than 95% of patients achieved cure rates and almost all patients completed therapy, with only about 2% discontinuing treatment. However, clinical trials rarely capture the real-life challenges faced by patients taking a new drug. The new CVS Health data also provides a first look at the drug’s use outside of the clinical trial setting and shows therapy discontinuation rates of 8.1%, approximately four times higher than in trials. Furthermore, patients who were completely new to hepatitis C treatment were more likely to discontinue therapy, a finding that has substantial implications for clinicians and their patients.
“While Sovaldi represents a breakthrough in the treatment of Hepatitis C, this is an expensive drug that needs to be taken as directed for the full course of treatment in order to achieve the maximum clinical benefit demonstrated in the trials,” added Brennan. “Our data suggest that in order to help patients achieve their treatment goals, we need to ensure that those patients who are prescribed Sovaldi are adherent to their full course of therapy.”
The CVS Health Research Institute analyzed discontinuation rates for nearly 2,000 patients managed by CVS/caremark, the CVS Health PBM business, who filled prescriptions for Sovaldi since December. While overall discontinuation rates were around 8%, discontinuation rates for treatment-naïve patients who had not previously been treated for hepatitis C, were the highest at 8.7%. Patients who had been previously treated for hepatitis C, and presumably failed previous therapy, only discontinued therapy 5.3% of the time.
A comparison of patients who received their hepatitis C medications and care from CVS/caremark specialty pharmacy versus those who received their medications and care from pharmacies outside the CVS Health system finds that CVS/caremark specialty pharmacy patients achieved substantially improved adherence. The discontinuation rate for patients who filled their hepatitis C medications at either CVS/pharmacy retail stores or CVS/caremark specialty pharmacies was 5.9%. Patients who filled at channels outside of CVS Health discontinued at a rate of 8.5%.
“These findings reiterate that outside of clinical trials, patients are at a higher risk of not completing their course of therapy, representing a substantial cost to the health care system without achieving the desired clinical benefit,” added Alan Lotvin, EVP of CVS/specialty, CVS Health. “The data also suggest that the type of pharmacy care these patients receive can impact discontinuation rates, with those patients who have access to specialty pharmacies with expertise in managing Hepatitis C such as CVS/caremark specialty pharmacy, seeing improved adherence and outcomes.”
The company stressed that CVS/caremark specialty pharmacy and its Specialty Connect program strives to simplify getting started on therapies for complex conditions such as hepatitis C, and helps patients stay on therapy to support improved health outcomes. Patients can bring their specialty prescriptions to any CVS/pharmacy location as a complement to existing CVS/caremark specialty pharmacy processes and receive insurance guidance and clinical support by phone from a team of specialty pharmacy experts. The program also makes it easy for patients to access their specialty drugs, whether they choose in-store pickup at CVS/pharmacy stores or receive their medications in the mail.