Formulary Management of the Protease Inhibitors Boceprevir and Telaprevir for Chronic Hepatitis C Virus

BaCkground : Hepatitis C virus (HCV) is the most common chronic bloodborne illness in the u nited States. The incidence of acute hepatitis C in the u nited States peaked near 50,000 cases in the late 1980s but has stabilized since 2003 to less than 5,000 cases annually. The combination of pegylated interferon (peginterferon) and ribavirin has been the stan dard recommended treatment for HCV. Protease inhibitors telaprevir and boceprevir were approved by the F da in May 2011 for the treatment of hepatitis C genotype 1 in combination with peginterferon and ribavirin. oBjeCTIVe: To review the phase 3 trials for telaprevir and boceprevir and provide managed care considerations. MeTHodS: a MedLIne review was performed for articles published and available through September 15, 2011, using keywords “boceprevir” or “telaprevir” with an emphasis on phase 3 trials. The literature search was limited to articles in e nglish, clinical trials, randomized controlled trials, and research conducted in humans. additional information was obtained from the Fda website. reSu LTS: Three phase 3 trials are available for telaprevir, which provided data that were the basis for F da approval. Boceprevir demonstrated efficacy and safety in 2 pivotal phase 3 trials. Both agents demonstrated statistically significantly higher rates of virologic response compared with the standard of care involving peginterferons and ribavirin. Telaprevir and boceprevir also demonstrated efficacy in the treatment of patients who had previously failed dual therapy for hepatitis C. Safety concerns for both agents include anemia, drug interactions, skin rashes, and gastrointestinal adverse events. ConCLu SIonS: decision makers have many factors to consider in developing a strategy around hepatitis C. Increased drug costs, patient man agement, adherence, comparative safety and efficacy, and appropriate utilization management controls are important issues. Payers may consider developing clinical programs to encourage adherence and appropriate use and leverage an appropriate channel to ensure cost-effective therapy.