Clinical Briefs and
Emerging Topic Series
Prostate cancer is the second leading cause of cancer death in men in the United States. Sipuleucel-T (Provenge), the first autologous cellular immunotherapy approved by the U. S. Food and Drug Administration, improves survival in men with asymptomatic or minimally symptomatic metastatic castration-resistant (hormone refractory) prostate cancer. This Clinical Brief discusses the epidemiology, natural history, and risk factors for prostate cancer, current diagnosis and treatment modalities, and the emergence of immunotherapy as a novel treatment to improve survival in men with advanced disease. Roger Muller, MD, FACEP, comments on managed care considerations. Safety information and full prescribing information for Sipuleucel-T are also provided.
The second in a series of topics of interest for the managed care community, this brief details the background of comparative effectiveness research (CER) in the United States and discusses the goals versus the uses of CER and the importance of collecting real-world data to support evidence-based medicine. Included are examples of the effective use of CER in clinical practice.
The first in a series of topics of interest for the managed care community, this brief discusses the value of biomarkers that can complement or replace existing screening tools to detect cancer at an early stage and, therefore, guide optimum treatment. A history of biomarkers is included as well as a detailed discussion about trastuzumab (Herceptin®), developed with the support of biomarkers, and new biomarkers in development.
STELARA® is a subcutaneously administered biologic approved by the US Food and Drug Administration in September 2009 for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This Clinical Brief summarizes the 2 phase 3 multicenter, randomized, double-blind, placebo-controlled trials that demonstrated the efficacy and safety of STELARA®.
Since the U.S. Food and Drug Administration’s 1992 adoption of accelerated drug approval regulation, manufacturers often have turned to surrogate endpoints to speed the market arrival of new agents with the potential to save or extend lives. Despite its “gold standard” status, overall survival is increasingly regarded as a flawed measure of efficacy in colorectal cancer and advanced breast cancer. Surrogate endpoints can speed the time necessary to bring new anticancer agents to market, though each surrogate has its advantages and disadvantages.
Albert Tzeel, MD, MHSA, FACPE, Market Medical Officer for Humana Inc’s Great Lakes Region, discusses the importance of understanding surrogate endpoints for managed care decision makers.