The Patient-Centered Outcomes Research Institute (PCORI), mandated by the health reform law, has been working on its priorities and research agenda and expects to release the final version on May 21. During a Journal of the American Medical Association media briefing on April 17, Anne C. Beal, M.D., PCORI’s chief operating officer, explained that the organization “helps support comparative-effectiveness research [i.e., CER]” not only “in terms of prioritizing research but also synthesizing”... Read more

Yesterday SXC Health Solutions announced its intention to purchase Catalyst Health Solutions. The deal comes just a couple of weeks after the FTC’s approval of Express Script’s purchase of Medco Health Solutions, which formed the largest PBM in U.S. Read more

At a time when the health care and health insurance industries are under the microscope, nine U.S. societies each have developed lists of “Five Things Physicians and Patients Should Question”. The effort is through the Choosing Wisely initiative of the ABIM Foundation, as well as Consumer Reports, and the societies represent 374,000 physicians. The intent of the initiative is to help patients choose care that is necessary, evidence-based, not redundant and not harmful. Read more

Earlier this week in a unanimous decision, the Supreme Court ruled in favor of the Mayo Clinic when it struck down two patents issued to Prometheus Labs. The patents were tied to the dosing of certain drugs used to treat autoimmune diseases based on how they are metabolized. The Mayo Clinic had used the Prometheus test but then developed a similar test of its own, prompting Prometheus to file a lawsuit claiming patent infringement. Read more

Last summer, the National Institutes of Health requested comments on its planned Genetic Testing Registry, which it launched late last month. An online database, GTR would contain information submitted voluntarily by manufacturers and researchers on genetic tests in an effort to offer a one-stop shop on the thousands of tests available. Many comments, though, were critical of GTR, questioning its format, data, cost and usefulness. Do you agree with those concerns? Did the NIH do enough to... Read more

By now most everyone likely has heard about the counterfeit Avastin (bevacizumab) that 19 physician practices purchased from an unlicensed distributor. But is this simply the tip of the iceberg? The FDA recently notified health care providers about the risks of buying unapproved injectables. Read more

The FDA today issued three draft guidance documents on biosimilar development. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product describes how the FDA will determine biosimilarity through a stepwise approach to evaluating evidence. Read more