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December 2006FeaturesCover Story Step Therapy and Biologics: No Easy AnswerArguing that traditional therapies often are not worth the time and money, some moderately to severely ill patients and their physicians have sought to use biologics first line — particularly for diseases where some older drugs can involve adverse effects. Until payers see evidence to show superiority of biologics, however, use of step therapy with conventional drugs is not going away. Regulatory Newly Final CMS Policy May Help Plans When Evidence For Coverage Is LackingThe emergence of a biologic therapy often presents insurers with a dilemma: how to establish coverage policies when evidence of effectiveness and published guidelines could be years away? Medicare’s new policy may provide some guidance, but its application is controversial. Clinical Enzyme Replacement Therapies: Better Lives Versus the Bottom LineOn the highest end of the drug-cost spectrum, enzyme replacement therapies are beneficial to only a few thousand patients at most. But to give those with life-long struggles a chance at a ‘normal existence,’ can insurers and employers put a price on hope? The field is booming, making the question more important with each passing day. Leading Edge What the Parts Can Teach Us About the WholeSystems biology tackles a challenge of grand proportions: Can we ever know all the pathways of disease? With astonishing speed, this new brand of science is ‘well on its way,’ says one researcher, to producing major breakthroughs in science and medicine that could lead to lower-cost treatments and better diagnosis Reimbursement Application of ‘Functional Equivalence’ To Payment for Office-Administered BiopharmaceuticalsThe emergence of competing biotech products has led to much discussion about their interchangeability. Beyond the clinical implications of designating products as therapeutically equivalent, the dollars at stake with biopharmaceuticals promise to make reimbursement issues more and more important. Medicare’s approach could influence private payers, which have been slower to address these issues. DepartmentsOpeners Whole Systems Thinking
Michael D. Dalzell Editorial Threshold LoweringDavid B. Nash, MD, MBA, on nanotech. Washington Watch FDA Moves to Regulate Genetic Tests
John Carroll Diagnostics and Devices Diagnostic Assays a Key To Personalized MedicineBiodrugs with a diagnostic component: looking for the next Herceptin. Drug Track Approvals, FDA Actions, Clinical Trials
Bob Carlson, MPH Biotech Business Employer Specialty Pharmacy Trend Slows
Amanda Brower Corporate Spotlight Payers Have Biologic Alternative for Patients With Moderate to Severe Rheumatoid Arthritis Who Do Not Respond to Other DMARD TherapiesEarlier biologic therapies for rheumatoid arthritis represented a breakthrough in treatment of the disease, but there are still some patients who do not respond adequately to them. The market entry of abatacept, which allows for consistent dosing and predictable drug-acquisition costs, presents patients, physicians, and third-party payers with an effective alternative – the first therapy proven to be effective in patients with inadequate response to DMARDs such as methotrexate or anti-TNF-alpha therapies. Trends: Pipeline Biotechnology Drug Development Climbs 29 Percent in 2 Years418 biologic therapies in development. |
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