“About half of all new drugs approved in the United States since 2000 were compared with alternative treatments before being approved by the U.S. Food and Drug Administration.”
Data comparing the merits of similar medicines, useful in guiding a physician's treatment decisions and minimizing the use of expensive drugs when cheaper ones would do, is often not available until long after new drugs have been approved a new analysis finds.
The delayed availability of such data, measuring the comparative effectiveness of one drug versus another, is of increasing importance to both insurers and doctors, who can use it to help guide both treatment and reimbursement decisions and to help minimize or discourage potentially wasteful expenditures.
The point was brought into focus by a study released in April showing that two therapeutics manufactured by Genentech, Avastin and Lucentis, provide virtually identical improvements in visual acuity for patients suffering from age-related macular degeneration, but at vastly different costs. One dose of Lucentis costs approximately $2,000, while Avastin costs about $50 per dose.
The Harvard Medical School study, published in the Journal of the American Medical Association, found that about half of all new drugs approved in the United States since 2000 were compared with alternative treatments before being approved by the U.S. Food and Drug Administration.
Of 197 new molecular entities approved between 2000 and 2010, 100 had comparative efficacy data available at the time of market authorization.
For drugs treating conditions for which alternatives already exist, the proportion of approvals for applications submitted with comparative efficacy data increased to roughly two-thirds.
Despite $1.1 billion in funding provided in the American Recovery and Reinvestment Act to support the collection of such data, studies evaluating the comparative effectiveness of new drugs versus those already on the market remain voluntary. When the studies are undertaken it is often long after a drug is approved and often at great cost.
While the authors of the Harvard study stop short of calling for the broader use of comparative effectiveness studies, they do call attention to statements by the FDA and the Centers for Medicare & Medicaid Services indicating a desire to establish processes that meet common needs for evaluating the efficacy and coverage of medications. Ensuring more new drug approvals are submitted with comparative efficacy studies from the get-go and improving the accessibility of that data to clinicians and payers would be a step toward making that a reality.
May 06, 2011
http://www.burrillreport.com/article-room_for_improvement.html