Avastin is designed to restrict the formation of new blood vessels that contribute to the rapid growth of certain cancer tumors. The drug was granted "accelerated approval" in 2008 for treatment of advanced breast cancer after a single clinical trial showed that a combination of Avastin and chemotherapy increased delayed tumor progression by five months. The accelerated approval process allowed Roche to market the drug to breast cancer patients under the condition that it conduct new trials to confirm that Avastin actually postponed death. The evidence cited in the two follow-up studies indicated that although tumor growth in breast cancer patients taking Avastin was delayed one to three months, there was little or no change in life expectancy.
Even if FDA revokes Avastin's approval as a breast cancer treatment, it would remain on the market for treatment of other cancers, meaning that doctors could prescribe it off-label to breast cancer patients. However, insurers -- including Medicaid and Medicare -- likely would refuse to cover Avastin for breast cancer patients if FDA disproves of its use, according to the Fiscal Times/Kaiser Health News. One year of Avastin treatment can cost up to $100,000.
The threat of reduced access to a breast cancer treatment has prompted some advocacy groups and lawmakers to pressure FDA not to revoke Avastin's approval. In a letter to the agency last week, Susan B. Komen for the Cure CEO Nancy Brinker wrote, "We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer. However, we do know that for some women, Avastin offers a greater than modest benefit."
In a recent Washington Post article, Sen. David Vitter (R-La.) said he is concerned "this is the beginning of a slippery slope leading to more and more rationing under the government takeover of health care" (Goozner, Fiscal Times/Kaiser Health News, 8/16).
Opinion Piece Calls Accelerated Approval Process Beneficial
FDA is "likely to accept" the advisory panel's recommendation and revoke approval of Avastin to treat advanced breast cancer, "which would be entirely appropriate" because the "essence of the 'quick-on, quick-off' accelerated approval pathway is that the standard for approval is lenient but confirmation is required," American Council on Science and Health Associate Director Jeff Stier and Stanford University Hoover Institution fellow Henry Miller write in a Los Angeles Times opinion piece.
It is "worthy of emphasis that the vast majority of drugs marketed after accelerated approval are found in subsequent studies to be safe and effective," they argue, noting that FDA "had never withdrawn any of the 90 or so drugs on the market that had been given accelerated approval" until June, when it removed the leukemia drug Mylotarg. "And given that only medicines for 'serious or life-threatening diseases' that address an 'unmet medical need' are eligible for this pathway, accelerated approval has offered huge benefits to patients for almost 20 years by making important medicines available far earlier than they would be otherwise," they continue.
FDA "has a narrow mandate -- the assessment of the safety and efficacy of drugs," Miller and Stier write, adding that "[d]eterminations of cost-effectiveness and questions of reimbursement lie outside its expertise and mandate and must be decided by other agencies and in other forums." They conclude, "Amid controversies such as the one over Avastin, we should not lose sight of the fact that accelerated approval works" (Miller/Stier, Los Angeles Times, 8/17).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.
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View drug information on Avastin; Mylotarg.
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