However, since none of the trials in Avastin were powered to show an overall survival benefit, I think that perhaps the rules were changed mid-stream-hence the ODAC vote to reject permanent approval. For the first time in the war against cancer, high-priced cancer drugs are coming under CMS scrutiny; could Avastin be a harbinger of things to come?
I think a lot of people are looking at the Avastin story as a bellwether that presages the future of expensive targeted therapies. By design, the FDA or any of its advisory boards do not filter costs into their regulatory and approval process. I think the pressure to consider the cost-vs-efficacy question is going to come from Medicare.
The new head of CMS, Donald Berwick, has been moving very quietly but resolutely, looking at the way Medicare reimburses physicians. Part of the attempt to address the cost-vs-efficacy question is going to be a requirement that physicians demonstrate with outcomes data that they meet certain performance metrics.
Another part is going to be a payment cap on drugs and diagnostics to ensure that they meet a certain degree of benefit relative to their cost. While none of this has been codified yet, I think such moves are coming ecause studies indicate that many of the newer drugs and diagnostics have not been used in a discriminating manner. The Obama administration has devoted a lot of financial and intellectual capital to the comparative effectiveness research initiative, which in effect compares one drug or technology with another to determine which delivers the best cost for value.
Moreover, researchers and venture capitalists in the drug development field will have to fashion their business to accommodate the cost vs value model. Unfortunately, there will be some losers in this leaner business model, such as rare cancers, for which the incentives of risk vs reward will scare away potential investors.
At the same time, I think it will encourage the pharmaceutical industry to develop drugs and diagnostics that are more cost effective, and that will have a positive effect on our healthcare industry. Finally, the public sector will need to strategically fill in the gaps for innovation and progress in these areas. About Advertise CureToday. October 25, Debu Tripathy, MD.
A New Paradigm: Cost and Value For the first time in the war against cancer, high-priced cancer drugs are coming under CMS scrutiny; could Avastin be a harbinger of things to come? The complexity of carcinosarcoma. Read our disclaimer for details. Last Update Posted : March 9, Study Description.
Detailed Description:. Compare the objective response rate, duration of response, overall survival, and time to progression in patients treated with these regimens. Compare the toxicity of these regimens in these patients. Compare the quality of life of patients treated with these regimens.
Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by bevacizumab IV over minutes on days 1 and Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
MedlinePlus related topics: Breast Cancer. Drug Information available for: Paclitaxel Bevacizumab. FDA Resources. Arms and Interventions.
Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG J Clin Oncol. Erratum in: J Clin Oncol. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer.
N Engl J Med. Miller KD. Clin Breast Cancer. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Breast Cancer. Drug: bevacizumab Drug: Paclitaxel.
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