Medical Innovation in the Changing Healthcare Marketplace Conference Summary (2002) / Chapter Skim
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4. Cost-Effectiveness Studies: A Key to Innovation Development
4. Cost-Effectiveness Studies: A Key to Innovation Development
Pages 25-33
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From page 25... ...
described the more formal approaches to coverage decisions now being adopted by CMS. Finally, Mark McClellan described a government initiative to develop a more seamless approval and coverage process.
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Both of these trials found that :-PA and streptokinase were equivalent in mortality rates. This was a shock to U.S cardiologists and it had a serious negative effect on the market share of t-PA.
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RCTs tend to be carried out in idealized circumstances in which patients are highly selected and the therapies are administered in the best clinical settings by the best personnel. HIatky said that there have been at least three major RCTs analyzing patients who had an episode of cardiac arrest or ventricular tachycardia.
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From page 28... ...
, carried out by the National Health Service R&D Health Technology Assessment Programme in Britain found that if IVUS were used at the time of angioplasty by traditional methods using balloon catheter or by stent deployment, the restenosis rate was approximately 16 percent. Without IVUS use, the restenosis rate was approximately 24 percent.
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MEDICAL USAGE OFTEN PRECEDES EFFICACY ASSESSMENT Robert Young of the Fox Chase Cancer Center pointed to the frequent occurrence of therapies that are widely used but poorly assessed for costeffectiveness by referring to some of the tools for diagnosis of melanoma. He said that increasingly complex diagnostic technologies are emerging, ranging from photography, through digital imaging and epiluminescence microscopy, to qualitative image analysis.
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One trial is evaluating lung volume reduction surgery and the other carotid stenting. EVALUATION CHALLENGES FACING METASTATIC MELANOMA AND OTHER CANCERS As background to his presentation, Richard Pazdur of the FDA described the basis for New Drug Application (NDA)
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From page 31... ...
It was a strong advocate of the Rockefeller-Mack legislation to provide Medicare coverage of routine patient care costs in clinical trials and helped bring about President Clinton's Executive Order mandating this coverage. The NBCC has also been active in getting the CMS to implement this legislation.
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From page 32... ...
The national level, the third main route, handles only a minority of coverage decisions, for example, where the new technology represents a significant medical advance or there are inconsistent local coverage policies. Tunis said that over the last decade or two the national coverage process has drawn criticism for the length of time that it has taken to make coverage decisions and the lack of transparency of the process.
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From page 33... ...
1995. Cost Effectiveness of Thrombolytic Therapy with Tissue Plasminogen Activator as Compared with Streptokinase for Acute Myocardial Infarction.
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