2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC33
Submitter : Dr. John Santa Date & Time: 05/11/2004 06:05:52
Organization : Dr. John Santa
Health Professional
Category :
Issue Areas/Comments
CMS should take into account several current factors regarding prescription drug research including:
1)Most of current data is from research sponsored by the pharmaceutical industry. This is useful data but needs systematic review by researchers without bias and synthesis in a manner that Medicare consumers can understand.
2)Large amounts of research are currently done and not released for review and analysis.
3)While comparative data is available within drug classes and between drug classes, most of the data is related to effectiveness compared to placebo and adverse events compared to placebo.
4)Medicare consumers have no organized way to input into topic and key questions related to drug research on an ongoing basis.
5)Comparative effectiveness trials are often not performed on a 'level playing field' resulting in inappropriate comparisons.
6) There is no commitment to a long term updating process for key topics, key questions and key observations. Information becomes obsolete quickly without this.
7) The proposed Medicare benefit is unique. It appears that Medicare consumers will be very interested in information that will enable them to avoid the no coverage benefit range ('the doughnut hole').
8) Funds authorized by the bill are insufficient to lead to major sustained change but sufficient to catalyze different research approaches that could lead to sustained change.

Significant efforts are underway to review the current literature regarding comparative effectiveness of many of the most common drug classes. While these efforts will provide useful information it is apparent that more and better information would help Medicare consumers. Little or no comparative research has been done comparing some critically important medications.

CMS should consider a fundamental and long term commitment to this area including:
1) A portion of funds should be dedicated to training a cadre of evidence-based investigators who will focus on comparative effectiveness research. This funding should incent young investigators over the next ten years to pursue this as a career track. The elements described below would form a foundation for a career of research for these individuals.
2)A second portion should be used to fund an analysis of current randomized controlled trial and systematic evidence-based review methodologies using AHRQ/EPC staff and other investigators to do so. The outcome of the analysis should be used to improve the expertise of current EPC staff and the cadre of investigators previously referred to.
3)A third portion should be used to fund an inclusive process to identify topics and key questions relevant to Medicare purchaser---insurers, organizations serving Medicare patients and Medicare patients themselves.
4)A fourth portion should be used to fund a limited number of 'model' trials and reviews on most important topics. In some cases this may be accomplished by funding updates of work already done in a manner consistent with or close to the methodologies identified. Any work funded should include a provision for funding updates if the methodology meets standard and the topic is judged of sufficient priority.
5) CMS should provide partial funding for 'collaborative trials' involving the pharmaceutical industry and health purchasers that address comparative effectiveness and adverse effects of drugs in a class. Costs of these trials should be shared by the collaborators. The methodology used should be consistent with standards set by the AHRQ/EPC (Evidence-based Practice Centers) process above. EPCs should assist with trial design. Data should be released regardless of findings.
6) CMS should consider having QIOs translate the outcomes of this work for Medicare consumers and physicians using local groups of practitioners and consumers to review the research.