Comments to HHS on Medicare Prescription Drug Act


TO:                 Docket No. 2004S – 0170
FROM:           Consumers Union
DATE:            May 7, 2004
SUBJECT:   Medicare Prescription Drug, Improvement, and Modernization Act of 2003:
                       Section 1013: Suggested Priority Topics for Research
Consumers Union appreciates the opportunity to provide comments regarding priorities for research related to Section 1013 of the Medicare Modernization Act (MMA). This important provision of the MMA directs the Agency for Healthcare Research and Quality (AHRQ) to conduct research with respect to the outcomes, comparative clinical effectiveness, and appropriateness of healthcare items and services (including prescription drugs).
Consumers Union has strongly supported legislation to fund this type of review of the scientific evidence relating to the comparative effectiveness of prescription drugs. Better evidence-based information in the public domain is vitally needed in the prescription drug marketplace to make it possible to get better value for prescription drug dollars. It would free consumers from the biased information that comes to them over the airways and in magazines in direct-to-consumer (DTC) advertising. It would also help doctors by providing them with information about cost-effectiveness of drugs and decrease their reliance on marketing information provided by the pharmaceutical industry. When it comes to drugs, newer isn’t necessarily better, but newer is likely to be more expensive and more heavily advertised.
We were especially pleased that Section 1013 includes a provision that calls for broad dissemination of the findings to the public in a form that is easily understood by the individuals in need of health services such as prescription drugs. We strongly support strong efforts that will ensure that this information is readily accessible to the consumers who need it the most.
Consumers Union is pleased that the notice suggests that “the initial priority list should be directed toward evaluating existing evidence regarding the comparative clinical effectiveness of prescription drugs in anticipation of the Medicare prescription drug benefit.” It is important to focus on prescription drugs in light of the limited funding for this provision. Prescription drugs continue to be the fastest increasing component of national health expenditures, increasing 15.3 percent in 2002, to $162.4 billion in 2002, up to 10.5 percent of U.S. health spending.
As you select priorities for review, we urge you to:
1. Select therapeutic categories that have a broad impact on consumers. We urge you to include therapeutic categories that include expensive drugs that are used by a large number of people. It would be appropriate to include categories that encompass most of the drugs on the list of top 20 drugs (measured in retail sales dollars) as this measure would include both large numbers of prescriptions and large per prescription cost.
2. Consider existing credible databases in selecting priorities. The state of Oregon, now in partnership with other states, is creating a rich database of systematic reviews of the medical evidence for a number of important therapeutic categories. Globally, there are a number of organizations such as the Cochrane Collaboration, the U.K. National Institute for Clinical Effectiveness (NICE), the Canadian Coordinating Office for Health Technology Assessment, involved in systematic review of medical evidence. Given the limited funds available, it is important that the priorities be established to minimize unnecessary duplication. At the same time, a low-resource review (and validation) of existing credible sources by AHRQ might make it possible to greatly expand public access to existing research that is currently inaccessible to consumers.
We appreciate the opportunity to provide comments, and look forward to working with AHRQ to assure that when the results are ready to be disseminated to the public, consumers will understand the significance of the independent, objective, science-based research. This type of evidence-based, consumer-friendly information is needed in the marketplace to help consumers (and taxpayers) get better value for their prescription drug dollar. Ultimately, information holds the potential to improve the health of consumers who will be able to afford the medicines that they need.
If you have any questions about our comments, please contact Gail Shearer, Director of Health Policy Analysis, Washington Office, Consumers Union, 202 462 6262.

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