2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC14
Submitter : Mrs. Kaye Rote Date & Time: 05/11/2004 06:05:11
Organization : Oklahoma Mental Health Consumer Council
Consumer Group
Category :
Issue Areas/Comments
The Oklahoma Mental Health Consumer Council (OMHCC) is a Statewide Independent consumer-run advocacy organization. As the Director of this organization, I have seen numerous issues related to the cost-effectiveness of medications and mental health issues. This automatically calls in question the concern we have regarding HOW the cost effectiveness is measured. We ask that you maintain a pure research project on any drugs used to aid mental health disorders with the concept of the benefit to the consumer using those medications. The norm has been that researchers - austensibly paid by the State Medicaid Agency or ASO- provides data only on certain medications and how the 'cost-effectiveness' may be measured in terms of restricting access and requiring multiple levels of difficult authorizations before prescription may be filled. Cost-Effectiveness needs to include an element that relates to the cost of the prescription and the benefit provided to the consumer.

Secondly, we ask that you place on your priority list the comparative clinical effectiveness of SSRI's and anti-psychotic medication with the various mental health disorders and each associated secondary issue. For example, to study the clinical effectiveness of any drug for Bi-Polar disorder, we feel strongly that the research must seperate BPD with anxiety from BPD with paranoia. etc.

Third, we ask that you prioritize research on cost effectiveness based on the size and age of the individual consumer. For someone who has had a disorder for years and is approaching 70 (weighing in at about 100 pounds) the cost effectivenss of any medication must be weighed by the dosage level and frequency. We continually see the same recommended dosages and frequency levels for someone who is 35 years old and 250 pounds as we do for someone who is 70 years and 100 pounds. If dosages are the same (constant)in the various research components, clinical and cost effectiveness will automatically be skewed and not provide the information we need.

We also ask that you monitor this type of research very carefully to ensure that projects maintain an open mind and look at innovative medicines and therapies for mental health issues.