2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC27
Submitter : Mr. Doug Getter Date & Time: 05/11/2004 06:05:06
Organization : Iowa Healthcare Access Network
Health Care Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
As members of the Iowa Healthcare Access Network, a group of patient advocates and life science interests, we share the concern for affordable access to necessary prescriptions drugs for all people while ensuring that patients are part of the decision making process. We believe that the outcomes and comparative effectiveness studies required by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, have the potential to improve the quality of care and maximize patient outcomes. However, given the focus on prescription drugs as the first priority and not the patient, we are concerned that this research will be used to determine patients? access to medicines solely based on which prescription medicine is least expensive, as opposed to which would be most effective medicine.

We believe that there are limitations to a cost-effectiveness analysis including taking the patient out of the decision making process and failure to address health disparities. Consequently, we urge that the following comments be used as guidelines to help ensure that government-sponsored health outcomes research (including research on comparative- and cost-effectiveness of medicines) meets patients? needs and supports continued strides in overall medical care:

? Patients have unique medical needs that are not reflected in population-level research. Government health outcomes research should be just one tool to inform doctor-patient decision-making. Clinical judgment and patient choice, within the bounds of acceptable medical practice, must always be the overriding force in decisions about individual care.

? Research also should evaluate the needs of patient sub-populations, who often respond differently to medicines and need a variety of treatment options/combinations for the best outcome.

? Restrictions on access to care must include a fair and consistent appeals process readily accessible to patients and providers.

? Health outcomes research should consider the full range of health care interventions and evaluate total health care costs or savings over the length of a treatment horizon, not just the costs of specific treatments.

Thank you for your consideration.