2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC8
Submitter : Mr. Steve Tucker Date & Time: 05/06/2004 07:05:34
Organization : PacifiCare
Drug Industry
Category :
Issue Areas/Comments
Re: Suggested Priority Topics for Research, Demonstration and Evaluation Projects to Support the Medicare, Medicaid and State Children's Health Insurance (SCHIP) Programs:

As requested in the Federal Register of April 23, 2004, PacifiCare Health Systems would like to suggest the following topics for research prioritization. We believe that focused research in these areas has the potential to produce efficiencies and ultimately cost savings while preserving quality in the Medicare program. Our Prescription Solutions research subsidiary routinely conducts research studies based upon our Medicare + Choice membership utilization and contributed to the suggestions.

We recommend that funds be directed at studies that would:

1) In a natural (versus a research) setting, compare effectiveness of drugs in the top 10-20 therapeutic classes (e.g. statins, proton pump inhibitors, ACE Inhibitors, bisphosphonates, angiotensin receptor blockers, estrogens, selective serotonin reuptake inhibitors, COX 2 anti-inflammatory drugs, and antidiabetic, central nervous system, cardiovascular, anticoagulant, ophthalmic and pulmonary drugs, etc.) with respect to clinical, economic, and humanistic outcomes. The focus of the analysis should be on the effectiveness of drugs used to treat common conditions. Using claims data that integrate medical, laboratory and pharmacy experience, compare the results when patients with a certain condition such as hypertension are treated with a spectrum of commonly used medications in the same or different classes. Impact would be measured in terms of clinical outcomes, compliance, cost of drug therapy and total costs of care. The purpose of the investigation is to provide scientific information to P&T committees as they develop formularies and preferred drug lists. The impact of this research is essential to providing a clinically sound and affordable drug benefit. The data are available from payors and to some extent PBMs. What is needed to complete this type of investigation is skilled pharmacoeconomic analysis of such data sets.

2) Simplify the reimbursement guidelines for drugs with similar clinical benefits that are included in either/or both Part B and Part D programs. Accomplish this by developing a prospective and/or retrospective analysis identifying patients with multiple sclerosis or rheumatoid arthritis who are treated with injectable drugs including self-injectables; and patients with certain cancers effectively treated with oral-only chemotherapy. The drug utilization by these patients should be summarized with relative percentages of each drug to correlate with the category where reimbursement will occur. The appropriateness of therapy, clinical outcomes and relative costs should be analyzed. The analysis will help prevent gaming of the system by those intent on maximizing reimbursement rather than using drugs based upon the patient's needs.