been done. The lack of such comparison studies marks a huge failing of the Clinical Research Enterprise. In this part of the workshop, payers will examine how they are affected by each of these issues and will explore their relationship with the Clinical Research Enterprise.

WHAT PAYERS NEED FROM THE CLINICAL RESEARCH ENTERPRISE

Eric Book, M.D.

Chief Medical Officer

Wellmark

Wellmark Blue Cross Blue Shield is a mutual insurer, predominantly in Iowa and South Dakota. The company insures roughly half of the population in Iowa and about a third of the population in South Dakota. As a payer, Wellmark is “caught between a rock and a hard place” in these times of double-digit inflation in medical costs. Purchasers ask payers what they are going to do about this problem. Payers do have some control over the unit cost but not much control over volume.

Payers have two main questions concerning new products that to come to market: Why are we not paying less? Why are we not being given consideration with regard to the investment that we have already made in the development of the products and procedures being brought to market? These inquiries lead to the next question: What do payers expect to get from the enterprise? The short answer is structure and discipline or, said another way, a demonstration that the dollars are being spent wisely. Wellmark is receiving a greater number of requests from members to fund experimental or new procedures or interventions. These requests often concern terminal illnesses or those for which conventional care has not worked. The company does not want to be pushed into providing coverage, either by public opinion or by the courts, when a treatment has not been proven, has not demonstrated a cost-effective outcome, or has had deleterious effects on patients. An example is autologous bone marrow transplant for breast cancer.

The company does not want to be pushed into providing coverage, either by public opinion or by the courts, when a treatment has not been proven, has not demonstrated a cost-effective outcome, or has had deleterious effects on patients.

—Eric Book

What payers want from the Clinical Research Enterprise is evidence of disciplined and robust management. They would like some individual or some entity to be accountable for the “big picture.” They need assurance that the focus of research is appropriately prioritized and managed for cost-effective outcomes.



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