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PHARMACEUTICAL ECONOMIC ANALYSIS GUIDELINES

Executive Summary

PHARMACEUTICAL ECONOMIC ANALYSIS GUIDELINES in development by a task force at the Leonard Davis Institute of Health Economics at the University of Pennsylvania are intended "to minimize bias in the conduct and reporting of economic research of pharmaceuticals." The Task Force on Principles for Economic Analyses is scheduled to meet in Philadelphia in mid-December to begin drafting the voluntary guidelines and is seeking input from industry and academia. The task force is made up of "important stakeholders in economic analysis of pharmaceuticals," including members from "academia, consulting companies, the pharmaceutical industry, the health insurance industry, government, medical journalism and publishing, and selected professional organizations that conduct or set standards for health services research," the prospectus states. Government members come from FDA, the Institute of Medicine, HHS' Agency for Health Care Policy and Research and the Health Care Financing Administration. The group will focus on three areas at the December meeting: "ethical conduct" in economic studies; "who has responsibility and control in the funding, design, conduct and publishing of research"; and "minimalizing methodologic bias," a representative said. The task force intends to establish "professional norms to reduce the opportunities for bias." Such uniform standards would be valuable to payers, managed care organizations, hospitals and governmment-subsidized health care programs, who may use economic analysis of pharmaceuticals to make coverage, formulary and purchasing decisions. The December meeting will be the task force's second. It first met July 20-21 to define issues to be addressed. The last two meetings are slated for March and June. At the latter, the task force will approve the guidelines in their final form. Within the task force is a rotating core of 15 voting members. The task force receives its funding from 13 pharmaceutical companies including: Abbott, Amgen, Astra, Genentech, Lederle, Merck, Ortho Biotech, Rhone-Poulenc Rorer, Sandoz, Searle, SmithKline Beecham and Upjohn. At each meeting, three firms have one voting member each.

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